ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01464307
Conditions: Post-stroke Spasticity of the Lower Limb
Sponsor: Merz Pharmaceuticals GmbH
Start date: 2011-12-01; Completion date: 2015-05-01
Enrollment: 290 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.

Detailed description:

Arms: arm 1: IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection. arm 2: Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Interventions: intervention 1: IncobotulinumtoxinA (400 Units) intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection. intervention 2: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection

Protocol documents:
Clinical trial NCT01465763
Conditions: Ulcerative Colitis
Keywords: tofacitinib CP-690 550 Moderate to severe ulcerative colitis phase 3 clinical trial Mayo score
Sponsor: Pfizer
Start date: 2012-04-01; Completion date: 2015-05-01
Enrollment: 614 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tofacitinib intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg oral BID intervention 2: Plabebo oral BID

Protocol documents:
Clinical trial NCT01467661
Conditions: Essential Thrombocythemia (ET)
Sponsor: Shire
Start date: 2010-10-27; Completion date: 2015-05-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SPD422 (anagrelide hydrochloride)
Intervention descriptions: intervention 1: Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.

Protocol documents:
Clinical trial NCT01491672
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Metastatic Renal Cell Carcinoma Second Line Everolimus RAD001
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2015-05-01
Enrollment: 134 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate everolimus as second-line therapy in patients with metastatic renal cell carcinoma. Each patient will be enrolled and stratified in one of three cohorts based upon their first-line therapy: 1) prior cytokines, 2) prior sunitinib, or 3) prior anti-VEGF therapy other than sunitinib.

Detailed description:

Arms: arm 1: Participants, received RAD001 10 mg orally once daily.
Interventions: intervention 1: RAD001
Intervention descriptions: intervention 1: Study drug was supplied as 5 mg tablets in blister packs.

Protocol documents:
Clinical trial NCT01511809
Conditions: HIV-1 Infection
Keywords: HIV-1
Sponsor: IRCCS San Raffaele
Start date: 2010-09-01; Completion date: 2015-05-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable suppressed viremia and no prior virologic failures.

Detailed description:
This is a randomised (1:1), multicentre, comparative, parallel-group, prospective, open label, non-inferiority controlled clinical trial.

Enrolled patients, taking an ATV/r based HAART and with stable HIV-RNA \< 50c/ml (24 weeks), will be randomized to:

* continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs (according to the specific dosing schedule) as backbone (HAART arm) with ATV/r
* or simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy (Monotherapy arm) with ATV/r The study follow up will be 96 weeks after randomization and primary objective will be evaluated at week 48.

Patients will be followed every 4 weeks for the first 16 weeks, and then every 8 weeks until week 48, then every 12 weeks until week 96 or discontinuation ; at each visit the following evaluations will be performed:

* clinical assessment.
* routine laboratory tests (hematological tests and hematochemistry) including creatinine, phosphorus, calcium, alkaline phosphatase, gammaGT; urine analysis, lipid profile, level of HIV-RNA and CD4 cell counts.

During follow-up, at randomization, week 48, week 96 or discontinuation, patients will additionally undergo:

* Fat redistribution evaluation by DEXA (dual-energy X-ray absorptiometry
* Vertebral and femoral bone mineral density evaluation by DEXA.
* ECG;
* Glicate haemoglobin.
* Adherence assessment (questionnaire and/or pills counts).
* Neurocognitive evaluation \[HIV-associated neurocognitive disorders (HANDs) evaluated by validated neuropsychological tests\].

In case of viral rebound (defined as 2 consecutive measurement of HIV-RNA \> 50 c/ml) patients will be immediately contacted in order to perform genotypic tests. Furthermore a plasma PK analysis will also be performed. Any patients with virological rebound will be selected for a reintensification therapy with NRTIs and if not suppressed after 12 weeks they will be discontinued.

Arms: arm 1: Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy arm 2: Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
Interventions: intervention 1: Atazanavir/ritonavir monotherapy
Intervention descriptions: intervention 1: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.

Protocol documents:
Clinical trial NCT01594424
Conditions: End Stage Renal Disease (ESRD)
Keywords: Donor-Specific Anti-HLA Antibodies Kidney Transplantation
Sponsor: Cedars-Sinai Medical Center
Start date: 2012-06-01; Completion date: 2015-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this Phase I/II trial, 10 highly sensitized patients will be entered after informed consent and will receive Intravenous Immunoglobulin (IVIG) at 2 gm/kg + Tocilizumab 8 mg/kg x 5 doses on days 15, 45, 75, 105, 119, 135, and 149. If robust reductions in anti-HLA antibody are seen, patients will progress to kidney transplantation when an "acceptable" crossmatch is achieved with a living donor (LD) or deceased donor (DD). Those receiving transplants will also receive Tocilizumab infusion monthly X7 doses post-transplant. All subjects will have intensive monitoring of Donor Specific Antibodies (DSA), viral PCRs, and routine post-transplant labs. At 6 months post-transplant, those who have retained their transplanted kidney will have a protocol biopsy.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tocilizumab intervention 2: Intravenous Immunoglobulin
Intervention descriptions: intervention 1: Tocilizumab 8mg/kg on Days 0, 15, 30, 45, 75, 105, 119, 135, 149, and 180 intervention 2: All HS who meet criteria for desensitization will receive IVIG 10% (2.0 g/kg \[maximum 140 g per dose\] on days 1 and 30).

Protocol documents:
Clinical trial NCT01595581
Conditions: Muscle Atrophy ACL Reconstruction Trauma Osteoarthritis
Keywords: Testosterone ACL Reconstruction Clinical outcomes Lean mass Strength Muscle atrophy
Sponsor: University of Southern California
Start date: 2012-04-01; Completion date: 2015-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study is being done to test whether taking testosterone can prevent loss of muscle mass and strength due to anterior cruciate ligament (ACL) reconstructive surgery. Testosterone is the principal male sex hormone and an anabolic (muscle promoting) steroid. It is essential for the development of male reproductive tissues and promotes increased muscle, bone mass, and the growth of body hair.

The investigators hope to learn whether testosterone given before and after ACL reconstructive surgery will increase muscle mass and strength and potentially improve recovery time following surgery.

Detailed description:
Overall Objective: The overall objective of this study is to determine if 8 weeks of testosterone first administered 2 weeks prior to surgery, can improve the outcome of anterior cruciate ligament (ACL) reconstruction.

Overall Hypothesis: Standard-of-care rehabilitation with the addition of testosterone administration will augment muscle mass, strength, and physical function following ACL reconstructive surgery compared to standard rehabilitation alone.

Significance: Muscle mass and strength are greatly reduced following ACL surgery. The investigators hypothesize that administration of testosterone will minimize these reductions or potentially increase muscle mass and strength. In doing so, testosterone may hasten a patient's return to physical activity. If testosterone improves recovery after ACL surgery, the same treatment may be used for other injuries that involve trauma and muscle atrophy. Furthermore, this study will examine the effect of trauma with or without testosterone on myogenic regulators in muscle tissue taken during ACL surgery-providing possible mechanistic insights for the clinical outcomes.

Arms: arm 1: Weekly injection of testosterone enanthate 200mg arm 2: Weekly injection of saline as the placebo
Interventions: intervention 1: Testosterone intervention 2: Placebo
Intervention descriptions: intervention 1: 8 weeks of testosterone administration beginning 2 weeks before ACL surgery intervention 2: 8 weeks of saline administration beginning 2 weeks before ACL surgery

Protocol documents:
Clinical trial NCT01599650
Conditions: Branch Retinal Vein Occlusion
Keywords: Macular Edema, Branch Retinal Vein Occlusion, visual impairment
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2015-05-01
Enrollment: 455 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will generate comparative data for 0.5-mg ranibizumab using PRN dosing administered with or without adjunctive laser treatment versus laser photocoagulation (the current standard of care) up to Month 6 in patients with visual impairment due to ME secondary to BRVO. Additionally the results of this study will provide long-term (24-month) safety and efficacy data for ranibizumab, administered with or without adjunctive laser treatment in this indication.

Detailed description:

Arms: arm 1: Ranibizumab 0.5 mg arm 2: Ranibizumab 0.5 mg + laser arm 3: Laser monotherapy with Ranibizumab 0.5 mg from Month 6
Interventions: intervention 1: Ranibizumab intervention 2: Laser
Intervention descriptions: intervention 1: None intervention 2: laser photocoagulation

Protocol documents:
Clinical trial NCT01605916
Conditions: Neoplasms, Metastatic Cancer, Non-Small Cell Lung Cancer Advanced Solid Malignancies
Keywords: Cancer, Tumour, Metastatic, Lung cancer, Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
Start date: 2012-06-01; Completion date: 2015-05-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study will be to investigate the safety and tolerability of AZD6244 given monotherapy or in combination with docetaxel as 2nd line therapy in Japanese patients with Advanced Solid Malignancies or Locally Advanced or Metastatic Non-Small Cell Lung Cancer. In addition, the pharmacokinetic profile of AZD6244 will be investigated. Following the combination regimen dose escalation phase (Part A) of the study additional patients may be enrolled to a dose expansion phase (Part B) to refine further the safety, tolerability, pharmacokinetics and biological activity of the combination in this patient population.

Detailed description:
The objective of the combination therapy part of this study will be to investigate the safety and tolerability of AZD6244 given in combination with docetaxel as 2nd line therapy in Japanese patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV). In addition, the pharmacokinetic profile of AZD6244 and docetaxel will be investigated.

The objective of the monotherapy part of this study will be to investigate the safety and tolerability of AZD6244 given as a monotherapy in Japanese patients with advanced solid malignancies. In addition, the pharmacokinetic profile of monotherapy AZD6244 will be investigated.

Arms: arm 1: monotherapy arm 2: monotherapy arm 3: monotherapy arm 4: Combination arm 5: combination
Interventions: intervention 1: AZD6244
Intervention descriptions: intervention 1: Tablet Oral bid

Protocol documents:
Clinical trial NCT01614912
Conditions: Schizophrenia
Sponsor: Sumitomo Pharma Co., Ltd.
Start date: 2012-08-01; Completion date: 2015-05-01
Enrollment: 284 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study evaluates the long term safety and efficacy of SM-13496 in patients with schizophrenia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SM-13496
Intervention descriptions: intervention 1: 40 or 80 mg once daily orally

Protocol documents:
Clinical trial NCT01634152
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2012-07-01; Completion date: 2015-05-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The overall purpose of the trial is to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat® inhaler once daily in the evening over 12 weeks, compared to placebo, as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Tiotropium low dose mcg intervention 3: Tiotropium high dose
Intervention descriptions: intervention 1: 2 actuations once daily in the evening intervention 2: 2 actuations once daily in the evening intervention 3: 2 actuations once daily in the evening

Protocol documents:
Clinical trial NCT01662505
Conditions: Leukemia, Myeloid, Acute
Sponsor: Boehringer Ingelheim
Start date: 2012-08-01; Completion date: 2015-05-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese patients with AML

Detailed description:

Arms: arm 1: Patient to receive escalating dose of volasertib
Interventions: intervention 1: Volasertib
Intervention descriptions: intervention 1: Patient to receive volasertib

Protocol documents:
Clinical trial NCT01668173
Conditions: Myeloproliferative Neoplasms
Keywords: HSP90 Inhibitor AUY922 12-076
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2012-08-01; Completion date: 2015-05-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test a new drug called AUY922. AUY922 is not FDA-approved. AUY922 is a new kind of drug that attacks a protein called HSP90. HSP90 is found in both normal and cancer cells, but the investigators think it is more important in cancer cells.

This study will see if AUY922 helps people with myelofibrosis, essential thrombocythemia and polycythemia vera. This study will also see if AUY922 is safe in people with myelofibrosis, essential thrombocythemia and polycythemia vera. It will find out what effects, good and/or bad, AUY922 has on the patient and the disease. The researchers hope that this study will help them to find better treatments for primary myelofibrosis, essential thrombocythemia and polycythemia vera.

Detailed description:

Arms: arm 1: This is an open-label phase II trial to assess the efficacy of the HSP90 inhibitor, AUY922, in patients with PMF, post-PV MF, post-ET MF, and with PV/ET who are refractory to hydroxyurea, phlebotomy or anagrelide.
Interventions: intervention 1: AUY922
Intervention descriptions: intervention 1: AUY922 will be administered as an intravenous infusion over 60 minutes, on a once weekly schedule. A cycle on study will be defined as 28 days. The dose to be studied are 70 mg/m2 and 55 mg/m2 if DLTs are identified in the first 3-6 patients. The same schedule of administration will be used for all patients in this trial.

Protocol documents:
Clinical trial NCT01683864
Conditions: Gastric Cancer Peritoneal Carcinomatosis
Sponsor: University Hospital Tuebingen
Start date: 2012-09-01; Completion date: 2015-05-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer

Detailed description:
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.

Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.

In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.

A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2\<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.

This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC\_Stomach) and was initiated in August 2012.

Arms: arm 1: gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative arm 2: gastric cancer cytology positive without HIPEC arm 3: gastric cancer with negative cytology
Interventions: intervention 1: positive cytology with HIPEC
Intervention descriptions: intervention 1: HIPEC with mytomycin and cisplatin

Protocol documents:
Clinical trial NCT01689779
Conditions: Hypovitaminosis D
Keywords: vitamin D surgery acute stress
Sponsor: Massachusetts General Hospital
Start date: 2013-01-01; Completion date: 2015-05-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of surgical site infections (SSIs). At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems. The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.

Detailed description:
While vitamin D insufficiency \[25(OH)D \<30 ng/mL\] is common in the general population, hypovitaminosis D may affect 40-80% of patients in the perioperative setting. Recent evidence also suggests that surgical stress may be associated with a 40% reduction in circulating 25(OH)D levels when compared to preoperative values. Moreover, the derangement in perioperative 25(OH)D levels may be sustained for up to 3 months after surgery. This finding has potential implications regarding modifiable risk factors for surgical site infections (SSIs), which account for nearly 40% of all nosocomial infections. On aggregate, SSIs result in 3.7 million extra hospital days per annum and an added burden of $1.6 billion in annual healthcare costs. A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of SSIs. At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems. Yet, optimization of perioperative vitamin D status remains grossly understudied. Although our overarching aim is to study the impact of vitamin D status on SSIs, the focus of the current investigation is to determine whether the administration of a "bolus" oral dose of cholecalciferol (vitamin D3) in the preoperative setting alters vitamin D status in the perioperative setting (compared to a placebo). The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.

Arms: arm 1: A maximum of 40 patients will receive a one-time oral dose of 100,000 IU cholecalciferol 3-7 days before their scheduled elective surgery. arm 2: A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.
Interventions: intervention 1: 100,000 IU cholecalciferol intervention 2: Placebo
Intervention descriptions: intervention 1: active drug intervention 2: comparator drug

Protocol documents: