cyrilzakka/clinical-trials huggingface dataset:
Renal Resistive Index as a Predictor of Renal Involvement in Rheumatoid Arthritis

Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by synovial hyperplasia and inflammation, progressive joint destruction, and significant disability (1). It can occur at any age, but it predominantly affects women, with a peak onset between the ages of 40 and 60. RA etiology is not yet clear, Recent studies have shown that its mechanism is closely related to genetics, environment, and immune response. Genes such as MHC and HLA-DR4 are involved in the occurrence of RA. (2) Renal complications in RA can range from mild abnormalities in kidney function to more severe conditions, such as glomerulonephritis and renal amyloidosis. Understanding these renal complications is crucial for healthcare providers to ensure comprehensive care for RA patients. (3.4) Vasculitis is an uncommon complication of RA (in approximately 2 to 5% of patients), males with RA are more likely (2 to 4 times more likely) than females with RA to develop RV. Rheumatoid vasculitis most often occur in people with at least 10 years of severe disease. Fortunately, recent reports have noted declines in the prevalence of RV ( 5.6). So The renal arterial resistive index (RI)which is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70. Elevated values are associated with poorer prognosis in various renal disorders .

Eligibility Criteria:
Inclusion Criteria:

* Patients of rheumatoid arthritis è renal affection
* Patients of rheumatoid arthritis without renal affection
* Patients of rheumatoid arthritis on drugs (NSAIDs, DMARDS, methotrexate..).

Exclusion Criteria:

* Diabetic and hypertensive patients, patients with hepatitis B, C viruses or liver cell failure, patients with acute kidney injury, patients with another autoimmune disease as (SLE, sjogren disease, multiple sclerosis, patients with malignancy, patients on another drugs otherwise rheumatoid arthritis drugs).
Serum Level of Calpains Product as a Novel Biomarker of Acute Lung Injury Following Cardiopulmonary Bypass

More than 2 million patients worldwide receive heart surgery every year, majority of these surgical patients will undergo cardiopulmonary bypass. However, the incidence of postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%. According to clinical experience, the earlier lung damage is detected, the more successful the treatment will be. On the basis of traditional detection, the investigators found a new indicator, serum calpains, which are easy to obtain and have certain specificity. Importantly, they can predict postoperative acute lung injury within 1 hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with early decision-making advice and immediate treatment for patients who may be at risk.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Underwent cardiac surgery using CPB technology.

Exclusion criteria :

* Patient's lack of consent to participate;
* Presence of abnormal liver, kidney or other organ function;
* Pulmonary inflammation, chronic obstructive pulmonary disease or tumors;
* Underwent cardiac surgery without CPB technology;
* Postoperative need for extracorporeal membrane oxygenation support.
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the real-world setting


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed Multiple Sclerosis (MS) diagnosis.
2. Participants who have not received any BRIUMVI® (ublituximab-xiiy) infusion prior to study start. Participants who have been prescribed BRIUMVI® (ublituximab-xiiy) but have not yet received their first infusion on Day 1 of 150 milligrams (mg) can be included.

Exclusion Criteria:

1. Have received any live or live-attenuated vaccines (including for varicella-zoster virus or measles) within 4 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration or any non-live vaccines within 2 weeks prior to first BRIUMVI® (ublituximab-xiiy) administration.
2. Any active infection (e.g., active Hepatitis B virus \[HBV\])
3. Concurrent participation in any interventional MS trials, or planned concurrent treatment with other Multiple Sclerosis Disease Modifying Therapy (MS DMT) during the study period.
Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

The aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (SSc).

Diffuse cutaneous systemic sclerosis (SSc) is a rare autoimmune disease characterised by excessive connective tissue in the skin (causing skin thickening called 'scleroderma'), muscle, joints and internal organs. A number of different drugs with effects on the immune system (known as 'immunosuppressants') are currently being used by clinicians in the treatment of early diffuse cutaneous SSc, but all can have significant side effects. We want to know whether any one is definitely effective and, if so, which is the most effective.

Eligibility Criteria:
Inclusion Criteria:

Age \> 18 Skin thickening \< 3 years Immunosuppressant use \< 4 months Proximal skin involvement to face/neck, elbow or knee

Exclusion Criteria:

Previous use of more than 4 months of methotrexate, mycophenolate mofetil, cyclophosphamide or other immunosuppressive treatments

Previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil or cyclophosphamide within previous months

Previous stem cell transplantation therapy
Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 18-45 years old, inclusive.
* Body weight ≥50kg and Body Mass Index: 19.0\~25.0 kg/m2, inclusive
* subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.

Exclusion Criteria:

* Subjects who have a history of clinical significanct drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
* History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
* Subjects with serious systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
* Subjects who have used over-the-counter drugs, health products, herbal medicine or traditional Chinese medicine within 2 weeks before screening, or are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours before the first administration).
* Subjects who have used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before screening.
Genetic Study in Patients With Stage II or Stage III Colon Cancer

RATIONALE: Genetic studies may help in understanding the genetic processes that cause some types of cancer.

PURPOSE: Genetic trial to study certain genes of patients who have stage II or stage III colon cancer.

OBJECTIVES:

* Determine the adverse prognostic significance of 8p allelic imbalance (AI) in patients with colon cancer.
* Determine if patient prognosis is dependent on the region of 8p AI.
* Perform fine mapping studies to further localize the putative tumor suppressor gene(s) on 8p.
* Perform multicolor FISH to examine the role that 8p loss and 8q gain play in the prognosis of patients whose tumors exhibit 8p AI.

OUTLINE: Matched normal and tumor DNA is analyzed for 8p allelic imbalance with at least 8 markers: D8S262 and D8S1825 localized to 8p23, D8S254 and D8S261 at 8p22, D8S560 and D8S136 at 8p21, and D8S1820 and D8S283 at 8p12. Normal/tumor tissue pairs are used for fine mapping studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of resectable stage II or III adenocarcinoma of the colon
* Participated in NCCTG-914653
* DNA extracted from both normal and tumor tissue

PATIENT CHARACTERISTICS:

Age

* Under 70
Study in Pediatric Subjects With Epilepsy

This is an open-label study to evaluate the pharmacokinetics, safety and tolerability of ezogabine/retigabine in subjects aged 12 years to less than 18 years with uncontrolled partial onset seizures or Lennos-Gastaut syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Between 12 and 18 years of age.
* Diagnosis of uncontrolled partial onset seizures (with or without secondarily generalized seizures) or Lennox-Gastaut syndrome.
* Taking between one and three antiepileptic drugs.
* Able to swallow tablets.
* Females must be of : (1) Non-childbearing potential or (2) Child-bearing potential and agrees to use acceptable contraception.

Exclusion Criteria:

* Epilepsy secondary to progressive cerebral disease, tumor or any progressive neurodegenerative disease.
* History of status epilepticus in the last six months.
* Currently treated with felbamate or has been treated with vigabatrin within the past 6 months.
* Following the ketogenic diet.
* Suicidal intent or history of suicide attempt in the last 2 years.
* Elevated liver enzymes or abnormal kidney function.
* Current disturbance of micturition or known urinary obstructions.
* History of vesicoureteric reflux.
* Abnormal post-void residual bladder ultrasound.
* Urinary retention and/or required urinary catheterization in the preceding 6 months.
* Abnormal urine sample at screening/.baseline.
* Abnormal blood sample at screening.
* Clinically significant arrhythmias.
* Abnormal ECG at screening.
* BMI lower than the 10th percentile for age and gender or subject weighs less than 30kg.
Effects of Artificial Sweeteners on Glucose Metabolism in Patients With Type 2 Diabetes

To investigate the effects of artificial sweeteners on glucose metabolism in newly diagnosed type 2 diabetic patients

Artificial sweeteners are among the most widely used food additives worldwide. Artificial sweeteners consumption is considered safe and beneficial owing to their low caloric content. However, recent studies demonstrated that consumption of commonly used artificial sweeteners formulations drives the development of glucose intolerance in healthy human subjects. However,the effects of artificial sweeter on glucose metabolism in newly diagnosed type 2 diabetic patients remains unknown. Thus, different doses of sweeteners will be given to newly diagnosed type 2 diabetic patients to investigate the effects of artificial sweeteners on glucose metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Participants with newly diagnosed type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital, Shanghai PuNan hospital，Shanghai ShiBei hospital, shanghai xinhua hospital, chongming branch;
* FBG≤ 9 mmol/L, HbA1c≤ 7% ;without any oral hypoglycemic agents or insulin,
* Age ≥30 and ≤ 60 years old.
* BMI \>24 and \<28 kg/m2; --no regular consumption of artificial sweeteners or foods that have added much sweeteners.(eg:Coca-Cola zero), no sucralose intolerance.

Exclusion Criteria:

* patients who had a history of acute and chronic diarrhea or constipation or severe chronic gastrointestinal disease..
* underwent enterectomy or other abdominal surgery (e.g., gallbladder removal) within one year;
* take antibiotics, antidiarrheic, antispasmodic, steroids and immune agents within three months.
* Patients who had a history of abnormal renal function(creatinine \>132μmol/L), active liver disease(ALT were 2.5 times higher than the normal upper limit), or accompany with other sever diseases, such as severe infection, severe anemia, neutropenia and mental illness.
* Other serious heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated heart disease,cardiac function(NYHA) classification\>level III.
* A history of acute complications such as diabetic ketoacidosis or hypertonic coma within 3 months.
* pregancy
* Allergic to sweeteners.
* participant in any clinical trail within 3 months
SBRT Combined With Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC

The study is a phase II clinical study. The purpose of the study is to evaluate the efficacy and safety of SBRT combined with Fruquintinib Plus PD-1/CTLA-4 Antibody for Third-line Treatment in mCRC.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have biopsy proven unresectable MCRC.
2. Patients must have received first-line and second-line chemotherapy, and approved a progressive disease.
3. Age ≥ 18 years
4. Patients must have measurable disease at baseline.
5. Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
6. Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
7. Patients must have a Karnofsky Performance Scores (KPS) \>60 8. Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin must be within the limit of normal.

9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. 10. Patients should have adequate renal function (serum creatinine ≤1.5 times the ULN). 11. Females of childbearing potential should have a negative pregnancy test. 12. Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.

13. Patients must provide verbal and written informed consent to participate in the study.

14. Total bilirubin: within normal institutional limits

Exclusion Criteria:

1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
2. Patients with serious, uncontrolled, concurrent infection(s).
3. Significant weight loss (\>10%) in the prior 3 months.
4. Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
5. Patients with more than 5 discrete metastatic lesions.
6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
7. Unwillingness to participate or inability to comply with the protocol for the duration of the study.
8. Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring (CGM) obtained during pulmonary exacerbations, both outpatient and inpatient, in youth with cystic fibrosis (CF).

This research is using continuous glucose monitoring (CGM) to study changes in blood sugar levels that may occur in youth with cystic fibrosis (CF) and cystic fibrosis related diabetes (CFRD) who experience a pulmonary exacerbation (PEx), whether admitted to the hospital or seen in clinic. We hypothesize that 1) youth experiencing a PEx will have greater blood sugar changes during the PEx than at least 6 weeks after the PEx , 2) that the changes in blood sugars will be greater during the PEx when compared to CGM data gathered at a baseline visit prior to the PEx (when available), 3) and that blood sugar changes during the PEx will compare with changes in short-term clinical outcomes collected using questionnaires about breathing problems, and that this data will be predictive of the need for additional antibiotics. This study aims to compare CGM measures of change during a PEx with those measured after recovery; to compare CGM measures of change during the PEx to those taken at baseline; and to examine the relationships between these changes and the changes in clinical findings including the need for additional antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* 6- 25 years old
* Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations)
* access to a smart phone and/or internet connection and the ability to complete remote telehealth visits

Exclusion Criteria:

* known type 1 or type 2 diabetes, monogenic diabetes
* critical illness requiring admission to the ICU
* pregnancy
Interventions to Decrease the Impact of Post-OPerative Ileus After Liver Transplant or Resection Surgery

This is a randomized controlled trial to assess ways to address post-operative ileus (POI) in adult patients on the liver transplant service undergoing either liver transplant or resection surgery. Patient who speak and understand English will be randomized into one of three groups including a.)control group receiving standard therapy for post-operative ileus, b.)group receiving standard therapy and acupressure bracelets, and c.)group receiving standard therapy and sugar free gum four times daily.

Any patient undergoing liver transplant or resection surgery will be asked to participate in the study and assigned to a control or investigational group. Pertinent information will be collected from the medical record including gender, age in years, diagnosis, type of surgery, length of stay, medications used for pain or nausea, and first bowel movement. The subjects will also be asked to keep a journal of their bowel habits, signs and symptoms of gastrointestinal distress/post-operative ileus, use of medications, first bowel movement, satisfaction with bowel management and any additional comments.

Aims of the study are to determine the effectiveness of the three arms of this trial for the resolution of POI as noted by first post-operative bowel movement; to determine if there is a difference in the length of stay based on the interventions; and to determine if there is a difference in patient satisfaction based on the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients 19 years or older who speak and read English and have had a liver transplant or liver resection surgery

Exclusion Criteria:

* Patients less than 19 years of age having liver transplant or liver resection surgery
* Non-English speaking
* Pregnancy
Amino Acid-based Oral Rehydration Solution in Children With Short Bowel Syndrome

This study will assess the tolerability and palatability of an amino acid based oral rehydration solution (enterade®) compared to current oral rehydration solution among children with short bowel syndrome .

Patients with short bowel syndrome (SBS) have a critical reduction of the gut mass/function that is below the minimum needed to absorb nutrients and fluids required for adequate homeostasis. There are limited data regarding the optimal choice for oral rehydration in the setting of SBS that can maximize fluid absorption in the setting of diarrhea with limited intestinal absorptive surface area. The investigators propose a preliminary open label single center study assessing tolerability and palatability of enterade® ( an amino acid (AA) based oral rehydrating solution (ORS)) and compare to baseline. Eligible patients with SBS will participate in a 14-day trial monitoring and measuring tolerability and palatability of an AA-ORS, enterade®, in addition to their regular diet.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a diagnosis of short bowel syndrome (as defined by surgical therapy for congenital or acquired gastrointestinal disease) between the ages of 1-17
* Patients who are in intestinal continuity or with diverting ileostomy, jejunostomy
* Patients must be on a stable enteral nutrition regimen with oral rehydration fluids that are taken orally.
* Stable GI medication regimen (e.g., loperamide, cholestyramine, small bowel bacterial overgrowth (SBBO) regimen)

Exclusion Criteria:

* Patients receiving IV antibiotics within the previous 72h.
* Patients with a primary diagnosis of a motility disorder (e.g., chronic intestinal pseudo-obstruction) or epithelial cell disorder (e.g., microvillus inclusion disease)
* Malnourished (as defined by Weight/Height Z-score (WHZ) \<-2)
Application of Three-Dimensionally Printed Navigational Template in Lung Biopsy

This is a prospective, randomized, controlled study to evaluate the diagnostic yield and safety of three-dimensionally printed navigational template in percutaneous transthoracic lung biopsy.

The feasibility of three-dimensionally printed navigational template-guided percutaneous transthoracic fine-needle aspiration was validated by a phase I study. To further investigate the non-inferiority of navigational template-guided lung biopsy to conventional CT-guided modality in terms of diagnostic yield, this prospective, randomized, controlled, noninferiority trial was conducted.

Eligibility Criteria:
Ⅰ. Inclusion Criteria:

A. CT confirmed peripheral lung lesion;

B. Nodule size larger than or equal to 30 mm;

C. Scheduled for percutaneous transthoracic fine-needle aspiration;

D. Percutaneous transthoracic lung biopsy was conducted at supine or partially lateral decubitus;

E. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;

F. Written informed consent provided.

Ⅱ. Exclusion Criteria:

A. Biopsy needle insertion route impeded by skeletal structures;

B. Lesion within 3 cm above diaphragmatic dome;

C. Insertion route longer than the biopsy needle;

D. Lung biopsy needed to be conducted at vertically lateral decubitus;

E. Any contraindication of percutaneous transthoracic lung biopsy;

F. Women who are pregnant or in the period of breastfeeding.