cyrilzakka/clinical-trials huggingface dataset:
Health Expenses and Outcomes of the DASH Diet in Egyptian Patients With Hypertension

DASH diet can reduce hypertension and decrease health expenses

Hypertension is a prevalent cardiovascular risk factor associated with adverse outcomes and obesity. Egypt's prevalence is 26.3%, exceeding rates in the U.S. and sub-Saharan Africa. Lifestyle interventions like the DASH diet effectively manage hypertension, offering a cost-effective alternative to pharmacological treatments. This study aims to assess the effects of the DASH diet on blood pressure, BMI, waist circumference, and fasting blood glucose, as well as its cost-effectiveness compared to pharmacological treatments. This open-label prospective controlled clinical trial was conducted in Esna Health Administration, Luxor Governorate. The FMREC of Beni-Suef University approved the study, which included 364 hypertensive patients aged 30-60. Exclusions were patients with severe comorbidities or those who declined participation. Measurements included height, weight, BMI, blood pressure, and laboratory tests. The intervention group received a DASH diet education program. Outcomes measured were blood pressure, BMI, waist circumference, weight, and fasting blood glucose at baseline and post-intervention. Our study demonstrates the significant benefits of the DASH diet in managing blood pressure, weight, and fasting blood glucose levels in the Egyptian population. The DASH diet substantially reduced systolic and diastolic blood pressure, with a notable decrease in the number of antihypertensive medications needed. Additionally, participants on the DASH diet experienced significant weight loss and reduced BMI and waist circumference compared to the control group. The economic implications of the DASH diet are also promising, with a notable decrease in the total cost of therapy due to reduced medication costs.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with primary hypertension (all stages) in the family medicine units of Esna Health Administration, located in Luxor Governorate.
* Individuals between the ages of 30 and 60, of both male and female genders.

Exclusion Criteria:

* • Patients with cancer and either hepatic failure or renal impairment.

  * Patients diagnosed with diabetes, metabolic illness, or terminal organ failure.
  * A patient with severe or malignant hypertension.
  * Individuals who decline to partake in our research.
Normal Tissue Oxygenation Following Radiotherapy

This study involves women who have had a diagnosis of breast cancer, and have had a lumpectomy with radiation treatments completed in the past year.

The study will determine the level of oxygen in the skin of the breast that has been radiated, compared with the normal skin of the opposite breast.

The purpose of this study is to determine if there is a decrease in oxygen levels in the skin which has been radiated, hopefully to find a treatment to limit skin damage caused by radiation treatments, for women with breast cancer in the future.

Successful completion of this study will provide data on changes in oxygenation in irradiated tissues. If changes are documented, this study would provide evidence supporting current models of tissue injury following radiotherapy. In addition, these data may provide a mechanistic rationale for clinical approaches to ameliorate the toxicities of radiotherapy. Finally, if a correlation exists between tissue oxygenation and toxicity, the rapid and simple tissue oxygenation test may provide a quantitative measure of toxicity and allow earlier and more precise assessment of both toxicity and efficacy of ameliorative therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of breast malignancy
2. Completion of breast irradiation one year (+/- 8 weeks) prior.
3. Surgical treatment with lumpectomy

Exclusion Criteria:

1. Inability to tolerate the 20 minute transcutaneous oxygenation measurements
2. Allergy to adhesives
3. Bilateral disease or absence of control breast or previous radiotherapy to "control" breast
4. More than one course of radiotherapy to the breast
Memory Support System Feasibility Study

The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners

A survey will be created and sent out to participants with MCI who have expressed interest in participating in research and have been seen at a memory clinic or geriatric day hospital after the initiation of the study. The survey will consist of a Likert scale and open questions related to patient interest in and preferred length of MSS administration and preference for in-person versus virtual administration.

During and after collection of the survey data, a sample of 20 individuals with MCI (ages ≥50) and their care partners will undergo MSS training.

At enrollment in the MSS training, participants with MCI and their care partners will complete measures of cognitive and functional status. Participants and partners will also complete measures of treatment adherence, IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden at baseline, treatment end, and 8-week follow-up. Participants will complete the MSS training consisting of ten 1-hour sessions delivered over two or six weeks, starting 7-10 days after initial assessment. Training will be offered in English or French. After the intervention, participants and their partners will complete a semi-structured interview, seeking suggestions for improving the MSS, teaching curriculum, and intervention logistics.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of single or multi-domain MCI
* Clinical Dementia Rating global (CDR) score of ≤ 0.5
* Montreal Cognitive Assessment score of ≥18
* available contact with a care partner ≥ 2 times weekly
* absence or stable intake of nootropic(s) for ≥ 3 months

Exclusion Criteria:

* visual/hearing impairment and/or history of reading or written inability/disability sufficient to interfere with MSS training
* concurrent participation in another related clinical trial
The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury

This is a double-blind, placebo-controled, randomized trial to investigate if aspirin pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Age \< 18 years
* Pregnancy or breast feeding or woman of childbearing potential not using
* adequate contraception.
* Participation in a clinical trial of an investigational medicinal product within 30 days
* Consent declined Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks
* History of asthma
* Known aspirin or NSAID hypersensitivity
* History of peptic ulcer disease
* Platelet count \< 150 x 106/ml
* Aspirin resistance
The Use of Ketorolac in Surgical Neonates

The general purpose of this study is to characterize the safety profile of ketorolac in infants age 0-3 months. Our hypothesis is that ketorolac is safe in neonates, and effective in controlling pain with less narcotic administration required. Ketorolac 0.5mg/kg intravenously every 8 hrs for 72hrs will be administered versus an equivalent volume of 0.9% normal saline as placebo.

Primary: The primary purpose of this study is to compare bleeding events in neonates who receive ketorolac and those who do not receive ketorolac. The investigators hypothesize that ketorolac is safe and effective in infants \> 37wks gestation and at least one week of age.

Secondary: The investigators intend to evaluate daily creatinine levels, pain scores, urine output per shift, platelet counts, hemoglobin levels, number of days on the ventilator, amount of narcotic administered, blood pressure, and reintubation events on all patients in this study as secondary study points.

This is a Phase II, single center, randomized controlled pilot study. Hospitalized patients one week of age to 3 months of age who undergo an abdominal surgical procedure within the moderate or severe degree of pain category (see attached Table 1: postoperative pain categories) will be randomized to receive standard pain management regimens plus placebo (0.9% saline of equivalent volume) or ketorolac 0.5mg IV q8h x 72h plus standard pain management regimens. The postoperative management will be unchanged and at the discretion of the attending surgeon, as appropriate for the surgical procedure. The patients will be followed for 5 days, or 48hrs from the end of ketorolac therapy for primary and secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

1. Infants gestational age \> 37 weeks and greater than or equal to one week of age to 3 months of age
2. Infants who are undergoing a surgical procedure on the abdomen
3. the parent or guardian has given informed consent.

Exclusion Criteria:

1. Gestational age \< 37 weeks
2. Age less than one week or greater than 3 months of age
3. Known renal disease/dysplastic kidneys
4. Serum Creatinine \> 0.4
5. Patients who have rising creatinine levels the day prior to surgery (increase of at least 1.5-fold from baseline)
6. Patients who are currently receiving other potentially renal toxic drugs or drugs that may interfere with hemostatic pathways as part of their clinical care (including but not limited to furosemide, hydrochlorothiazide, vancomycin, gentamicin, aspirin, tpa \[except for use of thrombosed central venous catheters\], enalapril, systemic heparin \[except for use in central venous catheter flushes\])
7. Patients who undergo nephrectomy
8. Patients with necrotizing enterocolitis
9. Patients with a hemoglobin value \< 10g/dL
10. Recent (within 3 months) GI bleeding, ulceration, and/or perforation
11. Platelet count \< 50,000
12. Ongoing disseminated intravascular coagulation or history of intraventricular hemorrhage
13. Recent (within 2 weeks) use or current use of other nonsteroidal anti-inflammatory drugs (NSAIDS) besides aspirin (ASA)
14. Allergy to ASA or other NSAIDS
Abdominal Pain and Symptoms Post Gastric Sleeve

Exploration of abdominal pain post sleeve gastrectomy in morbid obese patients

The primary aim is to evaluate abdominal pain in morbid obese patients before and after sleeve gastrectomy. The investigators will especially focus on chronic abdominal pain, and its relation to quality of life and weight loss. In a sub-analysis the investigators will compare the findings of the present cohort with patients operated with Roux-en-Y gastric bypass.

Primary endpoints/outcomes:

- Define the prevalence of chronic abdominal pain 2 years after sleeve gastrectomy

Secondary endpoints/outcomes:

- Evaluate and characterise chronic abdominal pain in regard to:

* Weight development
* Obesity-related comorbidities
* Health-related quality of life
* Postoperative complications
* Metabolic effects after surgery
* Nutritional status
* Socioeconomic status

Eligibility Criteria:
* Inclusion criteria

  * Patients undergoing sleeve gastrectomy at the Center for Morbid Obesity and Bariatric Surgery, Oslo University Hospital and a collaborating center.
  * Signed written and informed consent for study enrollment
* Exclusion criteria

  * Patients who dont understand Norwegian language
  * Previous bariatric surgery
  * Indication for sleeve gastrectomy for other reasons than for morbid obesity
Predictive Factors, Demographics and Mortality for ARDS in Burn Patients

This retrospective study characterizes the clinical course and identifies four independent predictors of Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS). In addition, a clinically useful prognostic score for pbARDS is introduced (ARDS burn score), which was derived from these independent predictors. The newly developed score may be helpful for the development of specific treatment strategies.

Rationale:

Acute Respiratory Distress Syndrome (ARDS) after burn injury (post-burn ARDS; pbARDS) is a severe complication associated with a mortality of up to 44%. To date, only few studies have been published on the clinical course and predictive factors of pbARDS.

Objectives:

To characterize the clinical course of pbARDS, to identify relevant predictors, including the development of a prognostic score, and to examine outcome parameters such as mortality and hospitalization days.

Methods:

A retrospective analysis of 400 patients admitted to the Burns Intensive Care Unit of the University Hospital Zurich from 2004 to 2009 was performed. Multivariate logistic regression was used to determine independent risk factors for pbARDS. A prognostic score was developed, which was tested with leave-one-out-cross-validation and Receiver Operating Characteristic (ROC) curves.

Eligibility Criteria:
Inclusion Criteria:

all patients treated at the Burns Intensive Care Unit (BICU) of the University Hospital Zurich (USZ) between January 2004 and December 2009.

Exclusion Criteria:

Exclusions were made because of incomplete or unavailable data, re-hospitalization due to complications of previous burns, and the initial decision not to resuscitate due to unfavorable prognosis.
Iron and Vitamin Supplementation in Hip/Knee Surgery

Randomized controlled trial to evaluate the efficacy of oral iron supplementation plus cofactors in reducing the prevalence of preoperative anemia in a cohort of 60 patients undergoing elective prosthetic hip or knee surgery.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* ASA 1, 2, or 3
* No neuropsychiatric conditions
* Acceptance of informed consent
* Elective prosthetic hip or knee surgery

Exclusion Criteria:

* ASA 4
* Present or past neuropsychiatric conditions
* Hip or knee revision surgery
* Use of iron as dietary supplement
* Known erythrocytosis
* Incompatible hypersensitivities
* Iron metabolism disorders
* Lymphoproliferative disorders
High-dose Prednisone in Duchenne Muscular Dystrophy

This study will help to determine whether a high-dose weekly course of prednisone therapy is safer than and at least as effective as daily dose therapy for people with Duchenne muscular dystrophy (DMD). Boys who are enrolled in this study should not have taken carnitine, other amino acids, creatine, glutamine, Coenzyme Q10 or any herbal medicines within the last three months. There will be a two-visit screening to take place in one week to ensure a reproducible manual muscle test. The subject will then be randomized and put into either the daily or weekly regimen. The duration of the study is twelve 28-day treatment cycles (approximately 12 months) with follow-up visits at month one, three and then every three months.

Duchenne muscular dystrophy (DMD) is the most common lethal inherited disorder worldwide. Despite the exponential increase in our understanding of the disorder since the discovery and characterization of the causative gene and its product dystrophin in 1987, current therapeutic management remains largely supportive. Awaiting a final genetic cure to be available in the future, further investments in developing better drug therapies for DMD remain important. The effect of a high dose prednisone regimen will be evaluated in comparison to a daily dose regimen in a multi-center, randomized, double-blind placebo-controlled 4-arm study. Ambulant children aged 4-10 years with an established DMD diagnosis will be studied. Patients will undergo 2 screening evaluations within 1 week. Patients will be randomized into treatment groups on the second screening visit, followed by a 12-month treatment period. During the treatment period, patients will be evaluated at monthly intervals. The primary endpoints are percentage change in average muscle strength score and QMT performance for specific muscle groups. Secondary endpoints include timed function tests, functional grades for arms and legs, and pulmonary function tests.

Eligibility Criteria:
Inclusion Criteria:

* 4 to 10 years of age
* Ambulant
* Confirmed DMD Diagnosis
* Steroid naive
* Evidence of muscle weakness by MRC score or clinical functional evaluation
* Ability to provide reproducible QMT bicep score

Exclusion Criteria:

* History of significant concomitant illness or significant impairment of renal or hepatic function, or other contraindication to steroid therapy
* Symptomatic DMD carrier
* Positive PPD
* Lack of prior exposure to chickenpox or immunization
* Use of carnitine, glutamine, Coenzyme Q10, other amino acids or any herbal medications within the last 3 months
* History of symptomatic cardiomyopathy
* Prior attainment of quota for the age group in which the patient belongs
Study to Determine the Phototoxity of Atralin (Tretinoin) Gel, 0.05%

To assess the potential of tretnoin gel 0.05% to produce phototoxic reactions, measured as skin reactions 24 and 48 hours after UV radiation of drug on skin.


Eligibility Criteria:
Inclusion Criteria:

* Normal healthy volunteers
* 18 years of age or older

Exclusion Criteria:

* Less than 18 years of age
Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome

The components of MetS (abdominal obesity, high blood pressure, high serum glucose, high triglyceride level and low HDL-C) differ according to demographic characteristics such as age, gender and comorbidities. Low physical activity level, genetic makeup, nutritional disorders, decreased muscle strength and low cardiorespiratory fitness can be counted among the risk factors associated with MetS. In our study, it was aimed to examine the relationship between the components of the MetS and muscle strength, physical activity, functional capacity and quality of life. Our secondary aim is to investigate the independent effects of different components of MetS on each parameter.

The participants' sociodemographic characteristics such as age, height, weight, body mass index, waist circumference, marital status and education level, and anthropometric measurements, body fat percentage distributions, fasting blood glucose, HbA1c and lipid profiles will be recorded from previous analysis reports. Lower extremity quadriceps muscle strength Hand-held dynamometer, grip strength hand dynamometer, physical activity level International Physical Activity Questionnaire-Short Form-IPAQ-SF, number of steps pedometer, functional capacity 6 minute walking test and quality of life will be evaluated with the European Quality of Life Scale-5 Dimension.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with MetS by an Internal Medicine Specialist according to NCEP-ATP III criteria
* Finding abdominal obesity component according to TURDEP-II criteria
* Being between the ages of 40-65
* To be able to read and write Turkish
* Having signed the informed consent form

Exclusion Criteria:

* Lack of cooperation
* Those with severe peripheral or central neurological disorders
* Patients with uncontrolled hypertension and uncontrolled arrhythmia
* Pregnant or breastfeeding patients
* Those with diabetic ulcer or neuropathy
* Chronic kidney failure (eGFR\<30 ml/min)
* Chronic liver disease (ALT/AST\<3X Normal upper limit)
* Those with serious respiratory system disease
* Patients with cardiac pacemaker
* History of previous stroke or myocardial infarction
* Presence of lower and upper extremity orthopedic problems that may prevent the application of clinical tests
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis

This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe active rheumatoid arthritis.

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female aged 18 to 70 years old, both inclusive.
* Patient must be able and willing to self-administer SC injections.
* Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria (Aletaha et al., 2010) for at least 24 weeks prior to the first administration of the study drug (Day 1).

Exclusion Criteria:

* Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
* Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
A Patient Portal Tool, E-assist, for Supporting CRC Screening

To compare patient perceptions, intent to screen, and screening use among those using a patient portal with and without a colorectal cancer (CRC) screening decision support tool, e-assist.

To evaluate whether the effectiveness of e-assist is moderated by multi-level factors, including patient health literacy, decision-making preference, and CRC screening decision stage.

To assess program impact and create an implementation guide for e-assist by combining results from Aims 1 \& 2, a program implementation analysis/process evaluation and the perspectives of staff from future diverse implementation sites including small primary care practices, University-based primary practices and federally-qualified health centers.

During initial project period, the content was developed for the online e-assist tool using messages and tools developed under prior NCI-funded applications combined with newly developed messaging specific to this application. Throughout development, the principal investigator will seek input and guidance from a quality improvement team at the Henry Ford Health System (HFHS) (i.e., the local performance site) that is tasked with patient portal innovation for Meaningful Use. Once finalized, the effectiveness of e-assist will be evaluated using a three-arm, practical randomized trial.

Trial participants will be randomized to one of the following three groups:

1. e-assist: Colon Health (treatment arm) \[n = 900\]
2. Healthwise Educational Program (active control) \[n = 900\]
3. Usual care control (observational only) \[n = 900\]

For the evaluation, the investigators employ an intent-to-treat design with primary effectiveness measured by electronic health record (EHR)-documented CRC screening use. Secondary outcomes of interest include patient-reported CRC screening intent, perceived barriers to and support for CRC screening as well as perceived susceptibility and screening benefits. Results from all analyses will be used to develop an implementation guide for the dissemination and implementation of e-assist among diverse primary care practices.

Eligibility Criteria:
Inclusion Criteria:

-CRC screening recommendation via colonoscopy and/or stool cards at time of primary care appointment. Receiving care in a HFHS primary care clinic and activated MyChart account.

Exclusion Criteria:

* EHR-documented colonoscopy in the past 10 years, sigmoidoscopy in the past 5 years, or fecal occult blood test (FOBT) or fecal immunochemical test (FIT) in the past 12 months.
* Elevated risk for CRC (i.e., personal or family history of CRC, those with prior polyps, or a history of inflammatory bowel disease, familial adenomatous polyposis, or hereditary nonpolyposis).