cyrilzakka/clinical-trials huggingface dataset:
Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

In this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20
* Patients of either sex with age between 18-65 years.
* Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle.
* Males who were willing to maintain contraception during and 3 months after completion/stopping of treatment.

Exclusion Criteria:

* Pregnant or lactating women.
* Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness.
* Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP \>1.5 times the upper limit of normal), viral hepatitis or cirrhosis.
* history of excessive alcohol consumption.
* Severe anemia, leucopenia or thrombocytopenia.
* Active infectious disease or immune system deficiency including AIDS.
* history of intolerance/hypersensitivity to methotrexate.
* history of phototherapy in past 6 months.
* Patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks.
* Body mass index (BMI) \> 30 kg/m2.
Five-year Mortality Rate in People With Diabetic Foot Ulcer

As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).

This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure.

Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.

But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010.

Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.

Eligibility Criteria:
Inclusion Criteria:

* type 1 or 2 diabetes
* consultation for new diabetic foot ulcer during the year 2010

Exclusion Criteria:

None
Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients

NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously in the follow-up of Locally Advanced Nasopharyngeal Carcinoma. Hence we establish this prospective cohort study.

Newly-diagnosed patients with stage III or IV non-metastatic Nasopharyngeal Carcinoma (AJCC 8th) will be recruited. All subjects receiving chemoradiotherapy will undergo a baseline integrated \[18F\]fluoro-2-deoxy-D-glucose (FDG) positron emission tomography/computed tomography (PET/CT) scan or traditional follow-up examination before the start of chemoradiotherapy.

NPC Patients receiving IMRT treatment will receive a dedicated FDG PET/CT and high-sensitivity PET/CT protocol simultaneously 12 weeks after the end of chemoradiotherapy (primary endpoint).

The results of FDG PET/CT and high-sensitivity PET/CT analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be informed of the investigational nature of this study and given written informed consent.
* Aged between 18-70, male/female.
* Staged III or IV (AJCC 8th) NPC patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, WHO II and III).
* Received induction chemotherapy and/or concurrent chemoradiotherapy. ECOG scale 0-1.
* Fertile women should practice contraception during the study period.
* HGB ≥90g/L ,WBC ≥4\*109/L , PLT ≥100\*109/L,
* With normal liver function test (ALT and AST ≤2.5\*ULN, TBil ≤2.0\*ULN)
* With normal renal function test (serum creatinine ≤1.5\*ULN)

Exclusion Criteria:

* Women in pregnancy or lactation
* Prior malignancy except adequately treated basal cell, squamous cell skin cancer, or cervical cancer in situ.
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
* Already involved in other clinical trial.
* Mental disorder, civil disability, limited capacity for civil conduct.
NEOZOL_Follow-up Study

Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France.

The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. In locally advanced breast cancer, a neo-adjuvant chemotherapy treatment is currently recommended as it may provide a sufficient tumour response to allow for conservative breast treatment.

Zoledronic acid (ZOL) is an N-biphosphonate used in the prevention of bone complications and in the treatment of hypercalcaemia In vitro and in vivo studies have shown an effect of ZOL on tumour and endothelial cells, supporting an anti-tumour activity of N-biphosphonates.

Between April 2010 and October 2013, 50 patients with locally advanced breast cancer were randomized in the NEOZOL study to receive neoadjuvant chemotherapy with (n=26) or without (n=24) zoledronic acid (ClinicalTrials.gov Identifier: NCT01367288). The primary objective of this study was to evaluate the effect of the addition of ZOMETA® to neoadjuvant chemotherapy on the change in serum VEGF concentration before and after neoadjuvant treatment (i.e. at the time of surgery).

Assessment of long-term survival was not planned in the NEOZOL study protocol. The objective of NEOZOL_FU study is to evaluate the survival of patients included in the NEOZOL study, 7 years after inclusion of the last patient.

This study will provide essential data on the long-term survival and risk of relapse of patients with locally advanced breast cancer who have received neo-adjuvant chemotherapy with or without zoledronic acid (ZOMETA®).


Eligibility Criteria:
Inclusion Criteria:

* Woman who signed a written consent, included and randomised in the main analysis of the NEOZOL study

Exclusion Criteria:

* Patient's opposition to the use of her data in this study
Remote Cognitive Assessment for Surgical Patients

This is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone.

This study is evaluating cognitive function in older adults that are undergoing surgery using remote assessments. Participants complete a battery of neuropsychological assessments prior to their surgery date. The battery includes smartphone adaptions of tests of thinking, memory, speech, and movement. The participant has a one-hour remote visit, where the investigators will conduct a Montreal Cognitive Assessment (MoCA) and have the participant complete the smartphone assessments. After their surgery, participants are evaluated on the delirium rating scale.

Eligibility Criteria:
Inclusion Criteria:

* Spine surgery with a duration greater than or equal to three hours
* Can speak, write, and understand English
* Ability to participate in remote visit

Exclusion Criteria:

* Participating in other cognitive studies
* Having more than one surgery (planned multiday surgery)
* Emergency surgery
An Epidemiological Study on Winter Sports Injury in Chinese Population

The aims of the study are to describe the injury patterns among recreational skiers and snowboarders in China and to provide primary data to guide the reconstruction of regional healthcare facilities to deal with the increasing number of participants in snow sports.

A retrospective study was performed in Ski Resorts in Chongli, China. 5000-10000 injured skiers and snowboarders will be recruited. Data of all injury patients in the resort clinic will be collected. Patients' information, including sex, age, equipment, skill level and injured body part, will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Skiing and snowboarding injuries

Exclusion Criteria:

* Skiing and snowboarding visitors without injuries
Psychology of Crohn's Disease

The purpose of this study is to determine whether emotional processing and somatic dissociation influence IBS-like symptoms in Crohn's Disease patients.


Eligibility Criteria:
Inclusion Criteria:

* Age of 19 or greater
* Outpatient with diagnosis of Crohn's disease
Vein of Galen Aneurysm

1. Foundations of the clinical research project:

   Vein of Galen vascular malformations are a group of rare cerebral vascular malformations with complex anatomy and severe clinical consequences. The pathology consists of direct communications between small intracerebral arteries and veins without the presence of capillaries. The result is a vascular malformation with low resistance and high flow, a lesion that will evolve during fetal development into aneurysmal dilatation.

   These lesions evolve towards rupture, but due to the high flow rate through these malformations, children very quickly develop cardiac decompensation (high-output failure). Treatment must be rapid, often on the first day of life. The technique currently used is iterative embolization. General anaesthesia is required for this procedure. However, neonatal anesthesia in children with cardiac decompensation and pulmonary hypertension poses major challenges for the anesthesia team. A high percentage of these patients require a short stabilization period with management of cardiac decompensation and pulmonary hypertension, most often by continuous milrinone infusion.

   Hôpital Erasme is a reference center for the management of vein of Galen malformations. In this work, we propose to analyze all cases of children with veins of Galen malformations managed by the interventional neuroradiology department.
2. Objectives of the clinical research project:

   2.1 Main objective:

   Description of cerebral lesions as described by angiography. Details of anesthetic management with all anesthetic drugs, details of cardiac management. Details of ventilatory management, intubation duration required.

   Description of embolization outcome. Description of the neurological and cardiac outcome.

   2.2 Secondary objectives:

   Possibly, depending on the number of patients, attempt to identify factors predictive of poor outcome.
3. Methodology of the clinical research project:

   We will carry out a retrospective analysis of the records of all patients who have been managed at Erasme for vein of Galen-type malformation. Activity began ± in 2011, and we will produce a listing of all patients from 2010 to August 2024. From this listing, obtained by the radiology department, we will collect data from the patients computer files.
4. Design of the clinical research project:

   This is a retrospective study based on file analysis.
5. Participants:

All patients treated at Erasme for a vein of Galen malformation. We will check the file to ensure that the parents have not expressed any opposition to the use of the patient medical data.


Eligibility Criteria:
Inclusion Criteria:

- All patients treated at Erasme for a vein of Galen malformation

Exclusion Criteria:

- Opposition of parents to the use of medical data
Prognostic Value of Sympathetic Modulation in Patients With Heart Failure

The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with systolic heart failure and New York Heart Association (NYHA)
* Ischemic, hypertensive, or idiopathic etiology
* Left ventricular ejection fraction less than 40%

Exclusion Criteria:

* Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases
* Renal failure
* Diabetes mellitus type II
The Relationship Between CMV* Reactivation and Anti-cytokine Treatment in Critical COVID-19 Patients

The risk of secondary infection is high in critical patients hospitalized with the diagnosis of COVID-19. Immunosuppressive treatments are commonly used in critical COVID-19 patients, and immune dysfunction and CMV reactivation can be unnoticed in these patients.

The records of critical patients were reviewed retrospectively. Whether these patients used tocilizumab and/or anakinra and their relationship with CMV reactivation were examined. Furthermore, the relationship between CMV reactivation and mortality and anti-cytokine treatment in patients was also examined. A total of 167 critical COVID-19 patients were included in the study, of which 38 (22.7%) were found to be CMV DNA positive. CMV positivity in patients treated with anti-cytokines (31.11%) was found to be significantly higher than in patients who were not treated with it (16.88%) (p:0.033). There was no significant difference in viral load levels (p:0.513). Furthermore, it was determined that anti-cytokine treatment significantly decreased mortality (p: 0.003) and that there was no significant relationship between CMV reactivation and mortality (p: 0.399). Even though CMV reactivation was high in critical COVID-19 patients who received anti-cytokine treatment, positive developments in morbidity and mortality were observed with early diagnosis and effective treatment.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients over the age of 18 diagnosed with COVID-19 and patients followed in the intensive care unit.

Exclusion Criteria:

* Patients under the age of 18 with a mild/moderate course of COVID-19,
* CMV PCR positive before anti-cytokine treatment,
* patients who underwent hematopoietic stem cell transplantation
Clinical and Pathophysiological Description of Ocular Ischemic Syndrome

The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.

The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Ocular ischemic syndrome

Exclusion Criteria:

* Any other active ocular disease
New Markers of Glycation to Predict Gestational Diabetes Mellitus and Macrosomia.

Gestational diabetes mellitus (GDM) increases the risk of macrosomia and other adverse pregnancy outcomes. Screening strategies are debated: universal vs. selective, and macrosomia may begin before the time of screening, suggesting that glycation markers may have an interest. The objective of this trail is to compare novel markers: skin autofluorescence and glycated albumin, to HbA1c (reference) as predictors of GDM, macrosomia and other adverse outcomes, in pregnant women.


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18 years
2. Singleton pregnancy (or twin pregnancy reduced spontaneously or medically before 14 weeks of amenorrhea)
3. Gestational age at inclusion \<28 weeks of amenorrhea
4. Participant affiliated with or beneficiary of a social security scheme
5. Collection of patient consent.

Exclusion criteria:

1. Gestational age at inclusion ≥ 28 weeks of amenorrhea
2. Multiple pregnancy
3. Known diabetes prior to pregnancy
4. History of bariatric surgery
5. Expected delivery in another maternity unit not participating in the study
6. Person deprived of liberty by judicial or administrative decision
7. Guardianship or curatorship
8. Participant not affiliated or not benefiting from a social security scheme.
Paperless Parotograph in Evaluation of Labour

Using Paperless partograph management of labour as simple tool to prevent obstructed labour or prolonged labour or its complications at the mother or her fetus

WHO PARTOGRAPH is very work load need more time and more stuff in both treaning and learning for plotting and for drowning but inside labour room needing simple partograph playing the simple partograph beast role in management of labour and stand test against time for saving live of labour women and her child Paperless parotograph can help obestitricianes to talk decision about when to transferr the labourus women to higher centers on to make medical intervention or what time to end labour by caesarian section

Eligibility Criteria:
Inclusion Criteria:

* women ln active phase of labour
* With single pregnanncy
* living fetus
* cephalic presentation
* occipt anterior
* 36 weak gestional age up to full term

Exclusion Criteria:

* preterm . .or women with antipartum hemorrhage .
* or multipregnanncy
* previous utrine surgery
* or abnormal cardiotocograph(CTG )PATTERN
* or any heart disease of mother or his fetus
Expressive Writing Intervention Study

This study aims to test to what extent an expressive writing intervention may reduce internalized anti-TNB (trans and nonbinary) stigma and promote well-being over time. Trans and/or nonbinary people may take part in this study, and can expect to participate for 3 months.

This study aims to decrease internalized transnegativity and to promote positive and affirming thoughts and emotions related to being transgender/nonbinary through a novel four-day expressive writing intervention. Participants will be trans/nonbinary English-speaking adults (18+) who reside in the US. They will be randomized to one of three study conditions (control, affirming identity, affirming identity + strengthening social connection) and will be enrolled in the study for period of 3 months (baseline, four day intervention, Days 7, 30, and 90 follow up).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* transgender or nonbinary
* access to a phone, computer, and/or device from which they can access the surveys and daily writing session tasks
* ability to read and write English

Exclusion Criteria:

* cisgender individuals
* self-reported severe levels of psychological distress
A Machine Learning Approach for Inferring Alcohol Intoxication Levels From Gait Data

This study aims to develop a phone app to assess gait differences at different levels of alcohol intoxication.

250 adult volunteers who will each participate in a single laboratory-based visit. At the orientation, each participant will provide informed consent, be weighed, and undergo a medical history to confirm eligibility. A urine drug quick-screen will be given. Female participants will take a urine pregnancy test. Baseline questionnaires will be administered. After giving participants the phone on which the AlcoGait 2.0 app is installed, baseline assessment of gait will be performed with the participant walking a distance of 50 yards ten times.

Drinking will then commence. The total amount will be consumed over 30 minutes. Participants will have their BrAC assessed multiple times during and after drinking has commenced and finished. At BrAC levels of .02, .04, .06 and .08 g%, will perform the gait task. After the last gait task, participant data will be transmitted to a secure server. Participants will receive a meal, and will be escorted to a sitting area with a DVR and videos, and allowed to use their own electronic devices. Their BrAC will be periodically tested until it reaches .02 g% or below, then a taxi will be called to take them home.

Eligibility Criteria:
Inclusion Criteria:

* ages 21-65
* drinking at least 5 drinks per occasion for men (4 for women) during a single drinking episode at least once in the last month to ensure, for safety reasons, that people are accustomed to consuming alcohol in amounts comparable to what we will administer
* willingness to drink beer (since only beer will be provided in the session to standardize drinks more easily).

Exclusion Criteria:

* past 6 months or current treatment for alcohol or drug abuse by self-report (for ethical reasons)
* Score \> 5 on (the short version of the Michigan Alcohol Screening Test \[SMAST\]48) given during the screening interview
* positive family history of alcohol use disorder
* weight ≥ 230 lbs (to prevent excessive volume of beverage)
* current use of medications that are contraindicated for alcohol
* a health condition that contraindicates alcohol (e.g. peptic ulcer disease)
* a health condition that affects ability to walk
* if female, pregnant or nursing
* use of recreational drugs (e.g., marijuana, opioids, stimulants, benzodiazepines) within the last week (self-report plus urine screening cup)
* persons who report alcohol-induced flushing, an untoward reaction that is often accompanied by headache, nausea and other symptoms
SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapy

The goal of this single blind placebo-controlled intervention study is to examine the impact of a supervised training program on disease-related quality of life and physical fitness in patient with advanced prostate cancer compared to usual care. The main question\[s\] it aims to answer are:

* What is the impact of exercise on quality of life
* What is the impact of exercise on physical fitness

Participants will have an individual training program with supervised training by physiotherapists.

Researchers will compare with usual care to see if advice about exercise has significant less effect than an supervised training program.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \> 18 years old
* Able to read and complete questionnaires in Dutch
* Proven histologically and /or radiologically metastatic prostate cancer (TxNxM1)

Exclusion Criteria:

* Other cancers
* Clinicians' judgement
* Age \>80 years old or not able to walk 400m
* Structural exercise (moderate-intensity exercise more than 150 minutes a week) during the past 3 months
* Musculoskeletal, cardiovascular, or neurological disorders that could inhibit them from exercising
* Spinal cord compression, history of pathological fractures