ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01853696
Conditions: Fuchs' Dystrophy Corneal Edema
Sponsor: Cornea Research Foundation of America
Start date: 2013-03-01; Completion date: 2015-01-01
Enrollment: 167 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.

Detailed description:

Arms: arm 1: Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months arm 2: Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
Interventions: intervention 1: loteprednol etabonate intervention 2: prednisolone acetate 1%
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01873989
Conditions: Chronic Pain Opioid Addiction Symptomatic Hypogonadism
Keywords: Chronic pain Opioid addiction Symptomatic hypogonadism Testosterone replacement Opioid agonist maintenance Methadone Buprenorphine
Sponsor: Yale University
Start date: 2012-04-01; Completion date: 2015-01-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction

Detailed description:
This study aims to assess the initial efficacy of testosterone replacement in male opioid agonist patients with symptomatic hypogonadism and chronic pain.

The study has two specific aims:

1. To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain.
2. To conduct a pilot randomized clinical trial to obtain data regarding the feasibility, acceptability, and efficacy (compared to waitlist control) of testosterone replacement for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism treated with opioid agonist maintenance treatment (N=40).

Arms: arm 1: Testosterone replacement for hypogonadism. arm 2: This arm involves watchful waiting.
Interventions: intervention 1: Testosterone replacement intervention 2: Waitlist control
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01888952
Conditions: Advanced B-cell Lymphoid Malignancies
Sponsor: Anand B. Karnad
Start date: 2013-07-01; Completion date: 2015-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 0/1 open-label, non-randomized, biomarker and pharmacodynamic study in patients with advanced B-cell lymphoid malignancies, including B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), acute lymphocytic leukemia (ALL), multiple myeloma (MM), Waldenström's macroglobulinemia (WM), mantle cell lymphoma, follicular lymphoma, or diffuse large B-cell lymphoma (DLBCL) who have failed at least one prior therapy and for whom no standard curative therapy exists. Patients with advanced stage disease are those whose disease is resistant or refractory to standard chemotherapy or biological therapies.

Detailed description:
This pilot study will evaluate whether the administration of roflumilast inhibits the activity of PDE4 and results in the modulation of AKT/mTOR pathways in patients with B-cell hematologic malignancies. Peripheral blood samples will be collected for the purpose of determining the pharmacodynamics of roflumilast on PDE4 activity and on biomarkers as related to GC resistance. Samples are obtained at baseline prior to starting study treatment, on Day 8 before the administration of the Day 8 study drugs (prednisone and roflumilast), and on Day 15. If a bone marrow biopsy is also performed prior to study treatment or at any time during treatment, a sample will be sent for analysis. Normal PBMC (and bone marrow when it is obtained) will be examined for changes in key targets related to the inhibition of PDE4 and potential reversal of glucocorticoid resistance. Biomarker blood samples will be analyzed in order to characterize the pharmacodynamics of roflumilast alone and in combination with prednisone on PDE4 activity and on biomarkers, such as phospho-AKT, phosphorylation levels of mTOR targets.

Arms: arm 1: Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).

In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.

In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.
Interventions: intervention 1: Prednisone intervention 2: Roflumilast
Intervention descriptions: intervention 1: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease. intervention 2: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease.

Protocol documents:
Clinical trial NCT01904721
Conditions: Alopecia Alopecia, Androgenetic Baldness
Sponsor: Allergan
Start date: 2013-08-01; Completion date: 2015-01-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Detailed description:

Arms: arm 1: Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. arm 2: Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. arm 3: Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. arm 4: Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. arm 5: Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. arm 6: Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. arm 7: Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Interventions: intervention 1: Bimatoprost Solution 1 intervention 2: Bimatoprost Solution 2 intervention 3: Bimatoprost Vehicle
Intervention descriptions: intervention 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months. intervention 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months. intervention 3: Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Protocol documents:
Clinical trial NCT01911780
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2013-07-01; Completion date: 2015-01-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.

Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.

In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.

In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.

Detailed description:

Arms: arm 1: telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet) arm 2: telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Interventions: intervention 1: placebo intervention 2: telmisartan + HCTZ intervention 3: telmisartan + HCTZ intervention 4: amlodipine
Intervention descriptions: intervention 1: placebo matching amlodipine capsule intervention 2: FDC tablet intervention 3: FDC tablet intervention 4: capsule

Protocol documents:
Clinical trial NCT01947491
Conditions: Psoriasis
Sponsor: Primus Pharmaceuticals
Start date: 2013-11-01; Completion date: 2015-01-01
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

Detailed description:

Arms: arm 1: DFD01 Spray twice daily for 28 days arm 2: Vehicle Spray twice daily for 28 days arm 3: Comp01 Lotion twice daily for 14 days arm 4: Vehicle Lotion twice daily for 28 days
Interventions: intervention 1: DFD01 Spray intervention 2: Comp01 Lotion intervention 3: Vehicle Lotion intervention 4: Vehicle Spray
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01961271
Conditions: Osteoarthritis Rheumatoid Arthritis Lower Back Pain Joint Pain Muscle Pain
Keywords: Norspan buprenorphine transdermal patch chronic pain non-malignant osteoarthritis rheumatoid arthritis lower back pain joint pain muscle pain opioid analgesic painkiller Mundipharma
Sponsor: Mundipharma Pte Ltd.
Start date: 2013-06-01; Completion date: 2015-01-01
Enrollment: 114 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and joint/muscle pain, who are not adequately responding to non-opioid painkillers.

Detailed description:
Baseline assessment (Visit 1) includes medical history, physical examination, vital signs.

At Visit 2 \[7 days ( ± 3 days) after Visit 1\] and subsequent optional titration visits up to (Visit 1 + 42 days) , patients will be titrated up to an effective and tolerated dose of Norspan® or Sovenor® transdermal patch and continue rescue analgesic, if necessary.

Titration period is dependent on time to achieving optimal pain control as determined by the investigator. The up-titration regime is planned on a weekly basis. Earlier dose titration (i.e. minimum 3 days after the patch application) is permitted at the investigator's discretion if the pain is uncontrolled. Effective and tolerated dose is assessed by data recorded in the case report form and patient diary.

According to country label, all patients will begin treatment with Norspan® or Sovenor® transdermal patch 5mg and will then be up-titrated, if necessary, to a maximum of Norspan® or Sovenor® transdermal patch 40mg or according to country label to achieve stable pain control. Patients that require oral opioid at any time during the study should be discontinued from the trial.

Arms: arm 1: Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.
Interventions: intervention 1: Buprenorphine transdermal patch
Intervention descriptions: intervention 1: Please see Arm Description.

Protocol documents:
Clinical trial NCT01963078
Conditions: PTSD
Sponsor: Megan Moran-Santa Maria
Start date: 2013-04-01; Completion date: 2015-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in men and women with and without PTSD who have experienced childhood trauma. The study will also compare the effects of oxytocin and placebo on amygdala response, and explore the interaction of oxytocin plasma levels and amygdala response in men and women with and without PTSD who have experienced childhood trauma.

Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to resilient subjects, and no sex differences in the magnitude of the response will be found.

Hypothesis 2A: In response to OT, women will exhibit a greater reduction in amygdala responding than men.

Hypothesis 2B: In response to OT, women with PTSD will exhibit a greater reduction in amygdala responding compared to women without PTSD.

Hypothesis 3A: Women with PTSD will have lower levels of plasma OT as compared to men with PTSD, and women and men without PTSD.

Hypothesis 3B: Plasma OT levels will be inversely correlated with amygdala responding to fearful faces in women but not in men.

Detailed description:

Arms: arm 1: Participants PTSD will self-administer matching placebo (containing all ingredients except OT) at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005). arm 2: Participants with PTSD will self-administer 24 IUs of OT nasal spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005). arm 3: Resilient controls will self-administer matching placebo spray at 10:30 a.m. on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005). arm 4: Resilient controls will self-administer 24 IUs of OT nasal spray at 10:30 a.m.on Day 1 of study procedures, approximately 45-minutes prior the scanning sessions. This dose and timing of administration were selected based on similar fMRI studies (Domes, et al., 2007; Domes, et al., 2010; Kirsch, et al., 2005).
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01967147
Conditions: Dry Eye
Keywords: Dry eye Lipid deficiency Tear film break-up time
Sponsor: Alcon Research
Start date: 2014-02-01; Completion date: 2015-01-01
Enrollment: 279 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate the superior efficacy of Systane® Balance over Preservative-Free 0.9% Saline following 35 days of QID (4 times a day) dosing in treating dry eye subjects with lipid deficiency.

Detailed description:
This study consisted of 4 visits conducted during 3 sequential phases: the Run-in Phase (which included a screening visit and run-in period), Treatment Phase I and Treatment Phase II. In Phase I, subjects were randomized to either Systane® Balance or Saline and dosed 4 times a day for 35 days. In Phase II (Day 35-90) subjects continued to dose with their assigned product on an as-needed basis.

Arms: arm 1: Propylene Glycol, 0.6% eye drops, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90). arm 2: Preservative-Free 0.9% Saline solution, 1 drop in each eye, 4 times per day, during Phase I (Day 0-35), followed by 1 drop in each eye as needed during Phase II (Day 35-90).
Interventions: intervention 1: Propylene Glycol, 0.6% eye drops intervention 2: Preservative-free 0.9% Saline solution
Intervention descriptions: intervention 1: Commercially available eye drops used during Treatment Phase intervention 2: Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase

Protocol documents:
Clinical trial NCT01997411
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2013-11-01; Completion date: 2015-01-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to assess how glucagon administered nasally, using a nasal dosing delivery device, works in children and adolescents compared with commercially-available glucagon given by injection. In addition, the safety and tolerability of glucagon given nasally was evaluated.

Detailed description:
This study was conducted to permit determination of appropriate dose level(s) for pediatric use based on the safety observations and results of glucagon and glucose assays.

Each participant 12 to less than 17 years of age underwent two visits in random order and received glucagon nasal powder once and commercially available glucagon (GlucaGen, Novo Nordisk) by intramuscular (IM) injection once. Participants 4 to less than 12 years were randomly assigned to have either 1 visit with commercially available glucagon (GlucaGen, Novo Nordisk) by IM injection OR to have 2 visits with a 2.0 milligram (mg) dose of glucagon nasal powder administered during one visit and a 3.0 mg dose of glucagon nasal powder administered during the other visit. For those randomized to complete two research dosing visits, the dose of glucagon nasal powder given during each visit was masked to the participant and study personnel.

Glucagon was administered after glucose was lowered to \<80 mg/dL using insulin if necessary on the dosing day. Participants were treated with either glucagon given nasally (either 2.0 mg or 3.0 mg for participants 4 to less than 12 years of age or 3.0 mg for those 12 to less than 17 years of age) or by intramuscular (IM) injection (1 mg for those 55 pounds \[lbs\] or more and 0.5 mg for those weighing less than 55 lbs) in the quadriceps muscle of the leg.

Blood glucose levels and adverse events were carefully monitored for 90 minutes post-dosing. After a wash-out period of 7 days or more, participants 12 to less than 17 years of age returned to the clinic and the procedure was repeated with each participant crossed over to the other treatment. Participants 4 to less than 12 years assigned to have 2 dosing visits returned to clinic for repeated procedures and received alternate dose of nasal glucagon (NG). Participants 4 to less than 12 years assigned to a single dosing visit did not return for a second dosing visit.

Arms: arm 1: Nasal glucagon (NG) doses of 2.0 mg and 3.0 mg for participants 4 to less than 12 years of age and 3.0 mg for those 12 to less than 17 years of age were administered in a nostril with a prefilled delivery device that delivered a single dose upon activation. arm 2: Participants who weighed at least 25 kilograms (kg)/55 pounds (lbs) were dosed 1 mg of IM glucagon; participants who weighed less than 25 kg/55 lbs, IM glucagon dosed with 0.5 mg
Interventions: intervention 1: Nasal Glucagon intervention 2: Intramuscular Glucagon
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02032758
Conditions: Occupational; Cramp(s)
Keywords: Occupational; Cramp(s)
Sponsor: Mayo Clinic
Start date: 2014-01-01; Completion date: 2015-01-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators will investigate golfers with visual evidence of an involuntary movement while putting before and after treatment with a low dose of propranolol.

Detailed description:
Dystonia affecting athletes has received little research attention and there has been a lack of awareness or interest among both physicians and athletes. Task-specific dystonias or occupational cramps affect people while writing, typing, and or playing a musical instrument. Our group has previously shown that a subset of golfers who complain of the yips appear to have a task-specific dystonia or golfer's cramp. The yips are characterized by an inability to appropriately complete a golf stroke, most often putting and chipping strokes. Most individuals with the yips describe a jerking or shaking movement that interrupts their swing. In many cases the yips are disabling and the golfer, including professional tour players, give up golfing.

Golfers who have evidence of golfer's cramp will putt a series of putts during which they will be monitored for arm movements and putter movements. They will then be treated with a low dose of propranolol to see if there is a change in these parameters.

Arms: arm 1: Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol. arm 2: Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
Interventions: intervention 1: Propranolol intervention 2: Opal Device intervention 3: Science and Motion PuttLab (SAM) intervention 4: Surface Electromyography EMG
Intervention descriptions: intervention 1: Single oral dose of 10 mg propranolol intervention 2: The Opal Device (APDM, Inc.) will be used to measure wrist movement. intervention 3: The SAM will be used to study putter stroke movement and ball movement. intervention 4: The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.

Protocol documents:
Clinical trial NCT02032888
Conditions: Hepatitis C
Sponsor: Bristol-Myers Squibb
Start date: 2014-02-01; Completion date: 2015-01-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.

Detailed description:

Arms: arm 1: Treatment-naïve participants received daclatasvir 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks arm 2: Treatment-naïve participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 8 weeks arm 3: Treatment-experienced participants received daclatasvir, 30, 60, or 90 mg, and sofosbuvir, 400 mg, once daily for 12 weeks
Interventions: intervention 1: Daclatasvir intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: