cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy, Safety and Immunogenicity of Subcutaneous HX575 in the Treatment of Anemia Associated With Chronic Kidney Disease (SWEEP)

This is an open-label, single-arm, baseline-controlled, multicenter efficacy and safety switch study involving 500 CKD subjects suffering from anemia and treated previously with a stable dose of ESA s.c.

Correction of anemia will be maintained by s.c. administration of HX575 in two frequencies (i.e. qw and q2w), in order to maintain an Hb target range of 10.0-12.0 g/dL.


Eligibility Criteria:
Inclusion Criteria:

* Male and female CKD subjects with or without dialysis treatment
* Age \> 18 years
* Subjects under documented stable maintenance therapy with ESA, s.c. at least once per week and in accordance with the relevant SmPC, for at least 3 months with a total weekly dose of ≤ 300 IU/kg/week
* Subjects with controlled symptomatic anemia, defined as mean Hb level between 10.0 g/dL and 12.0 g/dL, based on four Hb measurements during the four-week baseline period
* Adequate iron status, serum ferritin ≥ 100 µg/L or transferrin saturation ≥ 20%
* Confirmed negative anti-EPO antibody assay from sample taken at screening visit -4

Exclusion Criteria:

* Systemic cyclosporine
* History of PRCA or aplastic anemia
* History of anti-EPO antibodies
* Uncontrolled hypertension
Assessment of Safety and Efficacy of IM19 for Recurrent or Refractory (R/R) Non-Hodgkin's Lymphoma(NHL) Patients

This is a phase I/II, multicenter study to assess the efficacy and safety of IM19 CAR-T cells in adult with R/R Non-Hodgkins Lymphoma in China.

This is a phase Ⅰ/Ⅱ. The phase I is a single-center study. The main objective is to evaluate the safety of IM19 CAR-T cell therapy for patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma. The phase Ⅱ is a multi-center study,The main goal is to evaluate the efficacy of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive invasion of non-Hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with relapsed or refractory invasive non-Hodgkin's lymphoma, confirmed by CD19 positive cytology or histology, specific types.
* CD20 positive patients undergo corresponding targeted therapy.
* Patients must have evaluable evidence of disease (according to Lugano 2014 standards).
* ≥ 18 years old.
* The expected survival period is more than 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up
* Participate voluntarily in this experiment and sign the informed consent.

Exclusion Criteria:

* The investigators judged patients with gastrointestinal lymph nodes and/or central nervous system involvement who may be at risk for CAR-T treatment.
* Subject has graft-versus-host reactions and need to use immunosuppressants; or suffer from autoimmune disease
* Subject has used chemotherapy or radiotherapy within three days before the blood collection period.
* Subject has used systemic steroid drugs within 5 days before the blood collection period (except for recent or current inhaled steroids).
* Those who use drugs that stimulate bone marrow hematopoietic cells to produce drugs within 5 days before the blood collection
* Subject has used any gene therapy products before.
* Subject with a history of epilepsy or other central nervous system diseases.
* Active Hepatitis B Virus or Hepatitis C Virus infections
* The subject with other tumors in the past 5 years.
* Within 14 days before enrollment, there was active infection or uncontrollable infection requiring systemic treatment.
Prevention Of Nephrotoxicity Following Bone Marrow Transplantation Using Urodilatin and Mannitol

The purpose of the study is to combine Urodilatin (ANP analogue), which will increase glomerular filtration rate (GFR), and mannitol, which will increase the rate of urinary flow and solute excretion. We intend to treat twenty consecutive allogeneic bone marrow transplant patients in a phase II study comparing results with historical controls.

We hypothesize that the incidence of renal dysfunction, ARF and thus mortality in allogeneic bone marrow transplantation can be significantly reduced by the use of protective agents Urodilatin and mannitol. We feel that this combination is best administered prior to and during the first two weeks of treatment when patients encounter immunosuppressive agents and the onset of early transplantation complications.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Presence of malignancy or hematological disease whose treatment will be allogeneic stem cell transplant and high-dose conditioning therapy.
* Adequate baseline evaluation: adequate renal function (creatinine clearance \> 60 ml/min); Adequate hepatic function (SGOT, SGPT, bilirubin and alkaline phosphatase \< 1.5 times normal); adequate cardiac function (MUGA showing a left ventricular ejection at rest \> 45%); adequate pulmonary function (DCLO \> 60%).

Exclusion Criteria:

* Known hypersensitivity to ANP or mannitol
* Congestive heart failure
* Previous bone marrow transplant
* BP less than 90 mm systolic or less than 60 mm Hg diastolic
ESS as a Diagnosis Resource Aid of the Syndrome of Obstructive Sleep Apnea

The aim of this study was to analyze the effectiveness of the Epworth's sleepiness scale as a recourse aid in the diagnosis of the syndrome of obstructive sleep apnea. 475 patients attended this study, that sought the CESF to probable diagnosis of some sleep disorder. The data were collected from records, wich are of questionnaires, including the ESE, prepared by the CESF professionals and responded, previously, by the own patients. The study compared the result obtained in the scale of Epworth with the data of polysomnography. The analysis of data was performed using the SPSS, based on descriptive and inferential statistics, being used the average considering the standard deviation, and, to the crossing of variables, was used the chi-square test of Pearson, considering as significant statistically values of p\<0.05. The results showed that gender, age and BMI are predisposing factors to SOSA.


Eligibility Criteria:
Inclusion Criteria:

* Charts of whose admission of patients was from October 2005 to July 2007
* Patients referred to the CESF for possible diagnosis of a sleep disorder

Exclusion Criteria:

* incomplete data
* patients with concomitant diseases (heart disease, hormonal disease, chronic obstructive pulmonary disease and neurological patients)
* patients undergoing uvulopalatopharyngoplasty
The Effect of Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. Recently, the ultrasound-guided perineural injection with 5% dextrose was widely used for entrapment neuropathy with positive benefit. However, current studies have not entirely proved the effects of perineural injection on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided perineural injection with 5% dextrose in patients with CTS.

After obtaining written informed consent, patients of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-session ultrasound-guided perineural injection with 5% dextrose and control group received one-session ultrasound-guided perineural injection with normal saline. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd, 4th, 8th, 12th, 16th and 24th week after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-85 year-old.
* Diagnosis was confirmed using an electrophysiological study and ultrasonography

Exclusion Criteria:

Cancer

* Coagulopathy
* Pregnancy
* Inflammation status
* Cervical radiculopathy
* Polyneuropathy, brachial plexopathy
* Thoracic outlet syndrome
* Previously undergone wrist surgery or steroid injection for CTS
Trial of Combination Therapy to Treat COVID-19 Infection

In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
2. Healthy male or female subjects at least 18 years of age
3. Diabetic and obese (BMI \> 30) patients will be included in the Trial but randomization will be stratified.
4. Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
5. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
6. Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Negative test for COVID-19 by RT-PCR at screening
3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature \> 104.0 degrees F, pleuritic pain, or frequent cough.
4. Known drug allergy to any of the investigational medications
5. Currently taking medication with known drug interactions with investigational medications, found in Appendix II
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
8. Inability to attend daily for 10 days
Empiric Versus Selective Prevention Strategies for Kidney Stone Disease

The aims of this study are to 1) Conduct a randomized clinical trial of selective versus empiric diet plus pharmacologic therapy in high-risk stone formers and 2) Determine adverse effects from, and adherence to selective and empiric strategies.

Diet and pharmacologic interventions for preventing future kidney stone episodes are effective, however clinical guideline panels disagree on whether clinicians should perform selective therapy: performing 24-hour urine testing to guide choosing interventions to correct abnormal urinary parameters. The alternative strategy is empiric therapy: applying interventions without 24-hour urine testing. While 24-hour urine testing is considered the standard of care by nephrology and urology specialties for higher risk patients, the American College of Physicians does not recommend 24-hour urine testing.

This is a randomized clinical trial of selective versus empiric therapy for patients with presumed idiopathic calcium stone disease, representing \>80% of the kidney stone population. The primary outcome is change in urinary supersaturation, which associates with symptomatic stone recurrence. We will recruit patients with presumed idiopathic calcium stone disease with at least 2 stone events within the previous 5 years. Participants will be randomly assigned to empiric diet plus thiazide with potassium citrate daily, or to selective diet plus pharmacologic therapy based on the 24-hour urine abnormalities identified at baseline and adjusted during follow-up. The primary outcomes will be the calculated calcium oxalate and calcium phosphate supersaturations. In addition, we will determine adverse effects from, and adherence to, selective and empiric strategies.

Eligibility Criteria:
Inclusion Criteria:

* Two or more symptomatic kidney stone events in the last 5 years
* Adult

Exclusion Criteria:

* Medullary sponge kidney or renal tubular acidosis
* Untreated urinary obstruction
* Primary hyperparathyroidism
* Primary hyperoxaluria
* Pregnancy
* Inflammatory bowel disease or bowel resection
* Sarcoidosis
* Cystinuria
* Prior stone composition with uric acid, struvite, cystine, carbonate apatite
* Use of specific medications (thiazides, topiramate, xanthine oxidase inhibitors, citrate, bicarbonate)
* Chronic kidney disease stage 3 or higher (eGFR\<60)
* Gouty arthritis or 3 gout episodes in 1 year
* Known allergy to study medications
* Hypokalemia or hyponatremia at screening.
* Age \< 18 years
Testing ALERT With GTO in Middle Schools

To test the efficacy of Project ALERT with the support enhancement tool, Getting To Outcomes.

This study combines two programs that have been developed by RAND researchers: Project ALERT (PA) and Getting to Outcomes (GTO). Project ALERT is a widely used drug prevention program for middle school youth. Though it has an evidence-base for effectiveness, the program (like most evidence-based programs in schools) is not run with adequate fidelity representing a large gap between what is developed and tested for effectiveness and what is used in actual practice. Thus, the study will conduct an updated randomized controlled trial of PA and test GTO as a tool to increase adoption and adequate fidelity of the program in schools. GTO's previous evidence suggests it could be effective in public schools, yet this remains an empirical question. A successful demonstration of PA and GTO could fundamentally transform evidence-based prevention's delivery, reach, and thus impact, in the US.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility for student participants: all students in 7th grade, primarily aged 12-14, attending school at one of the enrolled schools in the study.
* Eligibility for school staff participants: all educators interested in enrolling in the study at each of the enrolled schools.

Exclusion Criteria:

* Not meeting eligibility criteria

Note: the age range is from 11 to 70 to account for both the student AND teacher populations.
A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants

The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments

Exclusion Criteria:

* Current or recent (within 3 months of study intervention administration) gastrointestinal disease
* History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply
Elliptical Training Versus Ergo-meter on Cardiopulmonary Parameters in Post CABG Patients

To determine the effects of elliptical training versus ergo-meter on cardiopulmonary parameters in post CABG patients

Worldwide, physiotherapists treat patients with CAD in the acute stage following a coronary event and/ or following coronary artery bypass graft (CABG) surgery. These patients are then later followed up as outpatients during cardiac rehabilitation(CR) in turn to improve cardio-respiratory fitness and quality of life and to delay the incidence of subsequent coronary events. Early mobilisation and physical activity is often the first choice of treatment, but evidence as to the optimal intensity, timing and choice of exercises is scarce. In 2018 the effect of obesity on functional capacity, anxiety and Daily life activities in patients with coronary artery disease and phase II cardiac rehabilitation. The results shows that When Group 1 patients were assessed at the end of 30 sessions of cardiac rehabilitation (CR) program, a statistically significant improvement was detected in 6MWT, physical functioning, physical role, mental health, social functioning and pain sub parameters.

In 2019, study Changes in 6-minute walk test (6MWT) distance and heart rate walking speed index following a cardiovascular prevention and rehabilitation programme .Patients increased their 6-minute walk test distance by 40 meters and decreased their heart rate walking speed index by 2.7, which translates into a saving of three heart beats for every 100 meters walked or 45 heart beats for every mile walked.

In 2012, conducted study Resistance and Balance Training Improves Functional Capacity in Very Old Participants Attending Cardiac Rehabilitation Participants were assigned randomly in a ratio of 1:1 to an intervention group (IG; inpatient CR plus resistance training and balance training) or control group (CG;inpatient CR)after Coronary Bypass Surgery. The study concluded that there is significantly greater improvement in functional capacity measured as 6-MWD,TUG time, and maximal relative workload in the IG than in the CG..

Eligibility Criteria:
Inclusion Criteria:

* CABG patients (after 4 months) undergone phase 2 rehabilitation.

Exclusion Criteria:

* Vitally Unstable patients
* Presence of arrhythmias
* History of unstable angina in last 3 months
* Intracavitary thrombus
* Recent thrombophlebitis with or without pulmonary embolism
* Sever/e obstructive cardiomyopathies
* Uncontrolled diabetes
* Severe orthopaedic problems
Preoperative Pediatric Fasting Regimens

The presence of gastric contents makes an aspiration event more likely , and as a result, preoperative fasting guidelines are designed to provide adequate time for gastric emptying in patients undergoing surgery. this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries

it is unknown how many patients have gastric volumes that place them at increased risk of aspiration despite adequate fasting.

There is a growing interest in the use of bedside ultrasonography to assess gastric content and volume. It has been suggested that the gastric antrum in particular can be assessed reliably by sonography.

hence, this study will be conducted to assess the gastric volume and content with the help of ultrasound in fasted pediatric patients scheduled for elective surgeries which will help to detect accuracy of preoperative fasting hours.

Eligibility Criteria:
Inclusion Criteria:

* paediatric patients aged 6-12 years old
* ASA physical status I and II
* scheduled for elective surgeries
* the anticipated duration of 30-60 min

Exclusion Criteria:

* parents' refusal
* overweight or obesity
* expected difficult airway management
* increased abdominal pressure
* diabetes mellitus
* congenital diseases
* GERD or esophageal disease
* uncooperative patients,
* mental retardation or neurological disease
* upper airway surgeries.
Accuracy of FNAC in Diagnosis of Thyroid Nodules

Detection of degree of accuracy of FNAC in diagnosis of thyroid nodules

Accuracy in diagnosis in any case is required, and this is beneficial to the patient and the physician, and with the development that currently exists and the trend to use less invasive techniques, accuracy of FNAC should be studied well.1.Thyroid nodules are common and the principal method of diagnosis is fine-needle aspiration cytology (FNAC).2. Can investigators depend on FNAC alone in diagnosis of thyroid nodule in the future?!3. In this study, investigators will compare the results of (FNAC) versus (Biopsy) in diagnosis of thyroid nodule in AUH , to detect the degree of accuracy of FNAC.4. FNAC is a simple, safe, cost-effective and accurate diagnostic tool for the initial screening of patients with thyroid nodules.5. Background Routine application of fine needle aspiration cytology (FNAC) has decreased unnecessary referral of thyroid nodules for surgical treatment and has also increased the cancer rates found in surgery materials. Success of thyroid FNAC depends on skilled aspiration, skilled cytological interpretation and rational analysis of cytological and clinical data. The aim of this study was to determine the diagnostic accuracy rates of thyroid FNAC results obtained in our hospital.6. The FNAC is a sensitive, specific, and accurate initial diagnostic test for the preoperative evaluation of patients with thyroid swellings in our setting as well. The correlation of cytological and histopathological diagnoses is an important quality assurance method, as it allows cytopathologists to calculate their false-positive and false negative results.7

Eligibility Criteria:
Inclusion Criteria:

1. thyroid disease
2. multinodular
3. single nodule
4. TIRAD 3 or more by US
5. thyroid disease underwent FNAC then surgery
6. all age groups
7. patient fit for surgery

Exclusion Criteria:

1. patients with comorbidities.
2. patients unfit for surgery
3. patients who refused surgery.
4. Patient with no diagnostic FNAC.
COVID-19 : Stress Within Hospital Workers

As of December 2019, the global pandemic of COVID-19 has spread rapidly throughout the world, putting healthcare staff at the frontline.

In this context, several factors leading to the appearance of psychiatric symptoms have emerged : work overload, fear of being infected or of infecting, exhaustion... (The Lancet, 2020)

Indeed, post-traumatic stress disorder (PTSD), depressive symptoms, anxiety symptoms, insomnia and increased stress have been reported (Rossi et al., 2020).

Furthermore, the increased anxiety and depression symptoms and stress associated with the COVID-19 pandemic may increase the risk of suicide in this already high-risk population. For example, suicidal ideation has been reported in up to 5% of healthcare workers in the United States (Young et al., 2021).

It is therefore essential to evaluate the incidence of psychiatric disorders (e.g. PTSD, depression, suicide) and their associated risk factors among the hospital staff.

To do so, Montpellier University Hospital healthcare staff was asked their mental state during the first wave of COVID-19.


Eligibility Criteria:
Inclusion criteria:

* Healthcare staff working at Montpellier University Hospital during the first wave of COVID-19
* Having responded to the online survey sent to all healthcare staff

Exclusion criteria:

- Refusal to participate