cyrilzakka/clinical-trials huggingface dataset:
Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation

Background and Aim: The immunosuppression influence on the response to antiviral therapy (AVT) for recurrent hepatitis C virus (HCV) infection in liver transplant (LT) recipients remains controversial, especially for the rarely investigated genotype 4.This study aims to compare the effects of the two widely used calcineurin inhibitors(CNIs)(Cyclosporine A (CsA) and tacrolimus (Tac)) on the therapeutic response to different AVT regimens. Method: In126 living donor liver transplant (LDLT) recipients with recurrent HCV infection, participants were categorized to three groups according to AVT. Group one received pegylated interferon (Peg IFN-α 2a) and ribavirin (RBV) (n= 44), group two received the direct antiviral agent (DAA) sofosbuvir plus RBV (n=52) and group three received daclatasvir, sofosbuvir (other DAAs) plus RBV(n=30) each group was further subdivided according to primary immunosuppression (CsA or Tac). The sustained virological response (SVR) and relapse rates were considered the primary therapeutic outcomes of AVT. The virological response guided therapy end points for AVT were considered the secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:group(I):participants received Peg IFN-α 2a and RBV therapy who fulfilled the following inclusion criteria:

* Age between 18 and 65 years ;
* elevated aminotransferase levels (ALT and AST)
* detectable HCV RNA by polymerase chain reaction (PCR)
* liver biopsy results consistent with HCV recurrence using the Metavir scoring system (Metavir ≥A1F1)
* For group II and III:
* age between 18 and 75 years
* detectable HCV RNA by PCR

Exclusion Criteria:group I

* if they were younger than 18 years or older than 65 years or had one of the following criteria
* alcoholic
* poorly controlled autoimmune disease
* significant cardiac disease
* suicidal ideation
* a history of suicide attempt
* major psychosis
* serum creatinine ˃3 mg/dl
* thyroid dysfunction
* combined kidney-liver transplantation
* were currently pregnant or planning pregnancy.

Group II and III:

* younger than 18 years or older than 75 years
* total bilirubin (T.Bil) \>3 mg/dl
* serum albumin\< 2.8 mg/dl
* international normalized ratio ≥1.7
* Platelet count \< 5000/mm3
* HCC, except 4 weeks after intervention with no evidence of activity using computed tomography or magnetic resonance imaging
* extra hepatic malignancy except after two years of disease free-interval
* uncontrolled diabetes evidenced by glycated haemoglobin \>9%
* were pregnant .
Video Laryngoscopy in Pre-hospital Critical Care

Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed.

The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway device for pre-hospital endotracheal intubation.

Hypothesis:

• In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the rate of difficult PHETI (defined as more than one intubation attempt needed to secure a patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in pre-hospital intubations.


Eligibility Criteria:
Inclusion Criteria:

* Patients where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.

Exclusion Criteria:

* Patients\< 15 years of age
Efficacy Comparison of Two Preoperative Skin Antisepsis Preparations in Colorectal Surgery

Surgical site infections (SSI) are one of the most common complications in the post-operative patient, and the second most common health care associated infection overall. It is estimated that there are between 500 thousand and 1.1 million surgical site infections in the United States each year. Given the magnitude of the problem, prevention of surgical site infections is a major goal of peri-operative care. However, skin preparation prior to surgery has not been as rigorously examined. The primary objective of this study is to compare the efficacy of two FDA approved, popular peri-operative skin preparations 2% chlorhexidine gluconate / 70% isopropyl alcohol to Iodine Povacrylex \[0.7% available Iodine\] / 74% Isopropyl Alcohol in the prevention of superficial surgical site infection. Male and female patients, age 18 years and older undergoing elective colorectal surgical procedures involving a laparotomy will be enrolled. These patients are at high risk of SSI. Eligible patients will be assessed at regular intervals for SSI and characterization of bacterial pathogen(s) in patients with SSI. Patients will remain enrolled into the study until 35 days postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older, male or female
2. Undergoing any large bowel procedure with an extraction incision site(including ileostomy closure and Hartman's colostomy reversals).
3. A clean-contaminated preoperative classification.
4. Patient must have decision-making capacity and undergo appropriate informed consent process.
5. Non-pregnant or post menopausal or surgically sterilized females. If of child-bearing age, patients must have a negative (serum or urine) pregnancy prior to surgery.

Exclusion Criteria:

1. Antibiotics taken within 5 days prior to surgery.
2. Infected wound classification.
3. Preoperative evaluation that may preclude full closure of the skin.
4. Undergoing any bowel procedure that will not result in an extraction incision.
5. Ongoing radiation or chemotherapy treatment.
6. Pregnant.
7. Refusal to accept medically indicated blood products.
8. Current abdominal wall infection or surgical site infection from previous laparotomy / laparoscopy.
9. History of laparotomy within the last 60 days.
10. Known allergy to iodine or to chlorhexidine gluconate.
11. Participating in a preoperative antibiotic trial.
12. Participating in a skin antisepsis trial.
13. Participating in Ulcerative colitis trial conflicting with this trial.
14. Women who are breast feeding (potential for transient hypothyroidism in the nursing newborn).
Hasan Kalyoncu University

Aggression is a serious problem that appears to be common in forensic psychiatric patients. Determining factors related to aggression is important for psychiatric nurses during the treatment, care and rehabilitation of patients. The aim of this study is to determine the relationship between childhood traumas, cognitive distortions and aggression in forensic psychiatry patients. This descriptive study was conducted with 103 male forensic psychiatry patients treated in a high security forensic psychiatry hospital. The data of study were collected Introductory Information Form, Childhood Psychological Traumas Scale (CTQ), Cognitive Distortions Scale (CDS) and Buss-Perry Aggression Scale (BAQ). In this study, 82.5% of forensic psychiatry patients were male, 50.5% were married, 49.5% had secondary education, 53.4% were not working. It was found that patients diagnosed with Schizophrenia Spectrum and Other Psychotic Disordersa and Bipolar Affective Disorders, who were hospitalised more than 5 times, who used alcohol/substances and who had previous experience of forensic events had higher levels of aggression. There was a significant positive correlation between the childhood traumas, cognitive distortions and aggression. The results of this study reveal important results that will contribute to psychiatric nurses caring for forensic psychiatric patients in determining the patients' aggression and affecting factors during the treatment and care process.


Eligibility Criteria:
Inclusion Criteria:

* people who do not have criminal liability
* do not have a reading comprehension problem
* volunteers to participate in the research

Exclusion Criteria:

* Patients who did not agree to participate in the study or who left the study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients

The goal of this observational case-control study is to evaluate the relationship between temporal bone computed tomography (CT) findings, bone mineral density (BMD), and audiological parameters in adults diagnosed with otosclerosis. The main questions it aims to answer are:

Is there a correlation between temporal bone CT density values and the severity of hearing loss in otosclerosis? Do bone mineral density and serum vitamin D levels differ between otosclerosis patients and individuals without otosclerosis? Researchers will compare patients diagnosed with otosclerosis to a control group without otosclerosis to determine if CT-based density variations are associated with disease severity and systemic bone metabolism markers.

Participants who have already had a temporal bone CT scan as part of their routine clinical evaluation will undergo:

Bone mineral density (BMD) assessment via dual-energy X-ray absorptiometry (DEXA) Serum vitamin D level measurement Audiological testing, including pure tone audiometry and speech discrimination tests This study aims to improve the diagnostic and prognostic understanding of otosclerosis by integrating imaging, metabolic, and audiological data.


Eligibility Criteria:
Inclusion Criteria (Otosclerosis Group):

* Adults diagnosed with otosclerosis based on audiological and clinical assessment
* Patients with available high-resolution CT scans and audiological data
* Individuals who have undergone stapedectomy or stapedotomy surgery
* Availability of bone mineral density and serum vitamin D data

Inclusion Criteria (Control Group):

* Patients without otosclerosis but with temporal CT imaging for other indications
* No history of conductive or mixed hearing loss
* Availability of BMD and vitamin D data

Exclusion Criteria:

* History of primary metabolic bone diseases (osteoporosis, Paget's disease)
* Use of medications affecting bone metabolism (bisphosphonates, corticosteroids)
* History of chronic otitis media or prior ear surgeries
* Patients who received head and neck radiotherapy
The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

The subjects in this study are the patients with head and neck cancer after completion of the radiotherapy. Radiation-induced fibrosis is inevitable and there is no effective treatment to prevent it. Therefore, there are two parts in this study :

The first part is a pilot study. There will be 10 subjects included and manual therapy and rehabilitation will be arranged for 6 months. The manual therapy would be once a week at most, and the rehabilitation would be twice a week at most.

The second part is a randomized controlled study. 60 patients would be randomized divided into two groups. The group 1 is manual therapy(once a week at most) and rehabilitation(twice a week at most), and the group 2 is rehabilitation only(twice a week at most). Patients would be evaluated at baseline, 3rd, 6th, and 12th month. The evaluation is including the degree of superficial soft tissue fibrosis, numerical rating scale of pain, range of motion(neck), range of motion(shoulder), width of mouth opening, EORTC QLQ C30, EORTC QLQ H\&N 35, and functional oral intake scale. Besides, swallowing video fluoroscopy would be done at baseline, 6th, and 12th month.

When the subject completes the evaluation in the 12th month, the study is ended.

Because the radiation-induced fibrosis is progressed with time, we will follow up the condition of subjects at the next year and the following third year.


Eligibility Criteria:
Inclusion Criteria :

1. Age \> 20 years
2. Head and neck cancer
3. After Completion of radiation therapy for 4 to 6 weeks
4. Be willing to accept manual therapy and long-term follow up

Exclusion Criteria :

1. Recurrence, metastatic cancer, or concurrent second cancer
2. With post-radiation dermatitis at neck or shoulder
3. Current pregnancy or lactation
4. Life expectancy of \< 12 months.
Isometric Exercises in Healthy Elderly Individuals

A total of 58 participants were selected and divided into two groups equally, namely, elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively. The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2), and Mean Arterial Pressure (MAP) for each participant were assessed before and after the treatment session.

The elderly participants in the experimental group and the young participants in the control group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were normotensive males and females in the above age groups.

Exclusion Criteria:

* Participants with a chronic history of alcohol, smoking, resting tachycardia (\>100 beats per min), hypertension, history of any other cardiovascular disorders, any peripheral vascular disease, those on a regular exercise program, and uncooperative participants.
Evaluation of Pain and Anxiety in Patients With an Invasive Procedure in Emergencies

A large number of patients presenting to the emergency department will have an invasive or potentially painful treatment (suture, urinary catheterization, reduction of dislocation or fracture). This care is a source of pain and anxiety for patients.

Since 1998, the management of pain is a public health priority in France. Law No. 2002-3003 of 4 March 2002 on the rights of the sick and the quality of the health system has made pain management a right: "Everyone has the right to receive care to relieve his pain. This must be in all circumstances prevented, evaluated, taken into account and treated ".

In emergency departments, the use of antalgic drug treatments and local anesthetics is systematic.

Other techniques to create diversions proposed in the recommendations of the French Society of Emergency Medicine for the management of wounds in emergencies can be used to improve the experience of patients: the use speech during the gesture or certain forms of hypnosis.

Pain and anxiety are two important factors to integrate to improve the management of patients in emergencies.

To improve pain and anxiety, distraction is a technique that can be used. Virtual reality is a distraction technique not yet frequently used but studied. It combines the visual and the auditory allowing immersion in a virtual world thanks to a helmet retranscribing a three-dimensional image. The diversion of attention through the use of virtual reality allows the patient to immerse themselves in a fictional environment through a mask on the eyes inhibiting the vision of the outside world and a headphone reducing external sounds and reinforcing the mechanism of 'immersion.

The use of the virtual reality headset has already shown benefits during pain care in burn patients and children.

The virtual reality headset has not yet been studied as a distraction tool for invasive and potentially painful care in emergencies.

Eligibility Criteria:
Inclusion Criteria:

* Man and woman (age ≥ 18 years)
* Francophone
* Patient with medical insurance
* Patient with a wound requiring trunk or limb sutures
* Or male patient requiring an urinary catheter
* Patient with cutaneous and subcutaneous wounds (deep plane possible) but without repair of noble tissues (tendons or fasciae) with no limit on the number of points to be made (i.e. without impact on the main endpoint).

Exclusion Criteria:

* Patient with a wound or skin infection of the face
* Patients with nausea, vomiting, dizziness
* Patients with a history of neurological disorders with epilepsy
* Patient whose investigator judges that he can not wear a virtual reality helmet
* Patient under tutorship or curatorship
* Patient deprived of liberty
* Refusal to participate in the study.
A Study to Evaluate the Effect of IV Doses of GMI-1070 on Qtc Intervals in Healthy African-American Adult Subjects

This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug development.

Safety

Eligibility Criteria:
Inclusion Criteria:

* Healthy African-American male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Pregnant females; breastfeeding females; and females of childbearing potential. Males who are unwilling or unable to use 2 highly effective method of contraception for the duration of the study starting at least 14 days prior to the first dose of investigational product and for at least 28 days after the last dose of investigational product.
* Non African-American.
* 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 the time of dosing).
FIBRotic Interstitial Lung Disease and Nocturnal OXygen

Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.

The interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. This causes failure of the lung and patients become progressively more breathless over time. The commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years.

Many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (OSA - pauses in breathing at night time due to obstruction of the upper airway).

Patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long.

102 patients from specialist clinics at Guy's and St Thomas' and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited. This research is funded by a grant from the British Lung Foundation. The investigators aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year.

Patients will be asked to complete a two-night home sleep study which will involve wearing a probe over the finger connected to a sensor on the wrist. Patients will also be provided with a home spirometer to measure their breathing at home daily during the study.

Lung function testing (which is part of normal clinical practice), a six-minute walk test and quality of life questionnaires will be performed at the beginning of the study. These investigations will be repeated at six and twelve months and this will tell us how night time oxygen levels affect the progression of the disease, quality of life, exercise tolerance, hospitalisation frequency and survival of these patients.

Eligibility Criteria:
Inclusion Criteria:

* MDT diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), fibrotic organising pneumonia and unclassifiable fibrotic lung disease.
* Competent to provide written consent in English

Exclusion Criteria:

* Presence of an underlying connective tissue disease
* Daytime/resting hypoxaemia with pO2 \<8.0
* Other indication for oxygen therapy
* 3% ODI \>15 events/hour studied or established on CPAP
* Predominant emphysema on CT
* Inability to provide informed consent or complete health-related quality of life questionnaires in English
* Current participation in a research project which might alter lung function or sleep study results
Korean Transient Ischemic Attack eXpression Registry

This study is to determine the clinical and neuroimaging characteristics of Transient Ischemic Attacks in Korean populations.


Eligibility Criteria:
Inclusion Criteria:

* Clinical symptoms and signs consistent with transient ischemic attack
* Subject who admitted hospital within 24 hours after symptom onset
* Subjects who underwent MRI (including diffusion-weighted images) and MRA (or CT angiography)

Exclusion Criteria:

Transient neurological symptoms due to

* Migraine aura
* Basilar migraine
* Seizures
* Syncope
* Peripheral vertigo
* Transient global amnesia
Factors Predicting the Duration of Effectiveness of Viscosupplementation in Knee Arthosis

Knee osteoarthritis is a frequent condition whose prevalence is estimated at 7.6% of the French population aged 40 to 75, or approximately 2 million individuals . Viscosupplementation (VS) is a symptomatic treatment of knee osteoarthritis recommended by a large number of learned societies. It consists of the intra-articular injection (IA) of hyaluronic acid (HA), to reduce knee pain by restoring normal joint homeostasis impaired by endogenous HA deficiency.

The IA administration of HA can be performed using 2 protocols: repeated weekly injections (3, sometimes 5 injections) and single injections. To date and there is no argument to favor either protocol. Regardless of the formula used, the safety of HA is excellent (RR of adverse reaction versus saline = 1.01, 95% CI 0.96-1.07, P = 0.6). The indication for viscosupplementation is the symptomatic treatment of mild to moderate knee osteoarthritis after failure and / or intolerance of analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs). In this indication, after HA injection the responder rate is in the order of 70% to 75% at 6 months and approximately 50% at 12 months. However, the predictors of the duration of effectiveness of SV are still unknown. The objective of the study is to research the factors influencing the duration of the effectiveness of SV, under real life conditions.


Eligibility Criteria:
Inclusion Criteria:

* All adult outpatients, of both sexes, regardless of age, with a doctor-accepted diagnosis of knee OA and who have been treated with SV within the past 3 years

Exclusion Criteria:

* Patients who have not been treated with SV in the past 3 years.
* Patients who have been treated with VS for an indication other than osteoarthritis of the knee.
* Patients in whom the assessment could not be performed reliably