ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01606709
Conditions: Endometrial Receptivity Ovarian Hyperstimulation Syndrome
Keywords: GnRHa trigger endometrial gene profile quality of life
Sponsor: UConn Health
Start date: 2012-04-01; Completion date: 2014-12-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare gene expression profiles in endometrial biopsies during the window of implantation after triggers of oocyte maturation using GnRH agonist or hCG and compared with their natural cycles in order to identify genes that may be dysregulated in GnRH agonist-triggered cycles.

The investigators also intend to evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Detailed description:
Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation (COH) which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. The use of a GnRH agonist for induction of final oocyte maturation in ovarian stimulation cycles utilizing GnRH antagonist for pituitary suppression has proven to be an effective method of preventing the risk of OHSS development.

Unfortunately, some studies, but not all, have also reported lower pregnancy rates in these cycles as compared to cycles using hCG trigger and this has been attributed to possible impaired endometrial receptivity.

The investigators intend to obtain endometrial biopsies collected from the same subject in a natural cycle and then a biopsy during either a GnRH agonist or hCG triggered stimulation. Expression profiles of mRNAs will first be screened using microarray technology. Relative levels of specific mRNAs that display altered expression in the GnRH-triggered samples, as assayed by microarray, will then be confirmed by real-time, quantitative reverse transcription/polymerase chain reaction (Q-PCR). The investigators shall also evaluate patients feeling of well being and physical quality of life after GnRH agonist trigger compared with hCG trigger.

Arms: arm 1: Induction of oocyte maturation with GnRH agonist arm 2: Induction of oocyte maturation with hCG
Interventions: intervention 1: GnRH agonist intervention 2: hCG
Intervention descriptions: intervention 1: GnRH agonist 1mg one dose intervention 2: 5,000 IU one dose

Protocol documents:
Clinical trial NCT01618669
Conditions: Coronary Artery Disease (CAD)
Keywords: Coronary Artery Disease (CAD) regadenoson pharmacologic stress
Sponsor: Astellas Pharma Global Development, Inc.
Start date: 2012-06-01; Completion date: 2014-12-01
Enrollment: 1147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.

Detailed description:

Arms: arm 1: On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI. arm 2: On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus (1 hour after exercise recovery), and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
Interventions: intervention 1: Regadenoson intervention 2: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
Intervention descriptions: intervention 1: Administered as an intravenous (IV) bolus intervention 2: None

Protocol documents:
Clinical trial NCT01619176
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis blood gut intestinal microbiome
Sponsor: Chinese Academy of Sciences
Start date: 2012-10-01; Completion date: 2014-12-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis.

The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.

Detailed description:

Arms: arm 1: Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) arm 2: Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Interventions: intervention 1: methotrexate intervention 2: non-steroidal anti-inflammatory drug (NSAID) intervention 3: leflunomide intervention 4: methotrexate intervention 5: non-steroidal anti-inflammatory drug (NSAID) intervention 6: leflunomide intervention 7: Acupuncture
Intervention descriptions: intervention 1: methotrexate: 7.5mg/week to 15mg/week for 3 months intervention 2: NSAID: 100mg twice a day for 3 months intervention 3: leflunomide: 20mg/day for 3 months intervention 4: methotrexate: 7.5mg/week to 15mg/week for 3 months intervention 5: NSAID: 100mg twice a day for 3 months intervention 6: leflunomide: 20mg/day for 3 months intervention 7: 30 minutes acupuncture every other day for 3 months.

Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20.

Protocol documents:
Clinical trial NCT01623115
Conditions: Hypercholesterolemia
Keywords: PCSK9
Sponsor: Sanofi
Start date: 2012-07-01; Completion date: 2014-12-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab

Detailed description:
The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

Arms: arm 1: Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks. arm 2: Alirocumab 75 mg Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Lipid Modifying Therapy (LMT)
Intervention descriptions: intervention 1: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). intervention 2: Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen). intervention 3: Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Protocol documents:
Clinical trial NCT01625338
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy GS-7977 Ribavirin Open Label
Sponsor: Gilead Sciences
Start date: 2012-06-01; Completion date: 2014-12-01
Enrollment: 534 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Detailed description:

Arms: arm 1: SOF+RBV for 12 weeks arm 2: SOF+RBV for 24 weeks arm 3: SOF+RBV+Peg-IFN for 12 weeks
Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Peg-IFN
Intervention descriptions: intervention 1: SOF 400 mg tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Peg-IFN 180 μg administered once weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT01634113
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2012-07-01; Completion date: 2014-12-01
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.

Detailed description:

Arms: arm 1: Once daily, delivered with Respimat® inhaler arm 2: Once daily, delivered with Respimat® inhaler arm 3: Once daily, delivered with Respimat® inhaler
Interventions: intervention 1: tiotropium-bromide intervention 2: tiotropium-bromide intervention 3: placebo
Intervention descriptions: intervention 1: IMP intervention 2: IMP intervention 3: placebo matching tiotropium

Protocol documents:
Clinical trial NCT01639157
Conditions: Cocaine Use Disorders
Sponsor: William Stoops
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Cocaine use disorders are an unrelenting public health concern. Intensive research efforts have yielded behavioral interventions that reduce cocaine use, however, these interventions are not universally effective and treatment effects diminish over time. Development of a pharmacotherapy that enhances the efficacy of these interventions is a priority for the National Institute on Drug Abuse. This study proposes to determine the impact of buspirone maintenance on self-administration of cocaine and alternative reinforcers. These preliminary data will be used to support further research developing buspirone as a pharmacotherapy for cocaine use disorders. We hypothesize that buspirone will attenuate the reinforcing effects of cocaine and increase the reinforcing effects of alternative reinforcers.

Detailed description:

Arms: arm 1: Subjects will be maintained on 30 mg buspirone daily. arm 2: Subjects will be maintained on placebo (i.e., 0 mg buspirone daily).
Interventions: intervention 1: Buspirone intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be maintained on oral buspirone (10 mg administered 3 times daily) for 6 days each during the study in random order. intervention 2: Subjects will be maintained on oral placebo (0 mg administered 3 times daily) for 6 days each during the study in random order.

Protocol documents:
Clinical trial NCT01640964
Conditions: Compensated Cirrhosis and Portal Hypertension
Keywords: Portal hypertension, cirrhosis, TIPSS, MRI, MRA, portal pressure, portal pressure gradient
Sponsor: Novartis Pharmaceuticals
Start date: 2013-04-01; Completion date: 2014-12-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this exploratory study was to investigate the effect of serelaxin (RLX030) infusion on the hepatic and renal circulation in patients with compensated cirrhosis and portal hypertension. Measurements were acquired non-invasively using magnetic resonance angiography (MRA) (study part A) and more directly via cannulation of the hepatic portal vein during a routine transjugular intrahepatic portosystemic shunt (TIPSS) check procedure (study part B), to determine the acute haemodynamic response to serelaxin (RLX030).

Detailed description:

Arms: arm 1: Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection. arm 2: Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition arm 3: The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of Portal pressure gradient (PPG) data acquisition.
Interventions: intervention 1: Terlipressin acetate intervention 2: Serelaxin (RLX030)
Intervention descriptions: intervention 1: IV bolus injection intervention 2: Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours

Protocol documents:
Clinical trial NCT01648322
Conditions: Breast Cancer Neutropenia
Keywords: Breast Cancer Taxotere Chemotherapy Neulasta efficacy and safety single cycle doses of F-627 pegfilgrastim
Sponsor: EVIVE Biotechnology
Start date: 2012-06-01; Completion date: 2014-12-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.

Detailed description:
This is a randomized, multi-center, dose finding, open label, positive controlled Phase II study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta® (pegfilgrastim) in women with breast cancer who are receiving myelotoxic chemotherapy (TC: docetaxel + cyclophosphamide or TAC: docetaxel + doxorubicin + cyclophosphamide).

The primary objective of this study is to evaluate the efficacy and safety of various single cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study will be defined by the duration of moderate neutropenia; the number of days in which the patient has had an absolute neutrophil count (ANC) \< 1.0 × 10\^9/L during the first cycle of their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to be tested for subjects receiving TC chemotherapy are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose. For subjects receiving TAC chemotherapy, only 240 µg/kg/dose and 320 µg/kg/dose are to be tested.

Arms: arm 1: This dose of F-627 given only to subjects that are to have TC chemotherapy. arm 2: This dose of F-627 given to subjects receiving TC or TAC chemotherapy. arm 3: This dose of F-627 given to subjects receiving TC or TAC chemotherapy. arm 4: Given to subjects receiving TC or TAC chemotherapy.
Interventions: intervention 1: F-627 intervention 2: Neulasta® (pegfilgrastim)
Intervention descriptions: intervention 1: subcutaneous injection given 1 per chemotherapy. intervention 2: Single dose injection given once per chemotherapy cycle.

Protocol documents:
Clinical trial NCT01649804
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2012-07-01; Completion date: 2014-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This extension study of WA19926 will assess the long-term safety and the efficacy of RoActemra/Actemra (tocilizumab) treatment in participants with rheumatoid arthritis. Participants who have completed the core study WA19926 are eligible to participate. Participants will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. The anticipated time on study drug is 104 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg intravenously every 4 weeks for 104 weeks

Protocol documents:
Clinical trial NCT01653743
Conditions: Anovulation Oligo-ovulation Hypothalamic-pituitary Dysfunction Polycystic Ovarian Syndrome
Keywords: Japanese
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-09-01; Completion date: 2014-12-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MSJ-0011 intervention 2: urinary hCG (u-hCG) intervention 3: Follitropin alpha
Intervention descriptions: intervention 1: Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa \[recombinant human Chorionic Gonadotropin, r-hCG\]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (\>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of \>=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL). intervention 2: Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of \>=18 mm; not more than 3 follicles each with a mean diameter of \>=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL. intervention 3: Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days.

Protocol documents:
Clinical trial NCT01663103
Conditions: Renal Insufficiency, Chronic
Keywords: Interleukin-1 Endothelium, Vascular Vascular Stiffness Oxidative Stress Inflammation Endothelial cells
Sponsor: University of Colorado, Denver
Start date: 2012-08-01; Completion date: 2014-12-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Risk of cardiovascular diseases (CVD) is significantly elevated in patients with chronic kidney disease (CKD); however, this increased risk is only partially explained by traditional cardiovascular risk factors. Patients with CKD exhibit chronic inflammation, a key mechanism contributing to vascular dysfunction (i.e., large elastic artery stiffening and endothelial dysfunction). Inhibiting inflammation improves vascular dysfunction in other populations characterized by chronic inflammation. However, it is currently unknown if reducing inflammation with an interleukin-1 (IL-1) blocker enhances vascular function in CKD patients. Aim 1 will assess the efficacy of IL-1 blocking with rilonacept for treating vascular dysfunction in patients with stage III or IV CKD (estimated glomerular filtration rate 15-60 mL/min/1.73 m2). Aim 2 will determine if blocking IL-1 with rilonacept also reduces inflammation and oxidative stress. These studies could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis.

Detailed description:

Arms: arm 1: 12 weeks of treatment with rilonacept arm 2: Twelve weeks of treatment with placebo
Interventions: intervention 1: Rilonacept intervention 2: Placebo
Intervention descriptions: intervention 1: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk) intervention 2: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)

Protocol documents: