cyrilzakka/clinical-trials huggingface dataset:
Effect of Selective and Nonselective Cyclooxygenase Enzyme Inhibition on Arterial Blood Pressure and Cerebral Blood Flow With Exposure to Intermittent Hypoxia in Humans

The study has been designed to assess the effect of cyclooxygenase inhibition on blood pressure, cerebral blood flow, ventilation and renal hemodynamics following chronic intermittent hypoxia exposure.

The study will specifically evaluate:

1. Cardiovascular effect of cyclooxygenase inhibitors on cerebral, vascular, blood pressure and homeostatic responses following chronic intermittent hypoxia exposure.
2. Ventilatory response of cyclooxygenase inhibitors following chronic intermittent hypoxia exposure
3. Evaluate the renal hemodynamic effect of chronic intermittent hypoxia exposure and cyclooxygenase inhibition.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* 18 - 45 years of age
* Informed written consent

Exclusion Criteria:

* Any history of cardio-respiratory diseases, ongoing medication, smoking, trauma, acute illnesses, collagen vascular diseases, rheumatoid arthritis, osteoarthritis
Evaluation of the Effect of Mediterranean Diet on Breast Cancer Patients

In this study, it was aimed to evaluate the effect of the Mediterranean diet on body composition, oxidant stress and proinflammatory markers in overweight and obese breast cancer women.

Breast cancer is the most common type of cancer among women in both developed and developing countries and is the leading cause of cancer death among women worldwide. Breast cancer is a disease that can develop and progress for various reasons. In addition to unchangeable factors such as increasing age and genotype, modifiable factors such as smoking, alcohol consumption, lack of physical activity, malnutrition, and obesity play a role in the pathogenesis of the disease.

Breast cancer risk increases with increasing body mass index (BMI) in postmenopausal women. Chronic inflammation in obesity is associated with an increase in the release of proinflammatory factors (such as TNF-α, IL-1, IL-6). This situation; It is a risk factor for many types of cancer such as colon, stomach, breast and prostate carcinomas and supports a cause-effect relationship between obesity and cancer. These proinflammatory factors act as signal converters for tumor growth and progression. Obese women have elevated levels of TNF-α and IL-6 in the circulation, and this is associated with the development and progression of breast tumors.

The Mediterranean Diet, which consists of high amounts of monounsaturated fatty acids, fruits, vegetables and whole grains, has been widely evaluated and indicated as an important factor in preventing tumor formation from inflammatory pathways.

Weight loss improves the antitumor immune system, lowers estrogen levels, reduces the risk of breast cancer and has been associated with better outcomes in obese patients. Lifestyle intervention studies strongly suggest that weight loss is possible and observational studies can actually improve breast cancer survival.In this regard, a healthy lifestyle and diet are the first steps to prevent breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old,
* BMI value to be ≥25 kg/m2,
* To be diagnosed with breast cancer stage I, II or III,
* Being a positive hormone receptor status, one of the biological subtypes of breast cancer,
* Having completed chemotherapy and / or radiotherapy treatment at least 6 months before starting the study,
* Not applying any treatment for body weight loss,
* Accepting to participate in the study,
* Perceiving disorder and not having communication problems.

Exclusion Criteria:

* Being under the age of 18 and over the age of 65,
* BMI value to be 40 kg/m2,
* Having advanced stage breast cancer (IV and V),
* Being diagnosed with cancer or metastasis in other organs,
* Being one of the biological subtypes of breast cancer, hormone receptor status being negative,
* Using antioxidant vitamin-mineral supplements,
* Using herbal supplements,
* Being pregnant or planning a pregnancy,
* To stop working after starting diet therapy.
Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma

To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.

chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).

Eligibility Criteria:
Inclusion Criteria:

* ECOG PS≤1;
* pathologically confirmed adenocarcinoma of bile duct;
* R1 resection or R0 resection with these risk factors: lymph node metastasis, lymphatic vessel or blood vessel invasion, multiple tumors, tumor size \>5 cm, preoperative CA199\>200 U/mL.
* postoperative liver function Child Pugh Class A, leukocyte count\>1.5\*10\^9/L, platelet count\>100\*10\^9/L, serum alanine aminotransferase \<1.5\*ULN
* no tumor recurrence or metastasis on baseline examination
* no history of radiotherapy or intervention therapy

Exclusion Criteria:

* hepatocellular carcinoma, mixed carcinoma of ICC and HCC, or hilar cholangiocarcinoma
* distant metastasis
* prothrombin time \>14s
* severe cardiopulmonary dysfunction
* severe renal dysfunction
* bone marrow suppression before the initiation of therapy
* allergic to fluorouracil, gemcitabine, or platinum
* gemcitabine was used in combination with radiotherapy
A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden

Outpatients with at least one dispensing record of any medication will be included in the study. An index date will be assigned to each participant and prescription records for anticholinergics will be used in the study.


Eligibility Criteria:
Inclusion Criteria:

* Have at least one dispensing of any medication between January 22, 2016 and December 31, 2016.

Inclusion Criteria for Korea:

* Have at least one dispensing of any medication between January 1st, 2016 and December 31, 2016.
* Participant was diagnosed with OAB (ICD-10 N32.8, N31.0, N31.1, N31.2, N31.8, N31.9, N32.9, N39.8 and N39.40) at index date.
* Participant did not have dispensing record of an OAB medication during the washout period (6 months prior to the index date).

Exclusion Criteria:

* Participants who do not have a complete year of data availability in the database prior to index date.
* Have record of hospitalization on the index date.

Exclusion Criteria for Korea:

* Participant was hospitalized on the index date.
* Participant did not have an active insurance status during the washout period or on the index date.
* Participant received onabotulinumtoxin A and/or surgical intervention as part of the OAB treatment during the washout period.
* Participant was diagnosed with stress incontinence (ICD-10 N39.3 or equivalent) or had dispensing record of medication for stress incontinence (duloxetine) during the washout period.
* Participant was diagnosed with urinary tract infection (ICD-10 N30.0 and N39.0 or equivalent) during the washout period or on the index date.
Effect of Cognitive-Behavioral Strategies on Nurses Caring for Children With Autism Spectrum Disorder

The purpose of this study is to determine if a structured training program in cognitive-behavioral strategies can improve:

Self-efficacy: The belief in one's ability to succeed in specific tasks or situations.

Sense of coherence: A perception of life as comprehensible, manageable, and meaningful.

Psychological ownership: A sense of possession or attachment to one's job or role.

These outcomes are critical for nurses working with children with ASD, as their role involves unique emotional and professional challenges. The study will use a rigorous scientific approach to assess the effectiveness of the intervention.


Eligibility Criteria:
Registered nurses who provide direct care to children with ASD in settings such as hospitals, clinics, or specialized care centers.

Inclusion Criteria:

* At least 6 months of experience caring for children with ASD.
* Currently employed in a direct caregiving role for these children.

Exclusion Criteria:

* Nurses with prior formal training in cognitive-behavioral therapy.
* Nurses planning to leave their position during the study period.
Timing of Prophylactic Antibiotics for Cesarean Sections

This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.


Eligibility Criteria:
Inclusion Criteria:

Pregnant 24-43 weeks gestation \> 18 years old Requiring cesarean section -

Exclusion Criteria:

Receiving antibiotics \< 18 years old Allergy to cefazolin

-
Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children

The aim of the present study was to determine the effect of passive smoking on the levels of salivary TAS, TOS, LL-37 and dental status in children.In the study the parents of children were asked to fill out a complete survey about smoking habits. After filling out the questionnaire, according to the survey results, a total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalance of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial peptide LL-37' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.


Eligibility Criteria:
Inclusion Criteria:

-Systemically healthy children

Exclusion Criteria:

* The presence of orthodontic / intraoral appliance
* Any disease or condition known to affect defense system
* Uncooperative children
The Men Are Now United Program

The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.

The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Black/African American
* Male
* Tyep 2 Diabetes
* 21 years old or older
* Owns cell or smart (mobile) phone or willing to use one if provided

Exclusion Criteria:

* Non-ambulatory
* Serious physical illness
* Psychiatric diagnosis of serious mental illness
* Serious diabetes complications impeding meaningful participation
Effect of Game Based Approach on Oxygenation, Functional Capacity and Quality of Life in Primary Ciliary Dyskinesia

Impaired pulmonary function, decreased physical activity, functional capacity and depending on these factors are reported in patients with primary ciliary dyskinesia in recent studies. The purpose of this study to evaluate the effects of game based approach on pulmonary function, functional capacity and quality of life in patients with primary ciliary dykinesia.

Primary ciliary dyskinesia (PCD) is an autosomal recessive hereditary disorder characterized by congenital structural abnormalities and impairment of respiratory function. Mucociliary clearance is affected by disorders in the structure and movement of cilia. That causes repeated infections in the upper and lower respiratory tract.In addition to mucociliary effects and impaired lung function, it is thought that there may be a decrease in respiratory muscle strength and functional capacity. One of the factors affecting functional capacity is the level of physical activity. For these reasons, the management of the respiratory system in patients with PCD is very important. In addition to airway clearence techniques, approaches to increase physical activity are also important. It was thought that severe physical activity could be an important determinant of cardiopulmonary functional capacity in patients with mild to moderate PCD. The level of physical activity is known to be associated with quality of life.

In literature no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD. Game based approach is a new method lead to increase physical activity. In literature there is no study investigated the effects of game based approach on oxygenation, functional capacity and quality of life in patients with PCD.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with PCD
* Being clinically stable
* Between 6-18 years old
* Volunteer to participate in research

Exclusion Criteria:

* Not having a stable clinical condition
* Patients with severe neuromuscular, musculoskeletal and rheumatological problems
* Patients with loss of balance
* Not being cooperative
Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)

Eculizumab is an anti-C5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. The maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. A tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. The objective is to improve efficiency of eculizumab administration.

Eculizumab is a very expensive drug (450 000 euros per year per patient). According to the usual administration scheme, the eculizumab is administrated by intravenous infusion, every 14 or 21 days in hospital. Studies have shown the possibility of extending the administration intervals in patients with a high concentration of eculizumab.

A personalized spacing of eculizumab infusions, based on a therapeutic drug monitoring, is expected to improve the patient's quality of life and lead to substantial savings.

For these reasons, the objective of this study is to explore the efficiency of a personalized spacing of eculizumab infusions compared to the usual administration scheme (without personalization) from the French health Insurance perspective. The efficiency will be assessed by estimating the incremental cost per QALY (Quality-Adjusted Life Year) gained at 18 months (duration of follow-up in the clinical trial) and at 5 years thanks to a Markov model.

The total duration of the study is 24 months (6 months of enrolment and 18 months of follow-up).

Eligibility Criteria:
Inclusion Criteria:

1. Adults with an atypical Hemolytic and Uremic Syndrome defined by at least 2 of the following parameters:

   * Thrombopenia (platelet count \< 150 G/L)
   * Mechanical lytic anemia (Hb \< 10 g/L, Lactate dehydrogenase \> upper limit of normal, undetectable haptoglobin, presence of schistocytes on blood smear)
   * Acute renal failure
2. Eculizumab treatment

   * Without project of withdrawal in the next 18 months
   * Started since at least 6 months
   * Administrated with an unchanged administration schedule since at least 3 months (initial episode or relapse)
3. Atypical Hemolytic and Uremic Syndrome in remission
4. Patients who give informed consent.

Exclusion Criteria:

1. Patients on dialysis.
2. Women treated starting or planning a pregnancy.
3. Patients suffering from a typical or secondary microangiopathic hemolytic anemia (drugs, malignancies, autoimmune disease...)
4. Patients under protection of a judicial authority
The DIVINE Study: DIetary Management of Glucose VarIability iN thE ICU

To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.


Eligibility Criteria:
Inclusion Criteria:

* New admit to the ICU and expected to remain in ICU 5 days
* Ventilator dependent up to 48 hours prior to admission to the study
* Requiring tube feeding enteral nutrition (EN) 5 days
* Expected to receive 50% of caloric needs within 72 hours
* Body Mass Index 26-45

Exclusion Criteria:

* Trauma patients
* Major surgery in past 30 days or planned for next 7 days
* Diabetes mellitus (DM) type 1
* Admitted with diagnosis of diabetic ketoacidosis as primary diagnosis
* Pregnant or lactating
* Non-functioning GI tract
* Use of parenteral nutrition in past 30 days
* Admitted with burns \> 20% body surface area
* Traumatic brain injury
* Hemodynamic instability that prevents delivery of EN \> 24hr
* Unable to access GI tract for feeding via tube, unable to receive EN
* Other contraindication to tube feeding
* Any other condition that would not allow patient to complete the study protocol
* Use of enteral formula at enrollment that cannot be changed to the investigational product
Effect of a Polyphenol Rich Diet on Vascular and Platelet Function

Previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. Research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. The investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. A total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). They will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. The fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study.

Assessment of microvascular and platelet function will be undertaken before and after consuming this diet. Improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. This study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 40-65 years old
* Systolic blood pressure 140-179 mmHg or diastolic blood pressure 90-109 mmHg

Exclusion Criteria:

* diabetes mellitus
* an acute coronary syndrome or transient ischaemic attack within the past 3 months
* special dietary requirements, food sensitivities or vegetarian/vegan diet by choice
* oral anticoagulation therapy
* body mass index greater than 35kg/m2
* excessive alcohol consumption (defined as \> 28 units/week in men and 21 units/week in women)
* fasting triglyceride concentration \> 4 mmol/l
* pregnancy/lactation
* taking antioxidant supplements
* medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements
Development of the Drug and Alcohol Respiratory Health Test

The goal of this study is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and offer it for routine use in clinical assessment and medical reviews

Respiratory diseases are highly prevalent among adults with substance use disorder. Inhaling drugs are risk factors, and cigarette smoking contributes to 90% of COPD cases. The substance use disorders population faces barriers to accessing healthcare, leading to under-diagnosis and including stigma, exacerbating the unmet need for effective respiratory disease management. There is no population-specific screening instrument in NHS and Third Sector addiction services. The lack of a validated screening tool means Respiratory health symptoms may be overlooked or attributed to other causes. The aim of this trial is to develop a brief Drug and Alcohol Respiratory Health Test (DARHT) and make it available for clinical assessment and medical reviews. The primary research question is to determine if the DARHT achieves satisfactory diagnostic accuracy with gold-standard spirometry. The study will be open to any enrolled adult (age \>18 years) patients at our treatment clinic (NHS secondary care) who reports inhaling (smoking) tobacco, cannabis, cocaine, opioids, or consuming alcohol in the past 28 days. Volunteer and informed and consenting participants will be invited to: (1) complete a brief study questionnaire that includes the DARHT, then take a spirometry and pulse oximetry test; (2) return to the clinic after 3-7 day to complete the DARHT with a different interviewer. Participants with a positive case evaluation on the DARHT or spirometer will be referred to primary or specialist services. The investigators will contact participants referred after 6 weeks to determine their progress and the PHQ-4 and EQ-5D-L to evaluate changes in quality of life. The first 20 participants referred to specialist care will be invited to a Lung Health Clinic where the investigators will offer a psycho-social intervention for advice and support.

Eligibility Criteria:
Inclusion Criteria:

1. \>18 (no upper age limit)
2. Inhalation (smoking) of tobacco, or cannabis, or cocaine, or opioids, or use of alcohol in the past 28 days
3. Possession of a personal mobile phone to arrange follow-up appointments

Exclusion Criteria:

1. Reported physical health condition that would mean spirometry contra-indicated - including heart attack, unstable angina, pulmonary embolism,
2. Reported surgery in the past 3 months for an eye, chest, or abdominal condition that would mean spirometry contra-indicated
3. Likely inability to complete study due to criminal justice involvement with legal proceedings risking incarceration