cyrilzakka/clinical-trials huggingface dataset:
Turkish Cultural Adaptation, Validation and Reliability Study of MedRisk Instrument

The aims of this study were to perform cultural adaptation of the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS) instrument and provide information regarding the factor structure, group-level reliability, and criterion-referenced validity of the instrument in Turkish speaking patients.

Patient satisfaction with physical therapy has become an important concern in health care, used to monitor patient perceptions of the quality of physical therapy care services. Measurement of patient satisfaction may provide useful information which may improve the quality of health care. The "MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care" (MRPS) is one of these instruments, which has undergone reliability and validation testing.The MRPS is a 20-item (18 items and 2 global measures) questionnaire which assess patient experience about therapist, registration process and convenience of environment.

A survey on a consecutive sample of patients from various regions in Turkey who were receiving outpatient physiotherapy programs was recruited.The study was divided into two phases: Phase I, the cross-cultural adaptation, which involves the translation procedures into Turkish and preliminary probe in the target population; and phase II, which involves the reliability and validation study.

After providing informed consent, for test-retest reliability, all subjects were asked to complete the MRPS twice; the first at least after receiving three sessions of physiotherapy and the second four days later which could coincide with the date of their discharge but not later. Subjects provided information regarding their age, sex, and location of primary symptoms prior to completing the instrument.Factor structure.

The construct validity was evaluated by factor analysis method. An exploratory factor analysis, using principal components analysis with varimax rotation was performed.Criterion validity was addressed by determining the correlation between two global measures of satisfaction and each of the 18 items. The measurement properties of the potential factors were investigated by determining correlations of the factors to the global measures and 10-cm Visual Analog Scale (VAS) which evaluates the level of patient satisfaction with higher scores indicating better satisfaction. Pearson correlation coefficient was used to assess the strength of the linear relationships. Test-retest reliability was examined by calculating the Intraclass Correlation Coefficient (ICC). Internal consistency relates to homogeneity of an instrument, which is assessed with Cronbach's alpha

Eligibility Criteria:
Inclusion Criteria:

* All subjects had to be able to read and write in Turkish.

Exclusion Criteria:
Study of Outpatient Management for Promontofixation by Laparoscopy

Laparoscopic promontofixation is becoming increasingly common and is currently the standard surgical procedure for pelvic prolapse, with few complications including exposure and mesh infection.

The research hypothesis is that laparoscopic promontofixation is a relatively painless procedure and can be performed on an outpatient basis without increasing the number of postoperative complications and impairing patients' quality of life.

The objective of this study is to evaluate the number of rehospitalizations after management of promontofixation by laparoscopy on an outpatient basis.

To evaluate the feasibility of a postoperative H8 exit after laparoscopic promontofixation.

Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Woman with promontofixation indication by laparoscopy for prolapse cure
* Patient's desire for outpatient management
* Age ≥18 years and \<70 years
* Absence of a major medical or surgical history that would prolong hospitalization (ASA 1 or 2, absence of Obstructive Sleep Apnea Syndrome)
* Subject affiliated to a social security scheme
* Subject having signed an informed consent
* Availability of a caregiver, responsible and valid (for the first 48 hours after the potential early exit) at home
* Geographical distance less than one hour from a suitable care facility
* Access to a telephone or a means of transport if necessary
* Patient compliance
* Oral and written comprehension of pre- and post-operative instructions
* Correct housing condition
* Subject having been informed of the results of the prior medical examination

Exclusion Criteria:

* Laparoscopic contraindication
* Comorbidity needs of medical supervision most of 24h
* TVT-O procedure during the same surgery
* Mental handicap affecting autonomy
* Comprehension difficulties to understand the protocol
* No social protection
* Subject with curatorship or guardianship
* Morbid obesity
* Alcohol or drugs addiction
* Excessive anxiety
* Impossibility to give the subject enlightened information (subject in emergency situation...)
* Pregnant woman (positive urinary pregnancy test for women of childbearing age)
Sleep Enhancing Tools: Pilot Study

To demonstrate whether use of sleep enhancing aids (face mask, ear plugs or white noise machine) in hospitalized patients can positively affect subjective symptoms of sleep quality, fatigue and pain.

A randomized, clinical pilot to trial the effect of sleep tools on patients' perception of sleep within the hospital setting.

We propose to conduct this pilot study to improve subjective symptoms of sleep deprivation in non-ICU hospitalized subjects by performing a brief intervention, easily performed at the point of care. Given the heterogeneity of hospitalized patients with varying ages, co-morbidities and other factors (such as pain and fatigue), we felt that an initial pilot study should focus on acceptability of three sleep aids (ear plugs, eye masks and white noise machine) among hospitalized non-ICU patients. Patients will be able to choose which aid they use and will be allowed to change aids during their hospital stay.

The primary outcomes of this study will be 1) improvement in perceived sleep quality as measured by PROMIS, a validated patient-reported outcome information system and 2) quality of care measures (length of stay, medication use and participation in therapy sessions).

PROMIS (Patient Reported Outcomes Measurement Information System) is an NIH sponsored health survey tool.

Information on characteristics (both patient and environment) including demographics, illness severity, number of medications, specific medications (such as sedatives and pain medications) will be collected to examine which predictors of improved perception of sleep quality correlate with use of sleep aids. This study is intended to focus on modifying the environment at the patient level rather than addressing the sources of environmental hospital noise.

Our study has the potential to impact this field with a preventative education based intervention, using simple tools in the non-ICU setting. It is important to understand this is not a study measuring sleep objectively but whether hospitalized patients perceive they sleep better if sleep aids are used.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to a private room in the hospital
* Speak and read english
* expected length of stay \> 2 days

Exclusion Criteria:

* Hearing aids
* sleep apnea using positive airway pressure therapy
* medically or behaviorally unstable
Improving Quality of Care for Hip-Fracture Patients: Studies on Fast-track Surgery

The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

The aims of the studies are to examine the impact of delayed time to surgery for hip-fracture patients with regard to in-hospital complication rate and one-year mortality and to evaluate two different fast-track systems, the hip process pathway and the ambulance process pathway, for hip-fracture patients with regard to patient outcome, complication rate and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Hip fracture

Exclusion Criteria:

* Periprosthetic fractures
* Pathological fractures
Human Intervention Study With Calcium Phosphate and Vitamin D

The study was conducted to investigate the effect of vitamin d3 alone and in combination with calcium phosphate on bone metabolism and further physiological parameters in healthy subjects. It is postulated that calcium phosphate beneficially influences the bone specific action of vitamin d3.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* pregnancy, lactation
* intake of dietary supplements
CRF - Nociceptin Receptor Interactions

To determine if \[C-11\]NOP-1A receptor binding (VT) can be altered by an intravenous hydrocortisone (cortisol) challenge through CRF-NOP interactions

Examines changes in \[C-11\]NOP-1A pharmacokinetics caused by an intravenous hydrocortisone challenge (1 mg/kg)

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 18 and 40 years old

Exclusion Criteria:

* Current DSM-5 psychiatric disorders
* Binge drinking as defined in NIAAA criteria in the past month
* Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use
* Currently on any prescription medical or psychotropic medication;
* Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses
* Currently pregnant or breast-feeding;
* History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months
* Metallic objects in the body that are contraindicated for MRI;
* First-degree relative with psychosis or mood disorders
Study of Nivolumab With or Without Pazopanib in Metastatic or Unresectable Soft Tissue Sarcomas

This trial will assess whether nivolumab alone or nivolumab combined with pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months

The investigators hypothesize that the nivolumab alone or nivolumab plus pazopanib will be associated with an improvement in progression free survival (PFS) at 6 months compared to historical controls of placebo and pazopanib alone respectively.

This is a randomized, Phase 2 study of nivolumab alone or nivolumab plus pazopanib in adult (≥ 18 years old) male and female subjects with unresectable or metastatic soft tissue sarcoma either ineligible to receive an anthracycline-based first line treatment or after one prior systemic therapy. Up to 33 and 46 subjects will be randomized (1:1) in the nivolumab and nivolumab plus pazopanib cohorts respectively, with a Simon two-stage design. Preliminary endpoint analysis will be performed when at least 18 subjects in the nivolumab cohort and 16 subjects in the nivolumab plus pazopanib cohort, have completed the first 12 cycles of nivolumab (6 months). Accrual duration is expected to be around 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of metastatic or unresectable soft tissue or bone sarcoma
* No prior therapy with nivolumab in either cohorts or with pazopanib in the combination cohort
* At least one line of systemic therapy or ineligibility for an anthracycline based chemotherapy
* At least 2 distinct measurable metastatic sites
* Adequate organ and marrow function as defined by initial laboratory tests
* Life expectancy \> 3 months
* Stable brain metastases for at least 4 weeks and no steroid dependence

Exclusion Criteria:

* Autoimmune disease Any underlying medical or psychiatric condition, which in the opinion of the Investigator, will make the administration of study drugs hazardous or obscure the interpretation of adverse events
* Concomitant therapy with any non-study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigation therapies Chronic use of systemic corticosteroids greater than prednisone 10 mg daily or its equivalent
* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 5 months after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding;
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness.
Overweight, Quality of Life and Psychological Difficulties in Teenagers

Obesity is a major public heath issue. It may have various impacts on a patient's life by causing psychological problems, altering a patient's quality of life,etc. These led to the investigators' hypothesis which is examining the psychological dimensions of a teenager suffering for obesity.

There are two groups in this study : healthy volunteers and teenagers suffering from obesity.

Patients and healthy volunteers will come to the nutrition clinic center Naturalpha where the patient will complete a questionnaire. The included patients will also complete a questionnaire privately (without the presence of the parents), they will also be weighted and measured.

No further tests or questionnaires will be given after the enrollment day.

Eligibility Criteria:
Inclusion Criteria for obese teenagers :

* Patients aged between 11 and 16 years old at the moment of enrollment.
* Body Mass Index between the 1st and 2nd degree of the obesity zone (over the 97th percentile curve regarding corpulence curves of the Plan National Nutrition Santé (PNNS) based on the gender (boys/girls))
* The teenagers have an appointment in the pediatric unit of the Saint Vincent de Paul Hospital for an examination regarding excess weight

Inclusion Criteria for average weighted teenagers :

* Patients aged between 11 and 16 years old at the moment of enrollment
* Body Mass Index located between the 3rd and the 97th percentile on the corpulence curves of the PNNS
* The teenagers and their parents have replied to and advertisement of the trial

Exclusion Criteria for obese children :

* Body Mass Index over the 97th percentile curve on the corpulence curves of the PNNS
* Handicapped teenagers

Exclusion Criteria for average weighted children :

* Body Mass Index over the 97th percentile curve or under the 3rd percentile curve on the corpulence curves of the PNNS
* Handicapped, asthmatic, obese or diabetic teenagers
Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism

Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally, toric IOLs were used mainly for patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism which are much more prevalent with about 8% having a corneal astigmatism of 2.0D or more in the cataract population. 5Using toric IOLs for these eyes results in less spectacle dependence of patients due to the astigmatic correction. Other astigmatism reducing techniques, such as peripheral corneal relaxing incisions and opposite clear corneal incisions were shown to be less predictable. Although the use of toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery , there is still uncertainty, if low astigmatism should be corrected. Visser et al. showed that moderate astigmatism of than 1.5D should be corrected for monofocal IOLs and Hayashi showed that remaining astigmatism of 1.0D already decreases visual quality in eyes with multifocal IOLs. Although correction of low corneal astigmatism appears to be beneficial, some hurdles have to be taken into account. In eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low. Furthermore, different corneal measurement techniques are not always comparable and it is difficult to know, which device shows the correct amount of astigmatism. Additionally, the correction of the spherical equivalent is of high importance, as a refractive surprise will also attenuate the astigmatism reducing effect of the toric IOL. Aim of this study is to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.

Eligibility Criteria:
Inclusion Criteria:

* cataract
* Age 21 and older
* Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D
* written informed consent prior to surgery

Exclusion Criteria:

* relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome)
* Irregular corneal astigmatism on corneal topography
* In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
The Biomarker Prediction Model of Septic Risk in Infected Patients

Sepsis is defined as a life-threatening organ dysfunction caused by a dysregulated host response to an infection. Sepsis is associated with high mortality because of the complex mechanisms. In China, the mortality of sepsis in ICU was up to 35.5%. As a major and urgent global public health challenge，sepsis is hard to treat because of the complexion and highly heterogeneous in clinical manifestation. The early diagnosis and stratification of the infection is very important. If we can identify the patients who may developed into the sepsis, the therapeutic regimen was not only antibiotic, but also included stable the vascular endothelial cells，regulation of coagulation function and protection of organ functions. Biomarkers have an important place in sepsis because they are strictly related to the organ damage. Each organ has its own specific biomarkers, and these biomarkers will change according to the severity of the disease. So the investigators want to find the difference of biomarkers of each organ in patients from infection to spesis.

According to the definition, infection is the original source of sepsis. How can diagnose organ failure early is the most impotent thing which can prevention the sepsis. In 2021, the guidelines for management of septic and septic shock recommend Sequential Organ Failure Assessment (SOFA) and systemic inflammatory response syndrome (SIRS) to diagnose sepsis. The standards of SOFA were acquired from clinical manifestations，such as blood pressure, oxygenation index, platelet, etc. These indexes can abnormal at the end of organ failure. On the other hand, it is difficult to acquire these indexes in emergency. There is wide variation in diagnostic accuracy of these tools with most having poor predictive values.

The number of publications related to sepsis biomarkers has increased over the years. The proportion of new biomarkers has decreased. Because of the complexity of the sepsis response, single biomarker might be fruitless. The investigators want to use the cytokines which have found and can represent the function of the organ in septic patients. The investigations can use these biomarkers of respiratory system, circulation, liver, renal system, coagulation and nervous system, to build up a prediction model of septic risk in infected patients.

The participants will be divided into "training set" and "verification set" randomly. The proportion of training set: verification set is 3:2. In the training set, the investigators will compare the cytokines between infection and sepsis. In sepsis patients, the investigators will compare the data between "organ failure group" and "control group", and use these data to build up the prediction model of septic risk. These data will be verify the validity and accuracy of the model in the verification set.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet any of the diagnostic criteria of "suspected infection", "confirmed infection" and "suspected sepsis".

Exclusion Criteria:

* age \< 18 years old; pregnancy or breast-feeding; lack of informed consent by the patients or relatives.
A Phase 1 Study To Evaluate Tolerability, Safety, And Pharmacokinetics Of Topical PF-06263276 In Healthy Subjects

PF-06263276 is a first in class inhibitor of the Janus kinase (JAK) enzymes 1, 2, 3 and tyrosine kinase 2 (TYK2) that is being developed for the treatment of chronic plaque psoriasis. The goal of the study is to assess the safety, local tolerability, and pharmacokinetics in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects willing to avoid tanning beds and sun exposure of the back during the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of application).
* Subjects with any active skin condition at the application site possibly affecting drug absorption (e.g. rash, sun burn, scars, tattoos).
* Subjects with a Draize score \>0 of the test area (back) immediately prior to first treatment application.
* Subjects using topical prescription or nonprescription drugs/over the counter preparations on the back within 14 days of the first treatment application.
* Subjects not willing to avoid application of treatmentssuch as lotions or creams to the back throughout the study until follow-up.