ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01429350
Conditions: Ischemic Stroke
Keywords: ischemic stroke acute intervention thrombolysis rtPA internal carotid artery middle cerebral artery mechanical thrombectomy Penumbra System clot length mRS NIHSS
Sponsor: Penumbra Inc.
Start date: 2012-05-01; Completion date: 2016-10-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to assess the safety and effectiveness of the Penumbra System as an adjunctive treatment to intravenous (IV) recombinant human tissue plasminogen activator (rtPA)in patients with acute ischemic stroke from large vessel occlusion in the brain. IV rtPA is the only drug approved for the treatment of acute ischemic stroke but it does not work very well in cases where the stroke is caused by a large vessel occlusion. The hypothesis being tested is to determine if the addition of a treatment by a mechanical thrombectomy device like the Penumbra System can improve the clinical outcome of the patient over just using IV rtPA alone.

Detailed description:
Current therapies for acute stroke are limited to the intravenous administration of a intravenous (IV) recombinant human tissue plasminogen activator (rtPA) for thrombolysis of the affected cerebral arteries within 3-4.5 hours from symptom onset, and the use of intra-arterial (IA) endovascular mechanical clot retrieval devices within 8 hours from ictus, all of which have limitations as mono therapies. For example, IV rtPA may not be very efficacious in large vessel occlusion and the long term effects of mechanical thrombectomy devices on patient functional outcome is unknown. This is a randomized, concurrent controlled study to assess the safety and effectiveness of the Penumbra System as adjunctive therapy to IV rtPA in the acute intervention of acute ischemic stroke. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large clot burden (clot length \> 8mm) in the anterior circulation will be assigned to either IV rtPA therapy alone (0.9mg/kg to a maximum of 90mg) or a combined IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and intra-arterial (IA) adjunctive treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after enrollment.

Arms: arm 1: IV infusion of rtPA at 0.9mg/kg to a maximum of 90mg arm 2: Dual IV rtPA therapy (0.9mg/kg to a maximum of 90mg) and IA adjunctive treatment with the Penumbra System
Interventions: intervention 1: intravenous (IV) recombinant human tissue plasminogen activator (rtPA) intervention 2: Penumbra System
Intervention descriptions: intervention 1: 0.9mg/kg to a maximum of 90mg intervention 2: The Penumbra System is an aspiration based mechanical thrombectomy device

Protocol documents:
Clinical trial NCT01467999
Conditions: Cannabis Dependence
Keywords: cannabis dependence marijuana dependence guanfacine
Sponsor: New York State Psychiatric Institute
Start date: 2012-02-01; Completion date: 2016-10-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving as compared to baseline.

Detailed description:
Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has been developed yet. As such, the development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Lofexidine, an alpha-2 agonist, is effective in treating opioid withdrawal and shows promise as cannabis use disorder pharmacotherapy, though its use may be limited by a cumbersome (thrice daily) dosing regimen. An alpha-2-agonist with a longer half-life, such as guanfacine, may have some of the same benefits as lofexidine at comparable doses, but its easier (once daily) dosing regimen may promote compliance and treatment retention. The purpose of this study is therefore to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. This pilot study can also provide the basis for subsequently conducting a larger study aimed at determining efficacy with the appropriate randomized, placebo-controlled design.

Arms: arm 1: Guanfacine, 4mg given once daily
Interventions: intervention 1: Guanfacine
Intervention descriptions: intervention 1: Guanfacine, 4mg given once daily

Protocol documents:
Clinical trial NCT01518517
Conditions: Acute Lymphoblastic Leukemia, in Relapse
Keywords: acute lymphoblastic leukemia relapse asparaginase
Sponsor: ERYtech Pharma
Start date: 2009-12-01; Completion date: 2016-10-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also neutralize asparaginase without any clinical signs of hypersensitivity (silent inactivation). GRASPA improves pharmacokinetics, tolerability and maintain circulating asparaginase activity due to the protective barrier of the erythrocyte membrane.

This study is run to confirm the benefit/risk profile of GRASPA at 150 IU/kg in combination with the COOPRALL regimen in adults and children patients with relapsed ALL, with or without known hypersensitivity to L-asparaginase.

Detailed description:
This open, randomized international Phase 2/3 study will enrol patients with relapsed ALL. The co-primary endpoints were the duration of asparagine depletion \< 2µmol/L and the incidence of asparaginase hypersensitivity during induction. Key secondary endpoints are complete remission (CR), minimal residual disease (MRD), event free survival (EFS) and overall survival (OS).The study was powered to detect 3-fold difference in the incidence of allergic reactions between treatments. patients will be randomized to GRASPA or to Reference L-asparaginase. Patients with history of hypersensitivity to previous L-asparaginase treatment will be treated with GRASPA (exploratory arm)

Arms: arm 1: Each patient randomized in GRASPA® group is to receive at least 2 and up to 10 administration of GRASPA® 150 IU/kg, in combination with standard chemotherapy (COOPRALL).

GRASPA® administration takes place as below:

* for induction phase: at Day 4 and D18 (F1-F2 induction ) or at D6 if Vanda induction applies (according disease severity)
* for consolidation phase: at Day 6 of R2 / R1 blocks, each time block of chemotherapy is given (up to 8 cycles) arm 2: For patient randomized in control group, reference L-asparaginase 10,000 IU/m² will be administered every 3 days intravenously, in combination with standard chemotherapy (COOPRALL).

•for induction phase:at Day 4 , D7, D10, D13 (F1 block ) then at Day 18, D21, D24, D27 (of F2 Blocks).

NB: administrations take place at D6, D9, D12 and D15 in case of F1-F2 Induction is replaced by VANDA (according disease severity)

•for consolidation phase: at D6, D9, D12 ofR2/R1 blocks, each time block of chemotherapy is given (up to 8 cycles).
Interventions: intervention 1: GRASPA intervention 2: L-asparaginase
Intervention descriptions: intervention 1: one injection of GRASPA 150 IU/kg at each cycle of chemotherapy intervention 2: 3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy

Protocol documents:
Clinical trial NCT01533688
Conditions: Diabetes Mellitus
Sponsor: University of Oklahoma
Start date: 2011-10-01; Completion date: 2016-10-01
Enrollment: 212 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Poor bowel preparation and patient intolerance of the procedure are the most important factors contributing to the limitation of colonoscopy. Inadequate bowel cleansing results in incomplete testing, increased potential to miss lesions, increased cost, and decreased patient satisfaction. The investigators hope to gain better insight into which bowel preparation works best in diabetic patients and hence would increase patient satisfaction, tolerability of the bowel preparation and decrease overall costs. The investigators will investigate which bowel preparation for colonoscopy will work optimally in diabetic patients using three different regimens.

Detailed description:

Arms: arm 1: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely)+ placebo pill arm 2: split dose(2 L day before procedure and 2 L day of procedure) of 4 liters of Golytely + placebo pill arm 3: split dose (2 L day prior to procedure and 2 L day of procedure) of 4 liters of Golytely + bisacodyl 10 mg
Interventions: intervention 1: Golytely (polyethylene glycol electrolyte lavage solution) and placebo intervention 2: split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo intervention 3: split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl
Intervention descriptions: intervention 1: 4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy intervention 2: split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo intervention 3: split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg

Protocol documents:
Clinical trial NCT01617460
Conditions: Autistic Disorder
Keywords: Autistic Disorder, children and adolescents aripiprazole Long-term safety study children and adolescents
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-09-01; Completion date: 2016-10-01
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to investigate the safety and efficacy of aripiprazole orally administered over long term in subjects who complete a short-term treatment study of pediatric Autistic Disorder (031-11-002 study).

Detailed description:

Arms: arm 1: administered orally once daily
Interventions: intervention 1: Aripiprazole
Intervention descriptions: intervention 1: Flexibly dose administered orally once daily

Protocol documents:
Clinical trial NCT01626872
Conditions: Schizophrenia
Keywords: Schizophrenia Antipsychotic Agents Mental Disorder Psychotropic Drugs Dopamine Agents Risperidone Central Nervous System Agents
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-09-01; Completion date: 2016-10-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to evaluate the long-term safety, tolerability, and efficacy of MP-214 in patients with schizophrenia.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: MP-214 3mg intervention 2: MP-214 6mg intervention 3: MP-214 9mg intervention 4: Risperidone 4mg
Intervention descriptions: intervention 1: In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg). intervention 2: In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg). intervention 3: In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg). intervention 4: In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).

Protocol documents:
Clinical trial NCT01645176
Conditions: Osteoarthritis of the Knee
Keywords: OA Knee
Sponsor: Stanford University
Start date: 2012-05-01; Completion date: 2016-10-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study of a combination therapy of hydroxychloroquine and atorvastatin is to learn about the effects in inflammation and pain in patients with Osteoarthritis of the knee. These medications are FDA approved and commercially available.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Hydroxychloroquine/Atorvastatin
Intervention descriptions: intervention 1: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day

Protocol documents:
Clinical trial NCT01759407
Conditions: Traumatic Femur Fracture
Sponsor: Nationwide Children's Hospital
Start date: 2013-05-01; Completion date: 2016-10-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.

Detailed description:

Arms: arm 1: Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg arm 2: None
Interventions: intervention 1: Ropivicaine intervention 2: Epinephrine
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01773070
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C Hepatitis C virus Direct Acting Antiviral Sustained Virologic Response Hepatitis C Persistence of treatment-emergent substitutions
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2013-06-01; Completion date: 2016-10-01
Enrollment: 478 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).

Detailed description:

Arms: arm 1: Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Interventions: intervention 1: ABT-450/ritonavir intervention 2: ABT-333 intervention 3: ABT-267
Intervention descriptions: intervention 1: ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug. intervention 2: Drug is not administered -- this study is follow-up for participants previously receiving the drug. intervention 3: Drug is not administered -- this study is follow-up for participants previously receiving the drug.

Protocol documents:
Clinical trial NCT01815138
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: OHSS, GnRH agonist trigger, low dose hCG, PCOS, IVF
Sponsor: UConn Health
Start date: 2013-03-01; Completion date: 2016-10-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels \< 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

Detailed description:
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.

Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 \< 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.

The study will evaluate patients at high risk of OHSS development with peak serum E2 \< 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.

Arms: arm 1: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger.

Placebo administered 35 hours after GnRH agonist trigger arm 2: Placebo administered at the time of GnRH agonist trigger

Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger.
Interventions: intervention 1: hCG intervention 2: hCG
Intervention descriptions: intervention 1: Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger intervention 2: Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger

Protocol documents:
Clinical trial NCT01846728
Conditions: Obesity
Sponsor: University of Colorado, Denver
Start date: 2013-04-01; Completion date: 2016-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Menopause is associated with weight gain, but the reasons why are not clear. In this study, the investigators will determine if reducing estrogen levels causes a decrease in the ability of the body to produce heat. If so, this would suggest this is one way that menopause may cause weight gain.

Detailed description:
The purpose of this pilot study is to investigate the role of the female sex hormone estrogen, on metabolism, thermoregulation and energy expenditure. Weight and fat gain increase after the menopause, but reasons for this are not clear. Loss of estrogen may cause changes in how women regulate metabolism and thermoregulation, possibly leading to weight gain. Specifically, this study will determine how loss of estrogen affects facultative thermogenesis. Loosely defined, facultative thermogenesis represents heat production that is turned on when needed. For example, when body core temperature falls below a certain threshold, a shivering response is invoked in skeletal muscle to increase heat production and, thus, energy expenditure. However, exposure over several hours to mild cold temperatures that do not trigger shivering (16-20⁰ C) also induces an increase in energy expenditure (cold-induced non-shivering thermogenesis). Although several different tissues may contribute to this response, the recent identification of functional brown adipose tissue (BAT) in humans has promoted an interest in how BAT is activated in humans and its potential role in regulating energy balance and body weight. The investigators will measure BAT activity using PET/CT scans pre and post three months of estrogen suppression.

Arms: arm 1: Estrogen production will be suppressed using Lupron, a drug that blocks normal production of ovarian hormones
Interventions: intervention 1: Estrogen suppression
Intervention descriptions: intervention 1: Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function

Protocol documents:
Clinical trial NCT01866943
Conditions: Post Operative Blood Loss
Keywords: Blood Loss Tranexamic Acid Total Hip Arthroplasty Post Op Post Operative Prevent Post Operative Blood Loss
Sponsor: Northwell Health
Start date: 2011-11-01; Completion date: 2016-10-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

Detailed description:

Arms: arm 1: Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. arm 2: Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Interventions: intervention 1: Tranexamic Acid intervention 2: Normal Saline Solution
Intervention descriptions: intervention 1: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug. intervention 2: None

Protocol documents: