cyrilzakka/clinical-trials huggingface dataset:
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors

The aim of this project is to determine whether, in liver transplant patients with side effects due to ICN, the use of MMF in monotherapy can be optimised by dose adjustment based on the area under the curve (AUC) of mycophenolic acid (MPA). It involves a multicentre phase IV trial with direct individual benefit.

A population of 130 liver transplant patients at 2 to 10 years post-transplant, showing significant clinical ICN side effects and being given bitherapy by ICN +MMF will be included and randomised 1:1 in two arms:

* Arm 1: progressive interruption of ICN after obtaining an AUC of MPA of 50 mg.h/l, followed by MMF monotherapy with dose adjustment based on the AUC of MPA,
* Arm 2: continuation of the ICN+MMF bitherapy without MMF therapeutic drug monitoring.

The main judgement criterion will be the incidence of acute rejection in the 2 groups at 6 months. The secondary judgment criterion will be the evaluation of the benefit of stopping ICN on the side effects caused by these drugs.


Eligibility Criteria:
Inclusion Criteria:

* Patient with first liver transplantion or retransplantation since more than 6 months: with a post-transplant lapse of time of 2 to 10 years and showing one of the following adverse effects of ICN:
* Renal insufficiency defined by a creatinine clearance \<50ml/mn (calculated or estimated according to the Cockcroft formula)
* Arterial hypertension not controlled by an anti-hypertensive bitherapy
* Diabetes mellitus (fasting glycaemia \>7.0mmol/l), whether treated or not
* Neuromuscular toxicity
* Immunosuppression by cyclosporine or tacrolimus and MMF
* Hepatic biopsy performed within the 6 months preceding the inclusion for the patients with a post-transplant period of \<5 years and in the 12 months preceding the inclusion for patients with a post transplant period of \>5 years.

Exclusion Criteria:

* Acute rejection within the 6 months preceding the screening
* Previous history of cortico-resistant rejection
* Chronic rejection
* Significant ductopenia (absence of inter-lobule biliary canals in more than 30% of the portal tracts) on the pre-screening biopsy.
* Existence of a pre-transplantation diabetes mellitus.
* Liver transplantation for auto-immune hepatitis or primary sclerosing cholangitis
* Patients transplanted for viral C cirrhosis with reinfection lesions of the transplanted organ, rendering treatment by ribarivine + interferon conceivable in the year following inclusion.
* Counter-indications to MMF (anaemia, leucopenia)
* Immunosuppression by sirolimus, everolimus, azathioprine or corticoids
Intravenous Hydromorphone for the Treatment of Acute Pain

To observe the efficacy and safety of hydromorphone in the treatment of acute chest pain, and to explore the potential advantages of hydromorphone for analgesia in patients with acute chest pain, so as to provide more theoretical basis for individualized analgesia and rapid recovery in patients with acute chest pain.


Eligibility Criteria:
Inclusion criteria:

1. Age 18-64 years old;
2. Gender is not limited;
3. Patients with acute chest pain, with the time from pain onset to visit the doctor ≤ 24 days;
4. Severe pain that requires the use of opioids to control as determined by emergency physicians;
5. Obtain informed consent from the patient or family members.

Exclusion criteria:

1. Known allergy to hydromorphone or morphine;
2. Systolic blood pressure \<100 mmHg, oxygen saturation \<95%, pulse less than 60 beats/min;
3. Use of acetaminophen or nonsteroidal anti-inflammatory drugs in the past 8 hours;
4. Chronic pain, defined as pain lasting for more than 12 weeks;
5. Delirium, alcohol withdrawal symptoms or other drug intoxication;
6. Pregnant or lactating women;
7. Patients with mental or neurological diseases, cognitive and consciousness disorders and inability to express correctly;
8. Participating in any other research at the same time;
9. Factors that increase the risk of participating in the study (life-threatening chest pain patients who require rapid diagnosis or treatment intervention, such as resuscitation status, excluding chest pain caused by myocardial infarction), who are judged by the researchers to be unsuitable for inclusion in the study.
Adenoma Detection by Polypectomy During Both Insertion and Withdrawal

Standard method of colonoscopy is to insert the colonoscope rapidly to reach the cecum, with careful inspection and polypectomy during the withdrawal phase. However, small polyps (e.g. \<1cm) seen during insertion phase are difficult to find during withdrawal phase. Also, colon is in different conformation during insertion and withdrawal phases. We think careful inspection and polypectomy during both insertion and withdrawal can improve adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing screening or surveillance colonoscopy

Exclusion Criteria:

* Previous colorectal resection, Polyposis syndrome, Inflammatory bowel disease
Intensive Short-term Dynamic Psychotherapy (ISTDP) in the Emergency Department

Objective: Somatization of emotions accounts for excess Emergency department (ED) visits. Intensive Short-term Dynamic Psychotherapy (ISTDP) has methods to diagnose and manage somatization. We examined the feasibility, acceptability and effectiveness of ISTDP diagnostic and treatment methods used for patients with repeated ED presentations for medically unexplained physical symptoms (MUS)

Herein we report the methods and outcomes of rapidly-accessed, emotion-focused diagnostic and treatment services for patients presenting to the ED with medically unexplained symptoms (MUS). Patients who were assessed and referred by ED physicians will serve as a non-randomized condition controlling for some relevant variables. Our a priori hypotheses were that assessed and treated patients would have a reduction in ED visits and self reported symptoms after this intervention and that controls would have a smaller reduction in ED visits if any.

Eligibility Criteria:
Inclusion Criteria:

* Unexplained symptoms

Exclusion Criteria:

* Psychosis, substance abuse, suicidality
Mechanically or Kinematically Aligned Total Knee Prosthesis

The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.

In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.


Eligibility Criteria:
Inclusion Criteria:

* Patient followed as part of a consultation 1 year after TKA placement
* Adult patient
* Patient affiliated to a social security system
* Patient informed of the study and formally included (signing of informed consent) before the first research review

Exclusion Criteria:

* Patient with a contralateral knee prosthesis
* Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
* Pregnant patient
* Patient deprived of liberty by judicial or administrative decision,
* Adult patient subject to a legal protection measure or unable to express consent
Evaluation of Choledochoduodonostomy Vs Hepaticojejunostomy in Paients with Choledocholithiasis Indicated for Shunt.

A biliary-enteric anastomosis can be needed for a number of indications, including malignant or pre-malignant biliary diseases, benign biliary stenosis, bile duct injury, and complex choledocholithiasis. Choledochoduodenostomy is the most simple form of biliary-digestive anastomosis, with only minimal alteration to the normal anatomy. Due to the reported specific complications of choledochoduodenostomy, such as sump syndrome and gastritis caused by biliary reflux, creation of a HJ was preferred in the past decades . A Roux-en-Y hepaticojejunostomy (HJ) does not cause sump syndrome and only rarely reflux gastritis, but the procedure is more extensive, requiring an additional jejuno-jejunostomy .Especially for patients with extensive intra-abdominal adhesions or with a history of small bowel resections, the creation of a Roux-en-Y limb might pose a problem. Some recent publications have concluded that CD leads to acceptable surgical outcome, with low reported incidences of sump syndrome and reflux gastritis. However, these studies do not make a direct comparison between CD and HJ. Especially comparisons of long-term outcomes between CD and HJ are lacking.

There are 2 options are available: Choledochoduodonostomy or Roux-en-Y choledochojejunostomy. Both can be accomplished via a laparoscopic approach; however, thereis no consensus to which is best due to a paucity of data comparing the techniques.

Choice of operation is largely left up to the individual surgeon. Athough performed infrequently for benign biliary disease, biliary bypass operations are fundamental for any surgeon and are considered a core operation by the American College of Surgeons for any general surgery resident. In our study we are going to describe in detail our technique and outcomes when used for choledocholethiasis.

Eligibility Criteria:
Inclusion Criteria:

residual stones. recurrent stones, failed ERCP due to imacted large stone, Multiple CBD calculi with distal narrowing (Funnel syndrome), Papillary stenosis; impacted calculi, Biliary sludge-symptomatic, Sphincter of Oddi dysfunction/stenosis, Primary CBD stones; previous choledochotomy and Marked CBD dilatation.

Exclusion Criteria:

surgically unfit patients, malignancy, infections e.g, cholangitis and coagulation disorders.
High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis

* Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder characterized by fibrosis of the skin and visceral organs that alters every aspect of an individual life
* Although some features of scleroderma phenotype are well established and represent the hallmarks of the disease, the primary cause is not fully delineated, though both endothelial cell damage, immunological abnormalities and excessive extracellular matrix production are well-documented
* Recently, excessive oxidative stress has been implicated in the pathogenesis of scleroderma
* N-acetylcysteine (NAC) exhibits direct and indirect antioxidant properties. Its free thiol group is capable of interacting with the electrophilic groups of ROS. This interaction with ROS leads to intermediate formation of NAC thiol, with NAC disulphide as a major end product. The net result is a decrease of the concentrations of OH-, H2O2, and HOCl. In addition, NAC exerts an indirect antioxidant effect related to its role as a glutathione (GSH) precursor. It serves as a central factor in protecting against internal toxic agents.
* In view of these considerations we expect that NAC can confer substantial benefit in patients with scleroderma reducing skin fibrosis in view of its antioxidant properties, and we have decided to conduct a double blind, multicenter trial to establish whether NAC could ameliorate skin fibrosis in scleroderma patients


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of early diffuse scleroderma
* ability to give an informed consent
* use of an acceptable method of birth control (if women in childbearing age). Pregnancy will be ruled out before study beginning.

Exclusion Criteria:

* connective tissue diseases or other autoimmune diseases other than SSc;
* history of intolerance to the study drugs;
* severe cardiac failure (NYHA \>=3 or left ventricular ejection fraction \<40%), recent (\<6 months) history of myocardial infarction; symptomatic ischemic myocardial disease, ventricular tachyarrhythmia, atrial fibrillation;
* resting PaO2 \<60mm/hg
* creatinine clearance below 90ml/h
* severe hepatic failure
* bronchial asthma h. hemorrhagic diathesis i. pregnancy or lactation
Comparison of Sport Injury Anxiety of Athletes Doing Sports on Different Surfaces

Due to its nature, sports are an activity in which injuries are common. Sports injuries have athletic and environmental reasons. In sports injuries, although the medical team is generally interested in the physiological aspect of the injury, in recent years, the psychological aspect of the injury has also started to be taken care of. One of these psychological aspects is anxiety. Athletes who develop sports injury anxiety are more prone to injury. One of the environmental reasons is the ground for sports. We could not find a study in the literature comparing the anxiety levels of those who do sports on different grounds in different sports branches. Our study will provide support to the literature in this direction.

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer athletes between the ages of 18-35 without any known health problems will be included in the study after obtaining their informed consent.

150 athletes competing on turf, artificial turf and wooden parquet will be included in our study.

The data of our study will be collected by Google survey. After obtaining the demographic information of the athletes participating in our study, the data on injury anxiety will be collected with the Sports Injury Anxiety Scale.

Eligibility Criteria:
Inclusion Criteria:

* To be a healthy, previous injury athlete

Exclusion Criteria:

* Have an ongoing injury
Dose-response of Talus Mobilizations

Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult. Secondarily, this research will appraise whether a likely improvement in ankle mobility may have an impact on the overall mobility (i.e. gait, get up from a chair).


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults
* Over 60 years
* Limited ankle dorsiflexion range of motion

Exclusion Criteria:

* Not willing to participate or signing a consent form
* Lower limb injury in the three months prior to the study (ex. sprain)
* Diagnosed condition that may influence mobility assessments (i.e. stroke)
Immune Checkpoint Inhibitor Combined With Pemetrexed Intrathecal Injection for Leptomeningeal Metastasis From Solid Tumors

This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors, to evaluate the safety and efficacy.

This is an open-label, single-arm, phase I/II trial of immune checkpoint inhibitor combined with pemetrexed intrathecal injection for leptomeningeal metastasis from solid tumors. The primary endpoint of the phase I study was to determine the recommended phase II dose (PR2D). The primary endpoint of the Phase II study was to assess the safety and clinical response rate of immune checkpoint inhibitor in combination with pemetrexed intrathecally under PR2D, with secondary endpoints of overall survival, and neurological progression-free survival.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
2. Male or female aged between 18 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
4. Patients with poor compliance or other reasons that were unsuitable for this study.
Blocking Blue Light in Pregnancy, Effects on Melatonin Profile and Sleep

Sleep disturbances are common in pregnancy, and the incidence increases during the third trimester. Light and specially the blue wavelengths of light, is affecting sleep and the circadian rhythm. The main aim of this randomized controlled study is to investigate the effect of Blue-blocking glasses (BB-glasses) used in the evening and night on sleep and mood in pregnant women in the third trimester. The outcome measures assess sleep variables, alertness, melatonin level, sleepiness (subjectively), mood and symptoms of anxiety and depression. In addition we want to measure the pregnancy related sleep problems, alcohol intake, physical activity and perceives stress in the study population, and the association with daily/nightly light exposure.

Several hormonal and mechanical influences can cause insomnia in pregnancy, and insomnia has been reported by 62% of pregnant women, a number that is significantly higher than found in the general population (10-15%). Disrupted sleep among pregnant women also includes nocturia (a frequent need to get up and urinate at night), dyspnea (shortness of breath), nasal congestion, muscular aches and pelvic pains, fetal activity, leg cramps as well as reflux.

Artificial light in the evening and during the night increases alertness, disturbs sleep, shifts the timing of the circadian clock and impairs the brains' restorative slow waves during deep sleep. Recent studies have however shown that use of BB-glasses in the evening improves sleep quality (subjectively reported) among persons with insomnia, and prevent alertness caused by blue-light emitting screens which are part of devices such as smart-phones and tablets.

This project will contribute with new knowledge on how filtering nightly light exposure in pregnant women in their third trimester affects their sleep and mood. Importantly, the project initiates new research on a potential non-pharmacological treatment of sleep disturbances by blocking blue wavelengths of light in the evening and during nocturnal awakenings. Blue light is known to increase alertness through a recently described retinal receptor; the intrinsically photoresponsive retinal ganglion cell (IpRGC), specialized for detecting daytime light signal. This project is highly innovative and may have significant practical implications Due to the variety of aims and outcome measures, we plan to present the outcomes in separate articles.

Eligibility Criteria:
Inclusion Criteria:

* nulliparous women
* expecting one child
* being in the third trimester of a normal pregnancy
* able to wear an actigraph during daytime and nighttime
* able to fill out a questionnaire in Norwegian

Exclusion Criteria:

* somatic or psychiatric disorders
* fever and other health conditions affecting sleep
* working at night during the study protocol
Multisystem Shortness of Breath Evaluation Study

The MUSE study is a prospective observational cohort study of patients referred to pulmonary and/or cardiology specialty clinic for evaluation of shortness of breath or dyspnea. Patients will undergo all pertinent testing and will be required to fill out a number of epidemiologic and quality of life related questionnaires. Follow up will continue for at least one year.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to Pulmonary and/or Cardiology clinic for the evaluation of unexplained dyspnea.

Exclusion Criteria:

* Patients with a known cause of dyspnea such as established cardiopulmonary disease
Knowledge Levels and Experiences of Intensive Care Nurses on the Prevention of Pressure Sores: Mixed Method

This research aims to determine the knowledge levels and practices of intensive care nurses regarding the prevention of pressure sores.

The main questions it aims to answer are:

1. What is the level of knowledge of intensive care nurses regarding the prevention of pressure sores?
2. What is the impact of sociodemographic characteristics of intensive care nurses on their knowledge level regarding the prevention of pressure sores?
3. What are the experiences of intensive care nurses regarding their practices for the prevention of pressure sores? In this research, a survey and interview technique will be applied to determine the knowledge levels and experiences of nurses working in adult intensive care units regarding the prevention of pressure sores and their practices.

This study is a mixed method research conducted to determine the knowledge levels and experiences of nurses working in adult intensive care units regarding the prevention of pressure sores. In accordance with the purpose of the study, parallel data type in convergent parallel mixed design will be used as the research design. The quantitative phase will be conducted as a descriptive survey, and the qualitative phase will be conducted as a descriptive case study design. In this mixed design, equal priority, parallel timing and combining results during interpretation are planned. The research will be conducted with nurses working in adult intensive care units of a public hospital located in a city center. \&#39;Sociodemographic Form\&#39;, \&#39;Pressure Ulcer Knowledge Level Assessment Tool 2.0- Updated Version\&#39;, \&#39;Semi-Structured Interview Form\&#39; will be used as data collection tools. Within the scope of our research questions, quantitative and qualitative data will be analyzed independently of each other. In the discussion section, the integration of quantitative and qualitative evidence will be interpreted by making analytical generalization by combining data without transformation.

Eligibility Criteria:
Inclusion Criteria:

* Nurses working in adult intensive care units Agreeing to participate in the research

Exclusion Criteria:

* Nurses who do not work in adult intensive care units Nurses who did not agree to participate in the research