cyrilzakka/clinical-trials huggingface dataset:
Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

The purpose of this study was to use machine learning to explore a more precise classification of NAFLD subgroups towards informing individualized therapy.

Clinical characteristics of NAFLD are heterogenous, but current classification for diagnosis is simply based on pathological examination. The conventional pathological classification is insufficient to reflect the complexity and heterogeneity of NAFLD and can not predict the prognosis. Towards precision treatment, a more refined metabolic classification of NAFLD phenotypes is highly demanded for a personalized diagnosis, aiming to identify patients at elevated risk of cardiovascular disease or cirrhosis. This kind of refined classification can provide a more precise diagnosis and enable more individualized preventive interventions and early treatments. In a cross-sectional cohort, unsupervised machine learning was used to cluster patients with biopsy-proved NAFLD from Drum Tower Hospital Affiliated to Nanjing University Medical School based on clinical variables. Verification of the clustering was performed in a longitudinal cohort.

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proved NALD cohort:

  1. age 18 to 75 years
  2. receiving liver biopsy at the time of metabolic surgery
  3. relatively complete clinical information, including physical examination, biochemical and haematological assessments
* longitudinal cohort

  1. age 18 to 75 years
  2. receiving abdominal imaging examinations,
  3. relatively complete clinical information, including physical examination, biochemical and haematological assessments (4）follow-up time at least more than 12 months

Exclusion Criteria:

* (1)consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females) •
* (2) with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.


Eligibility Criteria:
Inclusion Criteria:

* healthy children

Exclusion Criteria:

-
Developing an Opioid Taper Intervention Before Total Joint Arthroplasty

The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:

* Is the intervention feasible and acceptable to patients?
* Does the intervention result in a decrease in opioid dose during the preoperative period?

Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.


Eligibility Criteria:
Inclusion Criteria:

* decided to pursue primary, unilateral total knee or hip arthroplasty with planned surgery date in 4-8 weeks
* currently taking between 20 and 90 MME of oral opioids, and that dose has been stable for at least 3 months
* have a reliable telephone number for contact
* speaks English

Exclusion Criteria:

* Taking opioid medications that include:

  * Buprenorphine
  * Methadone
  * Long-acting formulations of opioid pain medications (e.g., extended-release oxycodone and extended-release morphine)
  * Transdermal formations of opioid pain medications (e.g., fentanyl patches)
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D

The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from "real-world" use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.

Eligibility Criteria:
Inclusion Criteria:

* Patient is age ≥18 and ≤85 years at date of consent.
* Patient has provided written informed consent for participation in the study prior to index procedure.
* Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D stent in accordance with the approved CE Mark indication and Instructions for Use (IFU)

Exclusion Criteria:

* Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system.
* Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis, severe hypertension or renal failure.
* Patients with known hypersensitivity to nickel-titanium.
* Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months.
* Patient is pregnant or breastfeeding.
* Patient is unable or is unwilling to comply with site standard of care procedures and follow-up visit schedules for patients undergoing femoropopliteal intervention.
Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia

It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.

There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=\>Th4) sensor block.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age 36 - 40 weeks
* Singleton pregnancies
* Elective caesarean section

Exclusion Criteria:

* Gestational age \<= 35 weeks
* Twins pregnancies
* Disease the cardiovascular system (hypertension, etc.)
* Non-elective caesarean section
Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain

Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection.

A web-based survey to the members of the Colorectal Chapter of 10 Spanish Associations of surgical nurses and surgeons of different specialities. A link to the web page containing the survey will be disseminated via email, newsletter and Twitter.

A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.

The survey aim to assess knowledge, beliefs, and practices of attending nurses and surgeons on preventative measures. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group.

The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using an specific program. The results will be analysed using the chi-square test with statistical significance defined as p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Nurses and surgeons pertaining to invited societies

Exclusion Criteria:

* None
DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour.

All first-time mothers in Sweden are offered parental support, but local conditions mean that not everyone gets the opportunity to take part in this. Studies show that there is a lack of evidence-based guidelines for the design of parental support in maternal health care. Early labour or latent phase of labour is the part of childbirth were women often feel insecure, in stress and left out from care. First-time mothers who have no experience of one labour before are particularly vulnerable. Many women today use digital applications during pregnancy and in connection with childbirth. There are several digital applications that will help the woman by guiding her and her partner in different decisions about labour, but it is necessary to offer evidence-based, credible electronic and digital solutions for expectant parents. A meta-synthesis from 2018 showed that women use the internet often and the information they receive there has a great influence on their different choices in connection with childbirth. Volume, accessibility, and convenience about digital solutions play a crucial role for women and partners. The digital application Contraction Coper is designed and tested by the company Birth By Heart © in order to facilitate in early labour for the pregnant woman and her partner. The overall purpose of the project is to evaluate whether the application Contraction Coper can contribute to reduced anxiety and stress during pregnancy and childbirth and whether an additional support from a midwife can increase the application use and satisfaction of women when using the application.

A randomized controlled trial is planned where first-time mothers after pregnancy week 25 are invited to participation via social platforms. Participating first-time mothers are randomly assigned to one of three groups; experiment group one, which gets access to the application Contraction Coper, experiment group two Contraction Coper Plus which gets access to both the application and support of midwives, so-called "blended" care, or three, the control group offered customary maternity care only.

Data collection is conducted using questionnaires, mobile application and activity bracelet.

The primary outcome is emotional stress in early labour measured with the dimension "Emotional Distress" in the questionnaire Early Labour Experience Questionnaire (ELEQ) Secondary outcomes are Fear of Birth Scale(FOBS), Childbirth Experience Questionnaire (CEQ), used pain relief methods during labour and birth, mode of birth, amount of time used in the application as well as heart rate, sleep and activity for the experimental groups that had activity bracelets in addition.

Eligibility Criteria:
Inclusion Criteria:

* First time mothers
* From pregnancy week 25.
* Swedish or English spoken.
* Having a Smartphone, Android or Apple application.

Exclusion Criteria:

°Multiparas.
Premedication for ERCP With Midazolam or Tramadol

OBJECTIVE:Purpose of this study is to set forth the sedative efficacy and effects on early period cognitive functions of two premedication drugs used for ERCP (Endoscopic retrograde cholangiopancreatography) METHODS:This randomized and double blind study was performed with forty (18-70 of age) ASA I-III risk group patients for who elective ERCP was planned. Cognitive functions of patients were determined by mini-mental test (MMT). 0.5 mg/kg midazolam or 1mg/kg tramadol drop was administered orally before intervention to patients who were randomly divided into two premedication groups.

Vital signs,BIS (Bispectral index), mRSS (modified Ramsay Sedation scale), NRS (numeric rating scale ) was evaluated. If MMT (mini-mental test) was ≤ 23 at 60th minute it was considered as cognitive impairment. Recovery period, post-procedure state of cognitive function at 60th minute were recorded.

The Outcome Measures are number of Participants with Adverse Events, and the incidence of Postoperative cognitive dysfunction assessed by MMT (mini-mental test) in first 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* This study was conducted in the Endoscopy Department for forty (18-70 years old) outpatients in ASA I-III risk group were randomized and double blind planned for elective ERCP.

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) class greater than 3,
* morbid obesity,
* major organ dysfunction (respiratory, renal and hepatic),
* history of drug addiction,
* known hypersensitivity for tramadol, midazolam and remifentanil,
* mini-mental test (MMT) ≤ 23 or
* refusal of the patient.
Safety and Efficacy of Two Oral Tinidazole Regimens for Refractory Trichomonas Vaginitis

We compare two oral tinidazole regimens for refractory trichomonas vaginitis.

Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.

Eligibility Criteria:
Inclusion Criteria:

* Women be at least 18 years of age
* Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)

Exclusion Criteria:

* Allergy to metronidazole or tinidazol
* Pregnant or nursing
* HIV or other chronic disease
Biomarkers of LONG COVID (LONG COVID_LCM)

This observational prospective study is aimed to investigate noncoding RNAs (ncRNAs) such as microRNAs (miRNAs) and long noncoding RNAs (lncRNAs) as potential peripheral blood biomarkers of severity and poor prognosis in COVID-19 patients. Patients with intermittent or permanent symptoms after COVID-19 at the moment of the recruitment were considered affected by LONG COVID disease. In particular, the aim is to clarify if COVID-19 biomarkers remain deregulated similarly in LONG COVID patients. To this purpose, plasma and peripheral blood mononuclear cells (PBMCs) will be collected and patients will be compared to individuals who have never been affected by COVID-19 or asymptomatic LONG COVID patients.

The investigators will collect plasma and PBMCs from consenting subjects. The investigators will evaluate the expression of miRNAs, lncRNAs and cytokines in patients affected by LONG COVID admitted to IRCCS Policlinico San Donato during the acute phase of COVID-19. In particular, miRNAs will be evaluated in plasma samples while lncRNAs in PBMC samples to clarify their potential as biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Previous COVID-19 infection

Exclusion Criteria:

-
Deep Learning Model to Predict the Recurrence of Stage IA Invasive Lung Adenocarcinoma After Sub-lobar Resection

This study aims to develop a deep learning model based on noncontrast CT images to predict the recurrence risk of stage IA invasive lung adenocarcinoma after sub-lobar resection，which can serve as potential tool to assist thoracic surgeons in making optimal treatment decisions.The study will use existing CT data to train and validate the model, without requiring any additional intervention for the participants.

This study is designed to develop a deep learning model to predict the recurrence risk of stage IA invasive lung adenocarcinoma after sub-lobar resection using noncontrast CT images. The best indications for sub-lobar resection in patients with early-stage LADC are still debated, making surgical method selection somewhat difficult. The deep learning model can noninvasively and objectively predict the recurrence risk of patients with stage IA ILADC following sub-lobectomy and are helpful in predicting prognosis of patients with stage IA ILADC after sub-lobectomy and can facilitate the choosing of the optimal surgery mode of these patients.

The study will utilize retrospective data from patients with stage IA invasive lung adenocarcinoma after sub-lobar resection . Noncontrast CT images will be collected at admission and used as inputs for the deep learning model. The model will be trained using convolutional neural networks (CNN) to identify patterns associated with recurrence.

In addition to model development, the study will also evaluate the model's performance on a separate validation cohort to assess generalizability. Statistical analyses will include performance metrics such as area under the receiver operating characteristic (ROC) curve (AUC) and precision-recall curve.

This study aims to provide a valuable tool for clinicians to make timely decisions in choosing the optimal therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:(i) pathological confirmation of LADC; (ii) undergoing sub-lobar resection (wedge resection or segmentectomy); (iii) CT scanning prior to surgery; (iv) pathological staging of IA; and (v) complete clinical and follow-up data.

-

Exclusion Criteria:(i) multiple primary LADC; and (ii) other pulmonary lesions that might interfere with the morphological assessment of tumors.

-
Nitropaste in Breast Reduction

The purpose of this study is evaluate the effect of Nitroglycerin paste on wound healing and scarring. Previous research has shown that Nitroglycerin paste can improve the blood flow to a wound, which may be associated with better wound healing, and ultimately, better scarring.

This will be a single-center, patient-blinded, (breast) randomized trial utilizing nitroglycerin paste on their breast reduction scar. The study team aims to randomize 100 patients, or 200 breasts. Each patient will receive treatment, but the breast that received treatment will be random. This will allow for a control breast to compare to. Patients will be followed for 12 months postoperatively to observe wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are female and transmen
* Undergoing bilateral breast reduction via Mount Sinai Plastic Surgery Clinic
* Reduction must be performed via Wise incisional pattern

Exclusion Criteria:

* Patients who are male or transwomen
* Patients who are under 18 years of age
The Predictive Biomarkers in Patients With Locally Advanced Non-small Cell Lung Cancer

This study is a prospective cohort study to evaluate the peripheral blood lymphocyte subsets as predicative biomarkers reflecting the efficacy and toxicity in patients with locally advanced non-small cell lung cancer (NSCLC) received chemoradiotherapy (CRT) with or without immune checkpoint inhibitors (ICIs).

All patients had a pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system and received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy. The peripheral blood samples at various time points including before radiation, 4 weeks after beginning of radiation, the end of radiation, 1 month post radiation, and 1 month post consolidation immunotherapy were collected for lymphocyte subsets detection.

The subjects will be divided into two groups according to whether patients received ICIs, namely, NSCLC patients received CRT plus ICIs and NSCLC patients received CRT.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years; ECOG score 0-2.
2. Pathologically confirmed locally advanced NSCLC according to the 8th AJCC staging system.
3. Received definitive radiotherapy, concurrently or sequentially combined with platinum-based doublet chemotherapy.
4. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.

Exclusion Criteria:

1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement.
2. Patients with other active malignancies within 5 years or at the same time.
3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome).
4. History of allogeneic organ transplantation.
5. History of active primary immunodeficiency.
6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness.
7. Women of child-bearing potential who are pregnant or breastfeeding.
8. The investigator judged other situations not suitable for inclusion in this study.
Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study

The purpose of this pilot study is to compare the dynamic response of microcirculation in the skin on the bottom of the big toe after applying controlled plantar stress in 25 diabetic subjects with a history of foot ulcer and 25 age-matched healthy controls to better understand the role of local hypoxia in neuropathic foot ulceration in subjects with diabetes.

The investigators hypothesize that if they apply a gait simulating load to the plantar foot and measure microvascular function, diabetic individuals will demonstrate an increased delay in reestablishing microvascular flow compared to healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* between ages 40 and 75
* history of diabetic neuropathic plantar ulcer (test subjects)
* no history of diabetes (control subjects)
* no peripheral sensory neuropathy (control subjects)

Exclusion Criteria:

* amputation or surgery on right Great Toe