cyrilzakka/clinical-trials huggingface dataset:
Lower Uterine Segment Thickness and Term Pain,Previous Cesarean Section

the purpose of the researchers; The aim of this study is to evaluate the consistency of niche dimensions measured by ultrasonography with visual measurement of the surgeon during the operation of the patient when presenting with pain in her current pregnancy.

If patients who have had previous cesarean section present to the emergency department with pain or NST pain, a panic occurs immediately for operation. Purpose of researchers; The aim of this study is to investigate whether a really fine determination of the thickness of the old incision line is associated with full-thickness rupture or incomplete rupture, which appears to be an operation, and if a relationship is found, there is a limit for this thickness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a previous cesarean section
* Those in term gestational week (37-42 weeks)
* Those who apply to the emergency with pain

Exclusion Criteria:

* Birden fazla sezaryen geçirilmiş öyküsü olan hastalar
* Önceden geçirilmiş uterin cerrahisi olan hastalar
* Miad olmayan gebeler
* Plesantal yerleşim patolojısı olan gebeler
A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure

The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute liver failure in encephalopathy grade 2-4

Exclusion Criteria:

* alcoholic hepatitis
* primary non function liver graft or graft dysfunction
* known chronic liver disease
* known malignancies
* clinical suspicion of brain death
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults

Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 19-64 years old
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
* Pregnant or lactating women
Cannabidiol as an Adjunctive Treatment for Bipolar Depression

Depressive symptoms are associated with significant psychosocial impairment. However, current treatments of bipolar depression are only partially effective.

Cannabidiol is a natural component of cannabis without psychotomimetic or addictive properties. Cannabidiol has been shown to produce therapeutic effects including anticonvulsive, anxiolytic, antipsychotic and neuroprotective effects. The investigators hypothesize that treatment with cannabidiol will result in improvement of depressive and anxiety symptoms, as well as, improvement in functioning and inflammatory biomarkers. During the clinical trial, subjects will receive study medication (cannabidiol 150-300mg/day) or placebo for a period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
* Young Mania Rating Scale (YMRS) ≤ 11.
* Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
* Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.

Exclusion Criteria:

* Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
* Young Mania Rating Scale (YMRS) score \> 12.
* Current or past drug sensitivity/intolerance to cannabidiol.
* Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
* Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
* Any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs.
* Actively suicidal or homicidal risk.
* Females who are pregnant or breastfeeding
RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) \[18F\]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, \[18F\]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform \[18F\]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care \[18F\]-DCFPyL-PET-CT with the \[18F\]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

PRIMARY OBJECTIVE:

I. To assess imaging performance of the fluorine F 18 piflufolastat (\[18F\]-DCFPyL) PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with prostate cancer.

SECONDARY OBJECTIVE:

I. To determine the feasibility of generating a biology-guided radiotherapy (BgRT) plan using X1 RMRS-acquired \[18F\]-DCFPyL PET data derived from the imaging-only session at the studied dose level.

OUTLINE:

Patients receive \[18F\]-DCFPyL intravenously (IV) and undergo \[18F\]-DCFPyL PET-CT over 30 minutes per standard of care (SOC). Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

After completion of study, patients are followed up within 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* Documented informed consent of the participant and/or legally authorized representative
* Age \>= 21 years
* Patients undergoing SOC \[18F\]-DCFPyL PET-CT
* Patients should be scheduled for \[18F\]-DCFPyL PET-CT prior to study entry

Exclusion Criteria:

* Known psychiatric or substance abuse disorder that would interfere with conduct of the study
* Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
Targeted Busulfan, Fludarabine Conditioning Regimen for Hematopoietic Stem Cell Transplantation in GRD

To evaluate the outcome of hematopoietic stem cell transplantation using targeted busulfan, fludarabine conditioning regimen in genetic rare disease

Busulfan is a highly toxic drug with narrow therapeutic window used for the conditioning of hematopoietic stem cell transplantation. High exposure is associated with systemic toxicity such as veno-occlusive disease (VOD) and underexposure is associated with graft failure or relapse. In this study the investigators plan to improve the outcome of hematopoietic stem cell transplantation by using optimal busulfan dose through pharmacokinetic study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are diagnosed as genetic rare disease.
2. Patients who need hematopoietic stem cell transplantation
3. Age: up to 21 years
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction \> 30% and ejection fraction \> 45%. 2. Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal. 3. Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci.
8. Patients (or one of parents if patients age \< 19) should sign informed consent.

Exclusion Criteria:

1. Pregnant or nursing women.
2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
Dual Therapy With Vonoprazan Plus Amoxicillin or Doxycycline Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication:A Prospective, Multicenter, Open-label Randomized Controlled Study.

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with Vonoprazan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

It is planned to select Hp infection patients in a number of tertiary hospitals in Jiangsu and randomly divide them into three groups: group A is the classic group, receiving Vonoprazan 20mg, bid + amoxicillin 1.0g, bid + doxycycline 0.1g, bid + colloidal pectin bismuth 0.3g, bid and group C are double groups, respectively, receiving standard dose amoxicillin (1.0 g, bid) combined with vonorrasan dual regimen and doxycycline (0.1g, bid) combined with vonorrasan dual regimen, the treatment course of the three groups was 14 days, and the oral dose of Vonoprazan was 20mg, bid, the eradication rate, adverse reactions, compliance and other aspects of the three groups were compared, In order to obtain a safe, efficient, economical and convenient Hp eradication program with a wider range of applications.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old;
2. Patients confirmed to be positive for H. pylori by 13C-UBT or 14C-UBT;
3. Patients who have not received Helicobacter pylori eradication therapy before, or patients who have failed to eradicate in the early stage but have not received eradication therapy within half a year;
4. Voluntarily join this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug (penicillin, amoxicillin, Vonoprazan, doxycycline, etc.);
2. Patients with confirmed active peptic ulcer;
3. Patients who have received Helicobacter pylori eradication therapy within half a year;
4. Use of antibiotics, bismuth, and histamine H2 receptor antagonists or PPIs for the first 2 weeks before starting study treatment;
5. Use of adrenocorticosteroids, non-steroidal anti-inflammatory drugs, anticoagulants, barbiturates, phenytoin, or carbamazepine drugs;
6. History of esophageal or gastric surgery;
7. Pregnant or lactating women;
8. Alcoholism
9. Suffering from serious concomitant diseases, such as liver disease, cardiovascular disease, lung disease, kidney disease;
10. Hepatic insufficiency caused by hepatitis, fatty liver and other reasons;
11. Gastric mucosa-associated lymphoid tissue lymphoma (MALT), malignant tumor diseases.
Positional Therapy After Stroke

Stroke is the leading cause of adult disability and the third leading cause of death in the United States. Unfortunately, there are few therapies that have been proven to improve stroke outcome. Sleep apnea is an emerging stroke risk factor and has a well established association with higher mortality and poor functional outcome following stroke. Over half of acute stroke patients have sleep apnea, suggesting that it may be a important target for therapy. Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the standard treatment for sleep apnea is not well-tolerated among stroke patients. An alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute stroke patients, and therefore this treatment may have particular relevance to the stroke population. The proposed study will be conducted in two phases. The first phase is a randomized, crossover design in which acute stroke patients will be given positional treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will be compared with another night of sleeping without positional therapy. The order of treatments (standard vs positional therapy) will be random. The first phase will demonstrate the proof of concept: that stroke patients given positional therapy to avoid supine sleep will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with positional therapy. In the second phase, those identified to have sleep apnea will be randomized to receive positional therapy at home for three months, or standard therapy. This second phase will demonstrate the adherence/feasibility of three months of positional therapy, and will allow us to estimate effect size based on a functional outcome measure. The data obtained from this pilot clinical trial are essential to plan a large efficacy study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Probable ischemic stroke within prior 14 days

Exclusion Criteria:

* Any medical condition precluding the avoidance of supine posture or dictating the need for a particular position.
* Current use of CPAP (or other PAP), mechanical ventilation, or supplemental oxygen.
Safety Study of of Intravenous CCL2-LPM in Patients With IgA Nephropathy

The purpose of this study is to evaluate the safety of several dose levels of CCL2-LPM in patients with IgA Nephropathy who have high levels of protein in the urine.

In spite of adequate blood pressure control and diet, 30 percent of patients with IgA nephropathy continue to secrete large amounts of protein in the urine and have a high likelihood of progressing to end-stage renal disease over 5-10 years and eventually requiring dialysis or kidney transplant. In IgA nephropathy, the injured kidney tissue secretes a messenger that recruits white blood cells (leukocytes) into the kidney. This messenger is the chemokine, CCL2. As a consequence CCL2 also is excreted into the urine and can be measured as evidence of inflammation in the kidney. This study evaluates the safety of a new potential therapy,CCL2-LPM (leukocyte population modulator), for IgA nephropathy. CCL2-LPM is composed of the messenger chemokine, CCL2, fused to an enzyme that inhibits protein production by the leukocytes and prevents the leukocytes from migrating into the kidney. The CCL2 end of the molecule targets only a small subset of leukocytes that have the corresponding receptor for CCL2 on the surface. After CCL2 binds to its receptor it is drawn inside the cell and carries the enzyme into the cell. The targeted cells are prevented from entering the kidney and causing further damage. Thus, CCL2-LPM may interrupt the ongoing cycle of inflammation that leads to end-stage renal disease.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven IgA nephropathy
* GFR \> 30 mL/min
* Urinary protein \> 700 mg/day
* Stable serum creatinine
* Urine CCL2/creatinine \> 250 pg/mg
* Stable doses of medications
* ACEI and/or ARB maximized to control hypertension and proteinuria

Exclusion Criteria:

* Other causes of nephropathy
* Pregnant or nursing females
* Prednisone \> 10 mg/day
* Other prohibited medications
* BP \> 140/90
* BMI \> 35
* Concurrent infection requiring treatment
* Clinical significant concurrent medical conditions
* Known allergy or sensitivity to formulation ingredients
Efficacy of Tyrosine in Restless Legs Syndrome

Tyrosine is a non essential amino acid that is the precursor of the neurotransmitter, dopamine. Tyrosine is converted into Levodihydrophenylalanine (L-Dopa) and L-Dopa is subsequently and avidly converted into dopamine. It is well known that dopamine deficiency leads to the manifestations of restless legs syndrome (RLS). Studies have shown dopamine agonists and L-dopa to be effective in controlling symptoms. No studies to date have been done to determine the role of tyrosine in RLS. This open-label pilot study aims to determine the efficacy and tolerability of tyrosine in RLS, as current agents have limitations in treating RLS in addition to adding another possible agent to the investigators arsenal of treating RLS that maybe more cost efficient. In this pilot study, the dose of tyrosine will be escalated from 750 mg once daily by mouth (PO) up to 3000 mg once daily PO, as tolerated, in increments of 750 mg every week in patients who meet the inclusion criteria for RLS. Patients' symptoms will be monitored on a weekly basis for six weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 to 80 years and
2. Newly diagnosed (medication-naïve) as having restless legs syndrome (using the International Restless Legs Syndrome Study Group (IRLSSG20) diagnostic criteria with a score of greater than or equal to 15, see Appendix A) and
3. That interfered with sleep onset and/or maintenance for greater than four nights/week for a minimum of six months
4. Currently not receiving treatment for RLS

Exclusion Criteria:

1. Patients suffering from secondary RLS (other movement and/or primary sleep disorders, chronic renal insufficiency - calculated from the creatinine clearance, and/or iron deficiency - baseline serum ferritin level less than 10 ng/ml)
2. Patients currently on pharmacotherapy for RLS (not medication-naïve) or previous use of pharmacotherapy for RLS in the past
3. Patients that are pregnant and/or breastfeeding
4. Patients that are on levothyroxine or monoamine oxidase inhibitors
Bladder Diary for Diagnosing Bladder Oversensitivity

Urodynamic study is an invasive procedure and applied for diagnosis of bladder oversensitivity. Bladder diary is a non-invasive measurement. The aim of this study was to elucidate whether bladder diary is a good surrogate for diagnosing bladder oversensitivity.

Between July 2009 and December 2020, medical records of all women with lower urinary tract symptoms but without cystocele who visited the urogynecological department of a medical center for urodynamic evaluation were reviewed. Those women who have no complete data of a 3-day bladder diary were excluded from this study. Bladder oversensitivity was diagnosed if the volume of strong desire was less than 300mL. We compared the urodynamic parameters to bladder diary parameters in order to find the best correlation between these 2 measurements for the diagnosis of bladder oversensitivity.

STATA software was used for statistical analysis. Chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. A p \< 0.05 was considered as statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with lower urinary tract symptoms
* Complete a urodynamic study
* Complete a 3-day bladder diary

Exclusion Criteria:

* Women with cystocele
* Chronic infection
* Incomplete data
HF vs NIV in Acute Cardiogenic Pulmonary Edema

The study's primary aim is

* to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain.
* to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed.
* to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort).

Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and echocardiographic evaluation


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 y.o.;
* Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology (ESC) guidelines \[4\];
* Hypertensive crisis with systolic blood pressure \>200 mmHg;
* Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
* Written informed consent.

Exclusion Criteria:

* Age \<18 y.o.;
* Hypercapnia with respiratory acidosis (PaCO2 \> 45 mmHg with pH \< 7.35);
* History of fever in the previous 4 days;
* White blood cell count \> 12.000;
* Increased procalcitonin serum levels;
* Consolidative areas at chest radiograph;
* Hypotension (systolic blood pressure \< 85 mmHg);
* Cardiogenic shock;
* Right ventricular (RV) dysfunction;
* Previous cardiac surgery,
* Glasgow Coma Scale score ≤ 8 points;
* Impaired ability to protect the airway from aspiration;
* Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;
* Respiratory arrest;
* Severe hemodynamic instability;
* Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.