cyrilzakka/clinical-trials huggingface dataset:
Telenursing and Breast Cancer: The Turkish Case

This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey.

This study aims to determine the effectiveness of telenursing services on chemotherapy symptoms and comfort levels in patients with breast cancer in Turkey. The study employs an experimental research methodology with a sample of 96 ambulatory patients (48 experimental, 48 control) who were receiving chemotherapy for breast cancer for the first time in a state hospital. Research data were collected by using "Patient Information Form", "Edmonton Symptom Assessment Scale", "General Comfort Questionnaire, "Symptoms Follow-up Form", and "Telephone Call Form". The experimental group received telenursing service every week until the end of the four-cycle chemotherapy treatment, which started one week after the first treatment. The control group did not receive any intervention. Investigators analyzed data with SPSS 15.0 (Statistical Package for the Social Sciences) with comparative statistical methods of MannWhitney U Test, Chi-Square Test, One Way Analysis of Variance in Repeated Measurements, and Pearson Correlation.

Eligibility Criteria:
Inclusion Criteria:

* is volunteering to participate in the research,
* is 18 years of age or over,
* can communicate in Turkish,
* has Turkish literacy skills,
* has no hearing, vision problems, and mental disability that may hinder communication,
* is female,
* has a diagnosis of breast cancer for the first time in her life and consequently receiving chemotherapy treatment in the same protocols for the first time,
* did not have a different diagnosis of cancer and related chemotherapy treatment.

Exclusion Criteria:

* Having been diagnosed with breast cancer before and received chemotherapy treatment accordingly,
* Having been diagnosed with different cancers before and had chemotherapy treatment related to it,
* Cancer treatment with oral medications,
* Refuse to participate in the study
* Refuse education/counseling
* Not knowing Turkish
OPTIMISE-CKD Drug Utilization

This is a multi-national, observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).

OPTIMISE-CKD is an observational study program using secondary data sources to address research questions related to 1) real-world dapagliflozin utilisation in CKD and potential for further utilisation, 2), the current CKD treatment landscape and 3) real-world effectiveness of dapagliflozin in CKD (pending feasibility assessment).

Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who are eligible for CKD treatment with dapagliflozin but untreated.

Secondary objectives: to describe the current clinical landscape among incident CKD patients, by:

1. Describing baseline demographic and clinical characteristics, drug utilization, and CKD treatment (RAASi and dapagliflozin 10 mg) patterns; and
2. Describing selected outcomes among overall, treated and untreated incident CKD patients.

Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD patients, pending feasibility.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged ≥18 years)
* Chronic kidney disease (diagnosis code, uACR \>30mg/g or 2 eGFR ≥90 days apart, second value ≥75ml/min/1.73m2)
* ≥365 days continuous enrolment in database

Exclusion Criteria:

* History of type 1 diabetes, gestational diabetes or dialysis
* History of dapagliflozin 10mg prescriptions before index date
Comparative Effectiveness Clinical Trial of MST Compared to ECT in Major Depressive Disorder

This study was a prospective, open-label comparative effectiveness clinical trial, comparing magnetic seizure therapy (MST) to ECT in patients with Major Depressive Disorder (MDD).

Magnetic seizure therapy (MST) has previously demonstrated fewer cognitive side effects than ECT in randomized trials of efficacy. However, there are currently no real-world effectiveness trials guided by the clinical decision making of the ECT psychiatrist as deemed best for the patient. The aims of this study are to: (1) Evaluate the comparative effectiveness of MST versus ECT in patients with MDD, and (2) Compare the cognitive adverse effects of MST and ECT, (3) Explore changes in SPECT that is associated with MST treatment and treatment response.

Patients will be clinically assigned to either ECT (n=30) or HD-MST (n=30) twice a week. Efficacy will be primarily assessed by the Hamilton Depression Rating Scale-21 (HAMD-21); primary cognitive side effects were assessed by Time to Reorientation (TRO) and secondarily cognitive battery. Brain SPECT will be done for patients before and after MST.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to consent
2. Clinically indicated for seizure therapy
3. Patients with MDD who had either never received antidepressant treatment or had discontinued antidepressants by their own choice for at least six weeks prior to enrollment (as commonly done in routine clinical care in this jurisdiction due to more negative views of psychotropics)
4. 18-65 years of age.

Exclusion Criteria:

1. Dementia,
2. Delirium
3. History of significant head trauma
4. Neurological disorders (e.g., epilepsy, stroke, multiple sclerosis)
5. Substance dependence
6. Active comorbidity with another psychiatric disorder
7. Patients who had previously received ECT or TMS
8. Current unstable or serious medical illness (e.g., myocardial infarction)
9. Pregnancy
10. Presence of implanted electronic devices (e.g., cardiac pacemaker, cochlear implants)
11. Inability to participate in testing
Analyzing How Genetics May Affect Response to High Blood Pressure Medications

High blood pressure is one of the most common health problems in the United States. There are many medications to treat high blood pressure, but there is a large variance in how people respond to these medications. It is believed that genetic variations may contribute to the inconsistent treatment response. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.

High blood pressure affects nearly one in three individuals in the Unites States. There are many factors that can cause high blood pressure, including family history and genetic traits, kidney disease, stress, diabetes, and diet. If left untreated, high blood pressure can increase one's risk for coronary heart disease (CHD), stroke, heart attack, and heart failure. While high blood pressure can be managed with medication, people receiving medication treatment for high blood pressure are still variably at risk for CHD and other cardiovascular conditions. This risk variation may stem from varying drug reactions that are likely due to genetics. This study will use genetic analysis to determine whether particular genes interact with high blood pressure medications to modify the risk of certain cardiovascular diseases.

This is a continuation study to the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT), which included a randomized trial of the four high blood pressure drugs chlorthalidone, amlodipine, lisinopril, and doxazosin. Using samples from ALLHAT participants, this study will analyze the interactions of candidate gene pathways of relevance with medications from the ALLHAT study. Researchers will examine both single DNA building blocks and multiple genes in the candidate gene pathways and determine whether their interaction with the ALLHAT drugs modifies the risk of cardiovascular outcomes. Researchers will perform genetic analysis on 96 genetic markers using structured association testing (SAT) and false discovery rate (FDR) methods. These methods will control for population stratification and multiple testing. Finally, the study will establish a mechanism for other researchers to continue further analysis of the genetic variants examined in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participant in the ALLHAT study
General Practitioner-performed Compression Ultrasound for Deep Vein Thrombosis

Numerous studies have demonstrated excellent diagnostic accuracy of Compression Ultrasonography (CUS) performed by hospitals doctors, skilled and unskilled in Radiology.

Recently, it was demonstrated that adequately ultrasonography-trained General Practitioners (GP) can perform reliable ultrasound to increase the speed and improve the quality of clinical management of various clinical conditions. To date, in the medical literature there are no studies that demonstrate the diagnostic accuracy of GP in performing CUS for the diagnosis of Deep Vein Thrombosis (DVT). Therefore, we plan to perform a prospective, multicenter, cohort study in which a large number of consecutive outpatients with symptoms or signs of DVT are subject to the CUS by the GP with the aim of evaluating the precision and the diagnostic accuracy compared to specialists in vascular ultrasound, which in this case will be the standard of reference.


Eligibility Criteria:
Inclusion Criteria:

* first episode of DVT of lower limbs

Exclusion Criteria:

* previous episodes of DVT
* ongoing anticoagulation
* age younger than 18 years
* pregnancy
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies

The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.

This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Documented history of migraine in the 12 months prior to screen
* 4-14 days per month of migraine symptoms
* \>=80% diary compliance during the Baseline period
* Failure of previous migraine prophylactic treatments

Exclusion Criteria:

* \>50 years old at migraine onset
* Pregnant or nursing
* History of cluster or hemiplegic headache
* Evidence of seizure or psychiatric disorder
* Score of over 19 on Beck Depression Inventory-2
* Active chronic pain syndrome
* Cardiac or hepatic disease
Rapid Turnaround, Home-based Saliva Testing for COVID-19

The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection.

Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients

  * Hospitalized at Stanford Health Care for COVID-related complications and tested positive for SARS-CoV-2 with a PCR-based test
  * Able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation
* High-risk/positive population

  * Seeking testing for suspected COVID or a participant in a study of COVID-positive outpatients
  * Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.
  * Willing to participate in the study for 6 months
* Low-risk population

  * Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos.
  * Willing to participate in the study for 6 months

Exclusion Criteria:

* All participants:

  * Participants with salivary gland dysfunction (including patients with Sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis)
  * Participants will not be eligible if they identify any reason they are unable to participate in the study
* High-risk/positive population

  * Participants who have color blindness
  * Participants unable to operate the SnapDx device
* Low-risk population

  * Participants with prior confirmed SARS-CoV-2 infection
  * Participants who have color blindness
  * Participants unable to operate the SnapDx device
Refugee Insect Production for Food and Feed: the School Meal Intervention

The goal of this randomized controlled trial is to assess whether edible insect-enriched school porridge has nutrition and health benefits for children aged 6-9 years in refugee communities in Uganda.

The main question the research aims to answer is: Does a daily serving of maize porridge enriched with yellow mealworm flour improve the gut health, growth, and micronutrient status of children in comparison to a standard maize porridge?

Participants will:

Consume a daily serving of yellow mealworm porridge or a maize porridge for one school term (3 months). Data is collected before, during and after the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Children in Primary 1 in Bukere and Kako primary school
* Age: 6-9 years
* Child can eat insects
* Written informed consent given by parent/caregiver

Exclusion Criteria:

* Severe acute malnutrition measured as MUAC \< 13.5 cm
* Known allergies related to consuming insects
* Disability that impedes eating capacity
* Disability that makes height assessment problematic
* Family plans to move away or deregister child from Kako and Bukere primary schools within the school term.
Closed-loop Oxygen Control for High Flow Nasal Therapy

In patients with acute hypoxemic respiratory failure (AHRF), High Flow Nasal Therapy (HFNT) improves oxygenation, tolerance, and decrease work of breathing as compared to standard oxygen therapy by facemask. Current guidelines recommend adjusting oxygen flow rates to keep the oxygen saturation measured by pulse oximetry (SpO2) in the target range and avoid hypoxemia and hyperoxemia. The hypothesis of the study is that closed loop oxygen control increases the time spent within clinically targeted SpO2 ranges and decreases the time spent outside clinical target SpO2 ranges as compared to manual oxygen control in ICU patients treated with HFNT.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>17yo) patients admitted to the ICU treated with HFNT for at least 8h
* Requiring FiO2 ≥ 30% to keep SpO2 in the target ranges defined by the clinician
* Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation.

Exclusion Criteria:

* Patient with indication for immediate continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), or invasive mechanical ventilation
* Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h
* Low quality on the SpO2 measurement using finger and ear sensor (quality index below 60% on the Massimo SpO2 sensor, which is displayed by a red or orange colour bar)
* Severe acidosis (pH ≤ 7.30)
* Pregnant woman
* Patients deemed at high risk for need of mechanical ventilation within the next 8 hours
* Chronic or acute dyshemoglobinemia: methemoglobin, carbon monoxide (CO) poisoning, sickle cell disease
* Tracheotomised patient
* Formalized ethical decision to withhold or withdraw life support
* Patient under guardianship
* Patient deprived of liberties
* Patient included in another interventional research study under consent
* Patient already enrolled in the present study in a previous episode of acute respiratory failure
Outcomes of Cesarean Section vs Vaginal Delivery: Instrumental Variable Adjusted Analysis

This study will examine the effect of cesarean section on perinatal mortality, using data provided by the Canadian Institute for Health Information.

This study will examine administrative data provided by the Canadian Institute for Health Information (CIHI). Maternal obstetrical delivery and neonatal hospitalization records provided by CIHI will be linked before analysis. The primary outcome is in-hospital perinatal mortality. The data will be analyzed by traditional multi-variate logistic regression, and the results from this analysis will be compared to the results from instrumental variable adjusted regression using the Generalized Method of Moments. The instrumental variable is the rate of cesarean delivery among women living within the same hospital catchment area. All analyses will be adjusted for maternal, infant, delivery provider, and hospital factors, as well as for clustering at the level of the delivery hospital.

Eligibility Criteria:
Inclusion Criteria:

* Mothers living in Canada and their infants delivering within the study period at Canadian hospitals outside of the province of Quebec.

Exclusion Criteria:

* Maternal record not linkable to neonatal record.
* Multiple gestation.
* Birthweight \< 500 gm.
* Gestational age at delivery \< 20 weeks.
* Deliveries at hospitals with less than 20 cesarean deliveries during study period.
* Records with missing data for important covariates
Safety and Efficacy Study of TRU-016 Plus Bendamustine vs. Bendamustine in Relapsed Chronic Lymphocytic Leukemia

The objective of the first part of the study is to determine a safe dose of TRU-016 that can be used in combination with bendamustine in patients with relapsed CLL. The objectives of the second part of the study are to compare the safety and efficacy of TRU-016 in combination with bendamustine to bendamustine alone in patients with relapsed CLL.

This study consisted of two parts. The initial dose escalation stage was a Phase 1b study evaluating the safety and tolerability of two doses of TRU-016 administered in combination with bendamustine to patients with relapsed chronic lymphocytic leukemia (CLL). In the randomized Phase 2 stage of the study, the efficacy and safety of the selected dose of 20 mg/kg TRU-016 combined with bendamustine was compared to bendamustine alone. The pharmacokinetics and pharmacodynamics of TRU-016 and the development of antibodies to TRU-016 were evaluated in both phases of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsed CLL with 1 to 3 prior treatments
* Demonstrated active disease requiring treatment
* No prior bendamustine treatment
* Not refractory to fludarabine or other purines, either as a single agent or in combination
* Age \>/=18 years; male or female
* Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
* Creatinine clearance \> 40 mL/min
* Absolute neutrophil count (ANC) \>/= 1,200/mm3
* Platelets \>/= 75,000/mm3
* Lymphocytes \>/= 5,000/mm3 in Phase 1b

Exclusion Criteria:

* Treatment with rituximab or other B-cell depleting agent within 30 days or alemtuzumab within 12 weeks
* Previous anticancer therapy within 30 days
* Refractory to prior fludarabine or other purine analog therapy either as a single agent or in combination
* Receipt of prior bendamustine or TRU-016
* Receipt of an investigational therapy or major surgery within 30 days
* Previous or concurrent additional malignancy (some exceptions apply)
* Any significant concurrent medical diseases or conditions
* Positive serology for HIV or hepatitis C, hepatitis B surface antigen positive or hepatitis B core antibody positive.
* Pregnant or breast feeding
* Drug or alcohol abuse
* Allergic to mannitol
Open Versus Robotic Retromuscular Ventral Hernia Repair

The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.

All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.
* At least one of the following risk factors: Body Mass Index \> 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)

Exclusion Criteria:

* Current abdominal wall infection
* Presence of ileostomy, colostomy, or ileal conduit
* Center for Disease Control wound class 3 or 4
* Hernia defect \< 7 cm or \>15 cm
* Pregnant women
Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.

All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 32 weeks gestation;
* Less than or equal to 1250 g;
* Mechanical ventilation;
* Echocardiographic findings of PDA with left to right shunting;
* Medical judgement of neonatologist for medical treatment;

Exclusion Criteria:

* Urine output less than 1 ml/k/hr over previous 12 hours;
* Serum creatinine greater than 1.5 mg/dL;
* Platelet count less than 100,000 per cubic mm;
* Significant skin breakdown at sensor areas;
* Significant congenital anomalies
* Intraventricular hemorrhage greater than or equal to grade III