cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impact of a Safe Medication Storage Device

Despite the initial success of the 1970s Poison Prevention Packaging Act, the incidence of pediatric medication poisonings in the United States remains high. Unintentional pediatric medication ingestions result in significant morbidity and are associated with substantial healthcare use and costs. A majority of these medication poisonings involve a caregivers' medication and are caused by modifiable unsafe storage behaviors. A better understanding of factors associated with pediatric poisonings and safe medication storage behaviors is needed to inform public health policy and develop targeted educational interventions. Furthermore, low-cost, scalable interventions that improve medication storage behaviors and reduce pediatric poisonings are necessary to address this ongoing preventable public health crisis.

In preliminary experiments, a baseline evaluation of caregivers demonstrated that they are unlikely to have a locked medication storage device in their home, but would be willing to use a locked device if one was available. Additionally, a follow-up assessment indicated that a majority of caregivers had used their medication over a one-month period. The latter feasibility assessment supports both caregiver willingness to use a safe storage device and demonstrates that a storage device can improve medication storage behaviors in the short-term.

Given these findings, we hypothesize that pediatric medication poisonings are due to improper storage, that medication storage behaviors are influenced by demographic and household specific factors, and that medication lockboxes improve safe medication storage behaviors and reduce pediatric poisonings. These hypotheses will be evaluated using the studies in the following Specific Aims: (1) to identify factors associated with pediatric poisonings, (2) to identify factors associated with medication storage behaviors, (3) to evaluate the effect of lockboxes on storage behaviors and pediatric poisonings.

Should this exploratory study reveal factors associated with increased risk for pediatric poisoning or with safe medication storage, and should safe medication storage interventions improve modifiable storage behaviors or show a reduction in pediatric poisonings, the results will be used to inform targeted public health campaigns and to develop a low-cost, scalable national program for improving safe medication storage and reducing pediatric poisonings.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers of pediatric patients less than 6 years of age presenting to the emergency department
* Adults (at least 18 years of age) who are responsible for supervising at least one child under the age of 6 years in their residence
* Supervision of at least one child under the age of 6 years for at least 3.5 days per week on average

Exclusion Criteria:

* pediatric patients who are critically ill or unstable
* pediatric patients presenting due to a poisoning related incident
* caregivers who are unable or unwilling to provide consent
* caregivers who are non-English speaking.
Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions

This study was designed to compare the relative bioavailability (rate and extent of absorption) of Divalproex Sodium ER Tablets 500 mg with that of Depakote® ER Tablets 500 mg following a single, oral dose (1 x 500 mg extended release tablet) administered to healthy, adult subjects under non-fasting conditions.


Eligibility Criteria:
Inclusion Criteria

* Subjects who have completed the screening process within 28 days prior to Period 1 dosing
* Subjects who are healthy adult men and women 18 years of age or older at the time of dosing.
* Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at least 110 lbs.
* Subjects who are healthy as documented by the medical history, physical examination (including bur may not be limited to and evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files and agreed upon by both the study physician and investigator prior to enrolling the subject in this study and for continued enrollment.
* Female subjects of postmenopausal (no menses) status for at least 1 year and has a serum FSH level greater than or equal to 30 mIU/mL or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).

Exclusion Criteria

* Subjects who report receiving any investigational drug within 30 days prior to Period 1 dosing.
* Subjects who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
* Subjects whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
* Subjects who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
* Subjects who report a history or allergic response(s) to divalproex or related drugs.
* Subjects who report the use of any systemic prescription medication in the 14 days prior to Period 1 dosing.
* Subjects who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period 1 dosing.
* Subjects who report a history of clinically significant allergies including drug allergies.
* Subjects who report a clinically significant illness during the 4 weeks prior to Period 1 dosing (as determined by the clinical investigators).
* Subjects who report a history of drug or alcohol addiction or abuse within the past year.
* Subjects who demonstrate a positive drug abuse screen for this study prior to Period 1 administration.
Tritanium® Study in Japan

The purpose of this study is to evaluate early fixation and stability of the Tritanium cup. It is expected that the Tritanium® cup will be equal to or better than conventional cementless cups in early fixation/stability and meet the expectations of Japanese surgeons.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is a candidate for a primary Total Hip Arthroplasty (THA).
2. Patient who has diagnosis of secondary osteoarthritis, avascular necrosis and rheumatoid arthritis.
3. Patient whose age is 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 40.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy), which limits ability to evaluate the safety and efficacy of the device.
7. Patient who is immunologically suppressed or receiving chronic steroids, which limits ability to evaluate the safety and efficacy of the device.
8. Patients who is judged ineligible with specific reason by primary doctor.
Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors

The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding

Social and environmental issues continue to impact disease morbidity and mortality resulting in the inequities of health, wellness, and quality of life experienced by African American breast cancer survivors (AABCS) living in urban Milwaukee. AABCS outcomes in Milwaukee are significantly worse (OR=1.55) than those of Caucasian survivors.

The American Diabetes Association/American Cancer Society expert committee recommends the promotion of a healthy diet, physical activity, and weight management with low waist circumference to prevent diabetes, cancer, and obesity and to extend life expectancy. According to the National Health Interview Survey, 56% of African Americans are inactive. Yoga is one way to increase physical activity while improving wellness and health in AABCS.

The investigator's goal was to facilitate improved self-care efficacy through evidence-based integrative health and wellness strategies to help families overcome the effects of multiple negative, deep-rooted social determinants.

Eligibility Criteria:
Inclusion Criteria:

* Sex: female
* Race: African American
* Survivor of breast cancer
* Physical activity participation not limited by medical doctor
* English speaking

Exclusion Criteria:

* Sex: male
* Race: not African American
* No breast cancer history
* Physical activity limitations imposed by medical doctor
Randomized Comparison of Elemental Liquid Diet and Standard Semi-solid Diet on Gastric Emptying

The purpose of this study is to compare the effect of either elemental liquid diet or standard semi-solid diet on gastric emptying in both healthy subjects and bedridden patients receiving gastrostomy feeding.

A randomized, crossover trial using elemental liquid diet or standard semi-solid diet containing 13C sodium acetate as a tracer is performed in both healthy subjects and bedridden gastrostomy-fed patients. 13C breath tests is performed to estimate gastric emptying.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects bedridden gastrostomy-fed patients

Exclusion Criteria:

* regular use of gastric acid blockers, motility drugs, benzodiazepines or opioids, any clinical evidence of acute infection, a history of abdominal surgery, and an American Society of Anesthesiologists physical status of class IV or V.
Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
* Duration of type 2 diabetes diagnosis at least one year
* HbA1c 8.0-13.0%, both inclusive
* Body Mass Index (BMI) between 25-40 kg/m\^2, both inclusive.

Exclusion Criteria:

* Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
* Recurrent major hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level
* Known or suspected abuse of alcohol or narcotics
* Any contraindications to metformin or glimepiride according to the local guidelines
Safety and Efficacy of Left Atrial Appendage Occlusion Devices

Atrial fibrillation (AF) is the most common cardiac rhythm disorder in clinical practice. In the last two decades the number of hospitalizations for AF has increased two- to three-fold. More than 6 million people worldwide suffer from atrial fibrillation (AF), a cardiac disorder that results in systemic emboli. Patients with AF are 5 times more likely to have a stroke compared with those without AF.

This registry will collection information on two devices that are used to treat AF. The WATCHMAN and LARIAT. The differences in techniques and subsequent effects of the two devices on outcomes related to AF has not been studied. This study will look to compare the two devices to see how the outcomes may vary.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a LARIAT LAA device occlusion

Exclusion Criteria:

* Patients who have PFO/ASD/critical carotid artery (\>70% blockage) disease and hemorrhagic strokes
Telephone Follow-Up on Outcome After Mild Traumatic Brain Injury

The purpose of this study is to see whether providing education and counseling after a mild traumatic brain injury will help in preventing symptoms from becoming chronic over the first six months after injury.

This study examines the effect of scheduled telephone calls on the outcome after mild traumatic brain injury (MTBI) or concussion. These calls offer subjects information, focused counseling, and referrals. MTBI is extremely common in the United States, numbering well over a million cases per year. Although recovery for most is quite good, 10-20% of persons have persisting symptoms that affect employment, quality of life, and health care expenses. We are examining one means to decrease persisting symptoms by offering early, consistent intervention before symptoms become persistent.

The subjects are enrolled in the emergency departments (ED) of the hospital and receive the baseline assessment while still in the ED. Subjects are randomly assigned to two groups: Group 1 standard care and Group 2 standard care, toll-free telephone number, and scheduled telephone calls for follow-up at 1-2 days, 2, 4, 8, and 12 weeks after injury. All subjects are contacted again at 6 months for an outcome assessment that is done over the telephone.

On the telephone, subjects are asked about current problems, and are given both information about recovery from MTBI and some counseling on dealing with symptoms or other complaints. They are also given community resources to obtain assistance if needed. Telephone call are reviewed by supervisors (physician and psychologist) for adherence to protocol and for training purposes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis consistent with mild traumatic brain injury
* Glasgow Coma Scale score 13-15
* Loss of consciousness less than or = to 30 minutes
* Any period of alteration of consciousness or post-traumatic amnesia
* age between 16 and 80
* permanent address
* ability to communicate in English

Exclusion Criteria:

* hospitalization within previous year for traumatic brain injury
* prior or current diagnosis of central nervous system or major psychiatric disorder
* Intoxication sufficient enough to cloud the diagnosis of mild TBI
* current alcohol dependence
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering

This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can prevent and relieve nausea and shivering, two of the more common complaints after cesarean delivery.

This study is a randomized, placebo controlled, double blind evaluation of the use of a single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to placebo) will have a reduced severity of postoperative shivering and nausea.

Study subjects will be have a scheduled cesarean section. They will receive written, informed consent obtained before surgery. After enrollment, patients will receive spinal anesthesia consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid will be warmed.

After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe consisting of either placebo saline, or 10 mcg of dexmedetomidine.

Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea, pain, pruritus, and sedation. Assessments will be performed on admission to the recovery room, and at 30 and 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean delivery
* ≥ 18 years of age
* Singleton pregnancy
* Term delivery (37 weeks or greater gestation)
* Spinal or combined spinal-epidural anesthesia is planned

Exclusion Criteria:

* Non-elective cesarean delivery
* Receiving misoprostil or carboprost
* Postpartum hemorrhage greater that 1000cc
* Chronic opioid use
* History of chronic nausea or itching in pregnancy
* Receiving medications for nausea
* Inability to provide written informed consent
* Receiving of any of the following medications intraoperatively: misoprostil, carboprost, medications for nausea
* Postpartum hemorrhage greater that 1000cc
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst


Eligibility Criteria:
Inclusion Criteria:

* Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Exclusion Criteria:

* N/A
Quality Control Study of Laparoscopic Sentinel Node Biopsy in Early Gastric Cancer

Laparoscopic sentinel lymph node biopsy and stomach preserving surgery in ealry gastric cancer is less invasive method which can increase quality of life. Multicenter phase III trial is requred to validate this method. In this study all items which are necessary for laparoscopic sentinel lymph node biopsy are identified according to checklist and evaluated the performance completement.


Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma in preoperative endoscopic biopsy
* clinical stage T1-2N0
* long diameter of tumor \<4cm
* distance between tumor and pylorus or cardia \>2cm
* age: 20-80
* ECOG: 1 or 0
* patients will undergo laparoscopic gastrectomy

Exclusion Criteria:

* definite criteria of endoscopic submucosal dissection (size\<2cm, differentiated type, no ulcer)
* no indication for surgery for cardiovascular, pulmonary disease
* pregancy
* drug allergy or previous abdominal surgery, radiotherpy
Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy Chinese subjects.


Eligibility Criteria:
Main Inclusion Criteria:

* Healthy male and female (24 male and 8 female) subjects of Chinese ethnic origin, age 40 years and older.
* Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
* Body weight according to a Body Mass Index (BMI) between 19 and 28 kg/\[m²\], (both inclusive) and a body weight ≥ 50 kg.
* Females with childbearing potential who are using medically acceptable and reliable method of contraception for the entire study duration, such as tubal ligation, hysterectomy, intrauterine device without hormones or post-menopausal females, the latter is defined as females who have had no menstrual period for at least 2 years.

Main Exclusion Criteria:

* History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
* History of allergic reactions to roflumilast or any inactive ingredients of the trial medication
* History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease (within the last 2 years)
* History of malignancy within the past 5 years
* Electrocardiogram (ECG) abnormalities of clinical relevance (e.g. QTc according to Bazett's formula: QTc \> 450 msec (male), QTc \> 470 msec (female), PQ ≥ 220 msec)
* Blood pressure ≥ 140 mm HG systolic or ≥ 90 mm HG diastolic
* Elevated transaminases \> 2 x upper Limit of normal range and or increased of the total bilirubin \> 1.5 upper Limit of normal range
* Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
* Chronic or clinically relevant acute infections
* Proneness to orthostatic dysregulation, faintings, or blackouts
* Positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis A, B, and C virus infections
* Positive drug screen
* Abuse of alcohol or drugs
* Positive β-HCG pregnancy test (female)
* Pregnant or lactating females