cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Early Mobilization Protocol in Patients Undergoing Gastrointestinal Surgery

In this study, the investigators aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.

This study is an experimental study. The participants in the control group are applied to the mobilization applied in routine clinics. The participants in the intervention group are applied to the mobilization protocol created in accordance with the Enhanced Recovery After Surgery (ERAS) guidelines. It is planned to evaluate the postoperative mobilization process of both groups.

In this study, the researchers aimed to evaluate the early mobilization protocol created in accordance with the accelerated recovery guide after surgery in patients undergoing gastrointestinal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age or older
* Agreeing to participate in the study
* Being able to understand, speak Turkish or have no obstacle to communication
* Having undergone open gastrointestinal surgery
* Having an American Society of Anesthesiologists (ASA) score \<IV
* Being fully independent according to the Modified Barthel Index during the pre-operative period
* Staying in the hospital for at least 48 hours after the surgery
* Having a phone
* Agreeing to download the 'StepsApp Pedometer' application to their phone
* Agreeing to carry the phone with them during the post-operative mobilization processes

Exclusion Criteria:

* Being taken into emergency surgery
* Having had major gastrointestinal surgery before
* Having a diagnosis that may restrict mobilization (neurological, cardiovascular, respiratory and musculoskeletal comorbidities)
* High risk of falling in the preoperative period
* Using medication that may affect mobilization
* Having a diagnosis of any psychiatric disease
* Having a Nutritional Risk Score score of ≥3
* Being in contact isolation
* Being morbidly obese
* Being in intensive care for more than 24 hours during the postoperative period
* Having an intubation period of more than 24 hours during the postoperative period
* Developing a complication that may prevent mobilization after surgery
* Withdrawing from participating in the study,
Follow-up of Patients Operated Upon for Type II-IV Hiatal Hernia

Surgical therapy for gastroesophageal reflux disease (GERD) and hiatal hernia (HH) can achieve outcomes that afford the patient lifelong satisfaction. The published results obtained with this surgery may not be considered to be definitive in relation to the length of follow-up or patients' life expectancy. The real recurrence rates and the results of surgery for GERD are difficult to assess due to the lack of serial time points during the follow-up. Further bias may have been introduced into the analysis by a lack of appropriate controls. The results of surgical therapy for type II-IV HH are even more controversial because of the high rate of anatomical relapse and the different methods of follow-up adopted in reported case series.

Aim of this study is to clarify the value of surgical therapy for type II-IV HH. The investigators report on patients who were followed up after surgery at various time points over the course of 30 years.

We reviewed the charts of patients who underwent primary surgery for type II-IV Hiatal Hernia during the period from January 1980 - December 2010.

Pre-operatively, the patients routinely underwent symptom assessment, a barium swallow, upper GI endoscopy and esophageal manometry.

The principles of surgery for GERD and hiatal hernias involve full isolation of the diaphragmatic pillars and E-G junction, full isolation and resection of the sac and fat pad into the mediastinum (except for the fat close to the lesser curvature, to preserve the integrity of the vagus nerves), evaluation of the degree of esophageal shortening, and a Collis gastroplasty in cases of short esophagi.

Post-operatively, the patients participated in a free-of-charge outpatient follow-up program at 6 months, 12 months and every year for 5 years.

The length of the follow-up was calculated from the day of the surgery to the day that the patient underwent the last complete follow-up. The type and severity of symptoms and the grade of reflux esophagitis were scored using a questionnaire with semi-quantitative scales (from 0 = absence of symptoms and esophagitis to 3 = severe symptoms and esophagitis). An evaluation scale for the surgical results, with scores ranging from "excellent" to "poor", was also used.

Eligibility Criteria:
Inclusion Criteria:

* patients aged \> 18 years, undergoing surgery for the treatment of type II-IV hiatal hernia ± GERD.

Exclusion Criteria:

* association of GERD with epiphrenic esophageal diverticulum
* collagen diseases
* undetermined esophageal motility disorders, redo antireflux surgery
* previous surgery on the thoracic and abdominal esophagus and stomach, on the diaphragm.
Optimising Health in Type 1 Diabetes

Type 1 diabetes is an autoimmune condition where circulating immune cells destroy the beta-cells in the pancreas that make insulin, resulting in a degree of insulin deficiency, whereby blood glucose levels rise and diabetes develops. When there is severe insulin deficiency, life-threatening ketoacidosis can develop. Treatment is lifelong insulin replacement therapy; dietary intervention is a also cornerstone of glucose management.

The Optimise Diet is a multi-pronged diet based on "best health" principles: to minimise blood glucose rises after eating, reduce the immune cells involved in destruction of the insulin-secreting beta-cells, and improve the gut microbiome and systemic inflammation. In this study, its effects will be compared to the Standard Diabetes Diet that is currently recommended in Australia and internationally.

The rationale for this study is to determine whether a diet based on recent scientific advances in diet-induced inflammation, will improve diabetes care in people with type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes

Exclusion Criteria:

* Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study.
A Study of Yervoy and Opdivo Combination Therapy in Participants With Unresectable Advanced/Recurrent Malignant Pleural Mesothelioma (MPM)

The purpose of this study is to observe the safety of the combination therapy with Yervoy and Opdivo in Japanese participants for the treatment of unresectable advanced/recurrent malignant pleural mesothelioma (MPM).


Eligibility Criteria:
Inclusion Criteria:

* Initiated treatment with Yervoy and Opdivo in combination for the first time in accordance with the Japanese package insert

Exclusion Criteria:

* Received combination therapy with Yervoy and Opdivo for indications other than Malignant Pleural Mesothelioma (MPM).
* Received the Yervoy and Opdivo combination for MPM, but for an indication that is outside of the Japanese package insert.
Clinical Study of QingReMoShen Granule to Treat Idiopathic Membranous Nephropathy

The purpose of this study is to evaluate the clinical safety and efficacy of QingReMoShen Granule to treat idiopathic membranous nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Women and men who had a clinic and biopsy-proven idiopathic membranous nephropathy;
* 6.0g≥24 hour urinary protein≥1.0g;
* serum albumin concentration≥26g/L;
* Chronic Kidney Disease (CKD)≤3 stage (eGFR\>30ml/min/1.73m2 MDRD);
* Willing to participate in the trial and signed an informed consent.

Exclusion Criteria:

* Secondary membranous nephropathy;
* Patients with one of the following circumstances- malignant tumors or malignancy, HIV infection, a history of mental illness, any serious systemic infection, serious gastrointestinal diseases, circulating hepatitis B surface antigens positive or persistent abnormal serum transaminase, abnormal glucose metabolism or diabetes mellitus;
* Pregnant and lactating women;
* Undergoing other clinical trials.
Clinical Efficacy and SAfety of Intravenous Infusion of Nicorandil During Primary Percutaneous Coronary Intervention

The investigators evaluate the efficacy and safety of intravenous administration of nicorandil as adjuncts to reperfusion treatment in acute ST-segment elevation acute myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI).


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years;
* acute ST-segment elevation myocardial infarction within 12 hours of symptom onset;

Exclusion Criteria:

* systolic blood pressure\<100mmHg;
* cardiac shock;
* aortic dissection;
* history of myocardial infarction or percutaneous coronary intervention or coronary artery bypass grafting (\<6 month);
* history of the treatment of nicorandil (\<6 month);
* history of intravenous nitrates before percutaneous coronary intervention;
* contraindicated or intolerable to nicorandil;
* pregnant or lactation period;
* patients with an estimated survival time of less than 1 year.
Von Willebrand Factor to Predict Postoperative Outcome

vWF is stored in weibel-palade-bodies of endothelial cells as well as alpha-granula of platelets and is released upon their activation. Endothelial cell dysfunction as well as platelet activation often occur in liver disease and portal hypertension, which may lead to an increase in circulating vWF levels. Indeed, multiple studies have reported that liver disease is associated with increased circulating vWF- antigen (vWF-Ag). Furthermore, increased circulating vWF -Ag Levels have been shown to be associated with increased mortality rates in patients with chronic liver disease. Within a prospective evaluation cohort, the investigators were able to document that patients with increased vWF-Ag levels prior to liver resection suffered from an increased incidence of postoperative liver dysfunction and morbidity. Within this prospective multicenter validation study, the investigators now aim to prospectively validate that circulating vWF-Ag prior to liver resection is a valuable marker to predict postoperative clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing liver resection
* only patients with either hepatocellular carcinoma, cholangiocellular carcinoma or colorectal cancer liver metastasis will be included

Exclusion Criteria:

* inherited coagulopathy
* age \> 85
Assess the Performance of Metagenomic Sequencing in the Diagnosis of STI (NGS-IST)

The main objective of the study will be to assess the performance of the Next-Generation-Sequencing (NGS) diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.

Sexually Transmitted Infections (STIs) have become a major global public health problem and are among the most common infections. The increase antibiotic resistance, particularly in Neisseria gonorrhoeae and Mycoplasma genitalium, is of concern. Currently, the diagnosis of STIs is based on specific tests by pathogen, mainly by standard culture allowing an antibiotic susceptibility testing, gene amplification tests possibly allowing the search for resistance genes and serologies.

Next-Generation-Sequencing (NGS) is based on the detection and analysis of any DNA and RNA present in the studied sample with a high degree of sensitivity, this method enables the precise identification of non-human sequences regardless its bacterial, viral or parasitologic origin, to detect resistance genes and to characterize the strains.

The investigators propose to assess the performance of NGS for the diagnosis of STIs. A cohort of 332 PrEP users from Saint-Antoine and Tenon Hospitals will be followed for this purpose every 3 months during 1 year (including also the intermediate visits if needed in case of STIs symptoms).

The main objective of the study will be to assess the performance of the NGS diagnostics of Chlamydia trachomatis and Neisseria gonorrhoeae compared to reference techniques.

The secondary objectives will be (i) to evaluate the performance of the diagnosis by NGS of the other STIs compared to the reference techniques, (ii) to evaluate the interest and the sensitivity of a 3 sites pooled sample "urine, throat and rectum" and the swab sampling from the ulcer lesions in the case of the ulcerations presence for the diagnosis of STIs, (iii) to describe the natural history of colonization with Mycoplasma genitalium and the appearance of resistance or pressure of antibiotic selection and (iv) to evaluate the prevalence of agents not usually sought in screening for STI (HSV-1, HSV-2, Haemophilus ducreyi, Campylobacter sp, Shigella sp, Clostridioides difficile, Entamoeba histolytica).

Improved diagnosis of STIs and resistance will allow a better patient management.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* MSM
* PrEP users
* Acceptance of study constraints
* With or without Social Security scheme or State Medical Aid
* Signature of consent form to participate in the study

Exclusion Criteria:

* Language barrier making questioning impossible.
Phase II Trial: uPAR-PET/CT for Prognostication in Head- and Neck Cancer

Head and neck cancer (HNC) is the 6th most common cancer worldwide. In the last decade, there has been made substantial improvements in diagnosis, staging and treatment of HNC. The overall survival has improved, but for some subgroups it is unchanged and therefore new prognostic and surveillance methods are warranted.

One of the hallmarks in cancer is the ability to invade the surrounding tissue and metastasize. Studies have shown that the urokinase proteolytic plasminogen activator (uPA) and its receptor (uPAR) are present at the very front of the invasive tumor and they are considered essential in cancer invasion and metastasis. Consequently, an uPAR-targeted tracer offers a very promising target for functional PET imaging and may be a stronger prognostic marker compared to routine FDG-PET/CT. We wish to clarify how uPAR-PET/CT correlate to patient outcome compared to routine FDG-PET/CT in patients with HNC in the pharynx, larynx and oral cavity, who are referred to curative intended radiotherapy. In this project all participants have an uPAR-PET/CT scan performed before initiation of the routine radiotherapy and the prognostic efficacy is determined by assessment of the recurrence rate and mortality at routine clinical follow-up.

In this study all included patients with head and neck cancer (HNC) have an uPAR-PET/CT scan performed before the initiation of the curative intended radiotherapy. After the radiotherapy treatment the patients attend the routine clinical follow-up programme at Rigshospitalet to follow the loco-regional control, signs of metastasis and the overall survival. These relapse- and survival parameters will be correlated to the SUVmax, SUVmean and the TNM stage obtained from the uPAR scan and will be compared to the findings on the routine FDG scan to clarify which tracer is the strongest prognostic marker in HNC.

If any previous tissue samples have been taken from the tumour before the patient enters the study the uPAR immunohistopathology of the tissue sample will be compared to the uPAR-PET/CT findings. We will not perform any biopsies or tissue samples in this study.

Eligibility Criteria:
Inclusion Criteria:The patient

* has a diagnosis of biopsy-verified cancer of the pharynx, larynx or oral cavity
* is referred to curative intended radiotherapy
* understands the given information and has given informed consent and
* age above 18 years.

Exclusion Criteria:

Pregnancy, lactation/breast feeding, age above 85 years, obesity (bodyweight above 140 kg), small cancers of the larynx (1A,1B), allergy to 68Ga-NOTA-AE105, metastasis on FDG-PET/CT, other previously known cancers, claustrophobia.

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DEXTENZA Compared to Topical Prednisolone in Patients Undergoing Bilateral LASIK Surgery

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral LASIK surgery.

This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to investigate the outcomes of patients undergoing bilateral LASIK surgery with the treatment of a dexamethasone intracanalicular insert compared to standard of care topical prednisolone. All eyes will receive treatment. Additionally, all eyes will receive topical moxifloxacin QID for 1 week.

Twenty patient eyes undergoing bilateral LASIK surgery will be randomized to receive either Dextenza (Group A) OR standard of care prednisolone acetate 1% QID for 1 week, BID for 1 week (Group B). The contralateral eye will receive treatment with either DEXTENZA or topical prednisolone as a comparator based on randomization of first eye to Group A or Group B. Post-operative evaluations will be performed on Day 1, Day 7, and Month 1 following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who is planned to undergo bilateral LASIK surgery.
* Refractive error between the 2 eyes of 2 Diopters or less
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Patients who choose to have monovision after LASIK
* Patients with corneal pathology that may interfere with LASIK outcomes
* Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
* Active infectious ocular or systemic disease.
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
* Patients with known hypersensitivity to Dexamethasone.
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
* Patients with a history of ocular inflammation or macular edema.
* Patients with allergy or inability to receive topical antibiotic.
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
* Patients with a corticosteroid implant (i.e. Ozurdex).
* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Ocular pain in either eye
* Proliferative diabetic retinopathy in either eye
* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
* Laser or incisional ocular surgery during the study period and 6 months prior in either eye
* History of cauterization of the punctum
2-HOBA: Multiple Dosing Study in Healthy Humans

The purpose of this study is to test how well people tolerate a new dietary ingredient called 2-HOBA and how it is metabolized in the body. 2-HOBA is a compound that occurs naturally in buckwheat seeds. This dietary ingredient has been used in animal studies, and single doses have been tolerated well when given to a small group of healthy people. In this study we will test how well people tolerate taking 2-HOBA over 2 weeks and how it is metabolized by the body.

Consenting healthy volunteers between 18 and 59 years old with no morbidity, including males, and females who are not pregnant will be recruited for the study. Eighteen volunteers will be studied with a reasonable sampling of ethnicities from the Nashville area, and an effort will be made to recruit equal numbers of males and females. The study will be conducted by the Vanderbilt Clinical Research Center (CRC).

Based upon single dose pharmacokinetics, two multiple dose regimens will be studied to determine the safety, accumulation kinetics, and pharmacodynamic effects of multiple daily doses administered over 2 weeks. A complete health history and physical examination will be conducted by a physician. An EKG, baseline blood and urine sample, and vital signs will be taken prior to supplement administration. A physician will oversee all clinical aspects of the study and will be responsible for all trial-related medical decisions. Additionally, DNA will be collected from the blood drawn and used to determine if there are any genetic differences in metabolism of 2-HOBA. Volunteers will be given 3 daily doses of either placebo or one of two levels of 2-HOBA to determine the safety, accumulation kinetics, and pharmacodynamic effects of the multiple dose administration over a 2 week period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals between 18 and 59 years old;
* Men and women who are not pregnant at the time of study; and
* Not taking any medication 2 weeks prior to or during the study.

Exclusion Criteria:

* Inability to give informed consent;
* Diseases that could manifest symptoms or signs that would confound interpretation of the relationship between 2-HOBA action and potential adverse effects;
* Diseases that could manifest morbidity;
* Known cardiac disease, kidney disease, or hepatic dysfunction;
* Need to discontinue any drug that is administered as standard of care treatment; and
* Unwillingness or inability to use approved birth-control methods.
Effective Feedback to Improve Primary Care Prescribing Safety

We hypothesise that feedback and feedback + psychology informed intervention delivered to primary care medical practices will reduce high-risk prescribing to patients compared to a simple educational intervention alone. The specific objectives are :

1. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified primary outcome of a composite measure of high-risk antipsychotic, non-steroidal anti-inflammatory drug, and antiplatelet drug prescribing
2. To test the effectiveness of the two EFIPPS feedback arms in reducing the specified secondary outcomes of the six individual measures constituting the composite
3. To assess the cost-effectiveness of the intervention

High risk prescribing is the use of drugs which carry significant risk to patients. Such prescribing is not always inappropriate but does require regular review to ensure that the balance of risk and benefit in individuals is appropriate. High risk prescribing is common and varies widely between practices, and there is evidence that intensive interventions (for example, pharmacist led medication review) can reduce rates of high risk prescribing. The aim of this study is to test whether a simpler and therefore cheaper feedback intervention can reduce high risk prescribing. The study is a three arm cluster randomised trial with primary care medical practices as the unit of randomisation and outcomes measured at patient level using routinely held prescribing for individual patients. The trial will compare two forms of feedback of practice rates of high risk prescribing with usual care. Usual care matches existing NHS working practice. The first active arm will receive quarterly feedback. The second active arm will receive the same feedback plus a health psychology informed intervention designed to promote response to feedback embedded in the feedback.

Eligibility Criteria:
Inclusion Criteria:

* General medical practices in NHS Ayrshire and Arran, NHS Lanarkshire and NHS Lothian

Exclusion Criteria:

* Practices with \<250 registered patients
* Practices with \<93% of scripts in the new PIS data warehouse having a unique patient identifier (the Community Health Index \[CHI\] number)
* Practices which were formed after 1st January 2011
* Practices which cease to exist during the trial
* Practices which merge during the trial, where the merging practices were originally in different arms of the trial