ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02255604
Conditions: Allergy Immune Tolerance Injection Site Discomfort
Keywords: Allergic Rhinitis Allergen immunotherapy
Sponsor: University of Aarhus
Start date: 2013-08-01; Completion date: 2017-02-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Detailed description:
Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.

The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.

The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.

Adverse events will be recorded.

Arms: arm 1: Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.

Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. arm 2: Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.

Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. arm 3: Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.

Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control.
Interventions: intervention 1: Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. intervention 2: alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml. intervention 3: 0.1 ml Isoton saline
Intervention descriptions: intervention 1: 4 intervention 2: 3 injection into a lymphnode intervention 3: 4 injection into a lymphnode

Protocol documents:
Clinical trial NCT02362672
Conditions: Low Back Pain Chronic Pain
Sponsor: Nektar Therapeutics
Start date: 2015-03-11; Completion date: 2017-02-01
Enrollment: 1189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.

Detailed description:
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.

Arms: arm 1: NKTR-181 twice daily (BID) tablets arm 2: Placebo to match NKTR-181 twice daily (BID) tablets
Interventions: intervention 1: NKTR-181 BID tablets intervention 2: Placebo to match NKTR-181 BID tablets
Intervention descriptions: intervention 1: NKTR-181 tablets 100-400 mg twice daily (BID) intervention 2: Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)

Protocol documents:
Clinical trial NCT02367911
Conditions: Plaque Psoriasis
Sponsor: Therapeutics, Inc.
Start date: 2015-01-01; Completion date: 2017-02-01
Enrollment: 144 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Detailed description:

Arms: arm 1: 122-0551 Foam, topically applied twice daily for two weeks arm 2: Vehicle Foam, topically applied twice daily for two weeks
Interventions: intervention 1: 122-0551 Foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: 122-0551 Foam applied twice daily to treat psoriasis intervention 2: Vehicle Foam applied twice daily to treat psoriasis

Protocol documents:
Clinical trial NCT02368210
Conditions: Plaque Psoriasis
Sponsor: Therapeutics, Inc.
Start date: 2015-01-01; Completion date: 2017-02-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.

Detailed description:

Arms: arm 1: 122-0511 Foam, topically applied twice daily arm 2: Vehicle Foam, topically applied twice daily
Interventions: intervention 1: 122-0551 Foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Topical Foam intervention 2: Topical Foam

Protocol documents:
Clinical trial NCT02384941
Conditions: Type 1 Diabetes Mellitus
Sponsor: Lexicon Pharmaceuticals
Start date: 2015-03-01; Completion date: 2017-02-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study was intended to demonstrate superiority of either sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult participants with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.

Detailed description:

Arms: arm 1: Two placebo-matching sotagliflozin tables, orally for 24 weeks followed by a 28 week extension period. arm 2: Sotagliflozin 200 mg (one 200 mg tablet and one placebo tablet), orally, for 24 weeks followed by a 28 week extension period. arm 3: Sotagliflozin 400 mg (two 200 mg tablets), orally, for 24 weeks followed by a 28 week extension period.
Interventions: intervention 1: Placebo intervention 2: Sotagliflozin
Intervention descriptions: intervention 1: Placebo once daily, before first meal of the day. intervention 2: Sotagliflozin once daily, before first meal of the day.

Protocol documents:
Clinical trial NCT02387359
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2014-12-01; Completion date: 2017-02-01
Enrollment: 1054 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Detailed description:
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.

Arms: arm 1: Plecanatide 3.0 mg dosed daily for 12 weeks arm 2: Plecanatide 6.0 mg dosed daily for 12 weeks arm 3: Placebo dosed daily for 12 weeks
Interventions: intervention 1: Plecanatide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02493452
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2015-06-01; Completion date: 2017-02-01
Enrollment: 1135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Detailed description:
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.

Arms: arm 1: Plecanatide 3.0 mg dosed daily for 12 weeks arm 2: Plecanatide 6.0 mg dosed daily for 12 weeks arm 3: Placebo dosed daily for 12 weeks
Interventions: intervention 1: Plecanatide intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02640482
Conditions: Chronic Hepatitis C Virus (HCV) Infection
Keywords: Treatment-Naive Hepatitis C Virus Genotype 2 Sofosbuvir (SOF)-Experienced Treatment-Experienced Non-cirrhotic
Sponsor: AbbVie
Start date: 2015-11-01; Completion date: 2017-02-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.

Detailed description:

Arms: arm 1: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period) arm 2: Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period) arm 3: ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)
Interventions: intervention 1: ABT-493/ABT-530 intervention 2: Placebo for ABT-493/ABT-530
Intervention descriptions: intervention 1: Tablet; ABT-493 coformulated with ABT-530 intervention 2: tablet

Protocol documents:
Clinical trial NCT02767869
Conditions: Metabolic Syndrome X
Keywords: Metabolic syndrome central obesity Banaba insulin secretion insulin sensitivity
Sponsor: University of Guadalajara
Start date: 2015-01-01; Completion date: 2017-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.

Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion.

The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load.

12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months.

The remaining 12 patients received placebo with the same prescription.

Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers.

Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.

Arms: arm 1: Banaba capsules, 500mg, two times per day before meals during 90 days arm 2: Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
Interventions: intervention 1: Banaba intervention 2: placebo
Intervention descriptions: intervention 1: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. intervention 2: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg

Protocol documents:
Clinical trial NCT02809976
Conditions: Vitiligo
Sponsor: Tufts Medical Center
Start date: 2016-01-01; Completion date: 2017-02-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if topical ruxolitinib 1.5% will provide repigmentation in vitiligo lesions.

Detailed description:
The hypothesis is that JAK inhibitors can also successfully treat vitiligo. Lesional skin of both alopecia areata and vitiligo primarily contain T cells in a TH1 response as opposed to a mixed cell infiltrate such as in psoriasis or lichen planus. Both alopecia areata and vitiligo are TH1 mediated diseases dependent on the production of IFN-gamma to drive the response. CD8+ T cells are both necessary and sufficient for melanocyte destruction in vitiligo (van den Boorn JG et al 2009) and CD8+NKG2D+ T cells are also necessary and sufficient for hair loss in alopecia areata (Gilhar A et al 2013).

Arms: arm 1: Ruxolitinib 1.5% phosphate cream twice daily to vitiligo patches.
Interventions: intervention 1: Ruxolitinib 1.5% Phosphate Cream
Intervention descriptions: intervention 1: twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20

Protocol documents:
Clinical trial NCT02908347
Conditions: Psoriasis Plaque Psoriasis
Keywords: Plaque psoriasis chronic moderate severe Plaque
Sponsor: MetrioPharm AG
Start date: 2016-05-01; Completion date: 2017-02-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase IIa study is designed to assess the safety, tolerability and pharmacokinetics of oral MP1032 in patients with moderate to severe psoriasis over a period of 6 weeks. Secondary endpoints to evaluate clinical parameters for psoriasis during the 6 week treatment period and a 4-week follow up will provide an opportunity to perform a first assessment of oral MP1032's clinical efficacy in the treatment of moderate to severe psoriasis.

The study population will consist of 44 enrolled (40 completed) patients with moderate to severe chronic plaque psoriasis. Patients must be able to provide written consent and meet all the inclusion criteria and none of the exclusion criteria.

Detailed description:
This study is a randomized, double-blind, parallel, placebo-controlled exploratory pilot study to evaluate safety, pharmacokinetics and efficacy of systemic oral (po) administration of 100 mg MP1032 bid in adult patients with moderate to severe chronic plaque psoriasis.

The study design consists of a 28-day screening/run-in period, a 42-day treatment period, 1 day for the End of Treatment visit, and a 28-day follow-up period. Forty-four patients who meet the entry criteria will be randomized on Day 1 in a 1:1 ratio to receive either 100 mg MP1032 or placebo orally twice daily for 42 days. The goal is to have 40 patients (20 in each treatment group) complete the study.

Pharmacokinetic sampling will occur on 3 designated study days. Safety will be monitored from the signing of the informed consent form (ICF) until the last follow-up visit on Day 71.

Efficacy will be assessed on 6 designated study days using the following assessments: PASI, PGA, DLQI, mNAPSI, and EQ-5D 5L (VAS).

Arms: arm 1: Test Product:

100 mg MP1032 (= 2 capsules a 50 mg) are provided orally twice daily for 42 days arm 2: Placebo to MP1032:

2 capsules of Placebo are provided orally twice daily for 42 days
Interventions: intervention 1: MP1032 intervention 2: Placebo
Intervention descriptions: intervention 1: hard gelatine capsules containing 50 mg MP1032 as active ingredient intervention 2: hard gelatine capsules without active ingredient

Protocol documents:
Clinical trial NCT03020004
Conditions: Chronic Hepatitis C
Keywords: Danoprevir SVR12 Chinese HCV G1 non-cirrhotic
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Start date: 2016-01-01; Completion date: 2017-02-01
Enrollment: 70 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

Detailed description:

Arms: arm 1: Participants will receive a combination of Ritonavir-boosted Danoprevir 100mg/100mg BID, subcutaneous injection of weekly peginterferon alfa-2a at 180 mcg and oral Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg) for 12 weeks.
Interventions: intervention 1: Danoprevir intervention 2: Ritonavir intervention 3: peginterferon alfa-2a intervention 4: Ribavirin (RBV)
Intervention descriptions: intervention 1: Danoprevir (DNV) 100mg tablet administered orally twice daily intervention 2: Ritonavir 100mg tablet administered orally twice daily intervention 3: PegIFN subcutaneous injection at 180 mcg weekly intervention 4: Ribavirin (RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)

Protocol documents:
Clinical trial NCT03020095
Conditions: Chronic Hepatitis C
Keywords: Ravidasvir HCV GT1 SVR12 Danoprevir/r
Sponsor: Ascletis Pharmaceuticals Co., Ltd.
Start date: 2015-08-01; Completion date: 2017-02-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.

Detailed description:

Arms: arm 1: Participants will receive Ravidasvir 200mg plus Ritonavir boosted Danoprevir 200/200mg,and Ribavirin 1000/1200mg daily for 12 weeks.
Interventions: intervention 1: Ravidasvir intervention 2: Danoprevir intervention 3: Ritonavir intervention 4: Ribavirin
Intervention descriptions: intervention 1: Ravidasvir 200mg tablet administered orally once daily intervention 2: Danoprevir 100mg tablet administered orally twice daily intervention 3: Ritonavir 100mg tablet administered orally twice daily intervention 4: Ribavirin(RBV)1000/1200 mg/day (bodyweight\<75/≥75 kg)administered orally

Protocol documents:
Clinical trial NCT01209442
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma Multiforme
Sponsor: University of Colorado, Denver
Start date: 2010-09-16; Completion date: 2017-02-03
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out whether Hypofractionated Intensity-Modulated Radiation Therapy (Hypo-IMRT) combining with temozolomide chemotherapy can be safely given with a targeted agent, bevacizumab, and how effective this study treatment will be in controlling your brain tumor.

Detailed description:
This is a pilot phase II trial of the combination of concurrent hypofractionated IMRT (60 Gy/2 weeks), temozolomide and bevacizumab followed by 6 cycles of adjuvant bevacizumab and temozolomide in patients with grade IV malignant gliomas (glioblastoma and gliosarcoma). The study will have survival and toxicity endpoints.

Arms: arm 1: Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily TMZ at 75 mg/m2 qd concurrent with IMRT (including weekends and holidays). Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Day 1 and the 1st Fx of IMRT must start on the same day. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab therapy, patients will have a brain MRI and if there is no evidence of disease progression, patients will receive 6 cycles of Bevacizumab and TMZ. Beginning a minimum of 28 days after the last radiation treatment the bevacizumab will be dosed at 10 mg/kg on day 1 and day 15 of each cycle. TMZ will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. Each cycle is 28 days.
Interventions: intervention 1: Bevacizumab intervention 2: Temozolomide intervention 3: RT (Radiation Therapy)
Intervention descriptions: intervention 1: Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, patients will receive 6 cycles of Bevacizumab. intervention 2: Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily temozolomide at 75 mg/m2 qd concurrent with IMRT. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, temozolomide will be given at 150-200 mg/m2 qd on days 1-5 of each cycle. intervention 3: Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx)

Protocol documents: