ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01844206
Conditions: Pain Morphine Adverse Reaction
Keywords: Post-cesarean analgesia Second dose of epidural morphine after surgery Post-operative analgesia Self-administered epidural morphine Pain management after cesarean
Sponsor: Columbia University
Start date: 2013-06-01; Completion date: 2014-06-01
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

Detailed description:
This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Arms: arm 1: Group receiving 3mg epidural morphine, 24 hours after the initial dose arm 2: Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.
Interventions: intervention 1: Epidural Morphine intervention 2: Epidural Saline
Intervention descriptions: intervention 1: Patients will be given 3mg epidural morphine, 24 hours after the initial dose. intervention 2: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.

Protocol documents:
Clinical trial NCT01852513
Conditions: Seasonal Allergic Rhinitis
Sponsor: University of Chicago
Start date: 2013-01-01; Completion date: 2014-06-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.

Detailed description:

Arms: arm 1: QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment arm 2: Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment
Interventions: intervention 1: QNASL intervention 2: Placebo nasal spray
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01879683
Conditions: Chronic Interstitial Cystitis
Keywords: Hunner's lesion
Sponsor: Allergan
Start date: 2013-07-01; Completion date: 2014-06-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.

Detailed description:

Arms: arm 1: LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
Interventions: intervention 1: LiRIS® 400 mg
Intervention descriptions: intervention 1: LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.

Protocol documents:
Clinical trial NCT01879722
Conditions: Schizophrenia
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-06-01; Completion date: 2014-06-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability of TAK-063 when administered as multiple oral doses at escalating dose levels in participants with stable schizophrenia and in healthy Japanese participants.

Detailed description:
The drug being tested in this study is called TAK-063. TAK-063 is being tested to find a well-tolerated dose and also to treat schizophrenia. This study will look at how well different doses of TAK-063 are tolerated in healthy people of Japanese descent and in people with stable schizophrenia.

Five dose levels will be examined, starting at the lowest, in each population with 10 participants in each dose level. These participants will be randomized to receive TAK-063 (8 subjects) and placebo (2 subjects) once daily (QD) for 7 days.

In total, approximately 60 participants will be enrolled in the study. This trial will be conducted in single site in the United States. The overall time to participate in this study is up to 42 days. Participants will make 2 visits to the clinic, including 8-10 days confinement to the clinic, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Dose escalation and the actual choice of the subsequent dose level will only occur following a review of the blinded data from the previous cohorts.

Arms: arm 1: TAK-063 3 mg, tablets, orally, once daily for 7 days. arm 2: TAK-063 10 mg, tablets, orally, once daily for 7 days. arm 3: TAK-063 20 mg, tablets, orally, once daily for 7 days. arm 4: TAK-063 30 mg, tablets, orally, once daily for 7 days. arm 5: TAK-063 100 mg, tablets, orally, once daily for 7 days. arm 6: Placebo matching TAK-063, tablets, orally, once daily for 7 days.
Interventions: intervention 1: TAK-063 intervention 2: TAK-063 Placebo
Intervention descriptions: intervention 1: TAK-063 tablets intervention 2: TAK-063 placebo-matching tablets

Protocol documents:
Clinical trial NCT01885559
Conditions: Kidney, Polycystic
Keywords: polycystic kidney disease polycystic kidney disease adpkd halt pkd blood pressure bp hypertension renal renin-angiotensin-aldosterone-system RAAS
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date: 2006-01-01; Completion date: 2014-06-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR \>60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years.

Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.

Detailed description:
\* Specific Aim of Study B

To study the effects of ACE-I/ARB combination therapy as compared to ACE-I monotherapy in the setting of standard blood pressure control (110-130/80 mm Hg) on the time to a 50% reduction of baseline estimated Glomerular Filtration Rate (eGFR), end-state renal disease (ESRD) or death, in hypertensive individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73m2).

\* Hypothesis to be tested in Study B

In hypertensive ADPKD individuals with moderate renal insufficiency (GFR 25-60 mL/min/1.73 m2), intensive blockade of the RAAS using combination ACE-I/ARB therapy will slow the decline in kidney function over ACE-I monotherapy, independent of standard blood pressure control (110-130/80 mm Hg).

Arms: arm 1: Monotherapy of lisinopril and placebo. Standard blood pressure control of 110-130/80 mm Hg arm 2: Dual therapy of lisinopril and telmisartan treatments. Standard blood pressure control of 110-130/80 mm Hg.
Interventions: intervention 1: Lisinopril intervention 2: Telmisartan intervention 3: Placebo
Intervention descriptions: intervention 1: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. intervention 2: Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg. intervention 3: Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.

Protocol documents:
Clinical trial NCT01886937
Conditions: Obesity
Sponsor: New York State Psychiatric Institute
Start date: 2012-07-01; Completion date: 2014-06-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.

Detailed description:
This study aims to explore whether short-term measures of eating behavior can be related to later, longer-term weight loss. In a double-blind, randomized fashion, participants will be asked to take study medication for three weeks: one week of phentermine and two weeks of placebo. At the end of the first and third weeks, participants will be asked to participate in a range of eating behavior studies. Following this three-week, double-blind phase, participants will be offered 6 months of open treatment for weight loss.

Arms: arm 1: In this arm, participants receive 37.5mg phentermine for one week followed by 2 weeks of placebo.

Other names for phentermine:

adipex ionamin arm 2: In this arm, participants receive Placebo (for 37.5mg phentermine) for two weeks followed by phentermine 37.5mg for 7 days.
Interventions: intervention 1: Phentermine intervention 2: placebo
Intervention descriptions: intervention 1: After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo. intervention 2: Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.

Protocol documents:
Clinical trial NCT01896193
Conditions: Hepatitis C
Sponsor: Gilead Sciences
Start date: 2013-06-01; Completion date: 2014-06-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1 (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: SOF+RBV for 16 weeks arm 2: SOF+RBV for 24 weeks
Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01910636
Conditions: Hepatitis C
Keywords: HCV genotype 2 (GT-2)
Sponsor: Gilead Sciences
Start date: 2013-02-01; Completion date: 2014-06-01
Enrollment: 153 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) plus ribavirin (RBV) in Japanese participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: Participants will receive sofosbuvir+RBV for 12 weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (\< 60 kg = 600 mg , \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Protocol documents:
Clinical trial NCT01916304
Conditions: Hypothyroidism
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2013-07-01; Completion date: 2014-06-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

Detailed description:
The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.

The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.

The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).

All participants will be asked to take a daily dose at the same time each day throughout the study.

This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.

Arms: arm 1: Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
Interventions: intervention 1: Levothyroxine sodium new formulation
Intervention descriptions: intervention 1: Levothyroxine tablets

Protocol documents:
Clinical trial NCT01917773
Conditions: Colonic Motility Index Constipation
Sponsor: Indiana University
Start date: 2013-08-01; Completion date: 2014-06-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The research study is designed to test how a medication called octreotide affects the motility (contraction or squeezing) of the colon (large intestine). Investigators are investigating whether octreotide can increase contraction and movement in the colon.

Detailed description:
As mentioned above.

Arms: arm 1: All patient received octreotide. We compared pre (fasting) and post octreotide colonic motility index.
Interventions: intervention 1: Octreotide intervention 2: Bisacodyl
Intervention descriptions: intervention 1: Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide intervention 2: None

Protocol documents:
Clinical trial NCT01929083
Conditions: Prolonged QT Interval in EKG and Sudden Death
Keywords: Torsades de pointes Progesterone Clinical trial Risk reduction Electrocardiography
Sponsor: Indiana University
Start date: 2013-04-01; Completion date: 2014-06-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Female sex is an independent risk factor for the potentially fatal drug-induced arrhythmia (irregular heartbeat) known as torsades de pointes (TdP), which is associated with prolongation of the corrected QT (QTc) interval on the electrocardiogram (ECG). Mechanisms for this increased risk in women are not well-understood. QTc interval duration has been shown to fluctuate throughout the phases of the menstrual cycle. Evidence indicates that the QTc interval response to drugs that may cause TdP is greater during the menses and ovulation phases of the menstrual cycle, during which serum progesterone concentrations are lowest, and lesser during the luteal phase, during which serum progesterone concentrations are highest. Additional evidence from our laboratory suggests that progesterone may be protective against TdP. Specific Aim 1: Establish the influence of oral progesterone administration as a preventive method by which to diminish the degree of drug-induced QT interval prolongation in women. Working hypothesis: Oral progesterone administration effectively attenuates enhanced drug-induced QT interval response in women. To test this hypothesis, progesterone or placebo will be administered in a crossover fashion to women during the menses phase of the menstrual cycle. QTc interval response to low-dose ibutilide, a drug known to lengthen the QT interval, will be assessed. The primary endpoint will be individually-corrected QT interval (QTcI) response to ibutilide, in the presence and absence of progesterone, which will be assessed by: 1) Effect on maximum change in QTcI, and 2) Area under the QTcI interval-time curves (AUEC). At the conclusion of this study, we will have established that oral progesterone administration is a safe and effective method of attenuating drug-induced QT interval prolongation.

Detailed description:

Arms: arm 1: Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days arm 2: Subjects will receive oral placebo, two capsules once daily every evening for 7 days
Interventions: intervention 1: Progesterone intervention 2: Placebo intervention 3: Ibutilide
Intervention descriptions: intervention 1: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days intervention 2: Subjects will receive oral placebo two capsules once daily every evening for 7 days intervention 3: Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval

Protocol documents:
Clinical trial NCT01935622
Conditions: Non-ischemic Cardiomyopathy Systolic Heart Failure (NYHA II-III)
Keywords: heart failure non-ischemic cardiomyopathy
Sponsor: Virginia Commonwealth University
Start date: 2012-07-01; Completion date: 2014-06-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Non-ischemic cardiomyopathy and heart failure are highly influenced by the presence of systemic inflammation.

Doxycycline is a FDA-approved drug to treat bacterial infections which also shows powerful anti-inflammatory effects.

In this study we plan to determine the effects of Doxycycline in patients with stable heart failure and non-ischemic cardiomyopathy on peak of aerobic exercise capacity (peak V02) and ventilator efficiency measured with a cardiopulmonary test.

Detailed description:
In this study of Safety and Efficacy of Doxycycline in Patients with Non-Ischemic Cardiomyopathy Population, we will enroll 24 patients with a clinical diagnosis of heart failure and non-ischemic cardiomyopathy (recent imaging study documenting LV ejection fraction \<50%, and no history of coronary or ischemic heart disease) in a single-center, randomized, double-blinded, placebo-controlled clinical trial with allocation 1:1:1 to Doxycycline 100 mg twice daily or Doxycycline 20 mg twice daily or Placebo for 2 weeks.

Arms: arm 1: Doxycycline 100 mg twice daily for 14 days arm 2: Doxycycline 20 mg twice daily for 14 days arm 3: Placebo
Interventions: intervention 1: Doxycycline intervention 2: placebo
Intervention descriptions: intervention 1: Doxycycline 1 tablet every 12 hours for 14 days intervention 2: Placebo 1 tablet every 12 hours for 14 days

Protocol documents:
Clinical trial NCT01936324
Conditions: Acne Vulgaris
Keywords: acne vulgaris
Sponsor: Dermira, Inc.
Start date: 2013-08-01; Completion date: 2014-06-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1/2a study.

The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers.

The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.

Detailed description:

Arms: arm 1: Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers arm 2: Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Interventions: intervention 1: Olumacostat Glasaretil Gel, 7.5% intervention 2: Olumacostat Glasaretil Gel, Vehicle
Intervention descriptions: intervention 1: Gel containing Olumacostat Glasaretil intervention 2: Vehicle (placebo) gel

Protocol documents:
Clinical trial NCT01949142
Conditions: Otitis Media With Effusion
Keywords: otitis media otorrhea middle ear effusion tympanostomy tubes
Sponsor: Otonomy, Inc.
Start date: 2013-11-01; Completion date: 2014-06-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

Detailed description:
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study of OTO-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring TT (tympanostomy tube) placement. One dose level (6 mg) of OTO-201 was evaluated relative to sham (empty syringe).

Study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring TT placement. On the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. Subjects with bilateral middle ear effusion were randomized to either 6 mg OTO-201 or sham. Subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures.

Approximately 264 subjects are planned to be randomized to OTO-201 or sham using a 2:1 allocation ratio. Randomization to OTO-201 or sham was stratified by age: 6 months to 2 years or \>2 years.

Subjects are to visit the study site for safety assessments and otoscopic examination on Days 4, 8, 15, and 29. The assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on Days 4, 8, and 15.

Arms: arm 1: OTO-201: Single, intratympanic injection:

One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery. arm 2: Sham: Simulated single, intratympanic injection:

One sham injection into each ear during surgery.
Interventions: intervention 1: OTO-201 intervention 2: Sham
Intervention descriptions: intervention 1: Single, intratympanic injection intervention 2: Simulated single, intratympanic injection

Protocol documents: