ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01194856
Conditions: HIV Infection Mitochondrial Dysfunction
Keywords: HIV Lipoatrophy mitochondrial dysfunction
Sponsor: The Cleveland Clinic
Start date: 2010-10-01; Completion date: 2011-12-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purposes of this study are to evaluate if switching an antiretroviral medication from efavirenz (EFV) to atazanavir/ ritonavir (ARV/r) will, in a 96-week period, change:

1. the amount of fat in HIV patients with lipoatrophy,
2. metabolic lab values such as your lipid (fat) profile, glucose (blood sugar), and insulin (a hormone that regulates glucose) in HIV patients with lipoatrophy.

Detailed description:
Our study will evaluate the effects on peripheral fat of switching from EFV to ATV/r over 96 weeks in HIV+ patients with clinical lipoatrophy. From a virologic standpoint, EFV and ATV/r are medications which are recommended equally as preferred components of antiretroviral regimens in the December 2009 version of the Guidelines for the Use of Antiretroviral Agents in HIV-1 Infected Adults and Adolescents.\[20\] The study subjects should be receiving a stable EFV-containing antiretroviral (ART) regimen for at least 48 weeks prior to study entry. Blood will be saved for further investigations if needed. Safety parameters will be regularly assessed throughout the study. In addition, a subcutaneous fat biopsy will be obtained to measure fat mtDNA, mtRNA, and fat apoptosis. These measurements would provide significant insight into the clinical changes which have been recently described.

Arms: arm 1: Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen arm 2: Atazanavir 300 mg orally with Ritonavir 100 mg orally once daily for 96 wks
Interventions: intervention 1: Atazanavir/ritonavir intervention 2: Efavirenz
Intervention descriptions: intervention 1: 300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks intervention 2: Maintain dosage - 600 mg orally QHS for 96 weeks

Protocol documents:
Clinical trial NCT01199068
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: PPAR gamma agonist Tumor Cancer Antineoplastic Agent Respiratory Tract Neoplasms Erlotinib Protein Kinase Inhibitors Neoplasms
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

Detailed description:

Arms: arm 1: Drug: CS-7017 from 0.25 mg to 0.50 mg twice a daily Drug: Erlotinib 150 mg once daily
Interventions: intervention 1: CS-7017 intervention 2: Erlotinib
Intervention descriptions: intervention 1: CS-7017 from 0.25 mg to 0.50 mg twice daily intervention 2: Erlotinib 150 mg once daily

Protocol documents:
Clinical trial NCT01209689
Conditions: Spondylitis, Ankylosing
Sponsor: Hoffmann-La Roche
Start date: 2010-10-01; Completion date: 2011-12-01
Enrollment: 113 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients.

This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

Detailed description:

Arms: arm 1: Patients received tocilizumab 4 mg/kg intravenously every 4 weeks for 24 weeks. arm 2: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks for 24 weeks. arm 3: Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01212471
Conditions: Dry Eye Syndrome
Keywords: Sign and symptoms of dry eye disease
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-09-01; Completion date: 2011-12-01
Enrollment: 840 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Detailed description:

Arms: arm 1: Bromfenac ophthalmic solution A arm 2: Bromfenac ophthalmic solution B arm 3: Placebo Comparator
Interventions: intervention 1: Bromfenac Ophthalmic Solution A intervention 2: Bromfenac Ophthalmic Solution B intervention 3: Placebo Comparator
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution intervention 3: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT01225549
Conditions: Asthma
Keywords: Allergen Challenge Asthma Inhaled selective glucocorticoid receptor agonist (iSEGRA)
Sponsor: AstraZeneca
Start date: 2010-11-01; Completion date: 2011-12-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.

Detailed description:

Arms: arm 1: AZD5423 75ug arm 2: AZD5423 300ug arm 3: Budesonide 200 microgram arm 4: Placebo
Interventions: intervention 1: AZD5423 intervention 2: Budesonide 200 microgram intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Suspension for nebulisation once daily 7 days intervention 2: Dry powder for inhalation twice daily 7 days intervention 3: Solution for nebulisation once daily 7 days intervention 4: Solution for nebulisation once daily 7 days

Protocol documents:
Clinical trial NCT01235403
Conditions: Partial Epilepsies
Keywords: Epilepsy treatment. Anti-epileptic drugs Seizures
Sponsor: UCB Pharma
Start date: 2010-06-01; Completion date: 2011-12-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg to 400 mg/d) as add-on treatment for patients with partial onset epilepsy.

Explanation of acronym: SELF = Safety Efficacy Lacosamide Flexibility

Detailed description:

Arms: arm 1: Flexible dosing between 200mg/day and 400mg/day
Interventions: intervention 1: Lacosamide
Intervention descriptions: intervention 1: Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Protocol documents:
Clinical trial NCT01237340
Conditions: Growth Hormone Deficiency (GHD)
Keywords: Adult Growth Hormone Deficiency (AGHD) immunogenicity growth hormone antibodies GH biomarkers IGF-I
Sponsor: EMD Serono
Start date: 2010-10-01; Completion date: 2011-12-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Saizen®
Intervention descriptions: intervention 1: Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.

Protocol documents:
Clinical trial NCT01252186
Conditions: Hemostasis Oral Contraceptive
Keywords: Contraception Hemostasis Blood Coagulation
Sponsor: Teva Women's Health
Start date: 2010-11-01; Completion date: 2011-12-01
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the impact of a 91-day extended cycle oral contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in healthy women.

Detailed description:

Arms: arm 1: Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles. arm 2: Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles. arm 3: Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
Interventions: intervention 1: 91-day Levonorgestrel Oral Contraceptive intervention 2: 28-day Levonorgestrel Oral Contraceptive intervention 3: 28-day Desogestrel Oral Contraceptive
Intervention descriptions: intervention 1: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE. intervention 2: 21 combination tablets containing 150 µg LNG/30 µg EE. intervention 3: 21 combination tablets containing 150 µg DSG/30 µg EE.

Protocol documents:
Clinical trial NCT01254344
Conditions: Infection Surgical Site Infection
Keywords: Colorectal surgery
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-12-01; Completion date: 2011-12-01
Enrollment: 599 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ertapenem sodium compared with ceftriaxone sodium/metronidazole for the prophylaxis of surgical site infection following elective colorectal surgery in Chinese adults. This study is designed to demonstrate that ertapenem sodium is non-inferior to ceftriaxone sodium/metronidazole in this participant population.

Detailed description:

Arms: arm 1: Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose arm 2: Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
Interventions: intervention 1: ertapenem sodium intervention 2: ceftriaxone sodium intervention 3: placebo to metronidazole intervention 4: metronidazole
Intervention descriptions: intervention 1: Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 2: Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 3: Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision intervention 4: Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision

Protocol documents:
Clinical trial NCT01255358
Conditions: Nervous System Disorder Genetic Syndrome
Keywords: Ataxia Teleangiectasia AT ERY-DEX Dexamethasone Dexamethasone sodium phosphate
Sponsor: Quince Therapeutics S.p.A.
Start date: 2011-02-01; Completion date: 2011-12-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study has the aim to evaluate the improvement in CNS symptoms measured by International Co-operative Ataxia Rating Scale (ICARS) in patients with ataxia teleangectasia (AT), during a period of treatment with ERY-DEX (dexamethasone sodium phosphate ex vivo encapsulated into human autologous erythrocytes).

Detailed description:
This is a multi-centre, single arm, open label, 6 months, phase II study to evaluate the effect of ERY-DEX in improving Central Nervous System (CNS) symptoms in patients with Ataxia Teleangectasia (AT). The study consists of a screening period (max duration of 30 days) and a treatment period (duration 6 months).

Arms: arm 1: Patients treated with monthly treatment of ERY-DEX (dexamethasone sodium phosphate encapsulated in autologous erythrocytes)
Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: Dexamethasone sodium phosphate (2 vials, 250 mg/10 ml each) to be administered via encapsulation into autologous erythrocytes (ERY-DEX system). Final amount administered to the patient: about 10-15 mg of dexamethasone sodium phosphate, encapsulated into autologous blood (2 vials of 250 mg each of dexamethasone sodium phosphate will be used in the ex vivo process together with 50 ml of blood previously taken from the same patient).

The treatment has to be repeated at intervals of 30 days (±10 days)

Protocol documents:
Clinical trial NCT01270841
Conditions: Secondary Hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2011-01-01; Completion date: 2011-12-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Detailed description:
This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Arms: arm 1: Placebo arm 2: Testim (topical testosterone) arm 3: Androxal 12.5 mg/day arm 4: Androxal 25 mg/day
Interventions: intervention 1: Placebo intervention 2: topical testosterone intervention 3: Androxal
Intervention descriptions: intervention 1: Placebo capsule 1x daily for 3 months intervention 2: testosterone gel applied 1x daily for 3 months intervention 3: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Protocol documents:
Clinical trial NCT01274611
Conditions: Axillary Hyperhidrosis
Keywords: sweating sweat underarm axillary hyperhidrosis botox liposuction suction-curettage suction curettage
Sponsor: Northwestern University
Start date: 2010-12-01; Completion date: 2011-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effectiveness of two methods in the treatment of excessive underarm sweating (axillary hyperhidrosis): suction-curettage and Botox injections. Suction-curettage is a method in which the doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located. This method has been shown in some studies to effectively reduce underarm sweating for months at a time. Botox is a Food and Drug Administration (FDA) approved drug that in small doses, paralyses muscles. It is most commonly and famously used in the treatment of facial wrinkles. However, it has also been approved to treat excessive sweating. When injected in areas that sweat excessively, sweating can be significantly reduced in that area for months at a time. This study is a pilot study designed to determine feasibility of these procedures.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Botulinum Toxin Type A intervention 2: Suction-Curettage
Intervention descriptions: intervention 1: Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating. intervention 2: The doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.

Protocol documents:
Clinical trial NCT01276847
Conditions: Psoriasis
Keywords: psoriasis Ustekinumab Stelara Etanercept Enbrel
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-01; Completion date: 2011-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-part study. The purpose of the pilot study (Part 1) is to optimize the acquisition, handling and shipping procedure for skin biopsies obtained from participants with plaque psoriasis. No treatment will be administered. Part 2 will include 2 cohorts. In Cohort 1, the effects of 16 weeks of treatment with either ustekinumab or etanercept on biomarkers in lesional skin in participants with moderate to severe psoriasis will be evaluated. In Cohort 2, biomarkers of lesional skin from participants with moderate to severe psoriasis who are not treated with biologic therapy will be evaluated over 16 weeks. The primary hypothesis is that treatment with ustekinumab reduces messenger RNA (mRNA) expression of genes in the interleukin 12 (IL-12) pathway that are modulated by interferon gamma (IFN-γ).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ustekinumab intervention 2: Etanercept
Intervention descriptions: intervention 1: Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing \> 100 kg on Day 1, and Weeks 4 and 16 intervention 2: Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks

Protocol documents:
Clinical trial NCT01277159
Conditions: Patients Undergoing Ankle Surgery
Keywords: Analgesia Duration Popliteal Fossa Nerve Block Dexamethasone Buprenorphine Additives Ankle surgery
Sponsor: Hospital for Special Surgery, New York
Start date: 2010-10-01; Completion date: 2011-12-01
Enrollment: 108 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.

Primary outcome:

Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?

Detailed description:

Arms: arm 1: Control Nerve Block. IV Dexamethasone (4 mg). arm 2: B. Nerve Block with Dexamethasone (4 mg). IV saline. arm 3: Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) arm 4: Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). arm 5: Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
Interventions: intervention 1: A. Control Nerve Block. IV Dexamethasone (4 mg). intervention 2: B. Nerve Block with Dexamethasone (4 mg). IV saline. intervention 3: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) intervention 4: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). intervention 5: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).
Intervention descriptions: intervention 1: A. Control Nerve Block. IV Dexamethasone (4 mg). intervention 2: B. Nerve Block with Dexamethasone (4 mg). IV saline. intervention 3: C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) intervention 4: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). intervention 5: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.

Protocol documents:
Clinical trial NCT01281306
Conditions: Systolic Hypertension
Keywords: hypertension blood pressure LCZ696 dual-acting neprilysin nep inhibitor vasopeptidase angiotensin receptor angiotensin receptor neprilysin inhibitor (ARNi)
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2011-12-01
Enrollment: 910 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Detailed description:

Arms: arm 1: Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks. arm 2: Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks. arm 3: Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks. arm 4: Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks. arm 5: Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks. arm 6: Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks. arm 7: Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
Interventions: intervention 1: LCZ696 intervention 2: Valsartan intervention 3: AHU377 intervention 4: Placebo
Intervention descriptions: intervention 1: LCZ696 was supplied as tablets in blister cards in 100 mg strengths. intervention 2: Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths. intervention 3: AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths. intervention 4: Placebo was supplied as tablets in blister cards.

Protocol documents:
Clinical trial NCT01283464
Conditions: Photodamaged Skin Wrinkles
Keywords: Retinol Tretinoin
Sponsor: Johns Hopkins University
Start date: 2010-11-01; Completion date: 2011-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the comparative efficacy of retinol 1.0% and tretinoin 0.02% in minimizing wrinkles, discoloration, roughness, and other signs of moderate to severe photodamage. Our hypothesis is that both products will be of comparable benefit.

Detailed description:

Arms: arm 1: Retinol 1.0% cream arm 2: Tretinoin 0.02% cream
Interventions: intervention 1: Retinol intervention 2: Tretinoin
Intervention descriptions: intervention 1: 1.0% cream intervention 2: 0.02% cream

Protocol documents: