ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02341495
Conditions: Acute Myeloid Leukemia
Keywords: Azacitidine Vidaza Deferasirox Exjade Cholecalciferol Vitamin D
Sponsor: Elizabeth Henry
Start date: 2013-02-01; Completion date: 2016-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia will go into complete remission (meaning the leukemia is completely gone), and to find out how long it stays away. The drugs used in this project are FDA approved and commercially available.

Detailed description:
The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard therapies for AML often have significant toxicity and are poorly tolerated by this patient population. Treatment strategies for elderly patients with AML are limited. In those patients who do achieve complete remission, duration of remission tends to be short. Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there is need for safer and more effective therapies for elderly patients with AML. This trial is a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in patients 65 years or older with newly diagnosed AML who are not fit for standard induction chemotherapy or hematopoietic stem-cell transplantation.

Arms: arm 1: Deferasirox (20mg/kg/day)on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Cholecalciferol(4,000 units/day), on days 1-7 of protocol, repeated every four weeks for 8 cycles given PO Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol, repeated every four weeks for 8 cycles given either subcutaneously or IV
Interventions: intervention 1: Deferasirox intervention 2: Cholecalciferol intervention 3: Azacitidine
Intervention descriptions: intervention 1: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO intervention 2: Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO intervention 3: Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks

Protocol documents:
Clinical trial NCT02358863
Conditions: Esophageal Cancer Gastric Cancer
Sponsor: Georgetown University
Start date: 2015-02-01; Completion date: 2016-11-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether molecular profile-directed therapy (otherwise known as personalized treatment) can improve the effectiveness of standard chemotherapy combinations for patients with esophagogastric adenocarcinoma. A series of tests will be performed on a sample of tumor; based on the results of these tests, a patient will be assigned to a chemotherapy treatment.

Detailed description:

Arms: arm 1: Standard chemotherapy doublet based on molecular testing using one of the following interventions:

Modified FOLFOX6 Docetaxel/Capecitabine Cisplatin/Irinotecan Cisplatin/Docetaxel IRI/EPI EPI/Docetaxel Irinotecan/Docetaxel Docetaxel
Interventions: intervention 1: Modified FOLFOX6 intervention 2: Docetaxel/Capecitabine intervention 3: Cisplatin/Irinotecan intervention 4: Cisplatin/Docetaxel intervention 5: IRI/EPI intervention 6: EPI/Docetaxel intervention 7: Irinotecan/Docetaxel intervention 8: Docetaxel
Intervention descriptions: intervention 1: Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1 intervention 2: Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14 intervention 3: Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days intervention 4: Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1 intervention 5: Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days intervention 6: Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2 intervention 7: Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1 intervention 8: Docetaxel 60-100 mg/m2 IV day 1 every 21 days

Protocol documents:
Clinical trial NCT02359058
Conditions: Stomach Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2015-02-01; Completion date: 2016-11-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in Japanese participants with advanced gastric/gastrooesophageal junction cancer who have not received chemotherapy.

Detailed description:

Arms: arm 1: Ramucirumab (8 milligram per kilogram (mg/kg) given intravenously (IV) on days 1 and 8 in combination with 1000 mg/square meter (m\^2) capecitabine given orally twice a day on days 1 through 14 and 80 mg/m\^2 cisplatin given IV on day 1 of each 21 day cycle (up to 6 cycles). Participants may continue to receive treatment until discontinuation criteria are met. arm 2: Ramucirumab 8 mg/kg given IV on days 1 and 8 of 21 day in combination with 40 mg/m\^2 tegafur/gimeracil/oteracil (S-1) given orally twice a day on days 1 through 21 and 60 mg/m\^2 cisplatin given IV on day 8 of each 35 day cycle (up to 8 cycles). Participants may continue to receive treatment until discontinuation criteria are met. arm 3: Ramucirumab 8 mg/kg given IV on days 1 and 8 in combination with 40 mg/m\^2 S-1 given orally twice a day on days 1 through 14 and 100 mg/m\^2 oxaliplatin given IV on day 1 of each 21 day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Interventions: intervention 1: Ramucirumab intervention 2: Capecitabine intervention 3: Cisplatin intervention 4: S-1 intervention 5: Oxaliplatin
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered orally intervention 3: Administered IV intervention 4: Administered orally intervention 5: Administered IV

Protocol documents:
Clinical trial NCT02400749
Conditions: Palmo-plantar Psoriasis
Keywords: moderate to severe non-pustular palmo-plantar psoriasis
Sponsor: Innovaderm Research Inc.
Start date: 2015-05-01; Completion date: 2016-11-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the safety and efficacy of Apremilast 30mg to placebo in subjects with moderate to severe plaque psoriasis involving palms and/or soles.

Apremilast will be administered orally twice daily for 16 to 32 weeks, and will be compared against placebo (dummy drug with no active ingredient).

This study will enroll approximately 100 adult subjects with moderate to severe plaque psoriasis involving palms and/or soles in approximately 20 centers in US and Canada. To be eligible, subjects must have moderate to severe plaque psoriasis involving palms or soles, with lesions covering at least 10% of the surface of palms and soles at the baseline visit. Study treatments will be assigned randomly (like flipping a coin) at a 1:1 ratio, meaning that there will be a 1 in 2 chance of either receiving Apremilast or placebo during the first 16 weeks. Subjects will not know which of the two treatments they receive. The study doctor, the study staff will not know which treatment they receive either. All subjects will receive Apremilast from Week 16 to Week 32.

Subjects will be asked to complete questionnaires about their hand and feet pain, their quality of life, their general health and the impact of psoriasis on their work.

Medical photographs of palms and soles will be taken for subjects at selected study sites only.

At Baseline and Week 16 visits, for willing subjects at certain study sites, skin biopsies can be taken. The biopsies will be analyzed for the presence of antibodies, antigens or certain cellular messengers that can be quantified. It is also possible to study the skin cellular structure and organization.

A total of 3 biopsies will be taken: At Baseline visit, one biopsy from psoriasis on palms or soles and one biopsy from normal skin of palms or soles will be collected. At Week 16 visit, only one biopsy from psoriasis on palms or soles will be collected.

Detailed description:

Arms: arm 1: Patients will receive Apremilast until week 32. arm 2: Patients will receive Placebo until week 16 and then receive Apremilast until week 32
Interventions: intervention 1: Apremilast intervention 2: Placebo
Intervention descriptions: intervention 1: Apremilast tablets will be provided to sites in blister cards.

Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at the Day 0 and week 16 visits (refer to section 6.1). Following the 6 day titration period (for Day 0 and week 16) blister packs will contain apremilast 30 mg bid or placebo bid. intervention 2: Placebo tablets will be provided to sites in blister cards.

Protocol documents:
Clinical trial NCT02415127
Conditions: Friedreich's Ataxia
Keywords: Interferon gamma
Sponsor: Amgen
Start date: 2015-06-01; Completion date: 2016-11-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of ACTIMMUNE® in FA patients.

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms: arm 1: Approximately 45 participants will receive subcutaneous (SC) doses of ACTIMMUNE® 3 times a week (TIW) for a total of 26 weeks. arm 2: Approximately 45 participants will receive SC doses of placebo TIW for a total of 26 weeks.
Interventions: intervention 1: Interferon γ-1b intervention 2: Placebo
Intervention descriptions: intervention 1: The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs). intervention 2: The volume of placebo is planned to correspond with volume of study drug that would be given to the participant if the participant was randomized to the study drug arm.

Protocol documents:
Clinical trial NCT02423200
Conditions: Alzheimer's Disease
Sponsor: EIP Pharma Inc
Start date: 2015-04-01; Completion date: 2016-11-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effects of VX-745 on markers of disease in the central nervous system of patients with MCI due to AD or with mild AD. The study will also evaluate the safety and tolerability of VX-745 in these patients during 6 weeks of dosing, as well as the plasma and cerebrospinal fluid concentrations of VX-745 during dosing.

Detailed description:

Arms: arm 1: Active Group 1: VX-745 dose level 1 twice daily arm 2: Active Group 1: VX-745 dose level 2 twice daily
Interventions: intervention 1: VX-745
Intervention descriptions: intervention 1: Orally-active P38 MAP kinase alpha-selective inhibitor

Protocol documents:
Clinical trial NCT02436759
Conditions: Acquired Blepharoptosis
Sponsor: RVL Pharmaceuticals, Inc.
Start date: 2015-05-01; Completion date: 2016-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.

Detailed description:
Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.

Treatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.

RVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.

The objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:

* RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)
* RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)

Efficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distance from the upper lid margin to the lower lid margin through the central visual axis). Safety assessment will include bilateral SLE/CFS, measurement of PD from external photographs, dilated ophthalmoscopy/fundus examination, tonometry, Snellen VA using recent correction, vital signs (BP/HR), and collection of adverse events (AEs).

Arms: arm 1: RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks arm 2: RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks
Interventions: intervention 1: RVL-1201 intervention 2: RVL-1201 Vehicle Placebo
Intervention descriptions: intervention 1: RVL-1201 Ophthalmic Solution 0.1% intervention 2: RVL-1201 Vehicle Placebo

Protocol documents:
Clinical trial NCT02506660
Conditions: Pain Shoulder Arthroscopy
Sponsor: Hospital for Special Surgery, New York
Start date: 2015-08-01; Completion date: 2016-11-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.

Detailed description:

Arms: arm 1: Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. arm 2: Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Interventions: intervention 1: Bupivacaine intervention 2: Perineural dexamethasone intervention 3: Intravenous dexamethasone intervention 4: Intravenous saline intervention 5: Perineural saline
Intervention descriptions: intervention 1: None intervention 2: Dexamethasone in nerve block intervention 3: None intervention 4: None intervention 5: Saline in nerve block

Protocol documents:
Clinical trial NCT02531321
Conditions: Contraception HIV
Sponsor: University of Southern California
Start date: 2015-08-01; Completion date: 2016-11-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged.

This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.

Detailed description:

Arms: arm 1: Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. arm 2: Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.
Interventions: intervention 1: Levonorgestrel and Ethinyl Estradiol
Intervention descriptions: intervention 1: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives.

Protocol documents:
Clinical trial NCT02563106
Conditions: Clostridium Difficile Clostridium Infections
Sponsor: Theriva Biologics, Inc.
Start date: 2015-10-01; Completion date: 2016-11-01
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Infection (CDI) in Hospitalized Patients receiving IV ceftriaxone with a Diagnosis of a Lower Respiratory Tract Infection (LRTI).

Detailed description:
This is a Phase 2b, randomized, double-blind, placebo controlled, parallel-group, multi-center proof-of-concept study to assess the potential of SYN-004 in the prevention of CDI and the unwanted side effects of IV antibiotic treatment in at risk patients who are hospitalized for LRTI and receiving IV ceftriaxone alone or in combination with a macrolide. Subjects will be 50 years or older. The entire duration of the study may be up to 59 days. All patients will be evaluated for the occurrence of CDI and AAD by testing according to local diagnostic standards and monitoring for diarrhea (3 or more unformed stools per 24 hour period).

Arms: arm 1: SYN-004 150 mg arm 2: Matching placebo
Interventions: intervention 1: SYN-004 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02583425
Conditions: Medication Overuse Headache
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2015-09-01; Completion date: 2016-11-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Efficacy and Safety Pilot Study of DFN-11 Injection in Medication Overuse Headache

Detailed description:

Arms: arm 1: DFN-11 Injection upon occurrence of migraine
Interventions: intervention 1: DFN-11 Injection
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02599129
Conditions: Alopecia Areata
Keywords: Alopecia areata
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2015-11-01; Completion date: 2016-11-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alopecia areata is a medical condition, in which the hair falls out in patches. The hair can fall out on the scalp or elsewhere on the face and body.

Alopecia areata is an autoimmune skin disease, which means that the immune system is recognizing the hair follicles as foreign and attacking them, causing round patches of hair loss. It can progress to total scalp hair loss (alopecia totalis) or complete body hair loss (alopecia universalis). The scalp is the most commonly affected area, but the beard or any hair-bearing site can be affected alone or together with the scalp. Alopecia areata occurs in males and females of all ages, and is a highly unpredictable condition that tends to recur. Alopecia areata can cause significant distress to both patients and their families.

Aim: To assess the effects of a new treatment called secukinumab in patients with alopecia areata. A total of 30 patients will be included in the study, which will run for a total of 28 weeks.

Detailed description:

Arms: arm 1: 300 mg subcutaneous injections arm 2: matching placebo subcutaneous injections
Interventions: intervention 1: Secukinumab intervention 2: Placebo
Intervention descriptions: intervention 1: subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20. intervention 2: ￼subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.

Protocol documents: