cyrilzakka/clinical-trials huggingface dataset:
Adaptation of the Intensive Care Unit-specific Pressure Injury Risk Scale to Turkish (RAPS-ICU)

The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the ICU-specific pressure injury risk scale

This was a prospective, cross-sectional study aimed at translation and cultural adaptation of the RAPS-ICU into Turkish, while also assessing its validity and reliability.Patients who meet the inclusion criteria and who are hospitalized in the Intensive Care Clinics of Istinye University Bahçeşehir Liv Hospital and Harran University Hospital will participate in the study. In this study, Turkish adaptation of the 'Intensive care unit-specific pressure injury risk assessment scale' is planned. After language adaptation, its validity and reliability will be tested. The reliability of the intensive care unit-specific pressure injury risk assessment scale will be assessed by inter-rater reliability and internal consistency (determined by calculating Cronbach alpha coefficient), and its validity will be assessed by convergent and divergent validity of the scale. Relative reliability was obtained by calculating the intraclass correlation coefficient (ICC). Relative reliability will be obtained by calculating the intraclass correlation coefficient (ICC). The receiver operator characteristics (ROC) curve has been used to estimate sensitivity and specificity and will represent the false positive rate versus the true positive rate across various thresholds for different scores.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* Staying in the Intensive Care Unit for at least 1 day,
* Agreeing to participate in the study by themselves or a family member.
* Volunteering to participate in the research
* Full orientation and no psychiatric problems

Exclusion Criteria:

- Having communication problems
Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period

The purpose of this study is to determine if a 10 week exercise rehabilitation program decreases anterior knee oain (PFPS) and improves function in patients with patellofemoral pain syndrome (PFPS). Individuals (age 18-50) with PFPS will be recruited to participate in this study to see if a 10 week exercise program focusing in core and hip strengthening, lower extremity strengthening foot intrinsic strengthening can decrease pain and increase function.

Patellofemoral pain syndrome (PFPS) is a very prevalent condition that presents in great number to patients in physician's offices and has a high recurrence rate. Physical therapy and exercise therapy to strengthen the quadriceps is often prescribed, however recurrence is common. It is hypothesized that PFPS patients have core weakness, hip strength abnormalities and neuromuscular control deficits.

Eligibility Criteria:
Inclusion Criteria:

* Individuals wishing to participate in study voluntarily
* Subjects diagnosed with patella-femoral syndrome. We will ascertain this by asking a few questions, which will not be recorded as they have not been enrolled in the study yet.
* Capable of following and completing a 10 week home exercise program

Exclusion Criteria:

* Individuals with prior knee surgery, tibial plateau fractures, known diagnosis of knee injuries such as meniscus or ligaments tears.
* Individuals unable to participate, i.e. cognitive deficits, weakness or functional deficits to upper extremities.
* Individuals unable to tolerate exercise program
Pharmacogenetic of Doxorubicin in HCC.

The study included 81 HCC patients, both male and female. Prior to being assessed for eligibility, each recruited patient with HCC received a comprehensive review of their medical history, physical status, and laboratory results. Every research participant take part in the experiment and provided written informed consent.

All patients had their baseline viral indicators for HBV and HCV evaluated. Additionally, blood samples were taken for genotyping. All patients underwent evaluations of their kidney, liver, and alpha fetoprotein (AFP) functions, as well as their complete blood count (CBC), at both the baseline and follow-up appointments. To evaluate the efficacy of TACE, triple pelvic abdominal CT scans were performed both prior to and one month later. Using triphasic pelviabdominal CT, patients who achieved complete response (CR) were monitored for up to 13 months following chemotherapy in order to identify recurrence. Follow-up appointments were planned to identify patients responces or any negative effects.

Eligibility Criteria:
Inclusion Criteria:

1. When diagnosing the patient with HCC, the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) were adhered to.
2. Be above 20 years old.
3. Individuals with intact organs.
4. There is no cure for HCC in surgery, microwave treatment, or radiofrequency ablation.

Exclusion Criteria:

1. The patients refused to sign the formal consent.
2. Be more than 75 years old.
3. There is a notable case of portal vein thrombosis.
4. Spreads beyond the liver.
5. Encephalopathy of the liver.
6. Present sickness.
Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions.

Colonic cancers are a major concern in the Middle East and the world in general, and every institute has attempted to initiate various clinical and investigatory procedures to detect the disease early in its development. From 2005 till 2010 an audit conducted at the Royal Liverpool University revealed that out of 8910 colonoscopies, 693 were incomplete (7.8%), and for 25% of failure was because of inadequate bowel preparation.

An adequate bowel preparation regimen is not only effective in cleansing the colon but should be well tolerated by patients. The polyethylene glycol (PEG) solution, an isosmotic non-absorbable polymer, is generally used for bowel preparation, because of its safety, effectiveness, and good tolerability. Quality of bowel cleansing depends not only on the formula used, but the preparation regimen also plays a role. Split dosing of the laxative offers, in general, better cleansing than a single dose preparation.

A large survey was also done in the USA in 2018 and demonstrated that split dose treatment was more tolerable than single-dose treatment for bowel preparation.

Also more recent study shows split-dose bowel preparation for colonoscopy with PEG is better than single-dose, in terms of adequate bowel preparation and polyp detection.

On the other hand , a large randomized trial of PEG regimens show, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose. Another most recent one demonstrated that same-day morning PEG regimen can be considered an effective well-tolerated, and acceptable bowel preparation for colonoscopy.

A same-day dose of bowel cleanser has several benefits compared with split-dose or previous-day dose: the fasting time is shorter and there is no sleep disturbance, which can be associated with split-dose or previous-day regimen.

Eligibility Criteria:
Inclusion Criteria:

- All patients undergoing elective colonoscopy

Exclusion Criteria:

* Presence of sever renal impairment. (Creatinine clearance \< 30 ml/min or patient on hemodialysis).
* Sever congestive heart failure (NHYA III or IV).
* Pregnant woman.
* History of bowel obstruction or resection.
* Known allergies to polyethylene glycol.
* Refusal of consent for the study.
* Signs of liver cell failure as ascites and hepatic encephalopathy.
* Electrolytes disturbances
Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)

Evaluation of the safety and effectiveness of ActiveCare+ CECT device +/- baby dose aspirin (81 mg QD) for lowering the potential risk for bleeding and of DVT during and after THA surgery in comparison with LMWH.

Patients undergoing total hip arthroplasty surgery are at particular risk for Thromboembolic disease. To date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \[IPC\]) and pharmacological (anticoagulant). Both are effective; however each carries its own advantages and disadvantages.

The purpose of this study is to compare in total hip arthroplasty (THA) patients the safety and effectiveness of the mobile ActiveCare CECT based prophylaxis protocol and compare it with LMWH standard of care protocol for this patient population.

The protocol is based upon the CECT system as the primary DVT prophylaxis method (with or without the addition of low dose baby aspirin \[81 mg\]).

Eligibility Criteria:
Inclusion Criteria:

Adult patient (Age \>18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form.

Exclusion Criteria:

Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial.
Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children

Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.

Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.


Eligibility Criteria:
Inclusion Criteria:

* To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M

Exclusion Criteria:

* Chronic disease or food allergies
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers

This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.

This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.

* The research study procedures include screening for eligibility, randomization and a series of questionnaires.
* Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed

Two methods of pre-genetic test education:

* video education
* in-person counseling
* Genetic testing will be performed by blood draw.
* It is expected that 500 people will participate in this study
* Participants will be in the research study for up to 5 yrs after enrollment

Eligibility Criteria:
Inclusion Criteria:

* Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
* A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
* Age ≥ 18 years
* Breast, ovarian, pancreatic, or metastatic prostate cancer
* No prior cancer genetic testing
* Ability to understand and the willingness to sign an informed consent document

Exclusion Criteria:

* Pregnant
* Prisoners
* Inability to understand English as a spoken language in a healthcare context
* Known hematologic malignancy (e.g. CLL)
Children With Aluminium Contact Allergy: Cutaneous Exposure Study

Aluminium is used in many different cosmetic products, including make-up, deodorants and sunscreen. The purpose of this study is to investigate whether these everyday skin products with small amounts of aluminium can cause skin reactions in children diagnosed with contact allergy to aluminium.

The study is conducted as a Repeated Open Application Test study (ROAT), a method originally developed to clarify the clinical relevance of questionable and positive patch samples, by imitating everyday use of a skin product.

The study is conducted as a Repeated Open Application Test study (ROAT), a method originally developed to clarify the clinical relevance of questionable and positive patch samples, by imitating everyday use of a skin product.

The skin products will consist of ordinary sunscreens with and without aluminium, with colour code red and blue, respectively (masked for both investigator and participants). At the beginning of the trial, the study participants will be given the two creams. On the lower back of the children, two areas each 10 cm2 are marked with red and blue, respectively. In each area, sunscreen corresponding to the generally recommended amounts must be applied twice a day.

The children should be seen on day 0 for interviews and objective examination. They must then be seen again on day 7 and day 14. On day 14 of the ROAT, a patch test is made to validate the results of the ROAT study. The study is scheduled to last for a maximum of 21 days with 4-5 consultations per child. If there is a skin reaction in connection with the ROAT study before the 14 days have elapsed, the study will end and a patch test will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Children with contact allergies to aluminium, demonstrated by patch tests at the Skin and Allergy Department, Gentofte Hospital and thus registered in the Clinical Database for Contact Allergy.
* Activity (itching) of the granulom within the last six months
* Written consent obtained from all custodians.
* Self-assessed worsening of skin symptoms after contact with aluminium-containing sunscreens.

Exclusion Criteria:

* Treatment with systemic steroid preparations within 1 week.
* Treatment with topical steroid preparations at or near the test area within 1 week.
* Treatment with systemic immune suppression.
* Treatment with antibiotics within 1 week.
* If the children become ill during the study, they should contact the project manager who will clinically assess the child and evaluate whether the child can continue to participate in the study or should be excluded due to the possibility of misinterpretation of any rash.
* Active eczema or other skin symptoms on the tested area
Combination of Cisplatin, Docetaxel and Bevacizumab in Patients With Non-small Cell Lung Carcinoma (NSCLC)

Despite recent advances in the treatment of NSCLC overall survival within these patients remains dismal and there is yet an unmet medical need for additional treatment options. In this phase II study a combination of chemotherapy with an antibody (cisplatin, docetaxel and bevacizumab) is tested to determine the objective response rate in patients with unresectable and advanced non-small cell lung cancer. This response rate will be compared with historical data.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented inoperable, locally advanced, metastatic or recurrent NSCLC other than squamous cell
* At least 1 measurable lesion according to RECIST criteria
* ECOG performance score 0 or 1
* Age between 18 and 70 years

Exclusion Criteria:

* Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component.
* History of haemoptysis
* Evidence of tumour invading major blood vessels on imaging.
* Previous neoadjuvant/adjuvant chemotherapy.
* Previous radiotherapy.
* Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6 months prior to study start or history of serious bleeding complications.
* Major surgical procedures within 4 weeks prior to study entry.
* Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
* Non-healing wound, active peptic ulcer or bone fracture.
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
A Study of Aleglitazar in Patients With Type 2 Diabetes

This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes, diagnosed \>=1 month of screening;
* either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
* HbA1c \<=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion Criteria:

* type 1 diabetes;
* currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
* clinically significant cardiovascular disease;
* Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
Physiological Effects of Androstadienone Exposure

The reason for doing this research is to understand why different people show different responses when they smell an odor called androstadienone. Androstadienone is a chemical found in male sweat. Other studies have shown that smelling this chemical can cause people to experience sweating, changes in skin temperature, and changes in a stress hormone call cortisol. These responses, which are called "physiological effects," are stronger in some people than in others.

We are interested in finding out whether these individual differences are genetic, that is caused by differences in our genes. Humans have about 1000 genes for odorant receptors. These are the molecules that bind and detect odor molecules in our nose and allow us to respond to so many different odors. It has been shown that some of these genes exist in two forms: a functional one and one that has been mutated and is therefore no longer functional.

We think that people who do not respond to a specific odor may carry the non-functional form of the gene for the receptor that detects the odor molecule. To test this idea we want to find people who respond strongly to a specific smell, and compare their odorant receptor genes with those of people who respond weakly to the odor.

The study consists of five visits. The first visit is a screening visit at which the eligibility of the subject is determined and a blood sample is taken. At this visit, the subject is also given ovulation test strips and instructions to perform urine-based ovulation self-tests at home for a period of several days following the onset of menstruation. The subject is instructed to test her urine at home until an LH surge is detected.

When the subject ovulates and is available for a visit she will come to the Rockefeller University Hospital within one day of detecting an LH surge for the first of four Test Sessions.

The four Test Sessions are identical with the exception that the subject is exposed to a different odor stimulus.

We will be measuring:

1. skin temperature
2. sweating, as measured by skin conductance
3. salivary cortisol levels.
4. mood

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult women between 18-35 years of age.
* Only subjects whose threshold to either vanillin or isovaleric acid is in the 90th percentile of the population tested in LVO-0539-0507 and who do not report any clinical conditions that may disturb their sense of smell will be enrolled in the study.

Exclusion Criteria:

* Use of oral contraceptives over the last 3 months
* Pregnancy
* Allergies to odors or fragrances
* History of nasal illness
* Irregular menstrual periods
* History of medical conditions that reduced or abolished sense of smell, such as: head injury, cancer therapy, radiation to the head and neck, or alcoholism.
Oxidative Stress and Vitamin E Requirements

The purpose of this study is to determine if oxidative stress derived from cigarette smoking increases vitamin E requirements. The study will also assess the role of vitamin C in modulating vitamin E requirements. Vitamin E requirements will be assessed by measuring vitamin E in plasma as well as by measuring the excreted vitamin E metabolite in the urine.

We will be investigating the fractional disappearance rate of tocopherols in cigarette smokers compared to nonsmokers. This will be accomplished by supplementing individuals with deuterium labeled alpha- and gamma-tocopherols. Quantification of plasma tocopherols as well as urinary metabolites, alpha- and gamma-carboxy ethyl hydroxychromanol, will be determined using liquid chromatography/mass spectrometry analysis. In addition, the role of vitamin C as it pertains to its influence on the fraction disappearance rate of vitamin E will also be evaluated.

Eligibility Criteria:
Inclusion criteria:

* non-smoking status or smokers (more than 1 pack per day)
* age: 18-35 y
* stable body weight, ranging between 80% and 130%,
* maintenance of normal exercise and activity patterns
* total cholesterol ≤ 7.758 mmol/L (300 mg/dl)
* triglyceride concentration ≤ 3.387 mmol/L (300 mg/dl)

Subjects will be excluded if they fulfill any one of the following:

* antioxidant supplement users
* resting blood pressure above 160/105 mm Hg
* engaged in aerobic activity more than five hours per week
* vegetarian or other restrictive dietary requirements
* fasting blood glucose concentration of ≥ 7.77 mmol/L (140 mg/dl)
* history of diabetes or uremia
* other known metabolic disease or medication use known to affect lipid metabolism