ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01253174
Conditions: Contraception
Sponsor: Bayer
Start date: 2006-08-01; Completion date: 2007-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to examine and compare the uptake of Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without Yasmin in the body, in healthy volunteers not using hormonal contraception.

Detailed description:

Arms: arm 1: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) arm 2: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\]) arm 3: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium \[MTHF-Ca\])
Interventions: intervention 1: EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131) intervention 2: EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca) intervention 3: L-5-MTHF Ca 0.451 mg (Metafolin)
Intervention descriptions: intervention 1: single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) intervention 2: single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin intervention 3: single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin

Protocol documents:
Clinical trial NCT01382901
Conditions: Restless Legs Syndrome (RLS)
Sponsor: American Regent, Inc.
Start date: 2006-03-01; Completion date: 2007-07-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02231918
Conditions: Restless Legs Syndrome
Sponsor: Boehringer Ingelheim
Start date: 2006-05-01; Completion date: 2007-07-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MIRAPEX® - low intervention 2: MIRAPEX® - medium intervention 3: MIRAPEX® - high
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT02288312
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-05-01; Completion date: 2007-07-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.

Detailed description:
Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.

Arms: arm 1: Tablets 800 mg. Administration:Oral. arm 2: Tablets 800 mg. Administration:Oral. arm 3: Tablets 2 x 400 mg. Administration:Oral.
Interventions: intervention 1: BIA 2-093
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00081458
Conditions: Short Bowel Syndrome
Keywords: Short Bowel Syndrome Parenteral Nutrition SBS
Sponsor: Shire
Start date: 2004-05-25; Completion date: 2007-07-06
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Detailed description:
Teduglutide is an analog of glucagon-like peptide 2 (GLP-2), a naturally occurring hormone that regulates the growth, proliferation, and maintenance of cells lining the gastrointestinal tract. Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells, thereby increasing the absorptive surface area of the intestines.

The multicenter, double-blind, international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 0.05 milligrams or 0.10 milligrams of teduglutide per kilogram of body weight, or a placebo. Dosing will continue for a period of six months. The primary endpoint in the study is a reduction in the use of intravenous feeding, which is often required to sustain life in patients with SBS.

Arms: arm 1: Placebo injectable subcutaneously daily into the thigh or abdomen arm 2: teduglutide 0.05 mg/kg/d arm 3: teduglutide 0.1 mg/kg/d
Interventions: intervention 1: Placebo intervention 2: Teduglutide 0.05 mg/kg/d intervention 3: Teduglutide 0.1 mg/kg/d
Intervention descriptions: intervention 1: placebo injectable subcutaneously daily into thigh or abdomen intervention 2: Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen intervention 3: Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Protocol documents:
Clinical trial NCT01059435
Conditions: Osteopenia
Keywords: Amgen First in Human Postmenopausal Phase 1
Sponsor: Amgen
Start date: 2006-12-13; Completion date: 2007-07-06
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study is to assess the safety and tolerability of romosozumab following single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.

Detailed description:

Arms: arm 1: Participants were randomized to receive a single dose of matching placebo administered by subcutaneous or intravenous injection. arm 2: Participants were randomized to receive a single dose of romosozumab administered by subcutaneous or intravenous injection. The starting dose was 0.1 mg/kg, with sequential escalation up to 10 mg/kg.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously or intravenously intervention 2: Administered subcutaneously or intravenously

Protocol documents:
Clinical trial NCT00422240
Conditions: Acne Vulgaris
Keywords: Acne vulgaris Adapalene Benzoyl Peroxide
Sponsor: Galderma R&D
Start date: 2006-06-27; Completion date: 2007-07-12
Enrollment: 1668 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Detailed description:

Arms: arm 1: Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. arm 2: Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks. arm 3: Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. arm 4: Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.
Interventions: intervention 1: Adapalene/Benzoyl Peroxide intervention 2: Adapalene Gel, 0.1% intervention 3: Benzoyl Peroxide Gel 2.5% intervention 4: Gel Vehicle
Intervention descriptions: intervention 1: Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks. intervention 2: 0.1% of adapalene gel topically daily in the evening for 12 Weeks. intervention 3: 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks. intervention 4: Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Protocol documents:
Clinical trial NCT00455923
Conditions: Asthma
Keywords: asthma exacerbation persistent bronchial hyperresponsiveness mild GINAII
Sponsor: GlaxoSmithKline
Start date: 2005-05-03; Completion date: 2007-07-31
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.

Detailed description:

Arms: arm 1: Eligible participants received a starting dose of 50/100 mcg Seretide (combination of Sal/FP) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. arm 2: Eligible participants received a starting dose of 100 mcg Flixotide (FP only) via Diskus inhaler, twice daily. During the first 6 months, when the asthma was unstable/uncontrolled, dose was increased in a stepwise fashion to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months.
Interventions: intervention 1: Seretide intervention 2: Flixotide
Intervention descriptions: intervention 1: Seretide intervention 2: Flixotide

Protocol documents:
Clinical trial NCT00003473
Conditions: Mixed Gliomas
Keywords: recurrent adult mixed glioma refractoy adult mixed glioma
Sponsor: Burzynski Research Institute
Start date: 1996-03-01; Completion date: 2007-08-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adults with recurrent or refractory mixed gliomas provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adults with recurrent or refractory mixed gliomas.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in adults with recurrent or refractory mixed gliomas.

OVERVIEW: This is a single arm, open-label study in which adults with recurrent or refractory mixed gliomas receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Atengenal intervention 2: Astugenal
Intervention descriptions: intervention 1: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal). intervention 2: Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00071396
Conditions: Chronic Lymphocytic Leukemia
Keywords: Chronic Lymphocytic Leukemia CD-52 and CD-20 Positive Refractory Relapsed
Sponsor: M.D. Anderson Cancer Center
Start date: 2002-10-01; Completion date: 2007-08-01
Enrollment: 48 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if giving CAMPATH-1H with rituximab can shrink or slow the growth of the disease in patients with chronic lymphoid disorders that have either not responded or whose disease has returned after treatment with standard therapies.

Detailed description:
Objectives:

1. To determine the efficacy and response rates of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in the treatment of chronic lymphoid disorders that are refractory to conventional therapy, have relapsed, or have no established frontline therapy.
2. To assess the safety of the combination of Campath-1H when given as a continuous intravenous infusion followed by subcutaneous injection plus rituximab in chronic lymphoid disorders that express both CD52 and CD20 cell surface antigens.
3. To measure levels of soluble (s) CD20 and sCD52 as well as levels of Campath-1H, rituximab and antibody complexes of rituximab/CD20 and Campath-1H/CD52 in patients with chronic lymphoid disorders treated with Campath-1H plus rituximab.

Arms: arm 1: Campath 15 mg/day continuous intravenous (IV) infusion x 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.

Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Interventions: intervention 1: Campath-1H intervention 2: Rituximab
Intervention descriptions: intervention 1: 15 mg/day Continuous infusion by vein (IV) for 6 days then given twice a week for remaining three weeks as 30 mg injection under skin to complete one treatment course of 4 weeks. intervention 2: 375 mg/m\^2 IV infusion on day 1, then 500 mg/m\^2 on days 8, 15, and 22.

Protocol documents:
Clinical trial NCT00201123
Conditions: Tuberculosis AIDS-related Complex
Sponsor: NYU Langone Health
Start date: 2005-04-01; Completion date: 2007-08-01
Enrollment: 89 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the lung's immune response to mycobacterium tuberculosis (Mtb) infection and will modulate that response with interferon-gamma.

Detailed description:
BACKGROUND:

Mtb infects one-third of the world's population and ranks seventh in terms of global morbidity and mortality. Patients with bilateral pulmonary tuberculosis (TB), cavitary disease, and persistently positive sputum smears pose a special risk for treatment failure and/or relapse.

DESIGN NARRATIVE:

Cavitary pulmonary TB will be studied and interferon-gamma will be used as the intervention. The outcome of this study will be the changes in mycobacteriology, chest radiography, and bronchoalveolar lavage (BAL) cells.

The primary outcome will be sputum conversion, which will be measured at Weeks 4 and 8.

The key secondary outcomes of this study will include a chest computerized tomography (CT) scan and BAL to measure the flow of cytometry and cytokine levels. Both outcomes will be measured at baseline and at Month 4.

Arms: arm 1: Isoniazid, Rifampin, Pyrazinamide Anti-Tuberculous Therapy arm 2: Aerosol Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide arm 3: Subcutaneous Interferon-Gamma plus Isoniazid, Rifampin, and Pyrazinamide
Interventions: intervention 1: Aerosol Interferon-Gamma intervention 2: Subcutaneous interferon-gamma intervention 3: Placebo
Intervention descriptions: intervention 1: Participants will receive aerosol interferon-gamma. intervention 2: Patients will receive subcutaneous interferon-gamma intervention 3: None

Protocol documents:
Clinical trial NCT00202722
Conditions: Labour Pain Satisfaction Adverse Effects
Keywords: Remifentanil, parenteral opioids, obstetric analgesia, IVPCA
Sponsor: Sorlandet Hospital HF
Start date: 2004-01-01; Completion date: 2007-08-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Remifentanil is a ultra short-acting synthetic opioid. It is rapidly metabolized by non-specific blood and tissue esterases. We wanted to investigate the efficacy and safety of remifentanil used as analgesia during labour. Intravenous patient controlled analgesia (ivpca) were used to administer remifentanil. Doses used were 0,15-1,05 mikrogr/kg, with a lock-out time of 2 minutes. 41 women were included in the study. Blood-pressure, heartrate, SaO2, respiration rate and sedation were recorded every 15.minute. Fetal heart rate was recorded for the whole periode of treatment (CTG, STAN). Vaginal contraction pain were assessed by the parturients every 15.minute using a Visual Analogue Scale (VAS). Midwives also recorded their impression of the parturients pain. The parturients level of sedation were recorded by anesthesiologist and midwife every 15.minute. Apgar scores were registered at 1, 5 and 10 min after delivery. Umbilical cord blood analysis regarding blood gases and concentration of remifentanil were performed. After delivery, both mother and midwife evaluated efficacy and safety; Global satisfaction score, if the remifentanil doses were sufficient, nausea, vomiting, level of sedation and dizziness.

Detailed description:
Primary and secondary outcome measures presented under "results"

Arms: arm 1: Bolus dose steps of 0.15 microgr/kg, with a 2-min lock-out time
Interventions: intervention 1: Remifentanil
Intervention descriptions: intervention 1: Intravenous patient controlled analgesia (ivpca) during labour

Protocol documents:
Clinical trial NCT00241631
Conditions: COPD
Keywords: COPD
Sponsor: Imperial College London
Start date: 2006-04-01; Completion date: 2007-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigator wish therefore to continue these studies on theophylline principally by conducting a small clinical pilot study on 20-30 COPD patients in a randomised, double-blind, placebo-controlled, parallel-group study.

Detailed description:
The global burden of COPD - a common and debilitating chronic inflammatory disease that is characterised by the progressive development of airflow limitation (shortness of breath - SOB) and is poorly reversible with currently available drugs -is increasing. Cigarette smoking is strongly linked with the ongoing inflammation; inflammation that can continue even when the patient has stopped smoking. The severity of airflow limitation (SOB) is correlated with the degree of pulmonary (lung) inflammation.

Histone deacetylases (HDACs)are important molecules in suppressing this pulmonary inflammation. We have recently shown that patients with COPD have a reduction in total HDAC which correlates with the severity of their lung disease.

Corticosteroids (anti-inflammatory treatment) act, at least in part, by recruitment of these HDACs to the site of active inflammatory gene transcription (which reduces the production of inflammatory molecules) and are widely used in COPD in patients with severe disease. Unfortunately, in COPD, inhaled corticosteroids seem to have little effect on the underlying inflammation (though in a selective group of patients with COPD they do reduce the number of infections a patient may have by a small amount).

Theophylline has been used in the treatment of asthma and COPD for over 70 years, but its use has recently declined. Data so far obtained in primary cells (cells from patients used in the laboratory) from COPD patients suggests that low dose theophylline (\~5mg/l) should be effective in restoring steroid sensitivity in patients with COPD (and hence reduce inflammation thus improving SOB).

Arms: arm 1: Inhaled Theophylline placebo capsule, then placebo, then active Theophylline arm 2: Inhaled Theophylline placebo capsule, then Fluticasone Propionate 500 ug bid, then active Theophylline
Interventions: intervention 1: Fluticasone Propionate intervention 2: placebo intervention 3: Theophylline
Intervention descriptions: intervention 1: 500 u intervention 2: None intervention 3: Theophylline placebo capcule

Protocol documents: