cyrilzakka/clinical-trials huggingface dataset:
Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis

Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.

In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.

Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).

It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.

The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Maintenance hemodialysis (\> 3 months duration)
* Informed consent

Exclusion Criteria:

* No consent
Effects of Resistance Exercise on Metabolic Responses

Healthy young adults will complete three trials in a randomized crossover counter-balanced order, including two different loads of resistance exercise and sedentary control. During each trial, blood samples will be collected.

The investigators hypothesized that high-load and low-load resistance exercise exert similar metabolic responses.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-30
* Healthy male
* Without experience of resistance training

Exclusion Criteria:

* No acute or chronic musculoskeletal symptoms
* Smoking
* Alcohol or drug abuse
* Fail to conduct resistance exercise
Study In Urology Practices Looking At Impact Of OncotypeDX GPS Test On Men Choosing And Remaining On Active Surveillance

Genomic Health's OncotypeDX® Prostate Cancer Assay is a commercially available laboratory test that measures the activity of certain genes in prostate cancer. The purpose of this study is to better understand how the use of this test result impacts or affects treatment decisions for men newly diagnosed with low risk prostate cancer, their confidence in the treatment decision, and the effects and side effects of the treatment chosen on certain aspects of Quality of Life. This study will also determine what percentage of men choosing an active monitoring program as prescribed by their doctor remain on Active Surveillance and have avoided any treatment at one year after diagnosis after receiving the assay result.

This is a multicenter observational study that evaluates eligible patients who will submit prostate cancer diagnostic biopsy tissues for Oncotype DX Prostate Cancer Assay testing. A physician treatment recommendation will be made and the assay is ordered. The physician will review clinical data, the GPS report and discuss treatment options with the patient. At the following visit, a shared physician-patient treatment decision (immediate treatment or AS) will be made.

Men selecting AS as primary treatment will be followed to assess persistence on AS.

There is no required or standardized AS protocol for this study and the intensity of surveillance will be at the discretion of the investigator. Patients will not be required, but may undergo a standard TRUS guided surveillance biopsy at one year. In this study, the Oncotype DX Prostate Cancer Assay will be assessed on the diagnostic biopsy only and will not be assessed on subsequent biopsies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage T1c/T2
* PSA ≤ 20ng/mL
* Biopsy GS ≤ 6 with any number of cores positive, or Biopsy GS 3+4 disease with ≤3 positive cores or ≤ 33% positive cores
* The patient must be ≥ 50 years of age
* The patient must have a life expectancy of \> 10 years
* Patient must be able to give consent in English or Spanish

Exclusion Criteria:

* Clinical stage T3a or above
* PSA \> 20ng/mL
* Biopsy GS 4+3 or \> 8
* Known metastatic prostate cancer
* Positive biopsy for prostate cancer \> 3 months ago
* Treatment decision has already been made
* Insufficient tumor in prostate biopsy tissue to perform the assay
* Treatment with androgen deprivation therapy (ADT) prior to prostate biopsy
* Diagnosis made by transurethral resection of prostate (TURP) shavings
* Any psychiatric or psychological conditions
* Contraindications to primary treatment according to physician's judgment
Low-calorie Diet in Isolated Impaired Fasting Glucose

This study aims to evaluate the preliminary efficacy of a low-calorie diet (LCD) intervention in addressing the underlying pathophysiological abnormalities and improving fasting hyperglycemia among individuals with isolated impaired fasting glucose (i-IFG). Additionally, it seeks to assess the feasibility and acceptability of the LCD intervention.

This proof-of-concept randomized controlled trial (RCT) will enroll 34 individuals aged 35-65 years with overweight or obesity and isolated impaired fasting glucose. Intervention participants will adhere to an 8-week low-calorie dietary (LCD) regimen (\~1,320 kcal/day) comprising specific macronutrient proportions (55% carbohydrate, 13% fat, 25% protein, and 2% fiber). Control participants will maintain their habitual dietary habits and physical activity levels. Primary outcomes at 8 weeks include between-group changes in weight, fasting plasma glucose, indices of ß-cell function and hepatic insulin resistance, and alanine aminotransferase levels. Secondary outcomes are feasibility metrics (response rate, screening yield, enrollment rate, intervention compliance, cost, staff time, and retention rate) and intervention acceptability. Qualitative research will explore facilitators, barriers, acceptability, satisfaction, and participant experiences with the LCD intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 35 to 65 years
2. Overweight (body mass index (BMI) ≥25 to \<29 kg/m² or ≥23 to \<29 kg/m² if Asian descent) or Obese (BMI ≥30 kg/m²)
3. Physically inactive (\<150 minutes per week of moderate-intensity physical activity or \<75 minutes per week of vigorous-intensity physical activity)
4. Prediabetes diagnosis or score ≥5 on the American Diabetes Association (ADA) risk tool

Exclusion Criteria:

1. Diagnosed with type 1 or type 2 diabetes
2. Cardiovascular disease (myocardial infarction, stroke, angina, heart failure, or other cardiac conditions)
3. Chronic kidney disease
4. Chronic liver disease (e.g., cirrhosis)
5. Cancers
6. Acute inflammatory bowel disease, irritable bowel syndrome, celiac disease, chronic pancreatitis, or other disorders potentially causing malabsorption
7. Food allergies
8. Participation in weight loss programs in the past six months
9. Currently following a specific diet (e.g., ketogenic diet, Mediterranean diet)
10. Participation in any exercise programs in the past six months
11. Currently taking weight-loss medications or drugs known to affect glycemia (steroids and antipsychotics)
12. Previous bariatric surgery or plan to have bariatric surgery during the study period
13. Planning to relocate during the study period
14. Intending to fast during the study period for religious or other reasons
15. Pregnancy or planning to become pregnant during the study period
16. Breastfeeding
17. Non-English speaker
Hyaluronan in Embryo Transfer Media

Prospective randomized double blind comparison of hyaluronan enriched embryotransfer media and conventional embryotransfer media in human IVF treatments. Embryos selected for transfer are incubated in a culture media containing high concentration of hyaluronan or low concentration of hyaluronan.

Primary outcome: implantation and pregnancy rates


Eligibility Criteria:
Inclusion Criteria:

* Infertile patients
* entering in vitro fertilization treatment
* at least 1 embryo transferred

Exclusion Criteria:

* IVF treatment with donated oocytes
* No embryo available for transfer
Peripheral Inflammation and Brain Structural Alterations in Patients With Disorders of Consciousness.

Evidence suggests that inflammatory processes are key elements in the secondary effects of severe traumatic brain injury (TBI). The present study was designed to examine whether the peripheral inflammatory markers and brain structural alterations be associated with clinical measures and primary outcome following severe TBI. We hypothesized that peripheral inflammatory markers might be correlated with voxel-based GM volumes in patients with disorder of consciousness.

Background: Systemic inflammation, neurocognitive impairments, and morphologic brain changes are associated with outcome in patients with disorder of consciousness.

Objective: The aim of this study is to assess the value of peripheral inflammatory markers and brain structural alterations in the chronic phase after severe traumatic brain injury.

Methods: Serum levels of Interleukin (IL)-1β, IL-4, IL-6, IL-10, IL-13 and TNF-α were investigated in patients with chronic disorder of consciousness and healthy volunteers. Correlations were carried out between GM, WM, and CSF volumes and inflammatory cytokines levels. In addition, the Coma Recovery Scale-Revised (CRS-R) score was used to quantify the severity, and long-term recovery clinical outcome at 12 month was determined according to Glasgow Outcome Scale (GOS).

Eligibility Criteria:
Inclusion Criteria:

1. Patients ages 14 to 65 years old;
2. Patients had a history of sTBI;
3. Patients had awakened from a coma (indicating preserved sleep-wake cycles), including vegetative state and minimally consciousness state;
4. Patients stay unconscious for more than 1 month.

Exclusion Criteria:

1. Patients with acute infectious diseases or liver dysfunction;
2. Patients with serious diseases such as cardiac or pulmonary problems.
Evaluation of an Anti-Shivering Protocol Cardiac Arrest

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019.

This will be a single center, retrospective, before-and-after, chart review of all patients undergoing TTM between June 1, 2017 and May 31, 2021 at MDMC. Initiation of the new TTM protocol occurred on April 22, 2019. To allow for an adequate washout period, patients who were initiated on TTM before April 22, 2019 will be in the "before" group and patients initiated on TTM on or after June 1, 2019 will be in the "after" group. Patients will be identified based on electronic medical records search of order sets utilized in TTM and confirmed with manual chart review. Statistical analysis will be performed as detailed below.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Diagnosis of cardiac arrest
* Initiation of TTM via Arctic Sun® device

Exclusion Criteria:

* Initiation of TTM \> 12 hours after cardiac arrest
* Receiving NMBs for an indication other than TTM
* Early termination of TTM (less than 24 hours)
Antibiotic Treatment in Ventilator Associated Tracheobronchitis (VAT)

Mechanically Ventilated patients in the intensive care unit (ICU) often present with fever, and purulent sputum, but without radiological evidence of pneumonia.

These patients may have tracheobronchitis. Some suspect that this condition precedes the development of pneumonia. Antibiotic treatment in tracheobronchitis is controversial.

The investigators will recruit patients with tracheobronchitis and randomize them into 2 groups. One group will be treated with antibiotics and the other group will serve as control.

Patients with proved tracheobronchitis who are mechanically ventilated for more than 48 hrs, will undergo a CT scan to rool our pneumonia that may not be seen on a routine chest x-ray.

After ruling out pneumonia by CT scan, patients will be randomized into 2 groups. Intervention group will receive 7 days of treatment with Piperacillin/Tazobactam. A control group will receive nothing.

Primary endpoint wil be the rate of new pneumonias and secondary endpoint will be ICU Length of stay, days on mechanical ventilation and 28 day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Tracheobronchitis as defined by:

  * Purulent sputum with \> 10 x 4 CFU
  * Leukocytosis or leukopenia
  * Fever
  * No pneumonia on CT scan

Exclusion Criteria:

* Recent treatment of pneumonia
* Abnormal Chest X-ray
* Evidence of Pneumonia on CT scan
Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies Beyond the Season

This a sub-study of a 5-year study designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients beyond the season of vaccination.

Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations.

Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year.

It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals.

Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests.

\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

Eligibility Criteria:
Inclusion Criteria:

* Receiving care Post-lung transplant at University of Wisconsin Hospital
* Healthy adult

Exclusion Criteria:

* Allergy to eggs
* Moderate to severe febrile illness
* Active treatment for acute rejection
* Received season's influenza vaccine prior to enrollment
D2 Versus D1 Gastrectomy of Operable Gastric Cancer

Surgery is the mainstay treatment of operable gastric carcinoma but the optimal extent of lymph node (LN) dissection is controversial. The aim of this observational study is to assess the outcomes after curative D2 compared to D1 gastrectomy of operable gastric carcinoma regarding operative and long term oncological outcomes.

This observational study included 80 consecutive patients presented by operable gastric cancer treated by D2 gastrectomy at Alexandria University hospital between January 2010 and January 2016, (Group I). Another 68 consecutive patients presented by operable gastric cancer treated by D1 gastrectomy earlier during the same period were included as a control (Group II). All patients had undergone preoperative gastroscopy and biopsy, chest and abdomen computed tomography (CT). All surgeries were performed by surgeons experienced in both D1 and D2 dissection and a standardized protocol for D1 and D2 gastrectomy was followed in all patients. The type of gastrectomy (distal or total) was done according to the site of the tumor; distal gastrectomy was done if there is a free safety margin of 4 cm beyond the proximal resection line otherwise total gastrectomy was done. Resection of the spleen and/or pancreatic tail were done if directly invaded by the primary tumor or metastatic LN. Patients with p T2 or greater, or with positive LN received adjuvant chemotherapy. Follow up was done as outpatient visits for average 5 years. Both groups were compared regarding postoperative morbidity and mortality, disease recurrence and survival rates.

Eligibility Criteria:
Inclusion Criteria:

* Patients younger than 80 years with a histologically confirmed operable adenocarcinoma of the stomach with complete follow up after surgery for average 5 years

Exclusion Criteria:

* Complicated gastric cancer (obstructed or perforated)
* Irresectable or metastatic disease
* Previous or coexisting cancer
* Prior gastric surgery.
The Potential Role Of MicroRNA-155 And Telomerase Reverse Transcriptase In Diagnosis Of Non-Muscle Invasive Bladder Cancer And Their Pathological Correlation

We try to assess the potential role of telomerase reverse transcriptase and MicroRNA (miR-155) in diagnosis of non-muscle-invasive bladder cancer and their correlation with stage and grade of the tumor.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years or older.
* Patient with hematuria suspected to be of bladder origin clinically.
* Willing to be participate in the study.

Exclusion Criteria:

* Patient having another malignancy.
* Hematuria of other causes as trauma and stones
Dual-task Training Combined with TDCS on Cognitive-motor Performance and Brain Activity in Stroke Patients

The purpose of this study is to evaluate tDCS combined with cognitive-motor training on dual-task interference during dual-task walking, dual-task foot pedaling and the corresponding alterations of brain activity.

In China, the prevalence of stroke increased by 106.0% (93.7-118.8) between 1990 and 2019, highlighting the persistent and substantial burden of this condition. Post-stroke recovery, particularly the ability to achieve community ambulation, plays a critical role in improving health-related quality of life. Effective community ambulation in daily life requires the ability to dual-task-namely, to perform concurrent tasks requiring attentional resources while maintaining walking function and balance. Emerging evidence suggests that stroke survivors face greater challenges in walking function and dual-task balance compared to their age-matched, able-bodied counterparts. For instance, when tasked with recalling a shopping list while walking, stroke patients exhibit a more pronounced decline in both walking speed and cognitive performance relative to control groups. Given the necessity for stroke survivors to reintegrate into the community, it is imperative to thoroughly investigate this phenomenon of cognitive-motor interference.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of stroke, stroke onset of more than 6 months,
* aged 50 or more,
* capable of following verbal and visual instructions,
* having a Montreal Cognitive Assessment score ≥ 22,
* able to walk for 10 meters with/without a mobility aid,
* community-dwelling, unilateral stroke

Exclusion Criteria:

* neurological disorders, gait-precluding pain or comorbidity,
* receiving any formal rehabilitation training,
* contraindications to exercise (e.g., unstable angina),
* contraindications to fNIRS, MRI, and tDCS (e.g., brain skin injury, pacemaker, metal implants in the brain),
* history of seizure or epilepsy,
* color blindness.
* unable to walk with/without a mobility aid while responsing stimulus by the remote control
Travoprost Intraocular Implant in Conjunction With Cataract Surgery

Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* clinically significant age-related cataract eligible for phacoemulsification in the study eye
* open-angle glaucoma or ocular hypertension in the study eye
* successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL

Exclusion Criteria:

* unmedicated (washed out) IOP of \>36 mmHg in the study eye
* hypersensitivity to travoprost or any other components of the travoprost intraocular implant
* vertical cup/disc ratio \> 0.8 in the study eye
* best spectacle corrected visual acuity of worse than 20/80 in the fellow eye
* any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study