ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02466516
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Keywords: GS-4997 Non-alcoholic fatty liver disease (NAFLD) Fibrosis Simtuzumab (SIM) Apoptosis signal-regulating kinase 1 ASK1 inhibitor
Sponsor: Gilead Sciences
Start date: 2015-06-08; Completion date: 2016-10-11
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.

Detailed description:

Arms: arm 1: Selonsertib (SEL) 6 mg for 24 weeks. arm 2: SEL 18 mg for 24 weeks. arm 3: SEL 6 mg plus SIM 125 mg for 24 weeks. arm 4: SEL 18 mg plus SIM 125 mg for 24 weeks. arm 5: SIM 125 mg for 24 weeks.
Interventions: intervention 1: SEL intervention 2: SIM
Intervention descriptions: intervention 1: SEL tablet administered orally once daily intervention 2: Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly

Protocol documents:
Clinical trial NCT01004003
Conditions: Carcinoma, Hepatocellular
Sponsor: Boehringer Ingelheim
Start date: 2009-10-22; Completion date: 2016-10-12
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aim is to determine maximally tolerated dose (MTD) of BIBF 1120 in HCC (hepatocellular cancer) and compare efficacy of BIBF 1120 to Sorafenib in HCC patients

Detailed description:

Arms: arm 1: Phase I dose escalation and phase II using dose determined in phase I ( 200 mg BID) arm 2: None
Interventions: intervention 1: Sorafenib intervention 2: BIBF 1120
Intervention descriptions: intervention 1: None intervention 2: Dose escalated in phase I until MTD or adjusted by investigator, dose in phase II part based on phase I data

Protocol documents:
Clinical trial NCT01682512
Conditions: Arthritis, Rheumatoid
Sponsor: Boehringer Ingelheim
Start date: 2012-09-05; Completion date: 2016-10-12
Enrollment: 294 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI 695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.

Detailed description:

Arms: arm 1: BI 695500, Two infusions separated by 2 weeks, Intravenous infusion arm 2: rituximab, Two infusions separated by 2 weeks, Intravenous infusion arm 3: rituximab, Two infusions separated by 2 weeks, Intravenous infusion arm 4: BI 695500, Two infusions separated by 2 weeks, Intravenous infusion arm 5: rituximab, Two infusions separated by 2 weeks, Intravenous infusion
Interventions: intervention 1: BI 695500 intervention 2: BI 695500 intervention 3: Rituxan® intervention 4: Rituxan® intervention 5: MabThera®
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT02224144
Conditions: End Stage Renal Disease Kidney Transplantation Bone Loss Fractures Vascular Calcifications
Keywords: Kidney Transplantation Calcitriol Bone Mineral Density Bone Mass and Strength Vascular Calcifications Hyperparathyroidism Parathyroid Hormone
Sponsor: Columbia University
Start date: 2014-08-18; Completion date: 2016-10-12
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

Detailed description:
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Arms: arm 1: 1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months

1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months arm 2: 1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months

1 pill of placebo (sugar pill) per day for 12 months
Interventions: intervention 1: Vitamin D3 intervention 2: Calcitriol intervention 3: Placebo
Intervention descriptions: intervention 1: Vitamin D3 1000 IU per day for 12 months intervention 2: Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months intervention 3: Placebo (sugar pill) 1 pill per day for 12 months

Protocol documents:
Clinical trial NCT02461589
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2015-09-21; Completion date: 2016-10-13
Enrollment: 706 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to investigate dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None arm 9: None arm 10: None arm 11: None arm 12: None arm 13: None
Interventions: intervention 1: semaglutide intervention 2: liraglutide intervention 3: placebo
Intervention descriptions: intervention 1: Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing. intervention 2: Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen. intervention 3: Administered subcutaneously ( s.c., under the skin) once daily.

Protocol documents:
Clinical trial NCT01855789
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-11-07; Completion date: 2016-10-14
Enrollment: 718 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, multicenter, double-blind, parallel group study will evaluate the impact of MTX discontinuation on the efficacy of SC TCZ in participants with moderate to severe active rheumatoid arthritis who have an inadequate response to current MTX therapy. Participants will initiate treatment with TCZ weekly or every 2 weeks along with MTX at a stable dose orally in an open-label manner for 24 weeks. Participants with a disease activity score based on 28 joints (DAS28) less than or equal to (\</=) 3.2 at Week 24, will be randomized to either continue receiving a stable dose of MTX or to switch to matching placebo up to Week 52. Participants without a DAS28 score \</=3.2 at Week 24, will continue the same treatment in a non-randomized open-label manner up to Week 52.

Detailed description:

Arms: arm 1: All participants will receive initial treatment with open-label TCZ + MTX. Participants who complete 24-week treatment with open-label TCZ + MTX and did not achieve a DAS28 score \</=3.2 at Week 24, will continue receiving TCZ + MTX in open label manner up to Week 52. arm 2: Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX up to Week 52. arm 3: Participants who complete the initial 24-week treatment with open-label TCZ + MTX and achieve a DAS28 score \</=3.2 at Week 24, will be randomized to receive TCZ along with MTX matched placebo (PBO) up to Week 52.
Interventions: intervention 1: Tocilizumab (TCZ) intervention 2: Methotrexate (MTX) intervention 3: Placebo (PBO)
Intervention descriptions: intervention 1: TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to \[\>/=\] 100 kilograms \[kg\]) or every 2 weeks (if body weight was less than \[\<\] 100 kg). intervention 2: MTX will be administered at a stable dose (15 mg to 25 mg per week) orally. intervention 3: PBO matching to MTX will be administered orally.

Protocol documents:
Clinical trial NCT01959529
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-10-29; Completion date: 2016-10-16
Enrollment: 7637 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.

Detailed description:

Arms: arm 1: All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product. arm 2: All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.
Interventions: intervention 1: insulin degludec intervention 2: insulin glargine
Intervention descriptions: intervention 1: Injected once daily subcutaneously (s.c., under the skin) intervention 2: Injected once daily subcutaneously (s.c., under the skin)

Protocol documents:
Clinical trial NCT01818726
Conditions: Aplastic Anemia
Keywords: Aplastic anemia deferasirox ICL670 renal function transfusion-dependent iron overload immunosuppressive treatment Cyclosporine A unosuppressive treatment without chelation therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2014-06-23; Completion date: 2016-10-17
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.

Detailed description:
The secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.

Arms: arm 1: Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study arm 2: Transfusion-dependent adult patients with AA and serum ferritin \< 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product
Interventions: intervention 1: ICL670 intervention 2: Chelation intervention 3: No chelation
Intervention descriptions: intervention 1: ICL670 was supplied in registered packages as 250mg or 500mg dispersible tablets. intervention 2: Main group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment (immunosupressant - Cyclosporine A) and received chelation with ICL670 (deferasirox). intervention 3: Comparative group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment ( immunosupressant -Cyclosporine A)

Protocol documents:
Clinical trial NCT01972724
Conditions: Type II Diabetes Mellitus
Keywords: Drug therapy
Sponsor: Takeda
Start date: 2013-12-16; Completion date: 2016-10-17
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic control when used in participants with inadequately controlled type 2 diabetes mellitus treated with stable combinations of metformin and sulfonylurea.

Detailed description:
The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This study will look at glycemic control in people who take triple oral therapy of metformin, sulfonylurea, and pioglitazone 15 mg.

The study will enroll approximately 114 patients. All participants will be asked to take one pioglitazone tablet at the same time each day throughout the study as well as continuing their previous dose of metformin and sulfonylurea.

This multi-center trial will be conducted in Korea. The overall time to participate in this study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's office, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Arms: arm 1: Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. arm 2: Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. arm 3: Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
Interventions: intervention 1: Pioglitazone intervention 2: Metformin intervention 3: Sulfonylurea
Intervention descriptions: intervention 1: Pioglitazone tablets intervention 2: Metformin as prescribed in clinical practice intervention 3: Sulfonylurea as prescribed in clinical practice

Protocol documents:
Clinical trial NCT02042014
Conditions: Severe Pulmonary Arterial Hypertension
Keywords: Pulmonary arterial hypertension, QTI571, open label study
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-22; Completion date: 2016-10-17
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide continued treatment to Pulmonary Arterial Hypertension (PAH) patients who are benefitting from treatment with QTI571.

Detailed description:
This was a multi-center open label study to provide continued supply of QTI571 to patients in Japan who were treated in the extension study (A2301E1) and were judged by the investigator to benefit from continued QTI571 treatment.

Arms: arm 1: Participants will receive QTI571 during 3 years.
Interventions: intervention 1: QTI571
Intervention descriptions: intervention 1: QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.

Protocol documents:
Clinical trial NCT01132612
Conditions: Plaque-type Psoriasis
Keywords: Chronic plaque-type psoriasis AIN457 dermatology Moderate to severe chronic plaque-type psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-11; Completion date: 2016-10-18
Enrollment: 275 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

Detailed description:
In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).

The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.

Arms: arm 1: Secukinumab 150 mg subcutaneous (sc) administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter arm 2: Placebo administered at Week 1 (baseline) of the extension study and every 12 weeks thereafter. If relapse, then switch to secukinumab 150 mg sc administered every 4 weeks arm 3: Secukinumab 150 mg sc administered every 4 weeks
Interventions: intervention 1: AIN457 intervention 2: Placebo
Intervention descriptions: intervention 1: AIN457A 150 mg powder for solution intervention 2: Placebo to AIN457A 150 mg powder for solution

Protocol documents:
Clinical trial NCT01380197
Conditions: Pain Sickle Cell Disease
Keywords: pain sickle cell nubain morphine acute chest side effects
Sponsor: Children's Healthcare of Atlanta
Start date: 2010-05-26; Completion date: 2016-10-18
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The pathophysiology of sickle cell disease (SCD) manifestations, are complex with interactions of intracellular hemoglobin, membrane and endothelial activation but the hallmark remains recurrent and painful vaso-occlusive episodes (VOC). These painful episodes are thought to result from ischemia caused when small blood vessels are occluded by misshapen, inflexible erythrocytes. Painful episodes are the most common cause of hospitalization, morbidity, and impairment for SCD patients. There is no therapy that completely prevents or directly aborts painful events for all patients. Consequently, treatment for acute VOC is primarily supportive using hydration and medicinal pain control. Every pain medication has the potential to relieve pain but is associated with significant limitations and side effects.

The primary hypothesis to be tested in this double blind, randomized controlled trial is that Nalbuphine is equivalent to morphine for pain control and patients will suffer fewer episodes of acute chest syndrome. The investigators also expect subjects will report fewer side effects from respiratory depression, abdominal distention from reduced peristalsis, reduced histamine release causing pruritis and still be provided adequate pain control. Further hypotheses to be tested is ability to recruit patient participants while being treated in the Emergency Department and that continuous infusion of Nalbuphine with accompanying patient controlled analgesia (PCA) is safe and effective in controlling pain, requiring less total opiates consumption, while decreasing length of hospitalization.

Detailed description:

Arms: arm 1: Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis arm 2: Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients
Interventions: intervention 1: Morphine intervention 2: Nubain
Intervention descriptions: intervention 1: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs). intervention 2: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).

Protocol documents:
Clinical trial NCT02058836
Conditions: Chronic Testicular Pain
Keywords: Chronic testicular pain Orchialgia Botulinum toxin Botox Urology
Sponsor: Wake Forest University Health Sciences
Start date: 2014-11-01; Completion date: 2016-10-18
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine if Botox injections will provide relief from chronic testicular pain. In the study, the spermatic cord of particpants will be injected with either Botox or a placebo of saline. Botox is currently used to treat other urological conditions like overactive bladder and lower urinary tract problems. For these conditions, Botox works by relaxing muscles in the affected areas. The investigators believe that Botox will act similarly in the treatment chronic testicular pain.

Detailed description:

Arms: arm 1: The participant will be given an injection of Botox along the spermatic cord under ultrasound guidance. Before drug administration, a nerve block using bupivacaine will be completed to numb the area for treatment. This will be a 10 mL injection done one time at the initial patient visit. arm 2: The patient will receive an inactive injection of normal saline along the spermatic cord under ultrasound guidance. This will be a 10 ml injection done once at the initial visit. Before the injection of saline, a spermatic cord block using bupivacaine will be completed to numb the area for treatment.
Interventions: intervention 1: Botox Injection intervention 2: Normal saline injection
Intervention descriptions: intervention 1: One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area. intervention 2: One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.

Protocol documents:
Clinical trial NCT02137226
Conditions: Arthritis, Rheumatoid
Sponsor: Boehringer Ingelheim
Start date: 2015-01-26; Completion date: 2016-10-18
Enrollment: 645 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a statistical comparison of the proportion of patients meeting American College of Rheumatology 20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and US-licensed Humira®.

Secondary Objectives:

The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks.

Detailed description:

Arms: arm 1: one injection every 2 weeks for 48 weeks (25 injections in total) arm 2: one injection every 2 weeks for 48 weeks (25 injections in total)
Interventions: intervention 1: BI 695501 intervention 2: US-licensed Humira®
Intervention descriptions: intervention 1: BI 695501, every two weeks for 48 weeks (25 injections in total) intervention 2: one injection every 2 weeks for 48 weeks (25 injections in total)

Protocol documents: