ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02595073
Conditions: Atopic Dermatitis
Sponsor: Sun Pharmaceutical Industries, Inc.
Start date: 2015-09-04; Completion date: 2017-08-29
Enrollment: 124 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Arms: arm 1: DSXS Active treatment arm 2: Placebo treatment
Interventions: intervention 1: DSXS intervention 2: Placebo
Intervention descriptions: intervention 1: Active treatment intervention 2: Placebo treatment

Protocol documents:
Clinical trial NCT00984282
Conditions: Thyroid Neoplasms
Keywords: RAI-Refractory Differentiated Follicular Papillary Hurthle
Sponsor: Bayer
Start date: 2009-10-15; Completion date: 2017-08-30
Enrollment: 417 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Detailed description:
Eligible subjects were randomized 1:1 to sorafenib 800 mg daily or matching placebo. Progression was assessed every 8 weeks by modified RECIST criteria. Subjects had the option to unblind study treatment after progression and to receive open label sorafenib regardless of initial treatment assignment. Following discontinuation of study treatment, subjects were followed for survival every 3 months in long-term follow-up. Subjects who terminated study treatment (either double only or double blind and open label) for reasons other than death, lost to follow-up or consent withdrawn entered long-term follow up

Arms: arm 1: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle arm 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours). intervention 2: Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).

Protocol documents:
Clinical trial NCT01871805
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2013-09-30; Completion date: 2017-08-31
Enrollment: 134 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This non-randomized, open-label, multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment. In Phase I, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Phase II, patients who failed crizotinib treatment will receive the recommended phase II dose.

Detailed description:

Arms: arm 1: Participants will receive escalating doses of alectinib capsules orally until disease progression, death or withdrawal for any other reasons. arm 2: Participants will receive recommended Phase II dose as determined from Phase I until disease progression, death or withdrawal for any other reasons.
Interventions: intervention 1: Alectinib
Intervention descriptions: intervention 1: Participants will receive alectinib as described in the arm descriptions.

Protocol documents:
Clinical trial NCT01890421
Conditions: Coronary Artery Disease
Keywords: Myocardial Perfusion Imaging
Sponsor: Bayer
Start date: 2013-07-19; Completion date: 2017-08-31
Enrollment: 426 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required.

This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study.

CMRI and CA/CTA images will be collected for an independent image review (blinded read).

Detailed description:

Arms: arm 1: Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
Interventions: intervention 1: Gadobutrol (Gadovist, Gadavist, BAY86-4875)
Intervention descriptions: intervention 1: Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.

Protocol documents:
Clinical trial NCT02467504
Conditions: Rheumatoid Arthritis
Sponsor: Peking University People's Hospital
Start date: 2015-07-01; Completion date: 2017-08-31
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rheumatoid arthritis (RA) is an immune-mediated inflammatory disease, characterized by symmetric poly-arthritis usually involving the small joints of the hands and feet. In addition, various extra-joint manifestations may develop. Several immunomodulating agents have been attempted in the treatment of RA without achieving satisfactory results. Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). The investigators hypothesized that low-dose IL-2 could be a novel therapy in active RA patients. This clinical study will test the efficacy and safety of low dose IL-2 treatment in RA. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in RA. The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for RA by randomized controlled study (hrIL-2 (N = 23) + Methotrexate (MTX)+ Loxoprofen versus placebo+MTX + Loxoprofen group (N = 24)).

Detailed description:
Each RA patients (n=47) with DAS\>3.2 received low-dose IL-2+MTX+ Loxoprofen or placebo+MTX + Loxoprofen (active group: placebo group =1:1, 1 million units every other day subcutaneously (hrIL-2 1×106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.

Arms: arm 1: hrIL-2 active (1 million U doses of hrIL-2s.c.injection) MTX Folic acid Loxoprofen arm 2: hrIL-2 placebo (1 million U doses of placebo s.c.injection) MTX Folic acid Loxoprofen
Interventions: intervention 1: hrIL-2 active intervention 2: hrIL-2 placebo intervention 3: MTX intervention 4: Folic Acid intervention 5: Loxoprofen
Intervention descriptions: intervention 1: hrIL-2 active (1 million U doses of hrIL-2s.c.injection) intervention 2: hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection) intervention 3: Methotrexate (oral administration) intervention 4: Folic Acid (oral administration) intervention 5: Loxoprofen (oral administration)

Protocol documents:
Clinical trial NCT01624233
Conditions: Psoriasis
Sponsor: Eli Lilly and Company
Start date: 2012-06-01; Completion date: 2017-09-01
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of ixekizumab in participants with moderate to severe psoriasis in Japan.

Detailed description:

Arms: arm 1: Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, followed by one 80 mg SC injection per Dosing Regimen 1 up to Week 12. Then administered by one 80 mg SC injection per Dosing Regimen 2 from Week 12 up to Week 52, and for up to 192 weeks following disease relapse occurring during a drug-free period beyond 52 weeks.
Interventions: intervention 1: 80 mg ixekizumab
Intervention descriptions: intervention 1: Administered SC

Protocol documents:
Clinical trial NCT01916941
Conditions: Alcohol Use Disorder
Sponsor: University of New Mexico
Start date: 2013-09-01; Completion date: 2017-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.

Detailed description:

Arms: arm 1: Prazosin titrated to 16 mg daily x 6 weeks arm 2: Placebo X 6 weeks
Interventions: intervention 1: Prazosin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02008318
Conditions: Myelodysplastic Syndromes
Sponsor: Eli Lilly and Company
Start date: 2014-03-01; Completion date: 2017-09-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS). Participants with different degrees of disease (very low, low, and intermediate risk) will be studied. The study treatment is expected to last about 6 months for each participant.

Detailed description:

Arms: arm 1: Ph 2. 150 milligrams Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. arm 2: Placebo administered orally BID for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive BSC according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. This arm is contingent on the data from the phase 2 arm. arm 3: 150 milligrams Galunisertib given orally twice daily (BID) for 14 days followed by 14 days with no study drug (28 day cycles). Participants will receive best supportive care (BSC) according to institutional guidelines. Treatment is expected to last for 6 cycles. Participants may receive additional cycles if they are deriving clinical benefit. This arm is contingent on the data from the phase 2 arm.
Interventions: intervention 1: Galunisertib intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally

Protocol documents:
Clinical trial NCT02260440
Conditions: Metastatic Colorectal Cancer
Sponsor: Anuradha Krishnamurthy
Start date: 2015-01-01; Completion date: 2017-09-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label, single-arm, Phase 2 trial to evaluate the anti-tumor activity, safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with chemo-refractory mCRC without any further standard treatment options

Dosage and regimen for all study periods

* Pembrolizumab will be given at 200 mg every 21 days.
* Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.

The first assessment of tumor response will be performed after cycle 3 (9 weeks), and thereafter approximately every 9 weeks, every 3 cycles of therapy. The modified RECIST 1.1 will be used to establish disease response or progression.

All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 4.0 (NCI-CTCAE).

Detailed description:

Arms: arm 1: 9 cycles

* Pembrolizumab will be given at 200 mg every 21 days.
* Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.
Interventions: intervention 1: Pembrolizumab intervention 2: Azacitidine
Intervention descriptions: intervention 1: Pembrolizumab will be given at 200 mg every 21 days intervention 2: Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.

Protocol documents:
Clinical trial NCT02535611
Conditions: Ischemic Stroke Excitotoxicity Memantine
Sponsor: Mazandaran University of Medical Sciences
Start date: 2015-10-01; Completion date: 2017-09-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The researchers aim to investigate the effect of memantine on stroke outcome in a randomized double-blind placebo-controlled clinical trial.

Detailed description:

Arms: arm 1: Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days. arm 2: Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive placebo(2 tab BID) for 7 days and continue placebo(1 tab BID) for 21 days.
Interventions: intervention 1: Placebo intervention 2: Memantine
Intervention descriptions: intervention 1: Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks. intervention 2: Beside the usual treatment for ischemic stroke this group will be treated by memantine.

Protocol documents:
Clinical trial NCT02623361
Conditions: Muscle Weakness | Patient Pain
Sponsor: University of California, San Francisco
Start date: 2015-02-01; Completion date: 2017-09-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients undergoing arthroscopic hip surgery have been shown to have significant post-operative pain that may delay discharge, recovery, and early mobilisation. A pre-operative regional anesthesia technique, the fascia iliaca block may be an effective method for acute post-operative analgesia.

This is a prospective, randomized controlled study of the preoperative fascia iliaca block for patients undergoing hip arthroscopy.

The enrolled patients will be randomized to receive either a fascia iliaca block with the local anesthetic ropivacaine or to have a sham block. All patients will receive a general anesthetic for the hip arthroscopy.

Detailed description:
Arthroscopic hip surgery is used to diagnose and treat interior joint pathology. Although minimally invasive in nature, patients have considerable amount of pain postoperatively, leading to prolonged recovery room stay and increased opiate requirements. The investigators performed a retrospective chart review in patients who underwent hip arthroscopy at the UCSF Orthopedic Institute. 89% of the patients had pain immediate after surgery requiring opioid therapy. Regional anesthesia has previously been shown to reduce discomfort after hip arthroscopy. However, there is currently no safe, well-established ultrasound guided regional anesthesia technique for arthroscopic hip surgery. The fascia iliaca block has shown to decrease acute pain related with hip fractures, as well as pain related with knee arthroplasty. The ultrasound guided fascia iliaca block is easy to perform and has an excellent safety record. The investigators believe that the ultrasound guided fascia iliaca block improves pain control in patients undergoing arthroscopic hip surgery.

Patients will receive a sham block group or a fascia iliaca block, performed in the preoperative area.

Pain scores and measurement of quadriceps strength will be assessed preoperatively and postoperatively. The patient will receive a pain diary consisting of pain scores, pain medication consumption, and a brief pain inventory. Within 48 hours postoperatively, an anesthesiologist will call the patient and review the patient's pain scores, pain medication consumption and brief pain inventory.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Peripheral Nerve Block intervention 2: Sham Block
Intervention descriptions: intervention 1: Regional Anesthesia by Local Anesthetic Injection intervention 2: Sham Block by saline injection

Protocol documents:
Clinical trial NCT02684357
Conditions: Psoriasis
Keywords: ABBV-066 BI 655066 risankizumab
Sponsor: AbbVie
Start date: 2016-03-01; Completion date: 2017-09-01
Enrollment: 577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized double blind, double dummy, placebo and active comparator controlled, parallel design study that is being performed to assess the safety and efficacy of risankizumab (BI 655066) to support registration for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Detailed description:
Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Arms: arm 1: Participants were randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). arm 2: Participants randomized to receive double-blind (DB) ustekinumab 45 or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). arm 3: Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Interventions: intervention 1: risankizumab intervention 2: ustekinumab intervention 3: placebo for risankizumab intervention 4: placebo for ustekinumab
Intervention descriptions: intervention 1: Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 2: Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 3: Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection intervention 4: Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection

Protocol documents:
Clinical trial NCT02684370
Conditions: Psoriasis
Keywords: Psoriasis Skin Diseases Skin Diseases, Papulosquamous ustekinumab Dermatologic Agents ABBV-066 BI 655066 risankizumab
Sponsor: AbbVie
Start date: 2016-02-01; Completion date: 2017-09-01
Enrollment: 560 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Detailed description:
Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Arms: arm 1: Participants randomized to receive double-blind (DB) placebo by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). arm 2: Participants randomized to receive double-blind (DB) ustekinumab 45 mg or 90 mg (based on screening weight) by subcutaneous (SC) injection at Weeks 0 and 4 (Part A). arm 3: Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 4 (Part A).
Interventions: intervention 1: risankizumab intervention 2: placebo for risankizumab intervention 3: ustekinumab intervention 4: placebo for ustekinumab
Intervention descriptions: intervention 1: Risankizumab administered by subcutaneous (SC) injection intervention 2: Placebo for risankizumab administered by subcutaneous (SC) injection intervention 3: Ustekinumab administered by subcutaneous (SC) injection intervention 4: Placebo for ustekinumab administered by subcutaneous (SC) injection

Protocol documents:
Clinical trial NCT02819284
Conditions: Dry Eye Syndromes Keratoconjunctivitis Sicca
Keywords: Ocular Discomfort Pain Corticosteroid Hyperemia Dry Eye
Sponsor: Kala Pharmaceuticals, Inc.
Start date: 2016-06-01; Completion date: 2017-09-01
Enrollment: 909 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Detailed description:
This is a Phase 3, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and efficacy of KPI-121 0.25% ophthalmic suspension versus vehicle in subjects with dry eye disease.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: KPI-121 0.25% Ophthalmic Suspension intervention 2: Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Prot_SAP_000.pdf: 
NCT02819284 
Study ID:  
KPI-121-C-007 (STRIDE 2)  
 
Study Title:  
A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% 
Ophthalmic Suspension Compared to Vehicle in Subjects with Dry Eye Disease 
 
Date:  
06 Jul 2017
Clinical trial NCT00423891
Conditions: Hepatitis B, Chronic
Sponsor: Bristol-Myers Squibb
Start date: 2007-06-30; Completion date: 2017-09-04
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Entecavir
Intervention descriptions: intervention 1: Tablets / Oral Solution, Oral, Naïve: 0.015 mg/kg up to 0.5 mg; Experienced: 0.030 mg/kg up to 1 mg, once daily, 48 - 120 weeks depending on response

Protocol documents: