ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00048061
Conditions: Post Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2002-04-01; Completion date: 2004-12-01
Enrollment: 1609 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day . arm 2: Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day. arm 3: Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day arm 4: Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Interventions: intervention 1: Ibandronate [Bonviva/Boniva] intervention 2: Ibandronate [Bonviva/Boniva] intervention 3: Ibandronate [Bonviva/Boniva] intervention 4: Ibandronate [Bonviva/Boniva] intervention 5: Calcium intervention 6: Vitamin D
Intervention descriptions: intervention 1: 2.5mg po daily intervention 2: 100mg po monthly on a single day intervention 3: 100mg po monthly over 2 consecutive days intervention 4: 150mg po monthly intervention 5: 500 mg/day intervention 6: 400 IU/day

Protocol documents:
Clinical trial NCT00067236
Conditions: Myocardial Infarction Heart Failure Heart Enlargement
Sponsor: Procter and Gamble
Start date: 2003-09-01; Completion date: 2004-12-01
Enrollment: 253 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of the study is to test whether a possible new drug (called PG-116800) can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

Detailed description:
Heart attacks cause damage to heart muscle that can weaken the heart and lead to changes in the shape and pumping ability of the heart. These changes can lead to heart failure. An enzyme called metalloproteinase (MMP) plays a role in this damage.

The main purpose of the study is to test whether a possible new drug (called PG-116800) that interferes with the MMP enzyme can prevent some of the damage to heart muscle in patients who have had a heart attack. The study will also supply information regarding possible uses of this compound in cardiovascular disease.

This is a Phase II "proof-of-concept" study; that is, it is a first attempt to treat sick people with the drug to see if it works.

The study is interventional since we will be using a drug to interfere with the heart tissue damage that follows a heart attack.

Arms: arm 1: PG-116800 tablet (200 mg) taken twice daily for 90 days arm 2: Placebo tablet taken twice daily for 90 days
Interventions: intervention 1: PG-116800 (given as PG-530742) intervention 2: Placebo tablet
Intervention descriptions: intervention 1: 200 mg tablet of PG-116800 (given as PG-530742)twice a day for 90 days intervention 2: placebo tablet, twice a day for 90 days

Protocol documents:
Clinical trial NCT00080288
Conditions: Excessive Sleepiness Shift Work Sleep Disorder
Keywords: Excessive Sleepiness Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cephalon Cephalon, Inc Nuvigil
Sponsor: Cephalon
Start date: 2004-03-01; Completion date: 2004-12-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.

Detailed description:

Arms: arm 1: Armodafinil 150 mg/day arm 2: Placebo
Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked. intervention 2: Matching placebo tablets once daily

Protocol documents:
Clinical trial NCT00088634
Conditions: Schizophrenia
Keywords: Schizophrenia Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2004-05-01; Completion date: 2004-12-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 6-week in-patient and out-patient study to test the effectiveness and safety of a new medication in the treatment of schizophrenia

Detailed description:
Study will evaluate the efficacy of a new compound versus placebo in the treatment of patients with schizophrenia (diagnosed by DSM-IV criteria) as measured by reductions from baseline on the total score of the Brief Psychiatric Rating Scale (BPRS) as extracted from the Positive and Negative Syndrome Scale (PANSS).

Arms: arm 1: 80 mg AM dosing once daily arm 2: None
Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: 80 mg AM dosing once daily intervention 2: Matching Placebo to 40mg lurasidone tablets

Protocol documents:
Clinical trial NCT00200343
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C, Ursodeoxycholic acid
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2002-07-01; Completion date: 2004-12-01
Enrollment: 596 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

Detailed description:
This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ursodeoxycholic acid 150mg / day intervention 2: Ursodeoxycholic acid 600mg / day intervention 3: Ursodeoxycholic acid 900mg / day
Intervention descriptions: intervention 1: Ursodeoxycholic acid, 150mg/ day, three times a day at meals intervention 2: Ursodeoxycholic acid, 600mg/ day, three times a day at meals intervention 3: Ursodeoxycholic acid, 900mg/ day, three times a day at meals

Protocol documents:
Clinical trial NCT00267111
Conditions: Pain
Keywords: Infant,newborn Topical anesthesia Intramuscular injection
Sponsor: Mount Sinai Hospital, Canada
Start date: 2003-07-01; Completion date: 2004-12-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the efficacy of topical amethocaine gel (Ametop) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K.

Study Hypothesis: We believe that topical amethocaine gel will be superior to placebo in decreasing the pain from intramuscular injection in term neonates.

Detailed description:
This randomized controlled trial will assess the efficacy of topical amethocaine gel (Ametop) compared with placebo (Eucerin plus) in decreasing the pain response in term neonates subjected to intramuscular injection for administration of vitamin K. Neonatal pain response between groups will be assessed using the Neonatal Facial Action Coding System (NFCS) which is currently the gold standard for infant pain assessment, latency to first cry and cry duration. Parents' (father) perception of infant's pain will be assessed using a visual analogue scale (VAS) when possible.

Neonates will be randomized to receive either amethocaine gel or identical appearing placebo administered locally at the injection site (the upper part of the neonate's thigh) using a pre-prepared syringe 30 minutes prior to the administration of vitamin K. The gel or placebo will be covered using a Saran wrap. Each neonate will be videotaped during the procedure. Parents (father) will be present during the procedure (observing) so that they (he) can assess their neonate's pain response using VAS.

Arms: arm 1: 1 g of topical amethocaine gel 4% arm 2: None
Interventions: intervention 1: Eucerin plus intervention 2: Amethocaine gel 4%
Intervention descriptions: intervention 1: 1g, single application intervention 2: 1 g, single application

Protocol documents:
Clinical trial NCT00575029
Conditions: Adrenal Insufficiency
Keywords: megestrol acetate adrenal insufficiency adrenal suppression
Sponsor: University of Arkansas
Start date: 2004-04-01; Completion date: 2004-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Megestrol Acetate (MA) is a progesterone-like hormone that has been utilized as a birth control agent, chemotherapeutic drug, and more recently, to induce appetite and weight gain in patients malnourished as a result of radiation therapy, chemotherapy, cystic fibrosis, AIDS, or dementia. The mechanism of MA-stimulated appetite and weight gain is unknown.

Although only approved to combat weight loss associated with AIDS and cancer, MA is frequently prescribed for long periods of time to prevent or reverse weight loss in nursing home residents and in elderly patients with serious illnesses in the community. Little data is available to support this practice. Among its many properties, MA acts as a partial glucocorticoid agonist, and long term and short term use of MA may results in adrenal suppression. The rapidity of the onset of MA-induced adrenal suppression and the time course of resumption of normal adrenal function after discontinuation of MA is completely unknown. As a consequence, it is unclear whether MA can be given safely for short periods of time or whether glucocorticoid administration is necessary after abruptly stopping MA treatment. The increased use of MA in the frail elderly, where even partial adrenal insufficiency may pose a substantial risk of adrenal crisis after an illness, requires a clear understanding of these issues. To address these concerns, we will evaluate adrenal function before, during, and after MA administration in healthy volunteers between the ages of 60 and 85 years.

Detailed description:

Arms: arm 1: Study subjects will be given 600mg of MA for oral ingestion per day for duration of 8 weeks. They will be monitored every week clinically for the development of adrenal insufficiency by review of symptoms, physical exam, body weight, pulse, and blood pressure. Subjects also will undergo biochemical evaluation of adrenal status every two weeks by measurement of serum electrolytes, serum cortisol, serum adrenocorticotropic hormone(ACTH) levels, and the adrenal response to a low dose ACTH (1µgm) stimulation test(see methods).
Interventions: intervention 1: megestrol acetate
Intervention descriptions: intervention 1: 600 mg by mouth daily

Protocol documents:
Clinical trial NCT00922701
Conditions: End-Stage Renal Disease
Keywords: Peritoneal dialysis L-carnitine
Sponsor: Iperboreal Pharma Srl
Start date: 2004-06-01; Completion date: 2004-12-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The development of glucose-sparing strategies able to provide an efficacious ultrafiltration profile represents one of the modern goals of peritoneal dialysis therapy. The study hypothesis is to evaluate the possibility to formulate peritoneal dialysis solutions containing L-carnitine as an osmotic agent to partially replace glucose.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: L-carnitine
Intervention descriptions: intervention 1: Instillation of glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the nocturnal exchange. Patients were treated with the experimental peritoneal dialysis solution for 5 days.

Protocol documents:
Clinical trial NCT01148537
Conditions: Healthy Volunteers
Keywords: Healthy subjects Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2004-07-01; Completion date: 2004-12-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of buprenorphine on QT interval corrected for heart rate (QTc) in healthy subjects.

Detailed description:
Drugs in this opioid class have been associated with prolonging QT interval/QT interval corrected for heart rate (QTc).

Arms: arm 1: Buprenorphine transdermal patches 5, 10, 20, and 2 \* 20 mcg/h. arm 2: Matching placebo transdermal patches 5, 10, 20 and 2 \* 20. arm 3: Moxifloxacin hydrochloride 400 mg tablets
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Matching placebo transdermal patch intervention 3: Avelox (moxifloxacin hydrochloride) tablet
Intervention descriptions: intervention 1: Buprenorphine transdermal patch 5, 10, 20, and 2 \* 20 mcg/h. intervention 2: Placebo transdermal patch to match BTDS 5, 10, 20, and 2 \* 20. intervention 3: Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13

Protocol documents:
Clinical trial NCT01606137
Conditions: Multiple Sclerosis Spasticity Pain
Sponsor: Jazz Pharmaceuticals
Start date: 2002-02-01; Completion date: 2004-12-01
Enrollment: 507 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.

Detailed description:
Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.

Arms: arm 1: Active treatment
Interventions: intervention 1: GW-1000-02
Intervention descriptions: intervention 1: Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.

Protocol documents:
Clinical trial NCT01879345
Conditions: Epilepsy
Keywords: Anticonvulsant
Sponsor: Bial - Portela C S.A.
Start date: 2004-10-01; Completion date: 2004-12-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single centre, double-blind, randomised, placebo-controlled study of two dosage regimens of BIA 2-093 - 1800 mg (Group 1) and 2400 mg (Group 2) - in two groups of healthy male volunteers

Detailed description:
Within each group (n=9) 3 volunteers were randomised to receive placebo and the remaining 6 volunteers to receive BIA 2-093. No volunteer was a member of more than one treatment group. In each group, the study consisted of a single-dose period (Phase A) followed by a 7-day multiple-dose period (Phase B). The multiple-dose phase started 96 h post single-dose. Progression to the 2400 mg dose (Group 2) only occurred if the 1800 mg dose (Group 1) was considered to be safe and well tolerated. An appropriate interval separated the investigation of the two groups in order to permit a timely review and evaluation of safety data.

Treatment consisted of a single-dose (Phase A) followed by a once-daily dose for 7 days (Phase B). Doses were prepared as follows: Group 1 = 3 tablets of BIA 2-093 600 mg plus 1 placebo tablet, or 4 placebo tablets; Group 2 = 4 tablets of BIA 2-093 600 mg, or 4 placebo tablets.

Arms: arm 1: 3 tablets of BIA 2-093 600 mg arm 2: 4 tablets of BIA 2-093 600 mg arm 3: placebo tablets
Interventions: intervention 1: BIA 2-093 - 1800 mg (Group 1) intervention 2: BIA 2-093 - 2400 mg (Group 2) intervention 3: Placebo
Intervention descriptions: intervention 1: 3 tablets of BIA 2-093 intervention 2: 4 tablets of BIA 2-093 600 mg intervention 3: placebo tablets

Protocol documents:
Clinical trial NCT00003456
Conditions: Glioblastoma Multiforme of Brain
Keywords: adult glioblastoma
Sponsor: Burzynski Research Institute
Start date: 1995-03-14; Completion date: 2004-12-07
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme 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.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme, 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 (≥ 18 years of age) with newly diagnosed Glioblastoma Multiforme.
* 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: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Adults with a newly diagnosed Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Protocol documents:
Clinical trial NCT03822078
Conditions: Osteoporosis
Keywords: Postmenopausal Denosumab
Sponsor: Amgen
Start date: 2003-09-30; Completion date: 2004-12-24
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Detailed description:

Arms: arm 1: Participants received a single subcutaneous injection of placebo to denosumab on day 1. arm 2: Participants received a single subcutaneous dose of denosumab on day 1. Doses included 0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg.
Interventions: intervention 1: Placebo intervention 2: Denosumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00151996
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Start date: 2004-08-16; Completion date: 2004-12-27
Enrollment: 75 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of administering SPD503 (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for treatment of ADHD in children and adolescents aged 6-17

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methylphenidate + SPD503 (Guanfacine hydrochloride) intervention 2: Amphetamine + SPD503
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00078377
Conditions: Narcolepsy
Keywords: Narcolepsy Excessive Sleepiness Cataplexy Sleep Attacks Excessive Sleepiness associated with Narcolepsy Cephalon Cephalon, Inc Nuvigil
Sponsor: Cephalon
Start date: 2004-03-01; Completion date: 2005-01-01
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)

Detailed description:

Arms: arm 1: Armodafinil 250 mg arm 2: Armodafinil 150 mg arm 3: Placebo
Interventions: intervention 1: Armodafinil intervention 2: Armodafinil intervention 3: Placebo
Intervention descriptions: intervention 1: Armodafinil 250 mg once daily in the morning intervention 2: Armodafinil 150 mg once daily in the morning intervention 3: Matching placebo tablets once daily

Protocol documents: