cyrilzakka/clinical-trials huggingface dataset:
Anxiety Depression and Rheumatoid Arthritis

Anxiety and depression are highly prevalent in people with rheumatoid arthritis (RA).This study is to investigate the effect of anxiety and depression on treatment response in people with RA using observational longitudinal study design.


Eligibility Criteria:
Inclusion Criteria:

* People diagnosed with rheumatoid arthritis according to the American College Rheumatology (ACR) criteria 2010

Exclusion Criteria:

* none
the Effect of Hyaluronic Acid on a Prefabricated CAD-CAM Bone Blocks for Ridge Augmentation

Each patient will receive 2 prefabricated CAD-CAM allogeneic bone blocks sterilized with gamma rays with different rehydration methods.

Side I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid \* Side II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution Both blocks are fixed with osteosynthesis screws, covered with non resorbable membranes\*\* The membranes will be removed after 6 months, dental implants will be placed and core biopsy will be collected from the site of the implant placement for histologic evaluation

10 patients will be included in this study with bilateral atrophic posterior mandible for split mouth research

. group I: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using hyaluronic acid group II: prefabricated CAD-CAM allogeneic bone block sterilized with gamma rays hydrated using saline solution under LA mucoperiosteal flap will be elevated to expose the atrophic ridge then the prefabricated CAD-CAM allogenic block either mixed with hyaluronic acid (group I) or saline (group II) will be fixed in its position with titanium miniscrews , The block was coated with a nonporous d-PTFE membrane then closure of flap with nylon second stage: 6 months later exposure of alveolar ridge core biopsy was taken for histological study then insertion of titanium implants.

the aim of the study is to investigate the effect of hyaluronic acid on a prefabricated CAD- CAM bone blocks for ridge augmentation radiographically and histologically.

Eligibility Criteria:
Inclusion criteria:

* Patients between 40 to 65 years old.
* Posterior atrophic mandibular ridge indicated for horizontal and vertical ridge augmentation for dental implant placement.
* Good oral hygiene

Exclusion Criteria:

* Systemic diseases that affect host healing responses.
* Heavy smoking.
* Poor oral hygiene.
* Traumatic occlusion, sever para-functional habits (ex. bruxism, clenching,)
Erasme Randomized Controlled Trial Surveys Hemodynamic Excursions During Esophagectomy

In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Adult, Capable of giving consent, two or three incisions esophagectomy (thoracoscopic/ thoracotomy) no laparotomy

Exclusion Criteria:

* patient refusal, total language barrier, coagulation disorders, thrombocytopenia \<75 000, contraindications to locoregional anesthesia (infection local site, allergy to local anesthesic), scoliosis Cobb \> 45%, atrial fibrillation, end stage renal disease),
Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)

This study will be a multicenter, randomized, double-blind, placebo-controlled study with a blinded Main Treatment Period (MT) and an Open Label Period (OLE) to evaluate the efficacy, safety, and tolerability of IMU-838 in adult patients with RMS.

The study will consist of the following periods:

Screening Period: Approximately 28 days Main Treatment Period: 72 weeks (approximately 15 months) Open Label Extension Period: Up to approximately 8 years

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient (age ≥18 to ≤55 years).
* Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
* Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014.
* Active disease as defined by Lublin 2014 evidenced prior to Screening by:

  1. At least 2 relapses in the last 24 months before randomization, or
  2. At least 1 relapse in the last 12 months before randomization, or
  3. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
* Willingness and ability to comply with the protocol.
* Written informed consent given prior to any study-related procedure.

Exclusion Criteria:

* Patients with non-active secondary progressive MS and primary progressive MS.
* Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
* Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis
* Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease)
* Use of experimental/investigational drug (with the exception of COVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening
* Previous or current use of MS treatments lifelong, or within a pre-specified time period.
* Use of the pre-specified concomitant medications.
* Clinically significantly abnormal and pre-specified lab values.
* History of chronic systemic infections within 6 months before the date of informed consent.
* Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study.
* Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis.
* History or clinical diagnosis of gout.
* History or presence of any major medical or psychiatric illness
* Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes
A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Unresectable metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
* ECOG performance status of 0 or 1
* The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges
* Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
* Able to sufficiently understand the clinical study and give written informed consent

Exclusion Criteria:

* Prior treatment history with nerve toxic chemotherapeutic agent
* Peripheral neuropathy or central nervous system damage
* Psychiatric disorder
* History of major hemorrhage
* High risk of hemorrhage
* History of other malignancies
* Active ulcer
* Patients using anti-coagulants and fibrinolytic drugs
* Active Hepatitis B, or known HBs antigen positive
* Prior treatment history with thrombomodulin alfa
* Administration of another investigational medicinal product within 30 days prior to randomization
* Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
* Patients otherwise deemed as inappropriate to participate in the study by the Investigator
Endogenous Endophthalmitis in the Inpatient Setting

The purpose of this study is to determine the rate of endogenous endophthalmitis in patients admitted to Stanford Hospital with a systemic infection and positive blood cultures, as this may improve the clinical care of this population of patients.

Some patients admitted to the hospital have blood-borne infections. Occasionally, these blood infections can end up inside the eye and cause an infection inside the eye (called endogenous endophthalmitis).

Prior to modern and rapid treatment of systemic infections, the rate of endogenous endophthalmitis was reported to be 37% in 1982. By 1997, the rate was reported to be 2.8%. This study aims to determine the rate of endogenous endophthalmitis at Stanford Hospital in the modern medical era in that our rates may be different as those reported in the literature. This potential difference may be a reflection of treatment protocols and antibiotics currently in use at Stanford Hospital.

Eligibility Criteria:
Inclusion Criteria:All patients admitted to Stanford Hospital that have a systemic blood-borne infection and on which an Ophthalmology consult to rule out endogenous endophthalmitis is performed will be included in the study. Exclusion Criteria:None
Prospective Collection of Female and Male Specimens for PANTHER® System Testing

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs and male first-catch urine and urethral swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® System


Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had intercourse within the past 12 months)
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an institutional review board (IRB)-approved waiver for parental consent for minors)

In addition, the subject must meet at least one of the following criteria:

* The subject reports symptoms consistent with a suspected STI such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
* Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
* Subject is asymptomatic and undergoing screening evaluation for possible STIs
* Subject (female) is asymptomatic and undergoing a routine examination with a pelvic examination

Exclusion Criteria:

* A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:
* The subject took antibiotic medications within the last 21 days
* Subject already participated in this study
* Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy

This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a sciatic nerve block (in popliteal fossa).

A total of 10 subjects will be enrolled in each of the 4 cohorts.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male or female volunteers ages 18 or older
2. American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
3. Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
4. Body Mass Index ≥18 and ≤40 kg/m2

Exclusion Criteria:

1. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (eg, amide-type local anesthetics, opioids, bupivacaine, NSAIDs)
2. Documented history of long-term diabetes or severe peripheral vascular disease
3. Renal (serum creatinine level \>2mg/dL \[176.8 μmol/L\]) or hepatic dysfunction (serum alanine or aspartame transferase \> 3 times the upper limit of normal).
4. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post dosing period for pain and which, in the investigator's opinion may confound the post dosing assessments
5. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
6. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
7. Previous participation in an EXPAREL study
8. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance
9. Currently pregnant, nursing, or planning to become pregnant during the study
10. Clinically significant medical disease that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other conditions that would constitute a contraindication to participation in the study
11. Currently on neuroleptic agent \[e.g., gabapentin, pregabalin (Lyrica), duloxetine (Cymbalta) etc.\]
12. Inadequate sensory function on the foot (monofilament test)
13. Chronic opioid use in the last 30 days (≥30 morphine equivalents/ day)

    In addition, the subject may be withdrawn from the study if the subject meets the following criterion during or post-surgery:
14. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that, in the opinion of the investigator, renders the subject medically unstable or complicates the subject's post-operative course
Study of Pantoprazole for Sleepiness Associated With Acid Reflux and Sleep Apnea

The purpose of this study is to determine if using Pantoprazole decreases your daytime sleepiness and improves your reaction time when compared to using a placebo (sugar pill).

Half of the patients enrolled in the study will begin the study taking Pantoprazole. The other half will begin the study taking a placebo (sugar pill). There is an equal chance of being placed in either group.

After two weeks, the patients will stop taking their first batch of medication to allow it to completely leave their bodies. Then the patients will begin taking the other medication so that by the end of the study, each patient will have been treated with pantoprazole for two weeks and placebo for two weeks.

At the end of each two weeks, patients will be asked to complete questionnaires regarding their daytime sleepiness and reflux symptoms. Patients will also complete reaction time testing as a measure of daytime sleepiness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Daytime sleepiness (ESS \>= 8)
* Mild to moderate OSD (AHI\<=30)
* Symptoms of GERD
* Symptoms of acid reflux

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Depression or unstable psychiatric disorder
* Allergy to Pantoprazole
* Taking a proton pump inhibitor within the last month
* Taking a histamine-2 receptor blocker within the last month
* Automobile or industrial accident due to daytime sleepiness
* Currently taking ketoconazole, itraconazole, ampicillin or iron salts
* Hypersecretory acid disorder (Zollinger-Ellison Syndrome)
* Active peptic ulcer disease
* Severe concomitant disease of another major body system
* Malignancy in the past 5 years
* Current abuse of alcohol, medication or drugs
* Sedative medications
* Additional treatment for obstructive sleep apnea (i.e. CPAP or surgery)
Construction and Validation of an In-hospital Mortality Risk Prediction Model for Acute Ischemic Stroke Patients

Firstly, the application effect of the existing predictive models, SOAR and GWTG-Stroke, was verified in Guangdong acute ischemic Stroke population, and the clinical application effect of the existing predictive models was verified.

Secondly, the predictive value of clinical indicators was analyzed, SOAR and GWTG-Stroke scores were optimized, and an improved prediction Model (New Model) was constructed.

The third is to apply the New Model to clinical practice, collect clinical data and evaluate the prediction effect of the Model, and evaluate the prediction efficiency of the improved prediction Model.

This research is mainly divided into two parts. The first part is to verify and optimize the existing prediction model. Through continuous collection of clinical data of acute ischemic Stroke patients hospitalized in Shenzhen Second People's Hospital from January 2017 to December 2021, including baseline indicators and end point events, based on the existing prediction model (SOAR, GWTG-Stroke), The predictive probability was calculated and compared with the actual mortality during hospitalization. The ROC curve, calibration curve and decision curve were used to evaluate the model's differentiation, calibration and clinical application value.

Using retrospective data, multivariate logistic regression was used to analyze the predictive value of baseline clinical indicators, screen risk factors, and optimize the prediction model of SOAR and GWTG-Stroke.

Extreme Gradient Boosting (XGBOOST) was used to select variables, and logistic regression model was used based on Akaike Information Criterion.

AIC) was used to construct an improved mortality risk prediction Model (New Model). Decision curves were used to compare the models. Combined with the clinical significance of the indicators, the construction of the prediction Model was improved.

The model was validated internally by resampling with computer simulation. The second part is to evaluate the clinical application effect of the improved prediction Model. The clinical data of acute ischemic stroke patients hospitalized in Shenzhen Second People's Hospital and Shenzhen Longhua District People's Hospital from January 2022 to December 2023 are collected continuously. The New Model is applied in the clinic, and the New Model is validated in the external time and space.

Evaluate prediction effectiveness and extrapolation.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. It meets the diagnostic criteria of China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, and bleeding is confirmed by head MRI or excluded by CT after admission;
3. Admission within 72 hours of onset. -

Exclusion Criteria:

1. Non-vascular causes and transient ischemic attack;
2. with severe hepatic and renal dysfunction;
3. Central nervous system infection, recent history of severe trauma, and malignant tumors affecting survival time;
4. Incomplete main clinical data. -
Role of Piwi-protein Interacting RNA, miRNA-194 and Amino Acids in Patients With Prostate Cancer

Prostate cancer is one of the most frequently diagnosed cancers and one of the main causes of death due to tumors in men . The mechanisms of its carcinogenesis have not been fully elucidated yet . Prostate tumours remain undetected or dormant for a long period of time before they progress loco-regionally or at distant sites as overt tumours. The molecular mechanism of dormancy is yet poorly understood

Currently, early detection of prostate cancer involves mainly digital rectal examination (DRE) and testing of prostate-specific antigen (PSA) level in blood . However, over the years it became clear that PSA is not a specific biomarker of prostate cancer . Finding out new biomarkers is pivotal for early detection of prostate cancer, increasing the accuracy of diagnosis, and reducing the false positives in PSA testing These biomarkers include many biological compounds such as, microRNAs, small nuclear RNAs (sncRNA), proteins and metabolites .

PIWI-interacting RNAs (piRNAs), a class of sncRNA molecules, are associated with the PIWI proteins. Moreover, MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs\[15\]. Studies have shown that the miRNAs have critical roles in a variety of biological processes such as: cell proliferation, differentiation, apoptosis and carcinogenesis. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions. Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.

Eligibility Criteria:
Inclusion Criteria:

* • Patients who are confirmed to have prostate cancer or benign prostatic hyperplasia based on digital rectal examination (DRE), trasrectal ultrasonography and histopathological examination of biopsy tissue

  * The control group consisted of healthy men with no cancer and no chronic diseases. They will be age-matched with patient group and recruited among men subjected to the routine periodic medical examination.

Exclusion Criteria:

* • Other coexisting cancers,

  * Prostate cancer treatment
Exercise and Nerve Function in Diabetes

The purpose of this study is to describe the effect of a 10-week exercise program on nerve function and number of nerve fibers in the skin in the lower leg in people with diabetic neuropathy.

The objective for this application is to quantify the benefits of exercise on nerve function including proprioception, and investigate the relationship of these findings with improvements in epidermal and dermal innervation. In this pilot project, we will pursue 2 specific aims: 1) determine the effect of an exercise intervention on nerve function in people with diabetic neuropathy, and 2) assess changes in cutaneous innervation following participation in an exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70
* Type 2 diabetes
* Peripheral neuropathy

Exclusion Criteria:

* Serious cardiac history or other medical problems that would prevent safe participation in exercise