cyrilzakka/clinical-trials huggingface dataset:
A Prospective Study of Airless Tubing in an Inpatient Acute Hemodialysis Unit in Hospitalized Patients

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis services. However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in both inpatient and outpatient dialysis practice.

Streamline bloodlines are designed to eliminate blood-air contact. This is thought to help reduce heparin use and decrease clotting rates. The goal of this study was to prospectively examine impact of the Streamline airless blood tubing set, in an inpatient setting, on dialysis circuit clotting rates, anticoagulation use, and dialysis efficiency.

The introduction of unfractionated heparin (UFH), which prevents clotting of the extracorporeal circuit, was one of the key advances that led to the rapid development and expansion of hemodialysis use, and remains the mainstay in hemodialysis practice today.

However, anticoagulation during hemodialysis of the patient at high risk for bleeding remains a frequently encountered problem in the nephrology practice. The need for anticoagulation to prevent clotting of the extracorporeal blood circuit and the need to prevent anticoagulation related bleeding complications in the patient has led to the development of numerous strategies; the safest from a bleeding standpoint being anticoagulant-free hemodialysis.

Streamline® bloodlines (Medisystems® Corporation, Lawrence, MA) are designed to eliminate blood-air contact. A pressure pod measures arterial and venous pressures without any blood-air contact. The venous chamber is run without an air gap. It is also designed so that blood flows in a circular vortex manner. This airless system is thought to provide several benefits: improved dialysis efficiency and blood flow rates, reduced heparin use and clotting rates.

The goal of this study was to prospectively examine the Streamline® airless tubing system in an inpatient setting and its association with clotting rates, and dialysis efficiency.

Eligibility Criteria:
Inclusion Criteria:

* All adult non-pregnant patients requiring inpatient hemodialysis at our center during the recruitment period until the target sample of dialysis sessions (n=1200) was reached.

Exclusion Criteria:

* Pregnant females
* Children
Comparing Efficacy and Safety of TJO-083 in Dry Eye Disease Patients

This is a prospective randomized study compared with active control and placebo arms.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Patient who have been diagnosed with dry eye syndrome at least 6 months ago
* Screening both eyes, the corrected visual acuity is 0.2 or more
* Written informed consent to participate in the trial

Exclusion Criteria:

* Screening visits within 2 months the patients with systemic or ocular disorders affected the test results (ocular surgery, trauma, or disease)
* Intraocular pressure(IOP)\> 21 mmHg
Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases

Published prognostic scores have limitations in prediction of long term survival after stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available for prediction of local failure. The value of radiomics is evaluated in this perspective.

Sensitivity is low for prediction of long term survival of currently available prognostic scores for brain metastases. First the current clinical models will be optimized with a new prognostic model and nomogram. Radiomics is a tool to analyze tumor characteristics based on CT and MR images. These tumor characteristics may reflect tumor biology and outcome. Therefore it is investigated if radiomics improves prediction of long term survival after stereotactic radiotherapy for brain metastases. Moreover, the predictive value of radiomics for local failure is investigated.

Eligibility Criteria:
Inclusion Criteria:

* Cerebral metastasized patients

Exclusion Criteria:

-
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer

This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.

This is a single-center, single-arm, prospective clinical study. The aim of this study is to explore the short-term and long-term efficacy and safety of total neoadjuvant therapy with irinotecan liposome in patients with locally advanced rectal cancer. Patients' nutritional status, quality of life, changes in symptoms, and adverse events will also be regularly assessed and registered during the implementation phase of the study, and patients will be treated promptly if symptoms are assessed as positive.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18\~75 years old.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
* Histopathologically confirmed rectal adenocarcinoma.
* The lower edge of the primary tumor is located below the peritoneal reflection or located ≤ 10 cm above the anal verge.
* Clinical stage: T3-4NanyM0 or T1-2N+M0.
* Adequate bone marrow function as evidenced by: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count ≥100×10\^9/L, Hemoglobin (Hb) ≥90 g/L.
* Adequate hepatic function as evidenced by: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, Serum albumin ≥3 g/dL.
* Adequate renal function as evidenced by: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
* Be willing to undergo UGT1A1 gene testing and UGT1A1 genotype of \*1\*1 or \*1\*28.
* Accept the neoadjuvant chemoradiotherapy protocol of this study and sign the informed consent.

Exclusion Criteria:

* Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
* Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment.
* Active HIV infection.
* Combined with uncontrollable systemic diseases.
* History of allergy or hypersensitivity to drug or any of their excipients.
* Any clinical indicators indicating contraindications to radiotherapy/chemotherapy and surgery.
* Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1.
* Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception.
* Patients with poor cognitive abilities who are unable to answer questions, fill out questionnaires, or have mental disorders.
* Patients who do not meet the inclusion criteria; patients who meet the inclusion criteria but are not suitable to participate in this trial judged by the investigator.
'Questions About Quitting' Smoking Cessation Trial

The current study tested the effectiveness of four potentially important tailoring factors (decisional framework, self-efficacy, navigation autonomy, and proactive outreach) in the context of an online motivational intervention for smoking cessation. A fifth factor was originally planned by dropped during intervention development due to confounds with the other planned factors. Information learned from this study will inform how to best design an online interventions for smoking cessation. Participants were recruited from a large, regional U.S. health plan. Using a full factorial design to screen for important main effects and 2-way interactions, participants were randomized to receive one of 16 different experimental factor combinations and followed for one year to assess program impact on smokers' use of empirically-validated cessation treatment and abstinence.

The current study is a factorial screening experiment, consistent with the Multiphase Optimization Strategy. Participants were randomly assigned to one of 16 different combinations of the 4 experimental factors. Each factor was explored on 2 contrasting levels. Each contrasting factor level was then compared to the other, resulting in 4 analytic arms. Within each arm, all participants (n = 1865) were analyzed to determine the relative effect of each contrasting factor level on the primary and secondary outcomes of interest.

Eligibility Criteria:
Inclusion Criteria:

* Member of Group Health Cooperative
* Currently Smoking at Least 5 Cigarettes/Day
* Access to Email and the Internet
* Read and Write English
* 18 years or older
* Not currently receiving tobacco cessation treatment
* Capable of participating in online and phone surveys

Exclusion Criteria:

* Persons will be excluded if they do not meet above criteria
Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit

Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.

This experimental study is conducted with minimum 24 subjects which divided into 6 groups; 1) 24-days pregnant and is given prenatal spermine, 2) 26-days pregnant and is given prenatal spermine, 3) 28-days pregnant and is given prenatal spermine, 4) 24-days pregnant and is not given prenatal spermine, 5) 26-days pregnant and is not given prenatal spermine, and 6) 28-days pregnant and is not given prenatal spermine. At the end of desired pregnancy period, hysterectomy is done and fetus are born. From each parent subject, three fetal samples are chosen using a random sampling. Intestinal tissues are taken from each fetal sample to be examined. Several data will be collected i.e. occludin, β-catenin, and β-actin, as well as histological morphologies.

Eligibility Criteria:
Inclusion Criteria:

* Intestinal tissue of fetal rabbit that is prematurely alive

Exclusion Criteria:

* Intestinal tissue of fetal rabbit that is dead before termination
* Intestinal tissue of fetal rabbit, in which the parent died before termination
Supervised Walking Groups as a Model to Increase Physical Activity in Type 2 Diabetes

The purpose of the study is to evaluate the impact of an exercise programme organized into supervised walking groups on metabolic control, functional capacity and overall quantity of physical activity in subjects with type 2 diabetes.

Regular, moderate-intensity physical activity can attenuate hyperglycemia in subjects with type 2 diabetes. In addition, these programmes may favourably affect several other cardiovascular risk factors in these subjects. However, it still remains unclear how this evidence can be transferred into clinical practice, considering the very large number of diabetic patients and the characteristics of this population, made up predominantly of elderly, sedentary and overweight patients. In this regard, a realistic approach to this issue requires simple and easily available intervention models.

Walking is a typical mild-moderate aerobic physical activity which is easy to organize and does not require specific skills or preliminary sophisticated medical evaluations. This activity could therefore fit well with the need of involvement of large numbers of patients in different logistic situations. However, it has been reported that, due to the low walking speed typical of type 2 diabetic subjects, self-paced walking is inadequate to obtain a significant metabolic improvement in these subjects.

Eligibility Criteria:
Inclusion Criteria:

* diabetes known for at least 2 yr
* physical inactivity
* haemoglobin (Hb)A1c between 6.5-9.9%
* treatment with oral hypoglycaemic agents alone or associated with a bed-time insulin injection
* willingness to participate in a programme of regular physical activity

Exclusion Criteria:

* moderate-severe autonomic or somatic neuropathy
* severe lower limb vasculopathy
* pre-proliferative or proliferative active retinopathy
* moderate to severe chronic renal failure
* unstable angina or recent (in the previous 3 months) myocardial infarction
* acute intercurrent diseases
* acute metabolic decompensation (blood glucose \>300 mg/dl or ketonuria in two consecutive checks)
* use of beta-blocker drugs
* subjects unable to complete a 6-min walk test
Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression

At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.


Eligibility Criteria:
Inclusion Criteria:

1. Having a good mental status,
2. Those aged ≥18 years,
3. Term pregnant (gestational age ≥ 36 weeks),
4. American Society of Anesthesiologists class II-III,
5. Patients who underwent cesarean section with spinal anesthesia will be included.

Exclusion Criteria:

1. Having labor at term or obstetric emergency,
2. Having a twin pregnancy,
3. Having a diagnosed psychiatric disorder/using psychiatric medication,
4. Those who are allergic to local anesthetics and/or drugs used in the study,
5. The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
6. Having peripheral neuropathy or neuromuscular disease,
7. Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.
Dialysis Exercise With a Bed Compatible Leg TRAiningstool

This study is a randomised controlled intervention trial for dialysis patients with chronic kidney disease (n=32). The aim of this study is to test the effectiveness of an intradialytic training with a simple bed compatible trainingstool in comparison to a control group.

Patients are randomised to either the intervention or control group at the beginning of the study. Both groups are evaluated at the beginning and after 2 months regarding their body composition, physical performance, fatigue and quality of life. The control group receives usual care. The intervention group receives an intradialytic exercise training with a bed compatible trainingstool.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Patients who started dialysis more than 3 months ago
* Patients must be mentally and physically able to participate in exercise

Exclusion Criteria:

* Patients who are not mentally or physically able to participate in intradialytic exercise. These include patients with uncontrolled high blood pressure and uncontrolled diabetes mellitus, diseases that impair physical performance or/and could be aggravated by activity, such as ischaemic cardiopathy or symptoms associated with coronary heart disease, chronic coronary heart disease, chronic lung disease and orthopaedic conditions that make exercise impossible.
keePAP Device for Treatment of Obstructive Sleep Apnea

The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.

Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.

The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.

Eligibility Criteria:
Inclusion Criteria:

* Age over between 18 and 80 years old;
* AHI/RDI \> 5

Exclusion Criteria:

* Uncontrolled or serious illness (angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure),
* Exhibiting any flu-like or upper respiratory illness symptoms at time of assessment;
* History of severe nasal allergies or sinusitis or difficulty breathing through the nose;
* Persistent blockage of one or both nostrils;
* Any previous operation or trauma to the nose;
* Any nasal, facial or head abnormalities that would not allow adequate placement of the device.
* Previous diagnosis of insomnia, narcolepsy, periodic limb movement disorder, respiratory failure.
* Female subjects of childbearing age were excluded if they were pregnant or intending to become pregnant.
The Real-world Treatment Satisfaction by Gefapixiant in RCC

Chronic cough has a high global prevalence and it is refractory to such treatments by approximately 20% of patients. Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with refractory chronic cough(RCC). Taste disturbance is the most frequent adverse event by gefapixant (approximately 60-70%). Although gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear. Therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients. the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients.

Chronic cough has a high global prevalence, but appears to be poorly recognized. Most patients respond to specific treatments against causes of chronic cough. Meanwhile, cough is refractory to such treatments by approximately 20% of patients and they are regarded as "refractory chronic cough (RCC). Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with RCC through the inhibition of ATP transmission to afferent nerves. According to the COUGH-1 and COUGH-2, taste disturbance is the most frequent adverse event by gefapixant, with the incidence of 59.3% in COUGH-1 and 68.9% in COUGH-2, respectively. Although 45 mg of gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear in RCC and UCC. Furthermore, both taste disturbance and the improvement of cough by gefapixant would be associated with treatment satisfaction. Therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients. The investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients. Furthermore, the investigator would like to evaluate the association of taste disturbance with cough-specific QoL in the real-world clinical practice. In addition, there are no biomarkers available that can predict the efficacy of the improvement of cough by gefapixant. The investigator will also explore biomarkers that can be helpful in predicting well response to gefapixant in RCC and UCC patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients with RCC and UCC (8 weeks or more).
2. Cough is refractory to intensive specific treatments for causes of chronic cough.
3. Never smokers and ex-smokers with having smoking history of ≤20 pack-years.

Exclusion Criteria:

1. Patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infection such as tuberculosis and acute pneumonia.
2. Current smoker, ex-smokers with having smoking history of \>20 pack-years, or those who quit smoking within six months prior to receiving gefapixant.
3. Those who are pregnant.
Incidence of Intracranial Hypertension During Liver Transplantation Estimated by Non-invasive Ultrasound Methods.

Acute or chronic liver failure (fulminant hepatitis or advanced cirrhosis) disrupts brain physiology. Beyond classical hepatic encephalopathy, intracranial hypertension may occur.During liver transplantation (LT) surgery, many factors can lead to cerebral assault. In addition, intracranial hypertension measured with invasive methods has been described in certain phases of LT, especially at the time of reperfusion.

The invasive monitoring of the intracranial pressure is not used in these patients, due to a high risk of infection and bleeding. The non-invasive monitoring of intracranial pressure has been widely developed in recent years : transcranial doppler and recently ultrasound of the optic nerve sheath (ONSD) allow an effective detection of intracranial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years
* Patients who underwent orthotopic liver transplantation
* Patients who have received clear information and not opposed to participate in the study
* Patients affiliated to a social security scheme or similar
* Patients not undergoing a measure of legal protection

Exclusion Criteria:

* Opposition to participation in the study
* Patients \< 18 years
* Pregnant women or breastfeeding
* Deprived of individual liberty
* Non-affiliated to a social security scheme
* Known ophthalmic pathology: untreated cataracts, glaucoma
Hsv 1 and 2 Gowey Protocol Versus Placebo

This study will compare efficacy of versabase gel with 20% sarracenia purpurea versus placebo applied every 3-4 hours to herpes lesions.

Patients screened for hsv one or two. Patients with herpes given a 1/8 oz of gel. Researcher does not know which is active and which is placebo (placebo is actually just versabase gel). Patent applies gel to lesions every 3-4 hours. Returns to clinic on days 3, 5, and 14 for evaluation. Up to 50 patients may be enrolled.

Eligibility Criteria:
Inclusion Criteria:

- Hsv 1\&2

Exclusion Criteria:

* No active lesions