ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01208038
Conditions: Hypoactive Sexual Desire Disorder
Keywords: Hypoactive sexual desire disorder
Sponsor: Imperial College Healthcare NHS Trust
Start date: 2011-03-01; Completion date: 2012-02-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the effect of the testosterone patch, in addition to hormone replacement therapy (HRT), on blood vessel walls, insulin levels and sexual desire.

Detailed description:
A woman's ovaries produce the hormone testosterone during her reproductive life but testosterone levels decline with age or when the ovaries are removed. Testosterone has been associated with sexual desire in both men and women. Low testosterone is also believed to cause symptoms of low energy. Thus testosterone is increasingly used in hormone replacement regimens to restore libido and energy in postmenopausal women.

In the past testosterone has been administered orally or via subcutaneous implants. Recently testosterone patches have been licensed for treating low libido in postmenopausal women. The testosterone patches deliver a dose of testosterone equivalent to the levels produced by the ovary during a woman's early reproductive years.

Oral testosterone can lead to changes to insulin and cholesterol levels which increase the risk of heart disease. On the contrary, testosterone patches may reduce or avoid this risk. To date, trials have predominantly focused on safety data in terms of side effects and basic blood tests. Reviews of the safety of testosterone replacement have emphasised the need for improved safety data, especially in terms of cardiovascular risk.

The investigators hypothesis that transdermal testosterone, in addition to HRT, will have no adverse effects on blood vessel walls and insulin levels and that transdermal testosterone significantly improves sexuality and psychological well-being in postmenopausal women.

Trial design:

The investigators aim to recruit 20 postmenopausal women to wear the testosterone patch for 3 months in addition to their usual hormone replacement therapy.

There will be 3 study visits - a pre study visit, week 6 and week 12. At each visit the following procedures will be performed:

* Medical history and physical examination
* Blood sample - for hormone levels, lipids and insulin levels
* Blood vessel stiffness measurements This will be performed using a small ultrasound device at the wrist with blood pressure measured every 5 minutes.
* Endothelial function (function of your arterial wall) is measured using a blood pressure cuff on each arm and finger probes on one finger of each hand. The blood pressure cuff is inflated for 5 minutes and is then deflated quickly. The finger probes will record the readings throughout this study.
* Sexual satisfaction questionnaire

Arms: arm 1: Testosterone transdermal patch 300micrograms, twice weekly for 12 weeks
Interventions: intervention 1: Intrinsa Transdermal testosterone patch
Intervention descriptions: intervention 1: 300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks

Protocol documents:
Clinical trial NCT01211665
Conditions: Immune Reconstitution Inflammatory Syndrome Leukoencephalopathy, Progressive Multifocal
Keywords: IVMP corticosteroids IRIS Progressive Multifocal Leukoencephalopathy Immune reconstitution inflammatory syndrome PML
Sponsor: Biogen
Start date: 2010-09-01; Completion date: 2012-02-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.

Detailed description:

Arms: arm 1: Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator. arm 2: Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper of prednisolone over 2 months (suggested dosages starting at 80 mg and tapering to 5 mg). If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
Interventions: intervention 1: Methylprednisolone intervention 2: Prednisolone
Intervention descriptions: intervention 1: In intravenous form (for a daily dose of 1 g/day on treatment days). intervention 2: Oral prednisolone used as a taper, with suggested dosages starting at 80 mg and tapering to 5 mg.

Protocol documents:
Clinical trial NCT01213576
Conditions: Lymphatic Filariasis
Keywords: Lymphatic filariasis microfilaria Albendazole ivermectin human immunodeficiency
Sponsor: London School of Hygiene and Tropical Medicine
Start date: 2009-01-01; Completion date: 2012-02-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Albendazole and ivermectin are currently used in combination for annual mass treatment of lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such programmes is very high and has proven to be a major impediment to the success of programmes in many countries with limited financial resources.

Data from albendazole treatment of other filarial infections and one study comparing single to multi-dose Diethycarbamazine/albendazole in lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may be more effective in clearing microfilariae. It is essential to determine whether such higher doses are indeed beneficial since this could have far-reaching effects on the conduct and management of the main mass treatment programmes and also in the management of programmes as they near elimination.

Detailed description:
The proposed study will enrol up to 120 volunteers with microfilaremic Wuchereria bancrofti infection who would be randomized to receive standard annual treatment (albendazole 400 mg + ivermectin 200 mcg/kg), annual treatment with an increased dose of albendazole (albendazole 800 mg + ivermectin 200400 mcg/kg) or semi-annual treatment with a standard (albendazole 400 mg + ivermectin 200 mcg/kg), or an increased albendazole dose (albendazole 800 mg + ivermectin 200 400 mcg/kg). Microfilarial levels, as well as measures of adult worm burden (circulating antigen) will be followed every six months for two years to determine whether the higher doses, or more frequent regimens are more effective.

The data obtained would be used, in combination with the data from other similar studies being conducted in Mali and in India to advise the Global Programme for the Elimination of Lymphatic Filariasis (GPELF) on improved methods of treatment both for mass treatment and for the management of problem areas within the global programme.

Arms: arm 1: Annual treatment arm 2: Annual treatment arm 3: albendazole 400mg and ivermectin 200mcg/kg given twice a year arm 4: Albendazole 800mg and ivermectin 400mcg/kg given twice a year
Interventions: intervention 1: Albendazole 400mg and ivermectin 200mcg/kg intervention 2: Albendazole and ivermectin intervention 3: Albendazole 400mg and ivermectin 200mcg/kg intervention 4: albendazole 800mg and ivermectin 400mcg/kg bi-annually
Intervention descriptions: intervention 1: 400 mg orally given annually intervention 2: albendazole 800 mg and ivermectin 400mg orally given annually intervention 3: Albendazole 400mg and ivermectin 200mcg/kg given twice a year intervention 4: albendazole 800mg and ivermectin 400mcg/kg given twice a year

Protocol documents:
Clinical trial NCT01214668
Conditions: Solid Tumors
Sponsor: Eli Lilly and Company
Start date: 2009-01-01; Completion date: 2012-02-01
Enrollment: 31 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The goal of this study is to determine the dose of LY573636-sodium (hereafter referred to as LY573636) that can be administered safely in combination with liposomal doxorubicin in patients with advanced cancer who have failed a prior treatment.

The study consists of a dose escalation phase to the maximum tolerated dose (MTD) and a dose confirmation phase in patients with platinum resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have never been treated with doxorubicin.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: LY573636-sodium intervention 2: Liposomal Doxorubicin
Intervention descriptions: intervention 1: Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle.

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met. intervention 2: 40 mg/m² on Day 1, given intravenously of each 28-day cycle

Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met.

Protocol documents:
Clinical trial NCT01224015
Conditions: Facial Rhytides Crow's Feet Lines Glabellar Lines
Sponsor: Allergan
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 684 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.

Detailed description:

Arms: arm 1: 24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. arm 2: Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. arm 3: 44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
Interventions: intervention 1: normal saline intervention 2: onabotulinumtoxinA 44 U intervention 3: onabotulinumtoxinA 24 U
Intervention descriptions: intervention 1: Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. intervention 2: 44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study. intervention 3: 24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Protocol documents:
Clinical trial NCT01224236
Conditions: Anemia
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2010-07-01; Completion date: 2012-02-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if iron supplementation in addition to routine iron intake decreases the risk of developing anemia in preterm infants.

Detailed description:
Objective was to determine if iron supplementation of 2 mg/kg per day, in addition to routine iron-fortified formula or mother's milk, increased the hematocrit (Hct) at 36 weeks' postmenstrual age (PMA).

All infants have a decline in hemoglobin(Hgb) after birth because of increasing PaO2 and Hgb saturation after birth. In very low birth weight (VLBW) infants (birth weight ,1500 g), the nadir at 1 to 3 months after birth is lower than in term infants because of (1) greater phlebotomy losses for blood tests, (2) shortened red blood cell survival, and (3)rapid growth.

VLBW infants may be at increased risk of developing iron deficiency anemia because of (1) low iron stores at birth, (2) rapid depletion of iron stores owing to phlebotomy losses, and (3) inability to regulate iron absorption by the gastrointestinal tract.

Arms: arm 1: 2 mg/kg/day of elemental iron as a multivitamin with iron solution arm 2: multivitamin solution without iron
Interventions: intervention 1: Iron Supplement intervention 2: control
Intervention descriptions: intervention 1: 2 mg/kg/day elemental iron as multivitamin with iron solution intervention 2: multivitamin solution without iron

Protocol documents:
Clinical trial NCT01228435
Conditions: Lung Cancer Stage IIIb Lung Cancer Stage IV Lung Cancer
Keywords: NSCLC IPI-504 ALK translocation Hsp90 inhibitor
Sponsor: Massachusetts General Hospital
Start date: 2010-10-01; Completion date: 2012-02-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IPI-504 blocks a protein that is in cancer cells and is also in normal cells. This protein is called Heat Shock Protein-90 (Hsp90). Hsp90 helps protect certain other proteins from being destroyed by cells. These proteins can mutate to give off signals that allow cancer cells to keep growing. By blocking the function of Hsp90, we hope that the cancer cell will block the mutated protein and cause the cancer cells to die. This drug have been used in other research studies and in the laboratory and information from those other research studies suggests that thsi drug may help to treat lung cancer with ALK mutations. In this research study, we are looking to see what effects IPI-504 has in patients with lung cancer who have an ALK mutation.

Detailed description:
* Participants will receive the study drug (IPI-504) twice weekly for two weeks followed by 10 days without study treatment. This 3-week period is called a cycle. Participants will receive a total of 4 doses per cycle. On the days the participant receives study drug, they will come to the clinic and be given the IPI-504 by being. Participants will continue to receive study drug for additional cycles as long as they are benefiting from it and do not experience any severe side effects.
* Participants will have CT scans to assess the size and location of their tumor. They may also have a PET scan or a combination of PET/CT scans. Imaging will be done at the beginning of treatment and every five to six weeks while on study to assess how the tumor is responding to IPI-504.
* The following tests and procedures will be done on the prior to the first dose of IPI-504: physical examination, vital signs, routine blood tests, EKGs, serum or urine pregnancy test (for women of child-bearing potential).
* After the first dose of IPI-504, the following tests and procedures will be done: EKGs, vital signs (pulse only).
* For all other visit days throughout the study, the following exams, tests and procedures will be done: physical examination, vital signs, blood tests, tumor imaging assessments, MRI of the brain (if applicable), review of medications and answer questions about any side effects or changes in health.
* After the final dose of study drug the following tests and procedures will be done within 30 days: physical examination, ECOG Performance status, blood tests, review of medications and answer questions about any side effects of changes in health.

Arms: arm 1: No prior exposure to ALK-inhibitor arm 2: Prior exposure to ALK inhibitor
Interventions: intervention 1: IPI-504
Intervention descriptions: intervention 1: Given intravenously twice weekly for 2 weeks followed by 10 day off treatment

Protocol documents:
Clinical trial NCT01251146
Conditions: Hypertension
Keywords: Hypertension Bisoprolol Atenolol
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2010-11-01; Completion date: 2012-02-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bisoprolol intervention 2: Atenolol
Intervention descriptions: intervention 1: Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. intervention 2: Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.

Protocol documents:
Clinical trial NCT01255592
Conditions: Bronchiectasis Lung Disease Respiratory Diseases
Keywords: Bronchiectasis Neutrophil Respiratory disease Sputum
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2012-02-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the effect of AZD5069 in patients with bronchiectasis.

Detailed description:

Arms: arm 1: Treatment arm AZD5069 arm 2: Placebo dose.
Interventions: intervention 1: AZD5069 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose bid intervention 2: Oral dose bid

Protocol documents:
Clinical trial NCT01258348
Conditions: Metastatic Renal Cell Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-07-01; Completion date: 2012-02-01
Enrollment: 21 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to determine a safe dose of LY573636-sodium to be given in combination with sunitinib to patients with metastatic Renal Cell Carcinoma (RCC) and to determine any side effects that may be associated with LY573636-sodium and sunitinib combination in this patient population. The tumor response rate will also be assessed.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Drug: LY573636-sodium intervention 2: Sunitinib
Intervention descriptions: intervention 1: Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle.

Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses.

Participants may continue on treatment until clinical or objective disease progression. intervention 2: 37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle.

Participants may continue on treatment until clinical or objective disease progression.

Protocol documents:
Clinical trial NCT01262118
Conditions: Rheumatoid Arthritis
Keywords: Cholesterol metabolism Cholesterol flux Rheumatoid Arthritis Tasocitinib CP-690 550
Sponsor: Pfizer
Start date: 2011-05-01; Completion date: 2012-02-01
Enrollment: 69 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).

Detailed description:

Arms: arm 1: None arm 2: No intervention
Interventions: intervention 1: CP-690,550 (tasocitinib)
Intervention descriptions: intervention 1: CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis

Protocol documents:
Clinical trial NCT01267227
Conditions: Hyperlipidemia Blood Pressure Oxidative Stress
Keywords: Hyperlipidemia Cholesterol Blood Pressure Oxidative Stress Pterostilbene Blueberry Grape Extract
Sponsor: University of Mississippi Medical Center
Start date: 2010-12-01; Completion date: 2012-02-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.

Detailed description:
Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.

Arms: arm 1: Pterostilbene 125 mg twice daily arm 2: Pterostilbene 50 mg twice daily arm 3: Pterostilbene 50 mg/Grape Extract 100 mg twice daily arm 4: Matching placebo twice daily
Interventions: intervention 1: Pterostilbene 50 mg twice daily intervention 2: Placebo intervention 3: Grape Extract intervention 4: Pterostilbene 125 mg twice daily
Intervention descriptions: intervention 1: Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks intervention 2: Matching placebo by mouth twice daily for 6 to 8 weeks intervention 3: Grape extract 100 mg twice daily for 6-8 weeks intervention 4: Pterostilbene 125 mg twice daily for 6-8 weeks

Protocol documents: