ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02942654
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2016-11-01; Completion date: 2016-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Detailed description:

Arms: arm 1: Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods. arm 2: Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.
Interventions: intervention 1: LY900014 intervention 2: Insulin Lispro
Intervention descriptions: intervention 1: Administered subcutaneously (SC) intervention 2: Administered SC

Protocol documents:
Clinical trial NCT02943213
Conditions: Anti-Psychotic Management of Manifestations of Psychotic Disorders Treatment of Schizophrenia Control Nausea and Vomiting Relief of Restlessness and Apprehension Before Surgery Acute Intermittent Porphyria Adjunct in the Treatment of Tetanus Control Manifestations of the Manic Type of Mani-depressive Illness Relief of Intractable Hiccups
Keywords: Chlorpromazine Hydrochloride Chlorpromazine Hydrochloride Bioavailability Variability Variable Absorption USL Pharma USL Healthy South Africa Cycle Anti-Psychotic
Sponsor: Cycle Pharmaceuticals Ltd.
Start date: 2016-11-01; Completion date: 2016-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.

The aim of this pilot study is to investigate intrasubject variability in the bioavailability of Chlorpromazine Hydrochloride 25 mg sugar coated tablets.

Cycle aims to demonstrate that Chlorpromazine Hydrochloride has a shallow dose response curve and a wide safety margin. This will then allow for the modification of bioequivalence acceptance criteria in future pivotal studies which will reduce the number of participants required whilst still maintaining assurance of safety and efficacy.

Pilot Subjects (n): 20 Periods: 2 (2xR) Dosing: Single-dose Strength: 25 mg Test Product: N/A Reference: USL PHARMA Chlorpromazine Hydrochloride Analytes (in plasma): Chlorpromazine; 7-Hydroxychlorpromazine Bioequivalence based on 90% CI (Cmax, AUC): Standard; 80.00 - 125.00%

Detailed description:
This will be a single-dose, open-label, two-period replicate pilot study with orally administered chlorpromazine hydrochloride 25 mg (sugar coated tablets) conducted under fasting conditions in at least 16 healthy male and female subjects at a single study center.

Up to 20 eligible subjects will be enrolled in the study with 16 evaluable subjects to complete the study.

Analytes to be measured will be Chlorpromazine and 7-hydroxy-Chlorpromazine (free) as stipulated by FDA Guidance for assessment of bioequivalence for Chlorpromazine.

Arms: arm 1: First dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet. arm 2: Second dosing period in which all enrolled subjects are administered a single dose of 25 mg Chlorpromazine Hydrochloride Tablet.
Interventions: intervention 1: Chlorpromazine Hydrochloride
Intervention descriptions: intervention 1: Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.

Protocol documents:
Clinical trial NCT02988219
Conditions: Arrhythmia, Cardiac Kidney Cancer Surgery Anesthesia, Local
Keywords: cardiac arrhythmia epidural anesthesia combined anesthesia general anesthesia NSS radical nephrectomy extraperitoneal
Sponsor: Medical University of Warsaw
Start date: 2010-06-01; Completion date: 2016-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)

Detailed description:
Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled.

A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM).

Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.

Arms: arm 1: Holter ECG monitor General anesthesia Open kidney cancer surgery arm 2: Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Interventions: intervention 1: Bupivacaine-fentanyl intervention 2: Holter ECG monitor intervention 3: Open kidney cancer surgery intervention 4: General anesthesia intervention 5: Epidural Anaesthesia
Intervention descriptions: intervention 1: Local anesthetic intervention 2: 3-chanel, CM5 leads intervention 3: Lateral position intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02995694
Conditions: Atrophic Vaginitis
Sponsor: Alvogen Pine Brook LLC
Start date: 2016-03-01; Completion date: 2016-12-01
Enrollment: 535 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the therapeutic equivalence of Alvogen's estradiol vaginal cream to Estrace® cream and superiority of both products to placebo. The protocol describes a randomized, double-blind, multi-dose, placebo-controlled, parallel study of a 7 day treatment.

Detailed description:
This randomized, double-blind, placebo-controlled, parallel group, multiple-site study was designed to evaluate the therapeutic efficacy and safety of a generic Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC) compared to the FDA Reference Listed Drug (RLD), Estrace® (estradiol vaginal cream USP, 0.01%, Warner Chilcott) in patients with atrophic vaginitis. Additionally, both the Test and the RLD formulations were tested for superiority against a Placebo.

Following the 14-day screening period, patients who continued to meet the inclusion/exclusion criteria were randomized in a 2:2:1 ratio (Test: Reference: Placebo) for 7 days of treatment.

Five hundred and thirty-five (535) patients were randomized to one of the three study products as follows:

* Test: Estradiol Vaginal Cream USP, 0.01% (Alvogen Pine Brook LLC)
* Reference: Estrace® (estradiol vaginal cream USP, 0.01%) (Warner Chilcott)
* Placebo: Test product vehicle cream (Alvogen Pine Brook LLC)

Patients completed up to three clinic visits as follows:

* Visit 1 - Screening: Day -14 to Day -1
* Visit 2 - Randomization: Day 1
* Visit 3 - End of Study: Day 8, maximum Day 10

Study product was self-administered by the patient for 7 days according to the dosing instructions provided. Each patient was required to dose once daily at approximately the me of day for 7 consecutive days.

Arms: arm 1: Estradiol Vaginal Cream arm 2: Estrace Vaginal Cream arm 3: Placebo with no active pharmaceutical ingredients. Topical vaginal cream
Interventions: intervention 1: Estradiol intervention 2: Placebos intervention 3: Reference
Intervention descriptions: intervention 1: Estradiol Vaginal Cream intervention 2: Placebo with no active pharmaceutical ingredients. Topical vaginal cream intervention 3: Estrace Vaginal Cream

Protocol documents:
Clinical trial NCT03106870
Conditions: Gestational Diabetes Mellitus in Pregnancy
Sponsor: Ain Shams University
Start date: 2016-06-01; Completion date: 2016-12-01
Enrollment: 62 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

Detailed description:
The current study was conducted at Ain Shams university maternity hospital during the period between June 2016 to December 2016.

All patients were subjected to:

1. History taking:
2. General and Abdominal Examination:

   With particular emphasis on :
   * Body mass index
   * Blood pressure.
   * Fundal height .
   * Estimated fetal weight .
3. Insulin and metformin doses :

   Insulin dose:

   0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.

   Metformin dose :

   Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

   If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
4. Investigations:

Fasting and two hours postprandial blood glucose levels were measured in two groups of pregnant women:

1. Group I: pregnant women who received oral metformin in addition to insulin therapy.
2. Group II: pregnant women who received insulin therapy only.

Arms: arm 1: Intervention 'Insulin Mixtard' and Intervention 'metformin' had included arm 2: Intervention 'Insulin Mixtard' had included
Interventions: intervention 1: Insulin Mixtard intervention 2: Metformin
Intervention descriptions: intervention 1: Insulin dose:

* 0.7 IU/Kg (at the second trimester of pregnancy).
* 0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration. intervention 2: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.

If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.

Protocol documents:
Clinical trial NCT05718466
Conditions: Recurrent or Progressive Glioblastoma
Keywords: glioblastoma
Sponsor: Henry Ford Health System
Start date: 2010-11-01; Completion date: 2016-12-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.

Detailed description:

Arms: arm 1: FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression arm 2: Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Interventions: intervention 1: Bevacizumab intervention 2: Chemotherapy intervention 3: Fractionated radiosurgery
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT03167541
Conditions: Healthy
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Start date: 2016-10-12; Completion date: 2016-12-02
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The Netherlands in order to support the registration of the Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).

Detailed description:

Arms: arm 1: Treatment Order: Test, Reference arm 2: Treatment Order: Reference, Test
Interventions: intervention 1: Test intervention 2: Reference
Intervention descriptions: intervention 1: RB naproxen sodium tablets (2x220mg) intervention 2: Aleve naproxen sodium tablets (2x220mg)

Protocol documents:
Clinical trial NCT02457793
Conditions: Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
Sponsor: Genentech, Inc.
Start date: 2015-06-16; Completion date: 2016-12-05
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable.

Detailed description:

Arms: arm 1: One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration. arm 2: Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. arm 3: Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. arm 4: Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off. arm 5: Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off. arm 6: Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
Interventions: intervention 1: Cobimetinib intervention 2: GDC-0994
Intervention descriptions: intervention 1: Cobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off. intervention 2: GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.

Protocol documents:
Clinical trial NCT02471183
Conditions: Pulmonary Arterial Hypertension
Sponsor: Actelion
Start date: 2015-10-12; Completion date: 2016-12-05
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study enrolls patients with pulmonary arterial hypertension (PAH) treated with inhaled treprostinil. During the study, the treatment with inhaled treprostinil will be tapered off and simultaneously replaced with an oral treatment (selexipag) targeting the disease in a similar way. The purpose of the study is i) to investigate the safety and tolerability of oral selexipag in patients who transition from inhaled treprostinil, ii) to investigate the effects of oral selexipag on PAH severity and exercise ability before and after transition, and iii) to gain new information about the patients experience taking oral selexipag compared to inhaled treprostinil. Study participants may stay in the study until the FDA has granted marketing authorization.

Detailed description:

Arms: arm 1: Subjects on inhaled treprostinil treatment participate in a 16-week main treatment period including down-titration of treprostinil to end of Week 8 and parallel up-titration of selexipag to the maximum tolerated dose (MTD) up to Week 12, for each individual patient but not above 1600 mcg twice daily.

From Week 12 up to Week 16, patients continue selexipag at their individual MTD. Patients could continue the study drug selexipag during the extended treatment period from Week 16 until commercial availability of selexipag.
Interventions: intervention 1: Selexipag
Intervention descriptions: intervention 1: Tablets for oral administration containing 200 micrograms (mcg) of selexipag to be administered twice a day. The individual dose is to be established during the first 12 weeks of the study. Doses are in the range from 200 micrograms (1 tablet) to 1,600 micrograms (8 tablets).

Protocol documents:
Clinical trial NCT02487199
Conditions: Hepatitis C Virus (HCV)
Keywords: hepatitis C infection hepatitis C severe kidney disease chronic kidney disease Genotype 1a Genotype 4 treatment experienced interferon IFN pegIFN
Sponsor: AbbVie
Start date: 2015-09-30; Completion date: 2016-12-05
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.

Detailed description:

Arms: arm 1: Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) for 12 weeks. arm 2: Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\]) for 12 weeks.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir and dasabuvir intervention 2: ombitasvir/paritaprevir/ritonavir
Intervention descriptions: intervention 1: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet intervention 2: Tablet; ombitasvir coformulated with paritaprevir and ritonavir

Protocol documents:
Clinical trial NCT02663687
Conditions: Hereditary Angioedema (HAE)
Sponsor: Shire
Start date: 2016-02-19; Completion date: 2016-12-05
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

Detailed description:

Arms: arm 1: Treatment A: 9 Subjects will receive dose level I of SHP623 intravenously (IV). B: 9 Subjects will receive dose level I of SHP623 subcutaneously(SC). arm 2: 3 Subjects will receive placebo for each cohort
Interventions: intervention 1: Recombinant human C1 esterase inhibitor intervention 2: Placebo intervention 3: SHP623 intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects will receive escalating doses I-IV as both IV and SC injections intervention 2: Subjects will receive matching placebo intervention 3: SHP623 intervention 4: Placebo

Protocol documents:
Clinical trial NCT01300234
Conditions: Hepatitis B
Keywords: tenofovir disoproxil fumarate chronic hepatitis B adefovir dipivoxil
Sponsor: GlaxoSmithKline
Start date: 2011-03-30; Completion date: 2016-12-06
Enrollment: 512 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating Chinese subjects with CHB (hepatitis B e antigen \[HBeAg\] positive subjects and HBeAg negative subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF 300 mg administered once daily.

Detailed description:
This is a multi-centre, double-blind, double-dummy, randomised, controlled study to evaluate the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. Four hundred and ninety-four subjects with CHB (200 HBeAg positive subjects and 294 HBeAg negative subjects) will be randomised (1:1ratio) to either TDF 300mg QD or ADV 10mg QD treatment arms. The primary endpoint is the proportion of subjects with blood hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \<400copies/mL (Roche COBAS Taqman HBV test) at Week 48 in HBeAg positive subjects with CHB and HBeAg negative subjects with CHB. This is a two-part study. The first treatment period (baseline to Week 48) will investigate the effects of TDF and ADV on safety and efficacy endpoints; dosing will be double-blind. This period will be followed by 192 weeks in which all subjects will receive open-label TDF (Week 49 to Week 240). Subjects will undergo regular safety and efficacy assessments every 4 weeks for the first 12 weeks followed by every 12 weeks for a total of up to 5 years.

Arms: arm 1: Tenofovir disoproxil fumarate (TDF) tablets arm 2: Adefovir dipivoxil (ADV) tablets
Interventions: intervention 1: Tenofovir disoproxil fumarate (TDF) tablets intervention 2: Adefovir dipivoxil (ADV) tablets
Intervention descriptions: intervention 1: white, almond-shaped, film-coated tablets containing 300mg of TDF intervention 2: white to off-white, round, biconvex tablets containing 10mg of ADV

Protocol documents:
Clinical trial NCT01345682
Conditions: Head and Neck Neoplasms Carcinoma, Squamous Cell
Sponsor: Boehringer Ingelheim
Start date: 2012-01-05; Completion date: 2016-12-06
Enrollment: 483 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

Detailed description:

Arms: arm 1: Once daily arm 2: Weekly
Interventions: intervention 1: Afatinib intervention 2: Methotrexate
Intervention descriptions: intervention 1: Once daily intervention 2: Weekly

Protocol documents: