ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01084265
Conditions: Hypogonadism
Keywords: Hypogonadism Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH)
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-02-01; Completion date: 2005-12-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.

Detailed description:
The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving a single cycle of treatment. Prior to entry into the study, the diagnosis of hypogonadotropic hypogonadism was confirmed by history, by the presence or absence of specific clinical features and by measuring serum gonadotropin levels. Once a subject has signed the informed consent form and after satisfying all eligibility criteria, the subject received a combination of daily injection of recombinant human follicle-stimulating hormone (rhFSH) 150 international units (IU) plus rhLH 75 IU. After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU human chorionic gonadotropin (hCG). Luteal phase function was assessed by serum progesterone level determination.

Interventions: intervention 1: Recombinant human luteinizing hormone (r-hLH) intervention 2: Recombinant human follicle-stimulating hormone (r-hFSH) intervention 3: Human chorionic gonadotropin (hCG)
Intervention descriptions: intervention 1: One r-hLH (75 International Units \[IU\]) injection s.c. once daily. intervention 2: One r-hFSH (150 IU) injection s.c. once daily. intervention 3: After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.

Protocol documents:
Clinical trial NCT01599234
Conditions: Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Start date: 2005-03-01; Completion date: 2005-12-01
Enrollment: 337 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis

Detailed description:
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Eligible subjects entered a seven day baseline period. Subjects then returned to the centre for randomisation and dose introduction. Visits occurred at the end of treatment weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew.

Arms: arm 1: Active treatment arm 2: Control
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours. intervention 2: Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.

Protocol documents:
Clinical trial NCT00159861
Conditions: Pulmonary Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2003-07-01; Completion date: 2006-01-01
Enrollment: 267 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension

Detailed description:

Interventions: intervention 1: Sildenafil citrate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00087555
Conditions: Fibromyalgia
Keywords: Fibromyalgia Pain
Sponsor: Jazz Pharmaceuticals
Start date: 2004-07-01; Completion date: 2006-01-01
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.

Detailed description:
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic that induces and consolidates sleep. In a few small studies Xyrem has been reported to offer relief to some fibromyalgia patients. This trial is designed to test this hypothesis. Patients who enroll in this study will stop taking any prescription medications for fibromyalgia (over-the-counter pain relievers will be permitted). They will then take either Xyrem alone or placebo alone. Patients will be followed for eight weeks to evaluate any relief of the pain or functional impairment of fibromyalgia from their study treatment. Sleep characteristics will also be assessed subjectively and by polysomnographic recordings at baseline and twice during the treatment phase.

Arms: arm 1: Sodium oxybate 6.0 g per day. arm 2: Placebo (one of two doses matching active treatment by volume). arm 3: Sodium oxybate 4.5 g per day.
Interventions: intervention 1: Xyrem (sodium oxybate) oral solution intervention 2: Xyrem (sodium oxybate) oral solution intervention 3: Placebo
Intervention descriptions: intervention 1: Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks. intervention 2: Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks. intervention 3: Placebo one of two doses matching active treatment by volume for 8 weeks.

Protocol documents:
Clinical trial NCT00105534
Conditions: Bacterial Conjunctivitis
Keywords: Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection Eye Discharge
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-07-01; Completion date: 2006-01-01
Enrollment: 685 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AzaSite intervention 2: Vehicle
Intervention descriptions: intervention 1: 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected

eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days. intervention 2: Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days.

Protocol documents:
Clinical trial NCT00234104
Conditions: Heart Failure, Congestive Edema
Keywords: OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2004-08-01; Completion date: 2006-01-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at 40 mg/d or more. This study is being conducted in Japan.

Detailed description:

Interventions: intervention 1: OPC-41061(Tolvaptan)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00666835
Conditions: Anemia
Keywords: Treatment of anemia in hemodialysis patients
Sponsor: Sandoz
Start date: 2004-04-01; Completion date: 2006-01-01
Enrollment: 478 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.

Detailed description:
The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.

Arms: arm 1: Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. arm 2: Eligible patients were randomized and continued to be treated with ERYPO® Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL.
Interventions: intervention 1: HX575 epoetin alfa Hexal AG intervention 2: ERYPO®, Janssen-Cilag
Intervention descriptions: intervention 1: HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin intervention 2: Solution for i.v. injection

Protocol documents:
Clinical trial NCT00791388
Conditions: Healthy
Keywords: Pharmacokinetics
Sponsor: Procter and Gamble
Start date: 2005-08-01; Completion date: 2006-01-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).

Detailed description:
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.

Arms: arm 1: placebo capsule arm 2: 50 mg PG 760564 active arm 3: 100 mg PG 760564 active arm 4: 200 mg PG 760564 active arm 5: 400 mg PG 760564 active
Interventions: intervention 1: Placebo intervention 2: PG-760564 intervention 3: PG-760564 intervention 4: PG-760564 intervention 5: PG-760564
Intervention descriptions: intervention 1: oral capsule, 2x/day for 14 days intervention 2: oral capsule, 50 mg, 2x/day for 14 days intervention 3: oral capsule, 100mg, 2x/day for 14 days intervention 4: oral capsule, 200 mg, 2x/day for 14 days intervention 5: oral capsule, 400 mg, 2x/day for 14 days

Protocol documents:
Clinical trial NCT00791817
Conditions: Healthy
Keywords: pharmacokinetics study
Sponsor: Procter and Gamble
Start date: 2005-08-01; Completion date: 2006-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.

Detailed description:
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.

Arms: arm 1: 200 mg PG 760564, Subjects Fasted, single dose arm 2: 200 mg PG 760564, Subjects Fed high fat meal
Interventions: intervention 1: PG-760564 intervention 2: PG-760564
Intervention descriptions: intervention 1: 200 mg capsule, single dose,fasted when dosed, duration is 4 days intervention 2: 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days

Protocol documents:
Clinical trial NCT02576145
Conditions: Kidney Transplantation
Sponsor: Hoffmann-La Roche
Start date: 2003-04-01; Completion date: 2006-01-01
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.

Detailed description:

Arms: arm 1: Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram \[mg/kg\]) with Day 1 vaccine administered immediately prior to the fifth dose. arm 2: Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.
Interventions: intervention 1: DT intervention 2: Daclizumab intervention 3: KLH
Intervention descriptions: intervention 1: Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response. intervention 2: The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses). intervention 3: KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

Protocol documents:
Clinical trial NCT00160667
Conditions: Neuralgia, Postherpetic
Keywords: Post-herpetic Neuralgia (PHN) Brivaracetam
Sponsor: UCB Pharma
Start date: 2004-10-11; Completion date: 2006-01-05
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.

Detailed description:

Arms: arm 1: Matching placebo tablets administered twice a day. arm 2: Brivaracetam 200 mg/day (100 mg administered twice a day). arm 3: Brivaracetam 400 mg/day (200 mg administered twice a day).
Interventions: intervention 1: Placebo intervention 2: Brivaracetam
Intervention descriptions: intervention 1: Daily oral dose of two equal intakes. intervention 2: Daily oral dose of two equal intakes.

Protocol documents:
Clinical trial NCT00116844
Conditions: Infections, Herpesviridae
Keywords: viral shedding Recurrent herpes genital herpes
Sponsor: GlaxoSmithKline
Start date: 2005-03-29; Completion date: 2006-01-10
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.

Detailed description:

Arms: arm 1: VALTREX 1 g once daily, Placebo arm 2: Placebo, VALTREX 1 g once daily
Interventions: intervention 1: Valaciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: Valtrex 1g once daily intervention 2: placebo

Protocol documents:
Clinical trial NCT00535288
Conditions: Postmenopausal Symptoms Menopause Vasomotor Symptoms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-09-15; Completion date: 2006-01-15
Enrollment: 946 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline.

Detailed description:
The most direct treatment of hot flushes may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo were investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary objective of this trial was to demonstrate superior efficacy in at least one of the four doses of esmirtazapine as compared to placebo on the four following co-primary endpoints: 1) the mean change from baseline in average daily frequency of moderate and severe vasomotor symptoms at Week 4; 2) the mean change from baseline in average daily frequency of moderate and severe vasomotor symptoms at Week 12; 3) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 4; 4) the mean change from baseline in average daily severity of moderate and severe vasomotor symptoms at Week 12. The number and severity of hot flushes was recorded by means of electronic diary by the subjects.

Arms: arm 1: Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks. arm 2: Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 3: Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 4: Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 5: Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks. intervention 2: Encapsulated placebo tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks.

Protocol documents:
Clinical trial NCT00560833
Conditions: Menopause Vasomotor Symptoms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2004-10-15; Completion date: 2006-01-15
Enrollment: 943 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other similar compounds have been investigated to manage hot flushes, confirming the role of the serotonergic system. In the present trial, the efficacy and safety of four different doses of esmirtazapine compared to placebo was investigated in women with moderate to severe vasomotor symptoms associated with the menopause. The primary study hypothesis was that esmirtazapine would show superior efficacy to placebo.

Detailed description:

Arms: arm 1: Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks arm 2: Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 3: Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 4: Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 5: Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
Interventions: intervention 1: esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00249834
Conditions: Infertility
Keywords: Assisted Reproductive Technology (ART) Infertility Ovarian stimulation
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2004-09-22; Completion date: 2006-01-16
Enrollment: 166 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: Gonal-f intervention 2: Recombinant human chorionic gonadotrophin (r-hCG)
Intervention descriptions: intervention 1: GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. intervention 2: When at least 1 follicle greater than or equal to (\>=) 18 millimeter (mm) and 2 follicles \>=16 mm in diameter develop, 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) will be administered.

Protocol documents:
Clinical trial NCT00150709
Conditions: Epilepsy, Partial
Keywords: Epilepsy Pediatric Partial onset epilepsy Levetiracetam Keppra
Sponsor: UCB Pharma
Start date: 1998-01-26; Completion date: 2006-01-25
Enrollment: 223 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Detailed description:

Arms: arm 1: Subjects had previously participated in study N159 in which they had received Placebo (PBO). arm 2: Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). arm 3: Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV). arm 4: Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).
Interventions: intervention 1: Levetiracetam
Intervention descriptions: intervention 1: * Pharmaceutical form: Oral tablets and oral solution
* Route of administration: Oral use

Protocol documents: