ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02070692
Conditions: Menstruation Disturbances
Keywords: Contraceptive implant Irregular vaginal bleeding Etonogestrel implant
Sponsor: Oregon Health and Science University
Start date: 2014-02-01; Completion date: 2015-12-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.

Detailed description:
Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.

Arms: arm 1: Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding. arm 2: Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.
Interventions: intervention 1: Tamoxifen intervention 2: Placebo
Intervention descriptions: intervention 1: 7 day course of tamoxifen during an episode of irregular vaginal bleeding intervention 2: 7 day course of placebo during an episode of irregular vaginal bleeding

Protocol documents:
Clinical trial NCT02073656
Conditions: Hepatitis C Virus HIV
Keywords: genotype 1 genotype 4 HIV
Sponsor: Gilead Sciences
Start date: 2014-02-01; Completion date: 2015-12-01
Enrollment: 335 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.

Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Detailed description:

Arms: arm 1: LDV/SOF for 12 weeks arm 2: LDV/SOF plus RBV for 24 weeks
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: 90/400 mg FDC tablet administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT02073929
Conditions: Polycystic Ovary Syndrome Cardiovascular Disease
Sponsor: Jens Faber
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.

The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.

70 women will be included in af RCT.

Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.

Detailed description:

Arms: arm 1: Liraglutide s.c. 1,8mg daily for 26 weeks arm 2: Placebo s.c. daily for 26 weeks
Interventions: intervention 1: Liraglutide for 26 weeks intervention 2: placebo
Intervention descriptions: intervention 1: GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks intervention 2: Placebo s.c. daily for 26 weeks

Protocol documents:
Clinical trial NCT02078492
Conditions: Pain
Sponsor: Antonios Likourezos
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Detailed description:
Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.

Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Arms: arm 1: Subjects will be administered 10 mg of Ketorolac for pain relief. arm 2: Subjects will be administered 15mg of Ketorolac. arm 3: Subject will receive 30mg of Ketorolac as a part of standard care.
Interventions: intervention 1: 10 mg of Ketorolac intervention 2: 15 mg of Ketorolac intervention 3: 30 mg of Ketorolac
Intervention descriptions: intervention 1: Patients will receive 10 mg of Ketorolac for pain control. intervention 2: Patients will receive 15mg of Ketorolac for pain control. intervention 3: Patients will receive 30mg of Ketorolac for pain control.

Protocol documents:
Clinical trial NCT02092116
Conditions: HIV I Infection
Sponsor: Bionor Immuno AS
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.

Detailed description:
The study is divide into two parts. In Part A the safety and tolerability of romidepsin will be evaluated and the effect of romidepsin treatment on HIV-1 transcription in HIV-infected patients virologically suppressed on cART will be determined.

In Part B the effect of treatment with Vacc-4x + rhuGM-CSF and romidepsin treatment on the HIV-1 latent reservoir in HIV-infected patients virologically suppressed on cART will be measured.

Six patients will be enrolled for part A and the safety and tolerability profile evaluated before enrolling 20 patients in B.

Arms: arm 1: Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.

Post-activation phase of \~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir. arm 2: Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).

A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of \~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.

A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33).
Interventions: intervention 1: Romidepsin intervention 2: Vacc-4x intervention 3: rhuGM-CSF
Intervention descriptions: intervention 1: Latency reversing agent intervention 2: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water. intervention 3: Granulocyte macrophage colony stimulating factor as a local adjuvant

Protocol documents:
Clinical trial NCT02097108
Conditions: HIV Infections
Keywords: HIV infection Raltegravir Switch Hyperlipidemia Women
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Start date: 2014-05-01; Completion date: 2015-12-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 24-week, one arm, open-label, interventional, non-comparative multicenter study to evaluate lipid changes in HIV infected women with hyperlipidemia on boosted PI based regimen after switching their boosted PI to raltegravir at standard dosage with 400mg twice daily.

This study aims to study the effect on metabolic profiles by switching hyperlipidemic HIV infected women from a PI based regimen to raltegravir.

Detailed description:

Arms: arm 1: Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.
Interventions: intervention 1: Raltegravir
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02097303
Conditions: Prostate Cancer
Keywords: Prostate Cancer Bone Metastasis Symptomatic Androgen Independent Hormone Refractory Castrate Resistant AIPC pre-chemotherapy Post-chemotherapy
Sponsor: Carolina Research Professionals, LLC
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.

Detailed description:
Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.

Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.

Arms: arm 1: All subjects receive concurrent administration of Radium Ra223 Dichloride and Abiraterone Acetate plus Prednisone
Interventions: intervention 1: Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone
Intervention descriptions: intervention 1: Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.

Protocol documents:
Clinical trial NCT02100579
Conditions: Complications; Arthroplasty Knee Injuries
Sponsor: Northwestern University
Start date: 2014-03-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Detailed description:
The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

Arms: arm 1: Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine arm 2: Ultrasound-guided sham block with 10 ml of preservative free normal saline
Interventions: intervention 1: Bupivacaine intervention 2: Preservative free normal saline
Intervention descriptions: intervention 1: 10 ml of 0.25% bupivacaine intervention 2: 10 ml of preservative free normal saline

Protocol documents:
Clinical trial NCT02105987
Conditions: Infection, Human Immunodeficiency Virus
Keywords: Abacavir/dolutegravir/lamivudine Fixed-dose combination Once daily Trii Single-tablet regimen
Sponsor: ViiV Healthcare
Start date: 2014-04-01; Completion date: 2015-12-01
Enrollment: 555 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study. This study is designed to demonstrate the non-inferior antiviral activity of switching to the Abacavir (ABC) 600 milligrams (mg)/Dolutegravir(DTG) 50 mg/Lamivudine (3TC) 300 mg fixed-dose combination (FDC) compared with continuing the subject's current suppressive regimen through 24 weeks. The study will be conducted in approximately 538 Human Immunodeficiency Virus -1 (HIV-1) infected individuals who are on stable suppressive combination antiretroviral therapy (cART) with 2 Nucleoside reverse transcriptase inhibitors (NRTIs) plus either a protease inhibitor (PI), an non-nucleoside reverse transcriptase inhibitor (NNRTI), or an integrase inhibitor (INI). Eligible subjects will be randomly assigned 1:1 to continue their current regimen (approximately 269 subjects) or be switched to ABC/DTG/3TC FDC (approximately 269 subjects) once daily for 24 weeks. At Week 24, individuals originally randomly assigned to continue their current regimen will switch to ABC/DTG/3TC FDC and be followed for an additional 24 weeks. Individuals initially randomly assigned to ABC/DTG/3TC FDC will continue on that treatment arm for an additional 24 weeks. A pharmacokinetic (PK) substudy will be conducted at a small number of sites (approximately 10) to evaluate predose DTG concentrations as well as residual drug concentrations of efavirenz (EFV), nevaripine (NVP), amprenavir (APV) and tipranavir (TPV) in a subgroup of subjects who switch from EFV, NVP, fosamprenavir/ritonavir (FPV/r) or tipranavir/ritonavir (TPV/r).

Detailed description:

Arms: arm 1: Subject will take ABC 600 mg/DTG 50 mg/3TC 300 mg FDC once daily in the morning or the evening, at approximately the same time each day for 24 weeks. After Week 24, subjects will continue on this treatment arm for an additional 24 weeks. arm 2: Subjects will continue on their current Combination antiretroviral therapy (cART) regimen for 24 weeks. At Week 24, subjects will switch to ABC/DTG/3TC FDC for an additional 24 weeks.
Interventions: intervention 1: ABC/DTG/3TC FDC intervention 2: Ongoing cART regimen
Intervention descriptions: intervention 1: Purple, oval, biconvex tablets containing 702 mg Abacavir sulphate which is equivalent to 600 mg ABC, 52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid and 300 mg 3TC intervention 2: Stable cART regimens including boosted PI (or ATV unboosted) + 2 NRTIs; NNRTI + 2 NRTIs, or INI (RAL or EVG)+ 2 NRTIs

Protocol documents:
Clinical trial NCT02135445
Conditions: Prostate Cancer
Keywords: Drug therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2014-06-01; Completion date: 2015-12-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of TAK-385 for achieving and maintaining testosterone suppression.

Detailed description:
The drug being tested in this study is called TAK-385. Men with prostate cancer benefit from receiving androgen deprivation therapy (ADT) to minimize testosterone levels before, during and after EBRT. This combination increases the potential success of treating their disease. This study will see if TAK-385 \[an oral gonadotropin-releasing hormone (GnRH) antagonist\] brings testosterone levels down sufficiently, with the convenience and comfort of taking a pill. It will look at the time it takes to restore testosterone levels after radiation therapy as well. One hundred participants will be assigned by chance (like flipping a coin) to a treatment group: 60 to TAK-385, and 40 to degarelix.

Those assigned to TAK-385 will take a daily pill. Those assigned to degarelix will receive an injection under the skin once every four weeks at the clinic. They will start radiation therapy when testosterone is low enough, after at least 12 weeks of treatment. This trial will be conducted at clinics in the United States (US) and United Kingdom (UK). Participants will visit the clinic up to 14 times over 37 weeks for physical exams and blood tests, and might receive one follow-up telephone call.

Arms: arm 1: TAK-385 320 mg, tablets, orally, once, on Day 1, followed by TAK-385 120 mg, orally, once daily for 24 weeks. Each participant may have one upward dose adjustment of 40 mg for efficacy and/or one downward dose adjustment of 40 mg for safety during the study. arm 2: Degarelix 240 mg, injection, subcutaneous, on Day 1, followed by degarelix 80 mg, injection, subcutaneous, once every four weeks, for 24 weeks.
Interventions: intervention 1: TAK-385 intervention 2: Degarelix
Intervention descriptions: intervention 1: TAK-385 tablet intervention 2: Degarelix injection

Protocol documents:
Clinical trial NCT02136914
Conditions: Dyskinesia Levodopa Induced Dyskinesia (LID) Parkinson's Disease
Keywords: Levodopa Induced Dyskinesia LID Parkinsonism
Sponsor: Adamas Pharmaceuticals, Inc.
Start date: 2014-05-01; Completion date: 2015-12-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

Detailed description:

Arms: arm 1: ADS-5102 (amantadine HCl extended release) arm 2: Placebo
Interventions: intervention 1: ADS-5102 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsules to be administered once nightly at bedtime, for 25 weeks intervention 2: Oral capsules to be administered once nightly at bedtime, for 25 weeks

Protocol documents:
Clinical trial NCT02156908
Conditions: Schizophrenia
Keywords: cognitive remediation
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2014-08-01; Completion date: 2015-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in a sensory based remediation (SBR) paradigm

Detailed description:
We will enroll 8 subjects in an open label, three session pilot in patients will receive three sessions of tone matching SBR.

5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions. Subjects will receive study drug 30 minutes prior to session.

3 subjects received no intervention

Arms: arm 1: D-serine
Interventions: intervention 1: D-serine
Intervention descriptions: intervention 1: D-serine 60 mg/kg

Protocol documents:
Clinical trial NCT02158533
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Alkermes ALKS 5461 Samidorphan
Sponsor: Alkermes, Inc.
Start date: 2014-05-01; Completion date: 2015-12-01
Enrollment: 385 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of ALKS 5461.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: High Dose ALKS 5461 intervention 2: Low Dose ALKS 5461 intervention 3: Placebo
Intervention descriptions: intervention 1: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 2: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 3: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Protocol documents: