ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00593736
Conditions: Sleep Disorders, Circadian Rhythm
Keywords: Delayed sleep phase syndrome; drug therapy
Sponsor: Takeda
Start date: 2007-10-01; Completion date: 2008-05-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.

Detailed description:
Delayed sleep phase syndrome is the most common circadian disorder in adolescents and most adults with the condition report onset of symptoms during childhood or adolescence. Delayed Sleep Phase Syndrome involves a chronic mismatch between the usual daily schedule required by the individual's environment and his or her circadian sleep wake pattern. Individuals suffering from delayed Sleep Phase Syndrome experience great difficulty when attempting to fall asleep before 1-2 am, if not later, as well as rising at acceptable hours of the morning despite having completely normal sleep architecture and sleep duration. Delayed Sleep Phase Syndrome is a sleep disorder that results from a dysregulation of the circadian sleep-wake rhythm. Delayed Sleep Phase Syndrome is often the cause of severe insomnia and is associated with excessive daytime sleepiness, major depressive disorder and severe disruption of education, work and social functioning. Its major symptom is extreme difficulty initiating sleep at a conventional hour and waking on time in the morning for school or work.

Ramelteon is a selective melatonin type 1 (MT1) and type 2 (MT2) receptor agonist. The purpose of this study is to evaluate the ability of ramelteon to advance the timing of sleep in individuals with delayed sleep phase syndrome. The effect of ramelteon will be analyzed based on collection of information from a post-sleep questionnaire completed by participants, and data collected by polysomnography in a sleep clinic setting. Total participation time involved in this study will be approximately 7 weeks.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Ramelteon intervention 2: Ramelteon intervention 3: Ramelteon intervention 4: Placebo
Intervention descriptions: intervention 1: Ramelteon 1 mg, tablets, orally, once daily for up to two weeks. intervention 2: Ramelteon 4 mg, tablets, orally, once daily for up to two weeks. intervention 3: Ramelteon 8 mg, tablets, orally, once daily for up to two weeks. intervention 4: Ramelteon placebo-matching tablets, orally, once daily for up to two weeks.

Protocol documents:
Clinical trial NCT00594464
Conditions: Parkinson's Disease
Keywords: Rotigotine NEUPRO® Parkinson's Disease (PD) perioperative use anaesthesia,
Sponsor: UCB Pharma
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Evaluation of efficacy and safety on the use of rotigotine in patients suffering from Parkinson's Disease during and after surgery requiring general anaesthesia.

Detailed description:

Arms: arm 1: Rotigotine
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h patch;

Single patches and a combination of 2 of these patches for a dosage of up to 16 mg/24 h;

One (1) regimen on day of surgery, but exceptionally extended for up to 2 (two) weeks if the patient requires unexpected ventilation after surgery.

Protocol documents:
Clinical trial NCT00605644
Conditions: Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-01-01; Completion date: 2008-05-01
Enrollment: 128 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Detailed description:

Arms: arm 1: Placebo arm 2: MOA-728 arm 3: MOA-728 arm 4: MOA-728 arm 5: MOA-728
Interventions: intervention 1: MOA-728 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Capsules intervention 2: Placebo

Protocol documents:
Clinical trial NCT00612508
Conditions: Contraceptive Usage Vaginal Epithelial Disruption
Keywords: contraception NuvaRing Desogen vaginal biopsy
Sponsor: Oregon Health and Science University
Start date: 2007-05-01; Completion date: 2008-05-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help determine if the route by which women receive hormonal contraception causes different changes to occur in the lining of the vagina. The investigators plan to compare an oral route (taking birth control pills) with a vaginal route (using a vaginal ring).

Detailed description:
The investigators intend to conduct a prospective, randomized study at Oregon Health and Science University. This study will be conducted over six 28-day cycles. Subjects enrolled in the study will undergo baseline vaginal biopsy and then be randomized to receive either intravaginal ethinyl estradiol and etonogestrel (NuvaRing®) or oral ethinyl estradiol and desogestrel (Desogen®). Repeat vaginal biopsies will be obtained after three and six months of exposure to either oral or intravaginal hormonal contraception. These will be analyzed to measure the thickness of the vaginal epithelium and to quantify the presence of Langerhans cell, macrophages, T-lymphocytes and dendritic cells.

Arms: arm 1: Drug: ethinyl estradiol and desogestrel

1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol; secen inactive pills every 28 days.

Subjects receive baseline vaginal biopsy, followed by treatment with the OC for six cycles and repeat biopsy at 3 and after 6 cycles arm 2: Intravaginal Contraception

ethinyl estradiol (0.15 mg/d) and etonogestrel (0.12 mg/d) Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Subjects had baseline vaginal biopsy followed by 6 cycles of ring use and repeat biopsy at 3 and after 6 cycles
Interventions: intervention 1: Desogen (ethinyl estradiol and desogestrel) intervention 2: NuvaRing (ethinyl estradiol and etonogestrel)
Intervention descriptions: intervention 1: 1 tablet every day; each tablet contains 0.15mg desogestrel and 0.03mg ethinyl estradiol intervention 2: Place the ring in the vagina for 3 weeks, remove for one week. Repeat with new Ring

Protocol documents:
Clinical trial NCT00613821
Conditions: Pain
Keywords: surgical abortion pain management
Sponsor: Oregon Health and Science University
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

Detailed description:
The Investigators intend to conduct a randomized, patient-blinded control trial at Oregon Health and Science University and Planned Parenthood of the Columbia Willamette. Women will be approached about this study after they have made a decision to terminate the pregnancy. The women will be blinded and randomized into one of two study arms.

Group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. This will approximate the steps involved in a paracervical block without injecting the patient. Following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm Novak curette. The infusion will be placed slowly over 3 minutes.

Group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. Following this, a 3 mm Novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. The curette will not be placed through the cervix and no infusion will be performed. This will approximate the steps involved in an intrauterine infusion without injecting the patient.

During the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (VAS).

Arms: arm 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. arm 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Interventions: intervention 1: Lidocaine intervention 2: Lidocaine
Intervention descriptions: intervention 1: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes. intervention 2: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Protocol documents:
Clinical trial NCT00628589
Conditions: Patients With Schizophrenia and Acute Agitation
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE
Sponsor: Alexza Pharmaceuticals, Inc.
Start date: 2008-02-01; Completion date: 2008-05-01
Enrollment: 344 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic patients

Detailed description:
This is an in-clinic, multi-center, randomized, double-blind, placebo-controlled study of 2 dose levels of Staccato Loxapine, 5 and 10 mg. Patients may receive up to 3 doses of study drug in a 24-hour period, depending on their clinical status. The primary endpoint is the change from baseline in the PANSS (Positive and Negative Symptom Scale) Excited Component (also known as PEC) score, performed at 2 hours after the first dose.

Arms: arm 1: Inhaled Loxapine 5 mg, may repeat x 1 or 2 after 2 hours arm 2: Inhaled Loxapine 10 mg, may repeat x 1 or 2 after 2 hours arm 3: Inhaled Loxapine placebo, may repeat x 1 or 2 after 2 hours
Interventions: intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo
Intervention descriptions: intervention 1: Inhaled loxapine 5 mg intervention 2: Inhaled loxapine 10 mg intervention 3: Inhaled placebo

Protocol documents:
Clinical trial NCT00638820
Conditions: Osteopetrosis
Keywords: osteopetrosis
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We believe that hematopoietic stem cell transplantation (HSCT) will help subjects with Osteopetrosis generate functioning osteoclasts, and by so doing assist in the resolution of the abnormal bone architecture, and the anemia and bone marrow failure that is also characteristic of this disease. However, we have found in past studies that approximately 30% of Osteopetrosis patients do not engraft. Therefore, in this study, we plan to use a different combination of pre-transplant drugs to try to make transplants safer for this disease, as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors. The purpose of this research is to find a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis, using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality.

Detailed description:
This transplant protocol will test the following: 1) the ability to achieve engraftment with the reduced intensity protocol, 2) the mortality associated with transplant by day 100, 3) patient outcomes, based on differential imaging and biologic evaluations prior to transplantation and at designated points after transplantation (day 100, 6 months, 1, 2 and 5 years). Additional biologic studies will include microarray analysis, Campath levels just prior to the administration of the graft, and establishment of mesenchymal stem cell lines. In older patients, studies to evaluation osteoclast differentiation and function will also be offered.

Arms: arm 1: Patients enrolled and received study treatment.
Interventions: intervention 1: Stem Cell or Umbilical Cord Blood Transplantation intervention 2: Campath, Busulfan, Clofarabine intervention 3: Total Lymphoid Irradiation
Intervention descriptions: intervention 1: Stem Cell (unrelated or matched related donor grafts (both peripheral blood and marrow) infusion on Day 0 and 42; Umbilical Cord Blood on Day 0 and 42 intervention 2: * 12 Campath-1H 0.3 mg/kg intravenously (IV) over 2 hours
* 11 Campath-1H 0.3 mg/kg intravenously over 2 hours
* 10 Campath-1H 0.3 mg/kg intravenously over 2 hours
* 9 Busulfan \<12 kg: 2.2 mg/kg/dose IV every 12 hours \>12 kg: 1.6 mg/kg/dose IV every 12 hours
* 8 Busulfan \<12 kg: 2.2 mg/kg/dose IV every 12 hours \>12 kg: 1.6 mg/kg/dose IV every 12 hours
* 7 "Rest"
* 6 Clofarabine 40 mg/m2 intravenously over 2 hours
* 5 Clofarabine 40 mg/m2 intravenously over 2 hours
* 4 Clofarabine 40 mg/m2 intravenously over 2 hours
* 3 Clofarabine 40 mg/m2 intravenously over 2 hours
* 2 Clofarabine 40 mg/m2 intravenously over 2 hours intervention 3: Dose 500 cGy via anteroposterior (AP) and posteroanterior (PA) fields (250 cGy AP and 250 cGy PA).

Protocol documents:
Clinical trial NCT00655746
Conditions: Healthy
Keywords: Healthy Subjects
Sponsor: Bristol-Myers Squibb
Start date: 2008-04-01; Completion date: 2008-05-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of dasatinib before and after 5 days of dosing with omeprazole in healthy subjects

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Dasatinib + Omeprazole
Intervention descriptions: intervention 1: Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days

Protocol documents:
Clinical trial NCT00658112
Conditions: Acne Vulgaris
Sponsor: Wake Forest University
Start date: 2006-07-01; Completion date: 2008-05-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to see how often benzoyl peroxide is applied for acne. Use of medication was monitored electronically.

Detailed description:
We give subjects topical benzoyl peroxide, a standard first line acne treatment, in a container that records when the container is opened and closed. Subjects will simply be asked to "return in six weeks to see how well benzoyl peroxide works for them." Subjects initially will not be told that they are participating in a formal study. When they return with their medication, we will seek their informed consent to participate in the study. Verbal consent will be obtained at the beginning of the study. There will be no written consent obtained until the end of the study. By doing this, subjects will not be aware that adherence is being measured. Subjects will not be aware that they are participating in a study. Only if they consent would we then collect the medication container and monitor and retrieve the adherence data. If they do not consent, we will not have collected any research data on them except baseline acne severity measures which may have been collected anyway as part of their clinic treatment.

Arms: arm 1: Subjects will be given standard instructions in the use of topical benzoyl peroxide gel and will be provided with a supply of medication fitted with a Medication Event Monitoring System (MEMS) cap. This cap records dates and times the assembly is opened which can be downloaded at the final visit and tabulated with associated software. When the tubes are weighed, data from the MEMS Caps will be collected. Study coordinators will record adherence, while assessors are blinded to adherence rates. All subjects will be assigned to treatment with topical benzoyl peroxide to the entire face.
Interventions: intervention 1: Benzoyl Peroxide
Intervention descriptions: intervention 1: Benzoyl peroxide 5% gel. Applied once daily to face, minimum amount usable to cover area. Every day for six weeks.

Protocol documents:
Clinical trial NCT00659490
Conditions: Pain
Keywords: Analgesic effect Molar extraction
Sponsor: AstraZeneca
Start date: 2008-02-01; Completion date: 2008-05-01
Enrollment: 151 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.

Detailed description:

Arms: arm 1: AZD1940 800ug given predose arm 2: Naproxen 500mg given pre-surgery arm 3: Placebo given pre-surgery
Interventions: intervention 1: AZD1940 intervention 2: Naproxen intervention 3: Placebo
Intervention descriptions: intervention 1: 800ug oral administration intervention 2: 500mg oral administration intervention 3: Placebo given pre-surgery

Protocol documents:
Clinical trial NCT00675922
Conditions: Burn
Keywords: Burn Wounds Wound infection Topical antimicrobials Cerium Dakins Sulfamylon Soaks Silver Nitrate
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 1995-07-01; Completion date: 2008-05-01
Enrollment: 98 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Detailed description:
Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Arms: arm 1: Application of Sulfamylon 5% Solution and Silver Nitrate soaked dressings to two different burned area. Sites were then monitored for infections during hospitalization.
Interventions: intervention 1: Sulfamylon 5% and Silver Nitrate Soaks
Intervention descriptions: intervention 1: Application of Sulfamylon and Silver Nitrate Solution to burn wound daily

Protocol documents:
Clinical trial NCT00679302
Conditions: Skin Diseases, Infectious
Keywords: skin abscess CA-MRSA
Sponsor: St. Louis University
Start date: 2006-07-01; Completion date: 2008-05-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.

Detailed description:
This is a double-blind, randomized controlled trial at an urban pediatric emergency department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power = 80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old, English-speaking patients with clinical or ultrasound identified skin abscesses who were not on antibiotics. Patients were block randomized to receive placebo or trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3 days \& a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution with development of new lesion (furuncle, carbuncle or abscess) at a different location. Compliance was evaluated by the return of the study medication or by patient report.

Arms: arm 1: Maalox and bitter mixture arm 2: Trimethoprim-sulfamethoxazole suspension
Interventions: intervention 1: Trimethoprim-sulfamethoxazole intervention 2: Placebo group
Intervention descriptions: intervention 1: Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL. intervention 2: Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.

Protocol documents:
Clinical trial NCT00712920
Conditions: Perennial Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-01-01; Completion date: 2008-05-01
Enrollment: 581 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if two allergy medications are more effective than placebo.

Detailed description:

Arms: arm 1: Placebo arm 2: 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks arm 3: 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
Interventions: intervention 1: 0.15% azelastine hydrochloride intervention 2: 0.1% azelastine hydrochloride intervention 3: Placebo
Intervention descriptions: intervention 1: 0.15% azelastine hydrochloride 1644 mcg intervention 2: 0.1% azelastine hydrochloride 1096 mcg intervention 3: Placebo

Protocol documents: