ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00000136
Conditions: HIV Infections Cytomegalovirus Retinitis
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 1990-03-01; Completion date: 1991-10-01
Enrollment: 234 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.

Detailed description:
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. The first two drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene) and foscarnet (Foscavir). At the time of this trial, both ganciclovir and foscarnet were available only as intravenous formulations. Both drugs were given in a similar two-step fashion: an initial 2-week course of high-dose therapy (induction) to control the infection followed by long-term lower dose therapy to prevent relapse (maintenance). The FGCRT compared foscarnet and ganciclovir as initial therapy for CMV retinitis.

The FGCRT was a multicenter, randomized, controlled clinical trial comparing foscarnet and ganciclovir as initial therapy for CMV retinitis. Patients with previously untreated CMV retinitis were randomized to therapy with either intravenous ganciclovir or intravenous foscarnet. The outcome measures of this trial were survival, retinitis progression, loss of visual function (visual acuity and visual field), and morbidity.

Arms: arm 1: The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day arm 2: The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.
Interventions: intervention 1: Foscarnet intervention 2: Ganciclovir
Intervention descriptions: intervention 1: 60 mg/kg every 8 hours, 90 mg/kg/day intervention 2: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours

Protocol documents:
Clinical trial NCT03855189
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 1993-08-23; Completion date: 1993-10-22
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.

Detailed description:

Arms: arm 1: Participants receive 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. arm 2: Participants receive 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. arm 3: Participants receive nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Interventions: intervention 1: Mometasone Furoate (MF) intervention 2: Beclomethasone Dipropionate (BDP) intervention 3: Placebo
Intervention descriptions: intervention 1: Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks. intervention 2: Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks. intervention 3: Placebo nasal spray administered for 4 weeks.

Protocol documents:
Clinical trial NCT03861559
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Organon and Co
Start date: 1994-03-30; Completion date: 1994-07-07
Enrollment: 201 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

Detailed description:

Arms: arm 1: Participants administered mometasone furoate nasal spray 200 mcg once daily (QD), as two 50 mcg sprays per nostril, for 14 consecutive days. arm 2: Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Interventions: intervention 1: mometasone furoate nasal spray intervention 2: placebo nasal spray
Intervention descriptions: intervention 1: intranasal administration intervention 2: intranasal administration

Protocol documents:
Clinical trial NCT03882047
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Organon and Co
Start date: 1994-08-11; Completion date: 1994-09-16
Enrollment: 313 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.

Detailed description:

Arms: arm 1: Participants receive 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily. arm 2: Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily. arm 3: Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily.
Interventions: intervention 1: Mometasone furoate intervention 2: Fluticasone propionate intervention 3: Mometasone furoate placebo intervention 4: Fluticasone propionate placebo
Intervention descriptions: intervention 1: Mometasone furoate nasal spray, 200 mg once daily intervention 2: Fluticasone propionate nasal spray, 200 mg once daily intervention 3: Mometasone furoate placebo matching nasal spray, once daily intervention 4: Fluticasone propionate placebo matching nasal spray, once daily

Protocol documents:
Clinical trial NCT00940927
Conditions: Asthma
Keywords: Albuterol Forced expiratory volume in one second Dose at fifty percent of maximum effect Maximum effective dose Metered dose inhaler Nebulizer
Sponsor: Nemours Children's Clinic
Start date: 1993-07-01; Completion date: 1994-10-01
Enrollment: 81 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to determine the lung function response after increasing doses of albuterol (a bronchodilator) in children and adults with asthma.

Detailed description:
Inhaled short-acting b2-agonists (SABA) are the most potent bronchodilators used today to treat acute symptoms of asthma and albuterol, a partial b2-agonist, is the most frequently prescribed asthma medication in the US. Although universally used in for acute asthma symptoms, SABA have been associated with a significant degree of interpatient variability. Many studies have characterized the SABA dose to bronchodilator response relationship under controlled conditions. However, few studies have explored the magnitude and sources of bronchodilator response variability, and no studies have characterized the dose versus bronchodilator response relationship using population pharmacokinetic/pharmacodynamic (PPK/PD) modeling. In the present study, we characterized the relationship between inhaled doses of albuterol and bronchodilation in 81 children and adults with moderate to severe persistent asthma using a population pharmacodynamic approach. The purpose of this study was to obtain estimates of the pharmacodynamic parameters that characterize the dose-response curve, including maximal dose for bronchodilation, and to quantify and identify sources of interpatient pharmacodynamic variability.

Interventions: intervention 1: albuterol
Intervention descriptions: intervention 1: Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)

Protocol documents:
Clinical trial NCT03855228
Conditions: Rhinitis, Allergic
Sponsor: Organon and Co
Start date: 1995-03-01; Completion date: 1995-08-07
Enrollment: 704 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet. arm 2: Daily administration of 200 µg of MFNS plus oral placebo tablet. arm 3: Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. arm 4: Daily administration of placebo nasal spray plus oral placebo tablet.
Interventions: intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Loratadine intervention 3: Placebo nasal spray intervention 4: Placebo tablet
Intervention descriptions: intervention 1: Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days. intervention 2: Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days. intervention 3: Daily dose of placebo administered as a nasal spray for 15 days. intervention 4: Daily dose of placebo administered as an oral tablet for 15 days.

Protocol documents:
Clinical trial NCT00911547
Conditions: Asthma
Keywords: chronic asthma
Sponsor: Organon and Co
Start date: 1995-03-01; Completion date: 1996-05-01
Enrollment: 642 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Detailed description:

Arms: arm 1: Montelukast + Beclomethasone arm 2: Montelukast + Placebo inhaler arm 3: Placebo tablet + Beclomethasone arm 4: Placebo tablet + Placebo inhaler
Interventions: intervention 1: montelukast sodium intervention 2: beclomethasone intervention 3: Placebo inhaler intervention 4: placebo tablet
Intervention descriptions: intervention 1: 10 mg tablet taken once daily at bedtime for 16 weeks intervention 2: 200 ug inhaled, taken twice daily for 16 weeks intervention 3: placebo inhaler taken twice daily for 16 weeks intervention 4: placebo tablet taken once daily at bedtime for 16 weeks

Protocol documents:
Clinical trial NCT00897949
Conditions: Migraine Headache
Sponsor: Organon and Co
Start date: 1995-03-01; Completion date: 1996-07-01
Enrollment: 1473 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate rizatriptan/MK0462 (5 and 10 mg) for the treatment of acute migraine attack and treatment of up to two headache recurrences compared to placebo.

The long term extension study which pools patients from MK0462-022, -025, and -029 is described in NCT01286207.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: rizatriptan benzoate (MK0462) intervention 2: Comparator: placebo
Intervention descriptions: intervention 1: Single dose administration of 5 or 10 mg oral tablet of rizatriptan, taken immediately upon development of acute/severe migraine headache. intervention 2: Placebo to rizatriptan

Protocol documents:
Clinical trial NCT03879772
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Organon and Co
Start date: 1996-03-12; Completion date: 1996-07-01
Enrollment: 679 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.

Detailed description:

Arms: arm 1: Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 2: Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 3: Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 4: Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. arm 5: Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms.
Interventions: intervention 1: Mometasone furoate nasal spray intervention 2: Beclomethasone dipropionate nasal spray intervention 3: Placebo nasal spray intervention 4: Chlorpheniramine maleate syrup
Intervention descriptions: intervention 1: intranasal administration intervention 2: intranasal administration intervention 3: intranasal administration intervention 4: oral administration

Protocol documents:
Clinical trial NCT00000135
Conditions: HIV Infections Cytomegalovirus Retinitis
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 1995-09-01; Completion date: 1996-08-01
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.

Detailed description:
CMV retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 to 40 percent of patients with AIDS. Untreated CMV retinitis is a progressive disorder, the end result of which is total retinal destruction and blindness. As of September 1996, drugs approved by the United States Food and Drug Administration (FDA) for the treatment of CMV retinitis were ganciclovir (Cytovene), foscarnet (Foscavir), and cidofovir (Vistide). All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment (induction) to control the infection followed by long-term lower dose treatment (maintenance) to prevent relapse. Ganciclovir is available in both intravenous and oral formulations, foscarnet only in an intravenous formulation, and cidofovir is given by intermittent intravenous administration. A surgically implanted intraocular sustained-release ganciclovir device (Vitrasert) is also approved by the FDA for the treatment of CMV retinitis.

Despite the use of continuous maintenance therapy, given enough time, all patients with CMV retinitis on systemically administered drugs relapse. Preliminary studies suggested that the anti-CMV monoclonal antibody, MSL-109, when administered in conjunction with ganciclovir, markedly prolonged the time to relapse. Therefore, a randomized controlled clinical trial evaluating MSL-109 as adjunct therapy was conducted.

The MACRT was a randomized, placebo-controlled, multicenter clinical trial evaluating the efficacy and safety of MSL-109 as adjunct therapy for the treatment of CMV retinitis. Patients with CMV retinitis, both those newly diagnosed and those suffering a relapse with active retinitis, were eligible. Primary therapy (e.g., ganciclovir, foscarnet, etc.) was determined by the treating local physician. The patients enrolled in the trial were randomized to either MSL-109 or placebo, administered as a rapid intravenous infusion every 2 weeks. Outcomes included survival, retinitis progression, change in amount of retinal area involved by CMV, loss of visual function (acuity and field), and morbidity.

Arms: arm 1: The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. arm 2: Placebo administered intravenous infusion every 2 weeks 60 mg.
Interventions: intervention 1: MSL-109 intervention 2: Placebo
Intervention descriptions: intervention 1: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout. intervention 2: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.

Protocol documents:
Clinical trial NCT00000392
Conditions: HIV Infections Cognition Disorders
Keywords: Acquired Immunodeficiency Syndrome AIDS-Related Complex
Sponsor: National Institute of Mental Health (NIMH)
Start date: 1990-01-01; Completion date: 1996-08-01
Enrollment: 215 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the chemical efficacy and safety of intranasally administered peptide T on neurocognitive function in HIV seropositive individuals.

Previous studies have shown that treatment with peptide T can result in cognitive improvement in HIV-infected patients.

Patients are randomized to receive either peptide T or placebo for the first 6 months. All patients then receive open-label peptide T for approximately 6 additional months. Neuropsychologic tests are used to determine drug effects.

Detailed description:

Arms: arm 1: Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months arm 2: Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months
Interventions: intervention 1: Peptide T intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00897104
Conditions: Migraine Headache
Sponsor: Organon and Co
Start date: 1995-08-01; Completion date: 1996-09-01
Enrollment: 933 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare rizatriptan (MK0462) 5 mg by mouth (p.o.) and sumatriptan 50 mg p.o. for the acute treatment of a migraine attack.

Detailed description:

Arms: arm 1: Rizatriptan arm 2: Sumatriptan arm 3: Placebo
Interventions: intervention 1: rizatriptan benzoate (MK0462) intervention 2: Comparator: sumatriptan intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: single dose 5 mg rizatriptan p.o. intervention 2: single dose 50 mg sumatriptan p.o. intervention 3: Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally

Protocol documents:
Clinical trial NCT00898677
Conditions: Migraine Headache
Sponsor: Organon and Co
Start date: 1995-09-01; Completion date: 1996-09-01
Enrollment: 1268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.

Detailed description:

Arms: arm 1: rizatriptan 5 mg arm 2: rizatriptan 10 mg arm 3: sumatriptan 100 mg arm 4: placebo
Interventions: intervention 1: rizatriptan benzoate intervention 2: rizatriptan benzoate intervention 3: Comparator: sumatriptan intervention 4: Comparator: Placebo
Intervention descriptions: intervention 1: single dose administration of 5mg rizatriptan (by Mouth) p.o. intervention 2: single dose administration of 10 mg rizatriptan p.o. intervention 3: single dose administration of sumatriptan 100 p.o. intervention 4: placebo to rizatriptan

Protocol documents:
Clinical trial NCT00389168
Conditions: Hypertension
Keywords: Hypertension Cardiac hypertrophy Angiotensin Human
Sponsor: Karolinska Institutet
Start date: 1995-04-01; Completion date: 1997-04-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The renin-angiotensin-aldosterone system has been implicated in the control of structural changes of the heart and the vasculature, beyond the effects on blood pressure.

This projects examines the importance of the renin-angiotensin-aldosterone system and the sympathetic nervous system in the control of cardiac and vascular structure and function in subjects with hypertension.Patients with hypertension and left ventricular hypertrophy were randomized to an angiotensin receptor blocker or a beta adrenergic receptor blocker for 48 weeks. Repeat investigations of blood pressure, structure and function of the heart and the vascular tree, and neurohormones were performed. Two control groups, consisting of normotensive subjects and of hypertensive subjects with no cardiac hypertrophy were also examined for comparison.

Detailed description:
We included 115 patients with hypertension and cardiac hypertrophy, established by echocardiography. Extensive echocardiographic examinations, ultrasonography of the carotid arteries, 24h Holter registrations, 24h ambulatory blood pressure monitoring monitoring, neurohormones and blood samples for inflammation and hemostasis markers and endothelial function were done at weeks 0, 12, 24, and 48. Matched control groups (1:3, i.e. 38 normotensive subjects and 38 hypertensive subjects with no signs of hypertensive heart disease were examined at one occasion. All patients obtained irbesartan or atenolol for 12 weeks; a diuretic and a calcium antagonist was added when needed thereafter in order to obtained a blood pressure below 140/90 mm Hg. All analyses were performed central in a core laboratory.

Arms: arm 1: Irbesartan per os titrated to 300 mg od, 48 weeks arm 2: Atenolol per os titrated to 100 mg od, 48 weeks
Interventions: intervention 1: Irbesartan intervention 2: Atenolol
Intervention descriptions: intervention 1: Titrated to 300 mg od, 48 weeks. intervention 2: Titrated to 100 mg od, 48 weeks.

Protocol documents:
Clinical trial NCT01286207
Conditions: Migraine Disorders
Keywords: Migraine headache
Sponsor: Organon and Co
Start date: 1995-03-01; Completion date: 1997-05-01
Enrollment: 1959 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.

Detailed description:

Arms: arm 1: Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) arm 2: Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) arm 3: Standard care at onset of migraine attack
Interventions: intervention 1: Rizatriptan 5 mg intervention 2: Rizatriptan 10 mg intervention 3: Standard Care
Intervention descriptions: intervention 1: Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) intervention 2: Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s) intervention 3: Active standard care

Protocol documents: