cyrilzakka/clinical-trials huggingface dataset:
Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

1. Knee pain in at least one knee for more than half the days in the month prior to screening
2. X-rays showing evidence of knee osteoarthritis by Kellgren and Lawrence Score two or three, with definite osteophytes and possible or definite joint space narrowing, consistent with mild to moderate knee osteoarthritis. If both knees are affected, patients would choose the more severe knee for outcomes assessments.
3. Willingness to maintain stable analgesic regimen throughout the study period

Exclusion Criteria:

1. Diagnosis of fibromyalgia
2. Presence of an underlying inflammatory disease in the affected knee, including Rheumatoid Arthritis, Psoriatic Arthritis, Gout, Pseudogout, or other inflammatory disease.
3. Patients who cannot give consent will be excluded, as will patients who cannot speak, read and understand English, as we will not have translated documents, consent forms, and surveys for them.
4. While this supplement is considered very safe and low risk, patients with underlying significant cytopenia (white blood cell count less than 4.0, hemoglobin less than 10, or platelets less than 100), or with impaired renal function (glomerular filtration rate less than 60) or elevated liver enzymes will be excluded as well.
BEing Safe in Treatment

Prior research has shown that many individuals with substance use disorders engage in HIV/sexual risk behaviors, and could strongly benefit from HIV prevention interventions that were delivered as part of their substance abuse treatment. However, discussions about sexual risk are not occurring at an appropriate frequency in treatment settings. This project will test the effects of counselor training and coaching, combined with a brief assessment and feedback tool, on counselor-patient communication about sex and on patient sexual risk behavior.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to substance use disorder treatment in the prior 45 days,
* Age 18 years or older
* Plan to remain in the local area for the next three months
* Assigned to a treatment counselor enrolled in the study.

Exclusion Criteria:

-
Ultrasound and Left Ventricular Systolic Function

The aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients intubated and ventilated.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients intubated and ventilated

Exclusion Criteria:

* Arrhythmia or variability of heart rate
* Technical impossibility to perform the ultrasound exam
* Known pregnancy or lactation
* Non-affiliation to a social security scheme (beneficiary or assignee)
* Patient under legal protection
* Patient refusal to participate
Bloodstram Infections in ICU. Single Centre Observational Study.

Hospital-acquired bloodstream infection (BSI) is serious care problem worldwide associated with significant morbidity and mortality. However, only few nationwide studies have focused on the incidence of BSI, and its results were often inconsistent.

The objective of this study was to analyze bloodstream infections in patients hospitalized in the intensive care unit of the tertiary, university hospital. Special attention was put on the etiology of the infections, the antimicrobial susceptibility/resistance of the isolated pathogens, as well as the incidence of central vein catheters infections in the analyzed population.

Data were collected in the intensive care unit of the Military Institute of Medicine, Warsaw, Poland, between January, 1, 2007 and December, 31, 2019.


Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalized in the ICU with clinically suspected infection.

Exclusion Criteria:

* none.
Effect of Fibromyalgia on Outcomes of Transforaminal Epidural Steroid Injection Treatment in Lumbar Radicular Pain

Lumbar radicular pain is defined as low back and leg pain caused by inflammation in the affected nerve root due to various etiological factors. In its treatment, there are various options such as anti-inflammatory drugs, physical therapy modalities, exercises, epidural steroid injections, and surgery. Epidural steroid injections have also become a frequently applied method in the treatment of lumbar radicular pain unresponsive to conservative treatments. The steroid applied here acts by suppressing the inflammation around the affected nerve root. Epidural steroid injections can be applied in lumbar radicular pain with 3 different approaches: caudal, interlaminar and transforaminal. In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term. As far as we know, there is no previous study investigating the effect of fibromyalgia on TFESE treatment outcomes. For this reason, the aim of our study is to examine the effect of fibromyalgia on treatment outcomes in patients who underwent TFESE for lumbar radicular pain.


Eligibility Criteria:
Inclusion Criteria:

* Findings of root compression on MRI, lumbar radicular pain for at least 3 months, no previous history of lumbar spinal surgery, pain score of 4 and above according to the numerical rating scale (NRS), and ACR 2016 diagnostic criteria for the fibromyalgia group were met. patients

Exclusion Criteria:

* Patients who received lumbar epidural steroid injection in the last 3 months, who have pregnancy-breastfeeding, bleeding diathesis, contrast hypersensitivity, and patients who did not give consent for participation in the study
French Observatory for Patients with Type 3 Glycogenosis

Glycogen storage disease type III (GSD-III) or Cori/Forbes disease, is caused by autosomal recessive mutations in the AGL gene, which codes for the glycogen debranching enzyme (GDE) involved in the release of glucose-1P from glycogen branches. Abnormal glycogen accumulation is responsible for frequent hypoglycaemia and symptoms in the liver and striated muscles (GSD-IIIa), although some patients present with liver involvement only (GSD-IIIb). In childhood, the phenotype is mainly characterised by hepatomegaly, short stature and hypoglycaemia, with minimal skeletal muscle involvement. While liver symptoms improve spontaneously around puberty, skeletal muscle weakness develops progressively in adulthood and becomes a major feature of GSD-IIIa.

Currently, there is no treatment other than dietary management tailored to the individual to limit glycogen storage and avoid hypoglycaemia.

The French GSD-III registry is a multicentre online registry dedicated to patients with type III glycogen storage disease followed in France. It has been approved by ethical and regulatory authorities. Its main inclusion criteria is the presence of a proven pathogenic AGL gene mutation and/or reduced glycogen debranching enzyme activity.

The aims of the registry are to provide a tool for recording detailed diagnostic, metabolic, neurological, cardiac and biological data on French patients with GSD-III, so as to enable i) a precise natural history of the disease, ii) identification of the outcome measures most sensitive to disease progression, iii) assessment of the frequency of the various complications of the disease and iv) identification of prognostic factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients with molecularly characterised Glycogen Storage Disease Type III

Exclusion Criteria:

* Patients diagnosed with GSD type 3 refusing to take part in the study
Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery

The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Are scheduled to undergo routine cataract surgery by the investigator's preferred technique.
* Have normal appearing, freely mobile, conjunctiva in the inferior temporal portion cul-de-sac site of the operative eye.

Exclusion Criteria:

* Have concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Have a history of ocular pemphigoid.
* Have ever had penetrating ocular surface surgery.
* Have had intraocular surgery within the past 3 months.
* Have ever had prior surgery or full penetrating trauma to the conjunctiva at the proposed surgical site.
* Have a planned cataract surgery in the contraleteral eye within 2 weeks of the study related surgical procedure and sample collection.
* Have a combined procedure planned (trabeculectomy surgery planned in the same eye as cataract extraction surgery).
* Have at the proposed conjunctiva biopsy site, signs of conjunctival shortening of the fornix, scarring or adherence to the underlying episclera.
* Have according to the investigator's judgment, risk of intra- or post-operative complications related to their cataract surgery as a consequence of participation in the study.
* Have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in AzaSite.
* Have had a known hypersensitivity to Vigamox or any fluoroquinolone antibiotics or to any of the ingredients in Vigamox.
* Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the ocular or systemic use of either azithromycin or moxifloxacin, when it is the same medication as the subject's assigned study drug. This relates as well, to the use of either of these medications as a pre-surgical prophylaxis.
* Are unable or unwilling to withhold for a minimum of 3 weeks prior to initiation of study drug, the use of erythromycin ointment or ofloxacin.
* Have any ocular pathology with the exception of cataracts that in the judgment of the investigator could confound study assessments or limit compliance.
* Have a serious systemic disease or uncontrolled medical condition or psychiatric condition that in the judgement of the investigator could confound study assessments or limit compliance.
Patient-Reported Outcomes HIV BItherapy

HIV Treatment simplification strategies that involve switching cART regimens from four or three antiretrovirals to two in virologically suppressed patients living with HIV are now available in order to reduce long-term toxicity and enhance treatment adherence. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with noticeable advantages, including a high genetic barrier to drug resistance, once-daily dosing and lower risk of drug-drug interactions because this agent does not inhibit or induce cytochrome P450 isoenzymes or P-glycoprotein transporters. Dolutegravir is generally well tolerated and the INSTI class is considered to be more "metabolically friendly" compared with other drug classes such as protease inhibitors (PIs). Thus, the combination of dolutegravir plus a second active agent is a particularly inviting option for maintenance treatment and research in this area is evolving. However, though safety and efficacy of dolutegravir are well known, there is no study evaluating patient-reported outcomes (PROs), i.e. subjective and self-reported measures of the patient's health perception. In an era of the efficacy of HIV regimens are more and more comparable, the main discriminant criteria to choose the best treatment option are now adherence and self-reported measures of a patient's health - termed "patient-reported outcomes" (PROs).

The study, based on a mixed methodology, include a qualitative part and a quantitative part. The qualitative study will explore patients' and health care professionals' perceptions, knowledge, and representations of triple or quadruple and dual therapies and detect the degree of agreement or disagreement between patients' and practitioners' perspectives. The quantitative study's main objective is to measure the Dovato regimen's impact on a patient's perception (Patient-Reported Outcomes - PRO) on acceptability, toxicity, preference, and Health-Related Quality of Life (HRQL). PRO are collected through self-administered questionnaires at D0 (when the patient switch treatment), M1 and M6.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected by HIV-1
* Patients who are prescribed the Dovato regimen by their clinicians in routine care
* Patients previously under the cART regimen with three or four antiretrovirals
* HIV-RNA \<=50 copies/mL for at least 3 months
* 18 years old and more
* Ability to understand and respond to questionnaires

Exclusion Criteria:

* Pregnant or breastfeeding women
* Known hypersensitivity to dolutegravir and lamivudine, their metabolites or formulation excipient
* Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to inclusion
* Any other clinical condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable to comply with protocol requirements.
* Active CDC Category C disease
* Treatment with radiation therapy, cytotoxic chemotherapeutic agents 30 days before inclusion
* Patient co-infected with HBV
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by Camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage III non-small cell lung cancer.

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided.
* Age 18-70 when signing the consent form, both male and female;
* The ECOG score is 0 or 1;
* Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）;
* Adequate hematological function, liver function and renal function;
* Female participants should not be pregnant or breast-feeding.

Exclusion Criteria:

* EGFR mutation or ALK mutation was positive;
* Previously received systemic anti-tumor therapy for non-small cell lung cancer;
* Subjects who have received chest radiotherapy in the past;
* Known human immunodeficiency virus (HIV) infection;
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
* Pregnancy or breast-feeding women;
* Ingredients mixed with small cell lung cancer patients.
Phase 1/2 Study of IMC-R117C in Selected Advanced Cancers

This phase 1/2 first-in-human study is designed to test the safety and efficacy of IMC-R117C (PIWIL1 × CD3 ImmTAC® Bispecific Protein) as a single agent and in combination with other therapies in HLA-A\*02:01-positive participants with selected advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* HLA-A\*02:01-positive
* Histologically confirmed advanced colorectal, esophageal, gastric, or ovarian carcinoma
* Archived or fresh tumor tissue sample that must be confirmed as adequate
* Evaluable/Measurable disease per RECIST 1.1
* Previously received applicable standard treatments
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control

Exclusion Criteria:

* Symptomatic or untreated central nervous system metastasis
* Recent bowel obstruction
* Ongoing ascites or effusion requiring recent drainages
* Significant ongoing toxicity from prior anticancer treatment
* Out-of-range laboratory values
* Clinically significant lung, heart, or autoimmune disease
* Ongoing requirement for immunosuppressive treatment
* Significant secondary malignancy
* Hypersensitivity to study drug or excipients
* Pregnant or lactating
Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System)

The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).

Secondary purposes are:

1. To determine the frequency of hypercoagulable phenotype in study population;
2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.


Eligibility Criteria:
Inclusion Criteria:

Cases :

* Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
* Any weight and height
* Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment

Controls:

* Patients with SLE and/or APL without thrombosis (venous or arterial)
* Any weight and height
* Possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations)

Exclusion Criteria:

Cases and Controls :

* Pregnancy
* Refusal of consent
* Difficulty of follow-up (not sufficient motivation)
Intubation Success Rate_Rigid Video Stylet Vs Video Laryngoscope

This study compare the intubation success rate between video laryngoscope and rigid video stylet in cervical spine surgery patients. Half of patients will receive endotracheal intubation by video laryngscope, other half of patients will receive endotracheal intubation by rigid video laryngoscope.

Video laryngoscope and lightwand are widely used at endotracheal intubation in cervical spine patients.

Video laryngoscope is useful because of identification of anatomic structure around the oral cavity and vocal cord.

Rigid video stylet resemble lightwand, but it has a video at the end of stylet. So rigid video stylet is useful at confirmation of vocal cord.

Eligibility Criteria:
Inclusion Criteria:

* 20\~80 years old adult patients, ASA class I-III
* Cervical spine surgery in general anesthesia

Exclusion Criteria:

* Patients who did not agree with the study
* History of GERD
* Congenital or acquired lesion like tumor, polyp, trauma, abcess, inflammation, foreign body
* Surgery of trachea or airway
* History of radiation around neck area
* Increased possibility of aspiration
* Coagulation abnormality
Evaluation of the Pupil Dilation Reflex in Response to Noxious Stimulation in Anaesthetized Children. A Proof of Concept Trial

After conduction a pilot study, pupillary dilation reflex (PDR) is measured in response to nociceptive stimulation perioperatively in infants, children and adolescents.

An infrared camera of the video pupillometer measures the pupillary dilation reflex (PDR) in response to incremental nociceptive stimuli. The PDR is a robust reflex, even in patients under general anesthesia, and may provide a potential evaluation of the autonomous nociceptive circuit. American Society of Anesthesiologists (ASA) classification I or II patients from the age of 28 days till 18 years undergoing elective surgery under general anesthesia are recruited. Enrolled patients perioperative undergo PDR measurement at 2 different standardized times (before and after opioid administration) generated by an inbuilt pupillary pain index (PPI) protocol. PPI, as a surrogate for nociception includes noxious stimulations from 10 up to 60 milli ampere (mA) until pupil dilation is larger than 13% from baseline diameter. Therefore, no inappropriate high stimulation is executed.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled abdominal, urological or otorhinolaryngology surgery under general anaesthesia
* ASA I-II

Exclusion Criteria:

* History of eye deformity, invasive ophthalmologic surgery
* Known cranial nerve(s) deficit
* Infection of the eye
* Predicted difficult airway management (Paediatric Difficult Airway Guidelines - Difficult Airway Society)
* Chronic opioid use (\>3 months)
* Ongoing treatment with beta-blockers, dopamine antagonists, topical atropine
* Preoperatively administrated benzodiazepins or antiemetics
Risk Factors for Recurrent Urinary Tract Infection in Children

The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.

It is known, that in the group of young children the most common reason of recurrent UTI is anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. However, not all recurrent UTI can be explained by anatomic abnormalities. The vast majority of school age children with recurrent UTI have anatomically normal urinary tract. Recent studies discuss about the role of behavioral and functional abnormalities (inadequate fluid intake, stool retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections. Influence of some these abnormalities for recurrent UTI is controversial. Family history, behavioral and functional abnormalities which predispose to urinary tract infections in children with normal urinary tract are neglected in most protocols of urinary tract infection.

Children in this study receive a careful evaluation including complete history, voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding cystourethrogram.

Follow up time - 1 year. Urinalysis once a month and during each episode of fever.

Eligibility Criteria:
Inclusion Criteria:

* 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital

Exclusion Criteria:

* urinary tract malformations
* neurogenic bladder dysfunction
* patients, who received immunosuppressive drugs
* pregnant girls
* children with non bacterial urinary tract infection