cyrilzakka/clinical-trials huggingface dataset:
Clinical Pharmacist-led Appropriate Acid Suppression Therapy Stewardship Program

To evaluate the impact of clinical pharmacist-led appropriate acid suppression therapy stewardship program in hospitalized older patients.

This prospective, nonrandomized controlled study was conducted in older patients who ordered proton pump inhibitor (PPI) at admission in an internal medicine service of tertiary training and research hospital. In the intervention group, clinical pharmacist-led services (including medication reconciliation and medication review) were conducted during hospitalization and at discharge by using the guidelines and potentially inappropriate medications (PIM) criteria \[American Geriatric Society-AGS Beers Criteria©, 2019\]. Medication Appropriateness Index (MAI), inappropriate PPI cost, and hospitalization for gastrointestinal bleeding within 1 year after discharge were calculated in both groups

Eligibility Criteria:
Inclusion Criteria:

* 65 years old or greater
* Admitted to the hospital with any reason
* Ordered at least one PPI dose within 48 hours of admission

Exclusion Criteria:

* Transferred to another ward (including an intensive care unit)
* Having active gastrointestinal bleeding
* Having active malignity
Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Use a lens care system on a regular basis.
* Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
* Willing to use drops 4 times per day.

Exclusion Criteria:

* Participating in a conflicting study.
* An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any grade 2 or greater finding during the slit lamp examination
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Aphakic.
* Amblyopic.
* Allergic to any component in the study care products.
* Have had any corneal surgery.
Pharmacokinetics of Daunorubicin in Young Patients With Cancer

This laboratory study is looking at the pharmacokinetics of daunorubicin in young patients with cancer. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about how patients respond to treatment with certain chemotherapy drugs.

OBJECTIVES:

Primary

* Determine the pharmacokinetics of daunorubicin hydrochloride in pediatric patients with malignancy.

Secondary

* Evaluate the relationship between body composition (percent body fat) and the pharmacokinetics of daunorubicin hydrochloride in these patients.
* Correlate the pharmacokinetics of daunorubicin hydrochloride with gender, age, or ethnic background in these patients.
* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and toxicity.
* Explore, in a preliminary fashion, possible relationships between pharmacokinetic results and renal and hepatic function and complete blood count.
* Explore, in a preliminary fashion, possible genetic polymorphisms that may influence daunorubicin hydrochloride disposition.

OUTLINE: This is a multicenter study.

Patients undergo blood collection prior to, periodically during, and after treatment with daunorubicin hydrochloride for pharmacokinetic analysis.

Patients also undergo body composition testing within 7 days before or after the administration of daunorubicin hydrochloride using dual-energy x-ray absorptiometry.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of any malignancy
* Must be receiving a chemotherapy regimen that includes daunorubicin hydrochloride administered as an infusion of any duration for \< 24 hours on either a 1- or a 2-day schedule, including bolus and all short infusion schedules

PATIENT CHARACTERISTICS:

* Not pregnant or nursing
* No significant uncontrolled systemic illness
* Large implanted prostheses allowed (should not undergo dual energy x-ray absorptiometry scan)

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study

The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.

The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.

Eligibility Criteria:
Inclusion Criteria:

* major depressive disorder
* depressive episode in bipolar disorder
* age 18 - 65 years

Exclusion Criteria:

* alcohol- and/or drug dependence or abuse in the past 3 months
* severe/life-threatening medical disease
* pregnancy
* type I diabetes
* neurodegenerative disorder
* inability to give written informed consent to participation in the study
* contradiction to MRI scanning.
Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body

People with Parkinson's disease and Multiple Sclerosis experience disabling motor and non-motor symptoms, which respond insufficiently to medication. To adequately alleviate disease burden, physical training is increasing acknowledged as an assisting therapy; however, the optimal dose of exercise in unknown.

Next to complex motor deficits, people with Parkinson's disease and Multiple Sclerosis experience highly disabling non-motor symptoms; for example, anxiety and depression, cognitive decline, fatigue, and sleep problems. Physical training is increasingly recognized as an assisting and, importantly, safe therapy for these patients to alleviate disease burden. However, the optimal dose (i.e., type, frequency, intensity, duration) of exercise has not yet been established. This study aims to investigate differences in response patterns of motor and non-motor symptoms, blood-based biomarkers of neuroplasticity and neurodegeneration, as well as functional brain connectivity to eight weeks of high intensity interval training \[2x/week, \~30 min/session\], continuous aerobic training \[2x/week, \~50 min/session\], or movement advice \[+3000 steps/day for 5 days/week monitored with an activity tracker\]. Frequently repeated assessment of outcomes measures will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease (PD) or Progressive Multiple Sclerosis (MS)
* Hoehn \& Yahr stage \<4 (PD), Expanded Disability Status Scale score \<6 (MS)
* Anxiety and/or depressive symptoms; Hospital Anxiety and Depression Scale (HADS) score \>=8 points on HADS-A and/or HADS-D
* Sufficient cognitive ability to understand training instructions; Montreal Cognitive Assessment score \>21 points
* Able to participate in intensive physical training, no contra-indications for exercise
* Stable medication regime for at least 4 weeks prior to inclusion
* Age \>=18 years

Exclusion Criteria:

* Participation in intensive exercise program in the month prior to inclusion
* Relapse in the month prior to inclusion (MS)
* Symptoms indicating cardiovascular, pulmonary, or metabolic disease or cardiovascular, pulmonary, or metabolic disease which are not under control with medication
* abnormal electrocardiography in rest
Esketamine Administration on Recovery Quality After Radical Mastectomy

Some studies have reported that intravenous esketamine reduce postoperative pain intensity. The investigators investigated whether esketamine could improve the the quality of recovery after modified radical mastectomy.

A total of 111 patients were randomly allocated into 3 groups. Patients in group LE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 2 µg/kg/min until before suture the skin. Patients in group HE received a bolus infusion of esketamine (0.5 mg/kg) before cutting the skin, and then esketamine was infused at a rate of 4 µg/kg/min until before suture the skin. Patients in group CON received a bolus infusion of the same volume saline before cutting the skin, and then the same volume saline was infused until before suture the skin.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status
* Scheduled for elective modified radical mastectomy

Exclusion Criteria:

* Severe respiratory disease
* Renal or hepatic insufficiency
* History of preoperative psychiatric
* Preoperative hypertension
* Preoperative history of chronic pain
Alternate Day Versus Daily Oral Iron Therapy in Adolescents

Iron deficiency anemia affects over half of girls and young women with heavy periods and is the most common cause of anemia worldwide. Most girls with heavy periods who also have iron deficiency anemia are prescribed iron to take by mouth every day by their doctor. There are some studies showing that taking iron every other day may actually help the iron be absorbed into the bloodstream better. This study is trying to compare how taking iron every other day compares to taking iron daily for treatment of anemia.

The goal of this clinical research study is to learn which of the two methods of care will be the best way for girls and young women with iron deficiency anemia to take iron supplementation.

The research will be conducted at the following location(s):

Baylor College of Medicine, TCH: Texas Children's Hospital, and TCH: Texas Children's Hospital Clinic.

If patient appears to qualify for the study they will sign and date this consent form, and the doctor will confirm that they are eligible for the study. The patient will complete the following procedures:

* Medical history including prior hospitalizations, lab results, medications, diet, social and family history
* Physical Examination
* Blood samples: The patient will not have any extra blood draws (pokes) for this study. However, we will ask to take about 1/2 (0.5) teaspoons (3 mL) of extra blood for an extra research test when you have follow up blood test(s) in one month.

Patient will be on the study for 24 weeks (6 months),and will receive an information sheet about how to take iron to help it absorb in the stomach and on iron-rich foods.

There are 2 different treatments in this study. If a patient enrolls, they cannot choose which treatment to receive. Instead, they will be randomly assigned to one of the two treatments. That means there is a fifty percent chance they will receive iron medicine to take every day and a fifty percent chance they will receive iron medicine to take every other day.

Eligibility Criteria:
Inclusion Criteria:

1. Age 9 years or greater and less than age 22 years
2. Heavy menstrual bleeding, defined as a Pictorial Blood Assessment Chart (PBAC) Score \>100
3. Iron deficiency anemia, defined as both hemoglobin \<12 g/dL and ferritin \<15 ng/mL within 7 days of enrollment.

Exclusion Criteria:

1. non-uterine cause of vaginal bleeding
2. pregnancy
3. chronic kidney disease
4. serology confirmed celiac disease
5. active gastrointestinal blood loss
6. active malignancy
7. inability to follow-up at Texas Children's Hospital
8. receipt of intravenous iron within 30 days prior to enrollment
9. allergy or known inability to tolerate oral iron
Delving Into Participation Trends in Renal Cell Carcinoma Studies

The study seeks to delve into the firsthand experiences of patients diagnosed with renal cell carcinoma who partake in a separate clinical study featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals.

By joining this clinical trial, individuals have the unique opportunity to contribute to the betterment of future renal cell carcinoma patients and play an active role in advancing clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been diagnosed with renal cell carcinoma
* Patient is a minimum of 18 years or older
* Patient has self-identified as planning to enroll in a clinical study

Exclusion Criteria:

* Patient does not understand, sign, and return consent form
* Inability to perform regular electronic reporting
* Patient is pregnant
Demonstration of an Electronic Clinical Decision Support Module for Dengue in Burkina Faso

The Integrated Management of Childhood Illness (IMCI) guideline has been implemented in Burkina Faso and is used across primary health facilities to assess children under the age of 5 years. A part from a rapid diagnostic test (RDT) for malaria, no other point of care in vitro diagnostic tests are widely used to improve disease diagnosis and inform treatment decisions. Dengue fever has been reported in Burkina Faso since 1925 and the recent epidemics in 2016 and 2017 have prompted the government to validate and deploy a clinical management algorithm for Dengue and a case reporting process to support surveillance for a targeted response.

The organisation Terre des hommes has digitalised IMCI and implemented the module through its Integrated electronic Diagnosis Approach (IeDA) programme across primary health care centers (PHCs) in the country with proven impact on clinical care and proven reduction in antibiotic prescriptions. Many recognize the need to update the IMCI guideline with current evidence. However this is challenging and may require large clinical trials. The advantage of electronic clinical decision support systems is plural: they improve quality of care through increased adherence and feedback information to the system; they strengthen surveillance systems by connecting relevant patient related data and provide geo-tagged coordinates for targeted responses; and they can become evidence-adaptive.

An electronic module of the Burkina Faso Dengue clinical management guideline accompanied with dengue rapid diagnostic tests has the potential to improve the diagnosis of non-malaria fevers in particular during "dengue seasons" and improve the efficiency of surveillance for this disease.

In this study, the investigators aim to assess the usability and the performance of the dengue module for patient management in primary health care facilities.


Eligibility Criteria:
Inclusion Criteria:

* Older than 6 month
* Presentation with fever (axillary temperature ≥ 37,5⁰C) or history of fever for 2-7 days without localizing signs of another pathology such as malaria diagnosed by RDT
* Malaria diagnosis: negative malaria RDT performed at the the study site by a nurse as part of the routine consultation, or a positive malaria RDT with antimalarial treatment failure

Exclusion Criteria:

* Neonates (0-2 months) and children ≤ 6 month for operational reasons such as difficulties with blood draw
* Patients with severe disease requiring urgent care
Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.

OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given. Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages: Stages IIB, IIIB or IV

PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper normal limit Renal: Not specified Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Less than one week of steroids for management of airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the mediastinum Surgery: Not specified
mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

Without intervention, approximately 70% of women diagnosed with GDM will develop type 2 diabetes mellitus in their lifetime. Abnormal results of a 2 hour oral glucose tolerance test (OGTT) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. The investigators hypothesize that use of the Malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.

The effect of smartphone applications for gestational diabetes management on risk of postpartum glucose intolerance, antenatal glycemic control, and other perinatal outcomes is unknown.

This study is a randomized control trial in which patients diagnosed with gestational diabetes will be randomized to use of the Malama app vs. standard care as described above.

The primary aim of the study is to investigate if the incidence of postpartum glucose intolerance is lower in patients using the Malama app for gestational diabetes management compared to patients receiving standard care.

Secondary outcomes that will be investigated include several markers of maternal and neonatal perinatal morbidity. Maternal outcomes that will be investigated include postpartum hemoglobin A1c level, interval pregnancy weight gain, incidence of hypertensive disorders of pregnancy, cesarean delivery, operative delivery, postpartum hemorrhage, and advanced perineal lacerations. Neonatal secondary outcomes include gestational age at delivery, birthweight and incidence of large for gestational age infants, shoulder dystocia, NICU admission, length of NICU stay, neonatal blood glucose nadir, and need for neonatal IV glucose support.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical Center
2. Gestational diabetes diagnosed between 14 0/7 and 31 6/7 weeks gestation on basis of 1-hour glucose challenge test result of \>=200 mg/dL or Carpenter-Coustan criteria
3. \>= 18 years of age
4. Literate in English or Spanish (?additional languages pending app translation)
5. Access to or ownership of a smartphone compatible with Malama
6. Willing and able to sign the informed consent

Exclusion Criteria:

1. Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)
2. Diagnosis of pregestational diabetes
3. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)
4. Does not own smartphone compatible with Malama application
5. Severe life-limiting fetal anomaly
Bone Strength and Physical Activity in Patients With a Recent Clinical Fracture

The risk for a subsequent fracture is significantly higher in patients presenting with a fracture compared to individuals without a previous fracture and is highest within the first 2 years after the initial fracture. The risk for a subsequent fracture is not dependent of BMD as measured by conventional DXA. In recent studies, it has been shown that HRpQCT measurements provide information about bone structure, bone quality and bone strength in addition to BMD measurements. Diagnostic strategies should be focussed on bone quality and bone strength and fall prediction in the patients at high risk for falls, subsequent fracture and mortality such as patients with a recent fracture. Therefore, the investigators conduct a prospective observational study in 500 patients aged 50 years and older who present with a clinical fracture for evaluation of bone strength, physical activity, falls, subsequent fractures and mortality during a follow-up period of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 50 years and older with a recent fracture that is being evaluated at the FLS at VieCuri MC.
* Patients who understand the conditions of the study and are willing and able to comply with the scheduled biochemical study procedures
* Patients who signed the Ethics Committee approved specific Informed Consent Form prior to inclusion.

Exclusion Criteria:

* Patients with malignancy metastatic to the bone.
* Patients with osteomyelitis.
* Patients with fractures due to failure of a prosthesis.
* Patients, who as judged by the Principal Investigator, are mentally incompetent. Patients who are compos mentis and understand the patient information, will not be considered mentally incompetent