ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02150213
Conditions: Adrenocortical Adenoma Endometrial Stromal Sarcomas
Keywords: Adrenocortical Adenoma, Endometrial Stromal sarcomas BGG492
Sponsor: Novartis Pharmaceuticals
Start date: 2014-08-01; Completion date: 2015-09-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805).

Detailed description:
The purpose of the study was to provide medical follow-up to patients exposed to BGG492 for more than 28 days in study CBGG492A2207 (NCT 01147003) and/or CBGG492A2212 (NCT 01338805). Data from study CBGG492A2216 was used to support the clinical safety assessment of BGG492 regarding the observance of uterine endometrial stromal tumors and adrenal cortical adenomas at least one year after the completion of BGG492 treatment.

Arms: arm 1: This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to \> 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
Interventions: intervention 1: MRI, CT or ultrasound was permitted if MRI was contraindicated intervention 2: Dexamethasone Supression Test intervention 3: Sonogram intervention 4: Biopsy intervention 5: BGG492
Intervention descriptions: intervention 1: MRI/CT/ultrasound of abdomen intervention 2: Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol intervention 3: Sonogram of the uterus (females only) intervention 4: Uterine endometrial biopsy (females only) intervention 5: No study-drug was administered in this study

Protocol documents:
Clinical trial NCT02151253
Conditions: Nocturia Daytime Sleepiness
Keywords: Nocturia Daytime sleepiness
Sponsor: Duke University
Start date: 2011-05-01; Completion date: 2015-09-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.

Detailed description:

Arms: arm 1: During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.

Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. arm 2: During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.

Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects. intervention 2: Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.

Protocol documents:
Clinical trial NCT02158039
Conditions: Neoplasms, Cystic, Mucinous, and Serous
Keywords: Intraductal Papillary Mucinous Neoplasm Mucinous Cystic Neoplasm Endoscopic Ultrasound Ethanol
Sponsor: Mayo Clinic
Start date: 2004-06-01; Completion date: 2015-09-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cystic tumors of the pancreas are fluid-filled growths. They are often treated by surgical removal. A safe and effective non-surgical treatment is desirable. Ethanol (alcohol) injection may treat cysts by killing the lining cells of the cyst, and is an accepted treatment for cysts of other organs. In this study, participants with pancreatic cysts underwent endoscopic ultrasound (EUS) guided ethanol injection of pancreatic cysts. This was a pilot study to assess safety and efficacy.

The hypotheses of this study were 1) complications of EUS guided ethanol injection requiring hospitalization will occur in \<10% of subjects, and 2) EUS guided ethanol injection, with retreatment as necessary, will ablate at least 50% of pancreatic cysts.

Detailed description:
EUS is performed via the mouth under sedation. After a needle is placed into the pancreas cyst under EUS guidance, an ethanol solution is placed into the cyst via the needle. The ethanol solution is withdrawn and new ethanol injected, and this process is continued for 5 minutes, repeatedly washing the cyst with the ethanol solution.

After this treatment, usual clinical follow-up is obtained including assessments of the cyst by CT or MRI scans. If a cyst of significant size persists, additional EUS-guided ethanol injections of the cyst were offered.

Arms: arm 1: EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
Interventions: intervention 1: Ethanol intervention 2: Lidocaine
Intervention descriptions: intervention 1: EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline. intervention 2: The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.

Protocol documents:
Clinical trial NCT02165111
Conditions: Scleroderma Raynaud's Syndrome
Keywords: Scleroderma, Systemic Raynaud Disease Botulinum Toxins, Type A
Sponsor: Johns Hopkins University
Start date: 2015-01-01; Completion date: 2015-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blinded, clinical trial assessing the therapeutic efficacy of Botulinum toxin A (Onabotulinumtoxin A) in treating scleroderma-associated Raynaud's syndrome. Each patient will undergo injection with a treatment dose of Botulinum toxin A in one randomly-selected hand, and the contralateral hand will be injected with sterile saline (placebo) to serve as a control.

Study participants at the first study visit will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging to assess blood flow. After this initial assessment, the patients will undergo peri-arterial injection of Botulinum toxin A in one hand, and of sterile saline solution (placebo) in the other, in a randomized, blinded manner.

Patient will report the severity of their Raynaud's symptoms weekly over the four month study period. At one month post-injection, the patient will complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. At four months post-injection, the patient will again complete study questionnaires, their hands will be assessed clinically for digital ulceration, and their hands will undergo non-invasive laser Doppler imaging. In addition, patient will be given the option of one week post-injection visit, at which point the same assessment will be performed.

At the conclusion of the study, unblinding will occur.

Detailed description:

Arms: arm 1: One hand of each patient will be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).

Injections are performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand. arm 2: One hand of each patient will be randomly selected for injection of sterile saline solution (placebo).

Injections are performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).
Interventions: intervention 1: Onabotulinumtoxin A intervention 2: sterile saline solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02180828
Conditions: Candidiasis, Vulvovaginal
Sponsor: Peking University Shenzhen Hospital
Start date: 2014-07-01; Completion date: 2015-09-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is focused to prove that the efficacy and safety of Clotrimazole vaginal tablet vs Fluconazole for the treatment of severe vulvovaginal candidiasis

Detailed description:
The current study is evaluating both the efficacy and safety of the 2 doses of 500 mg clotrimazole vaginal tablet administered intravaginally( at day 1 and day 4) v.s 2 doses of 150 mg fluconazole( at day 1 and day 4) for treatment of severe vulvovaginal candidiasis.The number of participants with adverse events as a measure of safety and tolerability.

Arms: arm 1: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) arm 2: 2 doses of 150 mg oral Fluconazole (at day1 and day4)
Interventions: intervention 1: Clotrimazole vaginal tablet intervention 2: Fluconazole
Intervention descriptions: intervention 1: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4) intervention 2: 2 doses of 150 mg oral Fluconazole (at day1 and day4)

Protocol documents:
Clinical trial NCT02201329
Conditions: Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2014-08-01; Completion date: 2015-09-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To identify the maximum tolerated dose or recommended dose for further development of volasertib in combination with azacitidine in Japanese patients with myelodysplastic syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability, pharmacokinetics and the preliminary efficacy of this combination.

Detailed description:

Arms: arm 1: Volasertib escalating doses + azacitidine
Interventions: intervention 1: Azacitidine intervention 2: Volasertib
Intervention descriptions: intervention 1: Azacitidine (subcutaneous) intervention 2: Volasertib escalating doses (intravenous)

Protocol documents:
Clinical trial NCT02201524
Conditions: Plaque Psoriasis
Keywords: Phase 2 randomized double-blind placebo plaque psoriasis safety efficacy JAK janus kinase moderate severe
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2015-09-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study B7451005 is a Phase 2 study which will assess the efficacy and safety of PF-04965842 in patients with moderate to severe psoriasis. The study will include three PF-04965842 groups (200 mg daily, 400 mg daily and 200 mg twice daily) and a placebo group. The treatment period will be 4 weeks in duration and will be followed up by a 4 week follow up period.

Detailed description:

Arms: arm 1: 200mg of PF-04965842 twice daily arm 2: 400mg of PF-04965842 once daily arm 3: 200mg of PF-04965842 once daily arm 4: Placebo comparator daily
Interventions: intervention 1: PF-04965842 intervention 2: PF-04965842 intervention 3: PF-04965842 intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks intervention 2: Subjects will receive 400 mg PF 04965842 daily for 4 weeks intervention 3: Subjects will receive 200 mg PF 04965842 daily for 4 weeks intervention 4: Subjects will receive placebo for 4 weeks

Protocol documents:
Clinical trial NCT02201940
Conditions: Hepatitis C Virus Infection
Keywords: Sofosbuvir SOF/VEL Velpatasvir Hepatitis C HCV cirrhosis
Sponsor: Gilead Sciences
Start date: 2014-07-01; Completion date: 2015-09-01
Enrollment: 741 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: SOF/VEL for 12 weeks arm 2: SOF/VEL placebo for 12 weeks
Interventions: intervention 1: SOF/VEL intervention 2: Placebo
Intervention descriptions: intervention 1: 400/100 mg FDC tablet administered orally once daily intervention 2: Tablet administered orally once daily

Protocol documents:
Clinical trial NCT02212678
Conditions: Parkinson Disease
Sponsor: University of Minnesota
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.

Detailed description:
The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry. The investigators' hypothesis is that repeated oral dosing of NAC will result in increased brain and red blood cell GSH concentrations in individuals with Parkinson's disease (PD) and healthy controls. The specific aims are to 1.) measure plasma and blood (red blood cell) glutathione (GSH) and ratio of reduced GSH to oxidized glutathione (GSSG) in individuals with PD and healthy controls at baseline and after four weeks of repeated high doses of oral NAC (6000 mg/day) and 2) measure cortical GSH levels (as ascertained through MRS) in those with PD and healthy controls at baseline and four weeks during repeated high doses of oral NAC (6000 mg/day) simultaneously with Aim 1. This study will combine information from a medical history, a physical examination, and disease rating scales with results obtained using Magnetic Resonance Spectroscopy (MRS) brain scans and pharmacokinetic studies from blood samples. This research will require 2 visits, one at baseline and one after approximately 28 days of therapy. Participants will provide their medical history during the first visit, and undergo a physical examination and rating scale each visit (duration: 1 hour). The first visit including the brain scans and blood collection will require approximately 3 hours of time. The brain scan and pharmacokinetic studies for the second visit will require approximately 8 hours of time. In total the second visit will take roughly 9 hours.

Arms: arm 1: Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days
Interventions: intervention 1: N-acetylcysteine capsule
Intervention descriptions: intervention 1: N-acetylcysteine capsule

Protocol documents:
Clinical trial NCT02219503
Conditions: Chronic Hepatitis C Infection Compensated Cirrhosis
Keywords: Hepatitis C Chronic Hepatitis C Compensated Cirrhosis Cirrhotic Hepatitis C Genotype 1b Hepatitis C Virus Interferon-Free Child Pugh A Ribavirin-Free
Sponsor: AbbVie
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

Detailed description:
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Arms: arm 1: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks
Interventions: intervention 1: Ombitasvir/Paritaprevir/Ritonavir intervention 2: Dasabuvir
Intervention descriptions: intervention 1: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir intervention 2: Tablet

Protocol documents:
Clinical trial NCT02220998
Conditions: Hepatitis C Virus Infection
Keywords: Hepatitis C HCV cirrhosis Sofosbuvir Sovaldi SOF/VEL GS-5816 GS-7977 liver Treatment naive Treatment Experience genotype 2
Sponsor: Gilead Sciences
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: SOF/VEL FDC for 12 weeks arm 2: SOF+RBV for 12 weeks
Interventions: intervention 1: SOF/VEL intervention 2: SOF intervention 3: RBV
Intervention descriptions: intervention 1: SOF/VEL (400/100 mg) FDC tablet administered orally once daily intervention 2: SOF 400 mg tablet administered orally once daily intervention 3: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02239926
Conditions: Diarrhea Predominant Irritable Bowel Syndrome
Keywords: IBS-D
Sponsor: Mayo Clinic
Start date: 2014-09-01; Completion date: 2015-09-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?

Detailed description:
This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.

Arms: arm 1: tablet, 1000 mg twice daily for four weeks arm 2: Placebo
Interventions: intervention 1: Ranolazine intervention 2: Placebo
Intervention descriptions: intervention 1: On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris. intervention 2: None

Protocol documents:
Clinical trial NCT02240628
Conditions: Pain on IV Injection of Propofol.
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2014-08-01; Completion date: 2015-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main objective is to evaluate if combining placing the Synera patch and using Propofol /Lidocaine mixture will further decrease the pain associated with the IV injection of Propofol.

Detailed description:
Commonly, anesthesiologists inject Propofol, a sleeping medication, intravenously to induce general anesthesia.Propofol injection is commonly associated with burning pain. In a previous onsite study we concluded that placing a Synera patch at least 30 minutes before placing the IV decreased the pain associated with the Propofol injection. Also,a study documented that adding Lidocaine to the Propofol decreases the pain associated with propofol injection. In our study here we are trying to evaluate if combining the use of both the Synera patch and the Propofol-Lidocaine mixture will further decrease the pain associated with the IV Propofol injection.

All children will receive a Synera Patch, it will be placed on the dorsum of both hands for at least 30 minutes.All Children will be Sedated with P.O Versed.

22 g IV will be started either in the holding area or in the OR. Children will be randomized into groups using a computer generated randomization list:- Group 1 will receive Propofol -Lidocaine mixture. Group 2 will receive Propofol-Saline mixture. An independent blinded observer and an anesthesia member will independently evaluate pain on Propofol injection according to pain scale.

1. No pain.
2. Mild Pain (associated with facial expression of pain).
3. Moderate Pain(Pulling the arm).
4. Severe Pain (screaming).

Arms: arm 1: All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member. arm 2: All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.
Interventions: intervention 1: Lidocaine/tetracaine transdermal patch intervention 2: Saline intervention 3: Lidocaine
Intervention descriptions: intervention 1: All patients in arm 1 and arm 2 will receive the Synera Patch. intervention 2: Patients in arm 2 will receive Saline with the Propofol. intervention 3: Patients in arm 1 will receive Lidocaine with the Propofol.

Protocol documents: