cyrilzakka/clinical-trials huggingface dataset:
Bortezomib Plus Dexamethasone for Acquired Pure Red Cell Aplasia Failure or Relapse After First-line Treatment

This is an open-label, single-arm study to evaluate the safety and efficacy of bortezomib plus dexamethasone for acquired pure red cell aplasia failure or relapse after first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

* ECOG ≤ 2.
* Age from 18 to 70.
* Diagnosed with acquired pure red cell aplasia.
* Meets the criteria of first-line treatment failure or relapse.
* Organs in good function.
* Signed informed consent.

Exclusion Criteria:

* Nursing woman.
* Active bacterial, virus, fungal or parasitic infection, including HIV infection, HBsAg or HBV DNA positive, HCV DNA positive, etc.
* Secondary PRCA caused by lymphoproliferative disorders, including large granular lymphocytic leukemia, waldenström macroglobulinemia, small lymphocytic lymphoma/chronic lymphocytic leukemia, etc.
* Secondary PRCA caused by either smoldering multiple myeloma or symptomatic multiple myeloma.
* Secondary PRCA caused by either ABO major mismatched stem cell transplantation or organ transplantation.
* Secondary PRCA caused by solid tumors except for thymoma.
* Secondary PRCA caused by drugs or pregnancy.
* Secondary PRCA caused by the B19 virus.
* Have contraindications for glucocorticoids, or unable to tolerate glucocorticoids for comorbidities.
* Previously received treatment in other trials within 4 weeks before enrollment.
* Previously treated with the proteasome inhibitor.
* Experience active hemorrhage condition, including gastrointestinal bleeding, respiratory tract bleeding and central nervous system bleeding within 2 months before enrollment or during bortezomib/dexamethasone treatment.
* Have a history of malignant tumors.
* Have a history of mental illness.
* Inability to understand or to follow study procedures.
Mutations of the Pre-core Region of Hepatite B Virus (HBV)

Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.

The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac.

These patients will not be on anti-HBV treatment.

Exclusion Criteria:

* Patients under 18 years old
* Patients with their hepatitis B
* Patients with HBV viral load undetectable or less than 100 IU / mL.
* Immunosuppressive treatments such as corticosteroids or other
* The co-infection with the hepatitis C and / or HIV virus
* Patients with cancer
Omega-3 Polyunsaturated Fatty Acids and Non-Muscle Invasive Bladder Cancer

The investigators hypothesize that omega-3 polyunsaturated fatty acids (n-3 PUFAs) might have a role in prevention of the recurrence of non-muscle invasive bladder cancer (NMIBC).

The patients who are suffering from high-risk NMIBC will be randomly allocated into two groups: The first group (n-3 PUFAs group): 55 patients will receive omega-3 plus twice daily for one year after transurethral resection of bladder tumor (TURBT). The second group (Control group): 55 patients will receive placebo twice daily for one year after TURBT.

All patients will receive intravesical Bacillus Calmette-Guérin (BCG) immunotherapy and they will be followed up for two years.

The chemopreventive effect of n-3 PUFAs on the recurrence of NMIBC after TURBT will be studied via magnetic resonance imaging (MRI), inpatient cystoscopy, histopathological examination and molecular studies of the resected bladder tissues.

The investigators hypothesize that omega-3 polyunsaturated fatty acids (n-3 PUFAs) might have a role in prevention of the recurrence of non-muscle invasive bladder cancer (NMIBC).

The patients who are suffering from high-risk NMIBC will be randomly allocated into two groups: The first group (n-3 PUFAs group): 55 patients will receive omega-3 plus (1200 mg) orally, twice a day for at least 12 months. The treatment will start after transurethral resection of bladder tumor (TURBT), as soon as the histopathology will be obtained. The treatment will be discontinued if recurrence develops, unacceptable or serious adverse events occur or according to the patients' request. The second group (Control group): 55 patients will receive placebo twice daily for one year after TURBT. Patients and care providers will be blinded to the medication given.

All patients will receive intravesical Bacillus Calmette-Guérin (BCG) immunotherapy and they will be followed up for two years.

The chemopreventive effect of n-3 PUFAs on the recurrence of NMIBC after TURBT will be studied via magnetic resonance imaging (MRI), inpatient cystoscopy, histopathological examination and molecular studies of the resected bladder tissues.

Eligibility Criteria:
Inclusion Criteria:

- Patients who are at high risk for recurrence of NMIBC after TURBT based on the following tumor characteristics:

* Stage Ta (G3, multifocal, or ≥ 2 occurrences within 12 months, including the current tumor),
* Stage T1 (any grade) and/or,
* Carcinoma in situ (CIS),
* Without any indication for radical cystectomy.

Exclusion Criteria:

- Patients with:

* ≥ T2 bladder cancer,
* Evidence of nodal metastasis,
* Associated upper tract urothelial carcinoma (UTUC) or
* Those who refuse.
US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia

participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected

participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .

pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.

Eligibility Criteria:
Inclusion Criteria:

* patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .

Exclusion Criteria:

* inability or refusal to sign informed consent
* younger than 65 years
* BMI greater than 35 kg/m²
* presence of contraindications for regional nerve block or spinal anesthesia
* impaired cognition or dementia
* multiple fractures
Short Term Outcomes of Children With Acute Respiratory Distress Syndrome

The study is a chart review of all children admitted over a two year period with the diagnosis of acute respiratory distress syndrome. Short term outcomes, such as mortality, length of ventilation and length of stay, will be reviewed. Factors that impact these outcomes will also be reviewed.

We would like to conduct a chart review of all patients with pediatric ARDS hospitalized in the PICU at Columbus Children's Hospital in the last two years. Patients would be included for review if they met the clinical criteria for ARDS. These criteria are: rapidly progressive respiratory failure, severe hypoxemia (PaO2/FiO2 \< 200), and evidence of bilateral pulmonary infiltrate on chest radiography. We estimate 40-50 patients will meet criteria.

Once criteria are met, patient charts will be pulled or reviewed electronically. We will then compose a database that includes no patient identifiers but contains information regarding the cause, length, and outcome of the ARDS admission and PICU stay. Factors such as nutritional status, antibiotic and muscle relaxant use, and type of ventilation used will be examined. Other care-related variables will be included if they are felt to impact outcome during the review process. The database will then be analyzed and information regarding pediatric ARDS outcomes in our institution will be published.

We anticipate that examining the factors that impact short term outcomes in pediatric ARDS will lead to research possibilities regarding ways to improve both short and long term outcomes in children with this illness. We propose that reviewing the disease entity as a whole will lead to improvements in caring for children with the disease, and eventually bring about a decline in mortality rates.

Eligibility Criteria:
Inclusion Criteria:

* Rapidly progressive respiratory failure,
* Severe hypoxemia (PaO2/FiO2 \< 200),
* Evidence of bilateral pulmonary infiltrate on chest radiography
* 0-18 years of age

Exclusion Criteria:

* Heart failure
* Cardiac shunt present
Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes

This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.

Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The mechanisms of asthma appear to be different between athletes and non-athletes, in that the occurrence of asthma is higher among endurance athletes and seems to be promoted by training. This suggests that factors inherent to athleticism, such as the parasympathetic nervous system, which has been shown to change with endurance training and is known to lead to narrowing of the airways, may be involved with the development of asthma in athletes. Although asthma mechanisms and treatments have been extensively studied in classic asthmatics, there is very limited data in athletes.

This will be a double-blind placebo-controlled study in which we plan to study 40 competitive endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2 exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the athletes' airway response to the exercise challenge with and without the active drug.

If ipratropium bromide proves to prevent EIA in athletes, this drug may be appropriate and effective to target EIA in this population. The results of this study may lead to improved clinical management of athletes with asthma.

Eligibility Criteria:
Inclusion Criteria:

* Athletes \> 13 years of age

Exclusion Criteria:

* History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea on exertion).
* History of cardiac disease or taking cardioactive medications.
* History of smoking.
* History of glaucoma.
Comparing Myopia Control Efficacy in Children With 4 Methods: Orthokeratology, DIMS, DISK, and SVS.

The goal of this clinical trial is to learn if 3 optical interventions（DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are:

Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes.

Participants will:

Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.

orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.

Eligibility Criteria:
Inclusion Criteria:

* Must agree to participate in the study
* Must have cycloplegic refraction with spherical equivalent refractive (SER)

  * - 2.00 D \~ - 5.00 D (including the boundary values)
* Clinical diagnosis of astigmatism was ≤ 1.00D
* Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
* Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
* Must have the front cornea curve value between 41.00D\~44.00D
* Must have axial length of the study eye between 23.00mm and 25.00mm at baseline

Exclusion Criteria:

* Dry eye
* keratitis
* Conjunctivitis
* Clinical diagnosis of entropion
* Clinical diagnosis of glaucoma
* Clinical diagnosis of retinal lesions
* Clinical diagnosis of amblyopia
* Clinical diagnosis of optic media lesions (e.g., central thick corneal scars, cataract)
* Clinical diagnosis of optic nerve dysfunction
* Have medical history of atropine eyedrops (including 1% high concentration , 0.05%, 0.01% or other low concentration)
* Have history of wearing peripheral defocus spectacles
* Have history of wearing duo-focal soft contact lenses
* Unable to follow up
* Investigators consider to be not eligible.
A Comparison of Two Colonoscopic Withdrawal Techniques

This study will compare two strategies for colonoscope withdrawal, using polyp detection as the primary outcome measure, to determine the optimal withdrawal strategy.

Null Hypothesis:

On withdrawal of the colonoscope, examining patients with dynamic position change does not yield more polyps than the supine position.

Alternative Hypothesis:

On withdrawal of the colonoscope, examining the patients with dynamic position change improves polyp detection compared to the supine position.

The identification and removal of polyps has been shown to prevent bowel cancer. Although colonoscopy is the best technique to identify polyps, polyps can be missed even in expert hands. Inspection of the bowel occurs predominantly during colonoscope withdrawal. Tailoring a patients position according to the segment of bowel being examined (dynamic position change) is a technique that has been shown to improve visualisation of the bowel wall and polyp detection. However, changing patient position during colonoscope withdrawal has not been widely accepted in clinical practice. This may be because of a lack of awareness of the literature, a perception that the benefit is negligible and the inconvenience of changing a patients position in addition to the small number of publications demonstrating this to be beneficial. We plan to compare the detection of polyps when colonoscope withdrawal is done with dynamic position change (a planned series of position changes to optimise mucosal visualisation) and the supine position (laid on back). These strategies will be compared by performing a double colonoscope withdrawal; The first withdrawal will be performed either supine or in the dynamic position. This will be followed by a second insertion and withdrawal in the alternative position. The order in which these strategies are performed will be randomised i.e. supine then dynamic or dynamic then supine.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnostic colonoscopy
* Age \>40 and \<80

Exclusion Criteria:

* Inflammatory bowel disease
* Known polyposis syndrome
* Poor mobility which would limit a patients ability to turn
Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1

The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.

This is a prospective pilot safety study based on the hypothesis that active, street-recruited heroin users can be successfully treated for hepatitis C after stabilization on buprenorphine. Eligible subjects will be actively using heroin and have hepatitis C viremia; screening will occur at street-based sites like syringe exchange programs. Those who are eligible will sign informed consent, and then be asked to attend 3 weekly educational sessions about hepatitis C and addiction as well as undergo an intake interview. After this, subjects will be inducted onto buprenorphine/naloxone combination therapy (Suboxone) and receive this medication for 12-24 weeks. Once reaching the 12-24 week study time point, subjects will have the option of a 12-week Suboxone taper, or instead of undergoing 6-12 months of hepatitis C treatment with pegylated interferon and ribavirin while being maintained on Suboxone. Once completing hepatitis C treatment, subjects will undergo a 24-week Suboxone taper, or be transitioned to outpatient Suboxone therapy by a medical provider.

Eligibility Criteria:
Inclusion Criteria:

* Active heroin or other illicit opioid use
* Active hepatitis C
* No medical or psychiatric contraindications
* Able to sign informed consent

Exclusion Criteria:

* No opiate dependence
* Age \<18
* Unable or uninterested in attending weekly group sessions
Dysbiosis & Long COVID

The SARS-CoV-2 virus causes COVID-19, which ranges from mild initial symptoms to severe multi-organ dysfunction. While some patients recover to their baseline states, others develop a long COVID, or post-acute sequelae of SARS-CoV-2 (PASC) consisting of symptoms persisting \>2-6 months post-infection. PASC symptoms include post-exertional malaise, fatigue, and heart palpitations as well as incident GI disorders, cognitive dysfunction, and arthritis. Based on prevalence/incidence studies, it is estimated that more than 30 million people in the US have ever developed PASC with 10-11% of patients or 11 million people continuing to feel symptoms to the present day10. SARS-CoV-2 vaccines are only \~32% effective against infection at 4 months post-vaccination11, only 15% effective against the development of PASC12, and only 20% of American adults have received an updated booster as of December 202313. It is therefore imperative that the scientific community make progress in identifying underlying causes of PASC to develop effective treatments.

This study will identify microbial metabolites associated with PASC-mediated gut dysbiosis and establish a tractable in vitro model to test T cell-gut epithelium dynamics to develop novel bio-therapeutics for multiple post-viral conditions. This case-control study will collect biospecimens (matched stool \& blood) samples from 400 people with and without long COVID (200 participants/group) to understand how COVID-induced dysbiosis impacts symptom severity, immune suppression, and gut barrier dysfunction both ex vivo and in vitro.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80
* Sex: Any
* Race: Any
* Last COVID infection: within past 3 years, PCR- or antigen-confirmed, symptomatic (mild/moderate/severe)
* COVID vaccination status: Any
* Presence of long COVID symptoms (GI, cardiac, pulmonary, neuro, musculoskeletal, and/or psych): 200 with symptoms, 200 w/o symptoms as defined by SBQ-LCTM.
* May or may not be doing routine endoscopy at UCM

Exclusion Criteria:

* Age \<18 or \>80
* Last COVID infection \>3 years ago (PCR/antigen-confirmed, symptomatic)
* Currently or within the last 3 months COVID+ by nasopharyngeal PCR/antigen test
* Currently diagnosed with cancer
* Currently pregnant (cannot take colon biopsy sample; only eligible for survey/blood \& stool collection)
* Currently on biologic immunomodulatory medications
* Official diagnosis of irritable bowel disease (IBD) or other chronic GI disorder

Vulnerable and/or Special Populations

* Healthy adult volunteers
* Pregnant people
* UCMC and UChicago employees
* Staff/faculty
Threshold Inspiratory Trainer Versus Trigger Sensitivity Adjustment on Weaning From Mechanical Ventilation

Ninety adult patients from both gender, with acute respiratory failure, intubated and mechanically ventilated. Their ages ranged from 50 to 70 years. They were selected from Intensive Care Unit (ICU), Department of Chest Diseases, Cairo University Hospitals. They have randomly assigned into three equal groups. Group (A): trained by threshold IMT device plus routine physical therapy. Group (B): trained by adjusting MV trigger sensitivity plus routine physical therapy. Group (C): only received routine physical therapy. (Negative inspiratory force NIF, arterial blood gases, P/F ration, respiratory rate RR, tidal volume VT, and rapid shallow breathing index RSBI) were measured before the study and at the end of the study (just before weaning for successfully weaned patients, or on the 10 day of intervention for failed weaning patients).


Eligibility Criteria:
Inclusion Criteria:

* Their age ranged from 50-70 years.
* The patients were diagnosed with acute respiratory failure duo to COPD exacerbation and need mechanical ventilation support for more than 48 hours.
* They were vitally stable and can tolerate pressure support
* PEEP less than 8Cm H2O , SpO2 more than 90).
* All patients were conscious and responded to verbal command.

Exclusion Criteria:

* Unstable hemodynamics,
* unstable neurological problems,
* lack of attention and cooperation
* skipping more than five training sessions.