ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00225212
Conditions: Non-Hodgkin's Lymphoma Diffuse Large Cell Lymphoma Mantle Cell Lymphoma Transformed Lymphoma Other Subtypes of B-cell Lymphoma Lymphoma
Keywords: non-Hodgkin's lymphoma diffuse large cell lymphoma mantle cell lymphoma transformed lymphoma other subtypes of B cell lymphoma recurrent lymphoma
Sponsor: Stanford University
Start date: 1997-11-01; Completion date: 2003-03-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Conventional therapy is effective for diffuse aggressive lymphomas and low grade lymphomas, but is limited by relapse occurs in 40 to 50% of subjects.

This study assesses autologous stem cell transplant (ASCT) supplemented with high-dose therapy increases the event-free survival in diffuse aggressive lymphomas and low grade lymphomas, as an alternative to the limitations of conventional therapy.

Preliminary studies with rituximab in low grade lymphomas indicate a response rate of about 50% with very little toxicity. Rituximab is hypothesized to be a candidate for post-transplant therapy because the majority of malignant lymphomas express the CD20 antigen; rituximab has impressive independent anti-tumor activity; and the antibody has little toxicity outside of the acute administration.

Detailed description:
The first 4 subjects received rituximab weekly for 4 weeks at the standard dose of 375 mg/m2, starting 6 weeks after ASCT transplant.

After an observation period to assess acute and late toxicity for the first 4 subjects, subsequent subjects received induction as above followed by an additional 4 week course at 6-months post-ASCT.

Arms: arm 1: Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT.
Interventions: intervention 1: Rituximab 375 mg/m2
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01282814
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2003-02-01; Completion date: 2003-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to compare the rate and extent of absorption of venlafaxine hydrochloride 150 mg capsules (test) versus Effexor® XR (reference) administered as the content of 1 x 150 mg extended-release capsule mixed with applesauce under fasting conditions.

Detailed description:

Arms: arm 1: Venlafaxine Hydrochloride 150 mg Extended-Release Capsules. arm 2: Effexor® XR 150 mg Extended-Release Capsules
Interventions: intervention 1: Venlafaxine Hydrochloride intervention 2: Effexor® XR
Intervention descriptions: intervention 1: 150 mg Extended-Release Capsule intervention 2: 150 mg Extended-Release Capsule

Protocol documents:
Clinical trial NCT02488980
Conditions: Falciparum Parasitaemia
Keywords: Falciparum Parasitaemia, Malaria
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2000-05-01; Completion date: 2003-03-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a placebo controlled, randomised, double-blind, double-dummy study of the efficacy of weekly tafenoquine compared with weekly mefloquine or placebo in the chemosuppression of P. falciparum in Nyanza Province, western Kenya.

Detailed description:
Subjects were treated for 3 days with halofantrine to clear any existing parasitaemia. At the end of the clearance period, subjects free from malaria parasitaemia were randomized and received a loading dose of the study treatment (tafenoquine 200 mg, Mefloquine 250 mg or placebo) for tree days, followed by study treatment (tafenoquine 200 mg, mefloquine 250 mg or placebo, respectively) once a week for 24 weeks. After the treatment period subjects attended weekly follow-up safety visits until week 28.

Arms: arm 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks. arm 2: Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks. arm 3: Placebo
Interventions: intervention 1: Tafenoquine intervention 2: Mefloquine intervention 3: Placebo
Intervention descriptions: intervention 1: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks. intervention 2: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks. intervention 3: Placebo for three days followed by placebo once a week for 24 weeks

Protocol documents:
Clinical trial NCT00003469
Conditions: Rhabdoid Neoplasm of CNS
Keywords: childhood rhabdoid tumor
Sponsor: Burzynski Research Institute
Start date: 1996-02-01; Completion date: 2003-05-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) with Rhabdoid tumors.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which children with Rhabdoid tumors 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 children with a Rhabdoid tumor, 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 children with a Rhabdoid tumor.
* 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: Children with a Rhabdoid tumor will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00044044
Conditions: Schizophrenia
Keywords: Schizophrenia Latuda Lurasidone
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2002-07-01; Completion date: 2003-05-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of the drug SM-13496 compared to a placebo and to haloperidol in patients with schizophrenia.

Detailed description:

Arms: arm 1: Lurasidone 20 mg tablets arm 2: Lurasidone 40 mg tablets arm 3: Lurasidone 2 40 mg tablets arm 4: Haloperidol 10mg tablets arm 5: Matching Placebo to Lurasidone and Haloperidol
Interventions: intervention 1: Lurasidone 20 mg intervention 2: Lurasidone 40mg intervention 3: Lurasidone 80 mg intervention 4: Haloperidol 10mg intervention 5: Placebo
Intervention descriptions: intervention 1: Lurasidone 20mg/day tablets intervention 2: Lurasidone 40mg/day tablets intervention 3: Lurasidone 80mg/day - 2 40mg tablets intervention 4: Haloperidol 10mg/day tablets intervention 5: Matching Placebo to Lurasdione and Haloperidol

Protocol documents:
Clinical trial NCT01249261
Conditions: Postmenopausal Women With Osteoporosis
Keywords: Postmenopausal Women Osteoporosis
Sponsor: Warner Chilcott
Start date: 2001-10-01; Completion date: 2003-05-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effects of stopping long-term (7 years) and short term (2 years) risedronate therapy on BMD (bone mineral density) and BTMs (bone turnover markers) will be summarized.

Detailed description:

Arms: arm 1: Placebo years 1-5, Risedronate 5mg/day years 6 \& 7, no drug year 8 arm 2: Risedronate 5mg years 1-7, no drug year 8
Interventions: intervention 1: Risedronate intervention 2: Placebo/Risedronate
Intervention descriptions: intervention 1: 5 mg/day intervention 2: placebo years 1-5 followed by 5 mg risedronate years 6 \& 7 and no drug year 8

Protocol documents:
Clinical trial NCT01259115
Conditions: Healthy
Keywords: Healthy subjects Opioid Transdermal
Sponsor: Purdue Pharma LP
Start date: 2002-10-01; Completion date: 2003-06-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacokinetics of buprenorphine and its metabolites in the presence and absence of ketoconazole.

Detailed description:
To assess the pharmacokinetics of buprenorphine and its metabolites (nor-buprenorphine, buprenorphine 3 glucuronide and nor-buprenorphine glucuronide) in the presence and absence of ketoconazole.

Safety evaluation of BTDS and ketoconazole in healthy subjects.

Arms: arm 1: BTDS 10 with ketoconazole 200 mg tablets twice daily in period 1 and BTDS 10 with ketoconazole placebo tablets twice daily in period 2. arm 2: BTDS 10 with ketoconazole placebo tablets twice daily in period 1 and BTDS 10 with ketoconazole 200 mg twice daily in period 2.
Interventions: intervention 1: Buprenorphine transdermal patch intervention 2: Ketoconazole tablet intervention 3: Placebo to match ketoconazole tablet
Intervention descriptions: intervention 1: Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear. intervention 2: Ketoconazole 200 mg tablets taken orally twice daily. intervention 3: Placebo to match ketoconazole 200 mg tablets taken orally twice daily.

Protocol documents:
Clinical trial NCT01710020
Conditions: End-Stage Renal Disease Hemodialysis
Keywords: CP-690 550 pharmacokinetics end-stage renal disease
Sponsor: Pfizer
Start date: 2003-02-01; Completion date: 2003-06-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
There were 2 study periods in this study. In the Period 1, CP-690,550 was to be administered approximately 1 to 2 hours following hemodialysis. If significant non-renal clearance of the drug occurred such that dialyzability of CP-690,550 could not be assessed in Period 1, a second period (Period 2) will be conducted. In Period 2, a single dose of drug will be administered approximately 4 hours prior to hemodialysis.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: CP-690,550
Intervention descriptions: intervention 1: CP-690,550 10 mg oral powder for constitution

Protocol documents:
Clinical trial NCT00003474
Conditions: Glioblastoma Multiforme of the Brain
Keywords: adult glioblastoma recurrent glioblastoma
Sponsor: Burzynski Research Institute
Start date: 1996-03-14; Completion date: 2003-06-21
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 residual/recurrent/progressive Glioblastoma Multiforme.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed 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 residual/recurrent/progressive Glioblastoma Multiforme following initial therapy, including radiotherapy, 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 residual/recurrent/progressive 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 residual/recurrent/progressive 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 NCT00003471
Conditions: Low-Grade Astrocytoma, Nos
Keywords: Recurrent/progressive adult low grade astrocytoma
Sponsor: Burzynski Research Institute
Start date: 1996-03-01; Completion date: 2003-07-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for adult recurrent/progressive low grade astrocytoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of adult recurrent/progressive low grade astrocytoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on adults with a recurrent/progressive low grade astrocytoma.

Detailed description:
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/progressive low grade astrocytoma 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 with a recurrent/progressive low grade astrocytoma, 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 a recurrent/progressive low grade astrocytoma.
* 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 recurrent/progressive low grade astrocytoma 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 NCT00912015
Conditions: Pain Osteoarthritis, Knee
Sponsor: Labopharm Inc.
Start date: 2002-03-01; Completion date: 2003-07-01
Enrollment: 238 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term safety (up to one year) of Tramadol Once-A-Day (OAD) tablets at the highest doses: 200-400 mg

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Despite provision in the protocol that the minimum daily dose was 200 mg, 2 patients took 100 mg against instructions.
Interventions: intervention 1: Tramadol OAD intervention 2: Tramadol OAD intervention 3: Tramadol OAD intervention 4: Tramadol OAD 100mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00027027
Conditions: Neoplasms
Sponsor: Genentech, Inc.
Start date: 2001-11-01; Completion date: 2003-08-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase I study is to test the safety of rhuMAb 2C4 to see what effects (good and bad) it has on patients with certain types of cancer, and also to find the highest dose of rhuMAb that can be given without causing severe side effects. All study participants will be assigned to specific group to evaluate different dosages of rhuMAb 2C4. The study is scheduled to run for up to one year depending on how patients respond to the study treatment.

Detailed description:

Interventions: intervention 1: rhuMAb 2C4
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00042432
Conditions: Secondary Hyperparathyroidism Chronic Renal Insufficiency
Sponsor: Amgen
Start date: 2002-06-01; Completion date: 2003-08-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess an investigational medication for patients with chronic renal insufficiency (pre-dialysis) who have secondary hyperparathyroidism.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: cinacalcet (AMG 073)
Intervention descriptions: intervention 1: Initially receive 1 tablet of study medication (cinacalcet or placebo) once daily. Possible sequential dose titrations are 30, 60, 90, 120, 180mg cinacalcet or placebo) daily. The titration phase was 12 weeks and the efficacy assessment phase was 6 weeks.

Protocol documents:
Clinical trial NCT00832416
Conditions: Pain Osteoarthritis, Knee
Sponsor: Labopharm Inc.
Start date: 2003-01-01; Completion date: 2003-08-01
Enrollment: 565 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the analgesic efficacy and safety of Tramadol Once a Day 100, 200, 300 mg and Placebo

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Tramadol Once A Day intervention 2: Placebo
Intervention descriptions: intervention 1: One Tramadol Once A Day tablet at randomized dose daily. intervention 2: One Placebo tablet daily.

Protocol documents:
Clinical trial NCT00834288
Conditions: Healthy Subjects Pharmacokinetics Bioavailability
Keywords: Healthy subjects Pharmacokinetics Bioavailability
Sponsor: Labopharm Inc.
Start date: 2003-06-01; Completion date: 2003-08-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to compare the pharmacokinetic profiles at steady-state of the test product, Tramadol HCl Once-A-Day (OAD) 200 mg tablets and the reference product, Tramadol HCl 50 mg (IR) tablets (Ortho-McNeil Ultram®). For this purpose, the extent of absorption of tramadol and formation of O-desmethyltramadol (measures of systemic exposure) after multiple administration of 50 mg 6-hourly at 07:30, 13:30, 19:30 and 01:30 (reference product) and 200 mg 24-hourly at 07:30 (test product), were compared.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tramadol HCl intervention 2: Tramadol HCl
Intervention descriptions: intervention 1: 1x200 mg Tramadol HCl OAD tablet daily intervention 2: 1x50 mg Tramadol HCl IR (Ultram®) tablet 6-hourly

Protocol documents:
Clinical trial NCT01225822
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2002-11-01; Completion date: 2003-08-01
Enrollment: 1973 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.

Detailed description:

Arms: arm 1: BIBR 1048 50 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus one placebo matching enoxaparin 0 mg once a day for the treatment period arm 2: BIBR 1048 150 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 3: BIBR 1048 225 mg b.i.d twice a day plus two capsules of placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 4: BIBR 1048 150 mg q.d once a day plus placebo matching BIBR 1048 0 mg twice a day plus placebo matching enoxaparin 0 mg once a day for the treatment period arm 5: placebo matching BIBR 1048 0 mg twice a day plus enoxaparin 40 mg s.c once a day for the treatment period
Interventions: intervention 1: Enoxaparin intervention 2: BIBR 1048 intervention 3: BIBR 1048 intervention 4: BIBR 1048 intervention 5: BIBR 1048
Intervention descriptions: intervention 1: Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period intervention 2: 50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period intervention 3: 150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 4: 225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period intervention 5: 300 mg q.d BIBR 1048 capsule for 5-10 treatment period

Protocol documents:
Clinical trial NCT00287690
Conditions: Coronary Artery Disease
Keywords: arteries blood flow coronary artery disease diet
Sponsor: Imperial College London
Start date: 1999-10-01; Completion date: 2003-08-18
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the effect of genistein administration on coronary arteries in humans. We will measure the size of a coronary artery and the speed and amount of blood flow in response after subjects have ingested Supro® drinks (a soy protein drink containing genistein).

Detailed description:

Arms: arm 1: Supro drink once daily for 3 days arm 2: Drink identical to Supro but containing no genistein, once daily for 3 days
Interventions: intervention 1: Genistein intervention 2: Placebo
Intervention descriptions: intervention 1: Drink taken once daily intervention 2: Drink taken once daily

Protocol documents:
Clinical trial NCT00152009
Conditions: Attention Deficit Disorder With Hyperactivity
Sponsor: Shire
Start date: 2003-01-29; Completion date: 2003-08-23
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and efficacy of SPD503 (Guanfacine hydrochloride) compared to placebo in the treatment of ADHD in children and adolescents aged 6-17

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SPD503 (Guanfacine hydrochloride) (2 mg) intervention 2: SPD503 (3 mg) intervention 3: SPD503 (4 mg) intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: