ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02435277
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Sponsor: NuSirt Biopharma
Start date: 2014-10-01; Completion date: 2016-01-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer term effect (i.e., additional 8 weeks) of various fixed-dose leucine and metformin combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects with type 2 diabetes using HbA1c as the primary endpoint.

Detailed description:
This is a randomized, 8-week, extension of Study NS-0100-01, to evaluate the effect of various fixed-dose (FDC) combinations of leucine and metformin compared to standard metformin monotherapy on glycemic control.

Subjects meeting all inclusion criteria and no exclusion criteria for the extension study, including completion of the 4-week treatment period of Study NS-0100-01 \[Day 28/Visit 7\]), will be eligible to enroll into the extension. During participation in the extension, subjects will continue to receive their assigned treatment based upon the randomization that occurred on Day 1 (Visit 4) of Study NS-0100-0. The study will include a total of 3 visits: Visit 1E (Day 28/Visit 7 of Study NS-0100-01), Visit 2E (Day 56/Week 8), and Visit 3E (Day 84/Week 12). Key assessments at Visit 2E and Visit 3E include HbA1c, fasting plasma glucose, and plasma insulin. In addition, 3-hour standardized meal tests will be performed on Day 28 (as part of the Study Termination \[Visit 7\] procedures of Study NS-0100-01 prior to enrolling into the extension) and at Study Termination for the extension (Visit 3E \[Day 84/Week 12\]).

Arms: arm 1: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 41.7 mg of metformin arm 2: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 83.3 mg of metformin arm 3: 3 capsules BID with each capsule containing 366.7 mg L-Leucine and 166.7 mg of metformin arm 4: 3 Capsules BID each containing 283.3 mg of metformin BID (1,700 mg/Day) at Day 14.
Interventions: intervention 1: Low Metformin intervention 2: Mid Metformin intervention 3: High Metformin intervention 4: Metformin
Intervention descriptions: intervention 1: 1100 mg L Leucine in combination with 125 mg of Metformin BID intervention 2: 1100 mg L Leucine in combination with 250mg Metformin BID intervention 3: 1100 mg of L Leucine in combination with 500 mg Metformin BID intervention 4: 500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID

Protocol documents:
Clinical trial NCT02435914
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2015-06-01; Completion date: 2016-01-01
Enrollment: 236 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.

Detailed description:

Arms: arm 1: 1 drop of AGN-223575 Dose A ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose A ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 2: 1 drop of AGN-223575 Dose B ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose B ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 3: 1 drop of AGN-223575 Dose C ophthalmic solution administered in each eye twice daily for 14 day followed by either 1 drop of AGN-223575 Dose C ophthalmic solution or 1 drop of vehicle to AGN-223575 in each eye once daily for 7 days. arm 4: 1 drop of Vehicle to AGN-223575 ophthalmic solution administered in each eye twice daily for 14 day followed by 1 drop of vehicle to AGN-223575 ophthalmic solution in each eye once daily for 7 days.
Interventions: intervention 1: AGN-223575 ophthalmic solution intervention 2: AGN-223575 vehicle ophthalmic solution
Intervention descriptions: intervention 1: AGN-223575 ophthalmic solution once or twice daily intervention 2: Vehicle to AGN22375 ophthalmic solution once or twice daily.

Protocol documents:
Clinical trial NCT02457611
Conditions: Hepatitis C Infection With HIV Co-Infection
Sponsor: Gilead Sciences
Start date: 2015-06-01; Completion date: 2016-01-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.

Detailed description:

Arms: arm 1: LDV/SOF FDC for 6 weeks
Interventions: intervention 1: LDV/SOF
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily

Protocol documents:
Clinical trial NCT02477527
Conditions: HIV AIDS Sleep Disorders
Keywords: atripla stribild dreams
Sponsor: Midtown Medical Center, Tampa, FL
Start date: 2015-02-01; Completion date: 2016-01-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Detailed description:
Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.

Arms: arm 1: Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
Interventions: intervention 1: Stribild
Intervention descriptions: intervention 1: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.

Protocol documents:
Clinical trial NCT02518048
Conditions: Skin and Connective Tissue Diseases
Keywords: Psoriasis
Sponsor: LEO Pharma
Start date: 2015-08-01; Completion date: 2016-01-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the anti-psoriatic effect of LEO 90100 aerosol foam compared with Betesil® medicated plaster

Detailed description:
The products will be applied on 6 test sites (each product on 3 test sites) once daily 6 days a week (except Sundays) for 4 weeks. The application sites for each product will be determined according to random assignment. Depending on the size of the psoriasis plaques, 2 or 4 test sites will be located within the same plaque; the treatment assignment will be done pair-wise.

Arms: arm 1: Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam) arm 2: Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone).(Betesil® )
Interventions: intervention 1: LEO 90100 Aerosol foam intervention 2: Betesil® 2.25 mg
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02536781
Conditions: Inflammation of Mouth Acute Mucous Inflammation
Keywords: Anthocyanin Inflammation Orthodontic treatment
Sponsor: Khon Kaen University
Start date: 2015-08-01; Completion date: 2016-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.

Detailed description:
Multiple inflammatory lesions caused from orthodontic treatments are commonly found in these patients and the irritations from the insertion of the orthodontic wire are hard to apply the topical cream or gel. Standard treatment to prevent oral mucosal irritation caused from orthodontic brackets and wires is an orthodontic wax to cover the appliances. However, the covering wax is just a prophylactic measure to protect the mucosal irritation. Thus, the patients still need a specific treatment for their oral inflammatory condition. Developing a product that can treat entire inflammatory areas in oral cavity, promote oral hygiene, and anti-fungal would be beneficial and useful for the orthodontic treatment. Anthocyanins, one of a natural compound from red, blue, purple vegetables, fruits, and flowers, have many beneficial effects including anti-inflammation and the most important effect superior to steroid usage is anti-candidiasis. Interesting in anthocyanins as the natural treatment, has drawn attention due to the benefits in oral inflammation. Previous study on the effect of a topical anthocyanin gel demonstrated positive effect of topical anthocyanins gel against oral inflammation in human subjects at 6 weeks. Unfortunately, anthocyanin is not stable and easily to be degraded. Therefore, stabilized anthocyanin oral formulation needs to be developed and the formulation needs to provide stable and active anthocyanins in suitable oral formula. This study aims to prepare and investigate effects of anthocyanin complex in order to formulate the mouthrinse for anti-inflammation caused by orthodontic treatment. Thus, to prepare and investigate the effects of anthocyanin activities after forming complexation in order to formulate the mouthrinse would be evaluated. In addition, the examination of anti-oral inflammation caused by orthodontic treatment by anthocyanin complex in clinical trial will be conducted.

Arms: arm 1: Placebo arm 2: Anthocyanin
Interventions: intervention 1: Anthocyanin intervention 2: Placebo
Intervention descriptions: intervention 1: Anti-inflammation gel intervention 2: Blank gel

Protocol documents:
Clinical trial NCT02567552
Conditions: Reproductive Techniques, Assisted
Keywords: endometrial receptivity endometrial predecidualization endometrial genomics endometrial receptivity array
Sponsor: IVI Barcelona
Start date: 2015-05-01; Completion date: 2016-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study the endometrial predecidualization by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day, to determine whether there are differences in the endometrial transformation and endometrial receptivity.

Detailed description:
The aim of this study is to compare predecidualization and endometrial receptivity as gene expression by using subcutaneous progesterone 25 mg/day versus intramuscular progesterone 50 mg/day in healthy women of childbearing age. Both, the two drugs and the doses administered in this clinical trial, are routine clinical practice.

A controlled ovarian stimulation will be previously performed and following routine clinical practice for 10-12 days at standard doses of subcutaneous FSH 150-225 IU/day, according to BMI and number of antral follicles. A GnRH antagonist shall be administered, being initiated according to donor's follicular growth from greater or equal14 mm diameter follicles. Final maturation shall be performed with a bolus of GnRH agonist when there exist at least 3 follicles greater or equal17 mm diameter, and therefore performing follicular puncture 36 hours after the bolus of agonist has been administered.

If the donor meets the inclusion criteria, she will be informed of the study and, if she agrees, she will sign the informed consent. Randomization shall be performed in 2 arms; arm 1 will be administered subcutaneous progesterone 25 mg/day (Prolutex; Angelini, Spain), and arm 2, intramuscular progesterone 50 mg/day (Prontogest IBSA, Italy). In each arm 12 donors (ITT population) will be included.

The randomization to a treatment group shall be performed the day the follicular puncture has been programmed. To that purpose, a randomized consecutive sampling will be used by means of assignment tables. The medication will be administered by a person not involved in the assessments and responsible for group assignment, data centralization and drug assignment.

At day 5 (5 days after follicular puncture):endometrial thickness measurement by means of transvaginal ultrasound and perform endometrial biopsy and take two samples: 1 sample to Anatomical Pathology and 1 sample to Endometrial Receptivity Array (ERA).

Arms: arm 1: Subcutaneous progesterone arm 2: Intramuscular progesterone
Interventions: intervention 1: Subcutaneous progesterone intervention 2: Intramuscular progesterone
Intervention descriptions: intervention 1: subcutaneous progesterone 25 mg/day intervention 2: intramuscular progesterone 50 mg/day

Protocol documents:
Clinical trial NCT02571634
Conditions: Minor Procedural Pain
Keywords: intranasal fentanyl conscious sedation
Sponsor: Defense and Veterans Center for Integrative Pain Management
Start date: 2015-05-01; Completion date: 2016-01-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness, feasibility and safety of intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to produce anxiolysis and improve patient comfort during and after radiofrequency ablations of the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to be feasible and safe for use during procedures, future larger scale studies can be done.

Detailed description:
The morning of the procedure/procedures the medication will be obtained from the omnicel by one of the qualified pain clinic study staff for the volunteers that have consented for that day. . It will be signed out on the designated form created for tracking and accountability purposes Patient consent for study participation will be confirmed.

Once in the procedure room a DVPRS (Defense and Veterans Pain Rating Scale) baseline pain score and POSS (Pasero Opioid-induced Sedation Scale) score will be assessed by a member of the research team. Baseline non-invasive blood pressure, heart rate, and oxygen saturation will be documented and continuous monitoring of these vital signs will commence by a provider credentialed by WAMC (Womack Army Medical Center) to perform anxiolysis with documentation every 15 minutes until discharge. A qualified RN (Registered Nurse), or physician will administer 100 mcg of Lazanda ten-fifteen minutes prior to the procedure The administration will be witnessed and confirmed on Appendix D. The unused 7 mcg will be wasted in a charcoal filled bag provided by the manufacturer and that bag will be disposed of per hospital policy. The waste will also be witnessed and noted. The Pasero Opioid-Induced Sedation Scale and a DVPRS pain score will be assessed every 15 minutes through the conclusion of the procedure and every 15 minutes up until discharge or for 1 hour post procedure whichever comes first. If naloxone is required during the procedure this will be noted as well. Any adverse or serious adverse events will be reported per regulatory regulations.

Arms: arm 1: Open label, no blinding, everyone receives Lazanda.
Interventions: intervention 1: Lazanda
Intervention descriptions: intervention 1: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.

Protocol documents:
Clinical trial NCT02589405
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2015-08-01; Completion date: 2016-01-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of this study is to evaluate a complete acne regimen consisting of a medication (Benzaknen® 5% Gel), and 2 cosmetic products Dermotivin® Soft Liquid soap and Cetaphil® Dermacontrol Moisturizer SPF30 in patients with acne.

Detailed description:
The main objective of this study is to evaluate subject satisfaction with the treatment regimen comprising Benzaknen® 5% Gel in association with 2 cosmetic products including a foam soap, Dermotivin® Soft Liquid soap, and a non comedogenic moisturizer, Cetaphil® Dermacontrol Moisturizer SPF30, in patients with mild to moderate acne, after 12 weeks of treatment.

Arms: arm 1: Benzac® 5% Gel (once daily) + Dermotivin® Soft Liquid soap (twice daily) + Cetaphil® Dermacontrol Moisturizer SPF30 (once daily)
Interventions: intervention 1: Benzoyl Peroxide intervention 2: Dermotivin® Soft Liquid cleanser intervention 3: Cetaphil® Dermacontrol Moisturizer SPF30
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02598622
Conditions: Vincristine Induced Neuropathy
Sponsor: Indiana University
Start date: 2009-09-01; Completion date: 2016-01-01
Enrollment: 8 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if a drug called Acetyl-L-Carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed ALL. Acetyl-L-Carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.

Detailed description:

Arms: arm 1: The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done. arm 2: Subjects 16-30 will be randomized to receive drug or placebo.
Interventions: intervention 1: Acetylcarnitine intervention 2: Placebo
Intervention descriptions: intervention 1: Acetylcarnitine is taken 2 times a day for days 1 through 21. intervention 2: Placebo is taken 2 times a day for days 1 through 21.

Protocol documents:
Clinical trial NCT02629354
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2015-11-01; Completion date: 2016-01-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibuprofen intervention 2: Caffeine intervention 3: Ibuprofen
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02663453
Conditions: Cholestasis
Keywords: preterm parenteral nutrition cholestasis fish oil
Sponsor: Thammasat University
Start date: 2013-12-01; Completion date: 2016-01-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.

Detailed description:
Intravenous lipid emulsions are the major sources of non-protein energy and provision of required essential fatty acids.

The reference lipid emulsion, widely used for many years, is prepared from soybean oil, which is rich in omega 6 polyunsaturated fatty acids and phytosterols that contribute to hepatotoxicity and their metabolites result in pro-inflammatory eicosanoid production.

Existing evidence strongly supports a pathogenetic role of inflammation and oxidative stress on parenteral nutrition associated liver disease.

Subsequent development of lipid emulsions has focused on reducing the amount of soybean oil and replacing it with other oils.Moreover the omega 3 fatty acids from fish oil are metabolized to anti-inflammatory eicosanoids which can prevent inflammatory responses.

A novel multicomponent lipid emulsion may prevent liver injury, improve growth and decrease morbidity in preterm infants.

Arms: arm 1: multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups. arm 2: pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.
Interventions: intervention 1: multicomponent lipid emulsion intervention 2: pure soybean oil lipid emulsion
Intervention descriptions: intervention 1: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached. intervention 2: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.

Protocol documents:
Clinical trial NCT02665260
Conditions: Molluscum Contagiosum
Sponsor: Montefiore Medical Center
Start date: 2012-07-01; Completion date: 2016-01-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if cantharidin is a safe and effective treatment for molluscum contagiosum in kids

Detailed description:
This was a double-blind, placebo-controlled trial. Participants were recruited from the Pediatric Dermatology clinic at Montefiore Medical Center. One hundred eligible participants were randomly assigned to receive cantharidin 0.7% topical, cantharidin 0.7% topical with occlusion, placebo, or placebo with occlusion. Treatments were applied at weeks 0 and 3 (blinded phase). At week 6, all participants were treated with open-label, topical cantharidin 0.7% without occlusion every 3 weeks until all lesions resolved (open-label phase).

Arms: arm 1: Cantharidin 0.7% topical with occlusion arm 2: Cantharidin 0.7% topical without occlusion arm 3: Placebo topical with occlusion arm 4: Placebo topical without occlusion
Interventions: intervention 1: Cantharidin intervention 2: Placebo intervention 3: Gauze occlusion bandage
Intervention descriptions: intervention 1: cantharidin 0.7% topical liquid intervention 2: Placebo topical liquid intervention 3: Gauze occlusion bandage with adhesive tape

Protocol documents: