cyrilzakka/clinical-trials huggingface dataset:
Effects Of Walnut-Enriched Diet On Blood Lipids And Glucose Profiles In Hyperlipidemic Subjects

Walnuts have been shown to reduce serum lipids in hyperlipidemic individuals with a well-controlled feeding trials. Current study have been determined the effects of daily walnut consumption on serum lipids, fasting glucose and insulin levels in hyperlipidemic individuals.

In this, randomized controlled trial, mild to moderate hyperlipidemic subjects were randomly divided into 2 groups as walnut-enriched (n=20) and control (n=17) groups for 6 weeks. All subjects adhered to a medical nutrition therapy as low-fat and low-cholesterol diet. The walnut-enriched group was supplemented with 40 g/day of walnuts added to their diets. In order to follow nutritional status of subjects, they were visited every 15 days (in total 4 times). Anthropometric measurements of the subjects were taken and were monitored at each visit during the study. Blood samples were measured at the beginning and again at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Hyperlipidemic patients who are not using any lipid lowering medications
* Non-smoker
* No alcohol consumption
* Individuals who are having ≤30kg/m2
* Individuals who do not have any allergy for nut consumption
* Female participants who are not pregnant or breastfeeding
* Individuals should not be in a weight loss programme
* Having not consumed regular nuts for the last 1 month,
* Except hypertension, they should not have other chronic diseases (such as diabetes, chronic renal failure)
* No intense exercise

Exclusion Criteria:

* Failure to meet the criteria for inclusion criteria.
Committed Actions for Successful Aging

The investigators are planning to recruit approximately 30 study participants aged 50 years and older that will undergo a 4 week attention and emotion regulation intervention. The intervention systematically targets thoughts, emotions and behavior in order to promote quality of life and advance successful brain aging. The investigators will assess the feasibility of recruiting and retaining participants for an attention and emotion regulation intervention. In addition, the investigators will determine the efficacy of the intervention to enhance and promote quality of life, sustained attention, emotions, motivation and cognitive health.

The CASA model is developed here in the investigators program (Geda et al) based on neuroscience and Acceptance and Commitment Therapy (ACT). The rationale for the study is that the cortico-cortical network linking the prefrontal cortex with the mesial temporal lobe is susceptible to the wear and tear of day to day life such as stress and emotional distress. The investigators hypothesize that the CASA intervention will promote emotional and cognitive health by targeting this network.

Eligibility Criteria:
Participants will be recruited from the community via advertisement in retirement communities, church, and other social gatherings. Eligible participants are cognitively normal males and females aged 50 years and older.

Inclusion criteria:

* Subject will sign approved consent form
* Male or female adults (age \> 50 years of age)
* Subject will complete all of the testing and procedures

Exclusion criteria:

* Refusal to sign the approved consent form
* Refusal to complete all testing and procedures of the study
* Males and females \< age of 50 years
Intensive Management of At-risk Patients

The purpose of this study is to assess if intensive management of at-risk participants, utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring, will lead to better patient outcomes than usual care.

At-risk participants will be randomized 1:1 to either usual care or intensive management utilizing longitudinal patient tracking, proactive outreach, multidisciplinary action planning and careful outcomes monitoring for 6 months. Participants in the intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them with the support of the study team. Staff will focus on contacting all patients within one week of any emergency department visit or hospital discharge, contacting all highest-risk participants weekly and all participants monthly, and completing high-priority tasks for participant care within one week. The primary outcomes of this quality improvement study are inpatient bed days and number of inpatient admissions.

Eligibility Criteria:
Inclusion Criteria: At-risk patients, meaning Gold, Silver, or Bronze tier, as identified by our member 360 platform:

* Gold tier - 6+ emergency department (ED) visits last year, annual spend \>$100,000, 8 or more hierarchical condition category (HCC) diagnoses, readmission \<30 days prior, or ambulatory care-sensitive condition (ACSC) hospitalization \<30 days prior
* Silver tier - 4+ ED visits last year, annual spend \>$75,000, 6 or more HCC diagnoses, readmission \<90 days prior, substance abuse HCC diagnosis, behavioral health admit \<90 days, 15+ chronic medications prescribed in the last 90 days (and not qualifying for Gold tier)
* Bronze tier - 3+ ED visits last year, annual spend \>$50,000, 5 or more HCC diagnoses, 3+ hospitalizations last year, end-stage liver disease, end-stage renal disease, Medicare and Medicaid dual-enrolled, disease-management program patients with ACSC admission or ED visit in the last year, 10+ chronic medications in the last 90 days, 6+ health risk-assessment score, 12+ Edmonton Frail Scale score (and not qualifying for Gold or Silver tiers)

Exclusion Criteria:

* enrolled in hospice
* enrolled in Institutional Special Needs Plan
* primary patient of study investigator
Short Active Lives Survey in Chronic Lung Conditions

Short Actives Lives Survey is a common tool used to measure physical activity in the UK population. Self-reported measures such as the Short Active Lives Survey can be prone to bias. As such, during project evaluations, benefits may be exaggerated due to over-reporting of physical activity or downplayed due to underreporting of physical activity. There is also a lack of research reporting the typical short-term and long-term changes in physical activity (measured by the Short Active Lives Survey) in people with chronic lung conditions who are not receiving support to become active (i.e. usual care, control groups). Accelerometers are small lightweight activity monitors that can be worn on the waist. These monitors are known to provide accurate and reliable objective assessment of physical activity in people with lung conditions.

This research study will recruit a cohort of inactive people with lung conditions and determine changes in physical activity measured by both the Short Active Lives Survey and one of the most valid accelerometers used in people with lung conditions (Actigraph GT3X). The study will also evaluate how these physical activity measures relate to general health (health status and health care use) of people with lung conditions over 12 months. This study will provide information on the usefulness of using the Short Active Lives Survey in the future for measuring physical activity in people with lung conditions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
* Physically inactive defined as completing less than 30 minutes ore more of moderate intensity equivalent physical activity per week (measured by the Short Active Lives Survey)

Exclusion Criteria:

* Adults without a diagnosis of Chronic Obstructive Pulmonary Disease, Bronchiectasis, Interstitial Lung Disease, Lung Cancer, Mesothelioma or Asthma
* Age \< 18 Years
* Completing 30 minutes or more of moderate intensity equivalent (MIE) physical activity per week
* Inability or unwillingness to sign informed consent
Natural Orifice Transgastric Endoscopic Surgical Removal of the Gallbladder

Hypothesis: Natural orifice transgastric cholecystectomy with laparoscopic assist will be feasible and have comparable complication rates as standard lap cholecystectomy. Patient benefits will include less pain and scaring.

In this study, we propose to use a surgical technique that eliminates the need for a 1.5-2.5 cm umbilical incision. A flexible endoscope will be inserted through the mouth and into the stomach. Using commercially available endoscopes, endoscopic instruments and accessories, a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. Two to three small laparoscopic trocars will be placed for laparoscopic instrument insertion to manipulate, retract and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. Once dissected free, the gall bladder will be removed through the stomach and out of the mouth. Commercially available endoscopic clips, sutures and/or tissue anchors will be used to close the gastrotomy; additionally, the gastrotomy will be tested for leaks and laparoscopically oversewn with suture as needed.

Patients will be discharged per the standard of practice for a laparoscopic cholecystectomy. During the hospital stay severity of pain and use of pain medications will be recorded. Length of time spent in the recovery room and in the hospital will also be collected. Patients will return and be evaluated by their surgeon two weeks following their procedure. At this visit, any complications will be noted in the patient's medical record. Additionally at this visit and at the preoperative visit, patients will complete a standardized Quality of Life (QOL) assessment (i.e., SF-36) and perceived pain levels and type and frequency of pain medications will be recorded in the patient's medical record.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to undergo general anesthesia
2. Age \> 18 years of age and \< 80 years of age
3. Ability to give informed consent

Exclusion Criteria:

1. Acute cholecystitis
2. Body Mass Index (BMI) \> 40
3. Contraindicated for esophagogastroduodenoscopy (EGD)
4. Gallstones \> 2.5cm in diameter
5. Gall bladder more than 15cm in length on U/S
6. Presence of common duct stones
7. Presence of esophageal stricture
8. Altered gastric anatomy
Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts

More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.

Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month
* if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated\> 6.5% (\> 48 mmol / mol)

Exclusion Criteria:

* inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months;
* age under 18 years or over 80 years
Platelet Transfusion Refractoriness

Platelet Transfusion Refractoriness is one of the severe complications after multiple transfusions in patients with severe thrombopenia. Platelet Transfusion Refractoriness is characterized by inefficient transfusion and arise from allo-antibodies specific of platelets antigenes, mostly carried by HLA-I molecules.

A preliminary study has shown different isotypes of anti-HLA I in patients with Platelet Transfusion Refractoriness. Our hypothesis is that the type of anti-HLA I antibodies (recognised epitope, quantity, isotype) should establish predictive and diagnostic criteria for Platelet Transfusion Refractoriness.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with Hematopoietic stem cells graft (autograft or allograft) or with acute leukemia with the indication of platelet transfusion.

Exclusion Criteria:

* Patient under guardianship
* Minor patient
Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer

This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.

Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
* Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
* Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
* Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
* ECOG Performance Status of 0-2 at enrolment.
* No prior exposure to immune-mediated therapy for cancer.
* Adequate hematologic and organ function.
* Life expectancy of at least 12 weeks.
* Body weight \>30 kg.

Exclusion Criteria:

* Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
* Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
* Active infection including tuberculosis, HIV, hepatitis B anc C
* Active or prior documented autoimmune or inflammatory disorders
* Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Volunteers

Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98 healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind, randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects in a three-way cross over, open label, partially randomised study.

Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing with food or AZD2423 single dosing, Fasting Condition


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and non-fertile female subjects aged ≥20 to ≤55 years inclusive and healthy male and female subjects aged ≥65 to ≤80 years inclusive with suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg.
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator. In addition, normal ophthalmoscopy is required for the CSF panel subjects (Part 2).

Exclusion Criteria:

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.
Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy

The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.

You and your child will be enrolled into the study during your child's scheduled surgery at DCH. Your child's surgery, anesthesia plan, and recovery will not change because of your participation in this study. Following discharge from the hospital, the study team will give you two follow-up phone calls that will take approximately 15 minutes. During these phone calls, we will ask you about your child's pain, any nausea or vomiting that has occurred, your child's intake of liquid and food, your child's activity level, and the medications they have been given over the course of the 5 days post-operation. Along with talking over the phone, we will ask you to document this information. After the post-operation day 6 phone call, you and your child will not be asked any additional questions for research purposes and we will ask you to return any documents you were given by the study team. Within 30 days of your and your child's participation in the study, the research team will pull medical information from your child's electronic medical record. Your child's electronic medical record will be reviewed to obtain demographic information such as date of birth, age, weight, ethnicity, medical history, and status information will also be collected such as allergies, potential complications, any pain scores collected during your child's post-anesthesia care unit (PACU) stay, and medical visits. 30 days after your child's surgery, you and your child will no longer be enrolled in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 3-12 that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes or Parent or guardian of a child aged 3-12 years old that is scheduled to undergo tonsillectomy or adenotonsillectomy, with or without ear tubes

Exclusion Criteria:

-
Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. In case of limitation, the level of skin fibrosis, Raynaud's syndrome and its complications, the search for painful joints with or without synovitis, and the presence of calcifications must therefore be assessed. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. No study to date has compared the functionality of one hand to the other. The hypothesis is that there is a difference in range of motion limitations between the dominant hand and the contralateral hand.

Patients in the active file of the Internal Medicine A department of the Limoges University Hospital who meet the inclusion criteria will be offered the study by telephone. Patients wishing to participate will be given an appointment on a dedicated consultation slot. During this visit, Patients will be given an information note and their consent will be collected. The study examinations will be performed and the questionnaire completed. At the end of this visit, the study will be completed for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Group 1 :
* Major patient
* Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
* Cochin hand score less than or equal to 16
* Group 2 :
* Major patient
* Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
* Cochin hand score greater than 16.

Exclusion Criteria:

* Overlap syndrome (Sharp or scleromyositis 2)
* Patient with another autoimmune disease
* History of surgery or trauma to the hand with proven functional sequelae
* Presence of synovitis
* Patient with Dupuytren's disease
Long Term Impact of Child Abuse in University Students

Based on research and studies, a broad conceptualization of child abuse and neglect has progressively been constructed, defining it as all actions carried out by caregivers that significantly interfere in the child's optimum development and do not adhere to social standards. This conceptualization contemplates aspects such as neglecting physical-biological, cognitive, emotional, and social needs, and the different types of child maltreatment are also classified.

This study aimed too evaluate the psychological and social long-term effects of different types of child abuse.


Eligibility Criteria:
* Inclusion criteria:

  1. University students passed through the experience of being abused in their childhood
  2. Males and females
  3. Residing in urban or rural area in Al Dakahleya governorate- Egypt
* Exclusion criteria:

  * Individuals with no or questionable history of child abuse