cyrilzakka/clinical-trials huggingface dataset:
Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction Versus Standard Robot-Assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy Surgery: A Comparative Prospective Study of 300 Patients

To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.

300 consecutive patients with clinically localized PCa underwent RS-RARP-S (Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction) or S-RARP (Standard RARP) or LRP by 6 experienced surgeons regardless of clinicopathological features. The indication for one technique or the others were surgeon preference; one surgeon exclusively performed RS-RARP-S( did not exclude high risk cases or those with apical and anterior tumors), two surgeons performed S-RARP, and three surgeons exclusively performed LRP. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures.

The primary outcome is early recovery of urinary continence compared to the conventional approach.

Eligibility Criteria:
Inclusion Criteria:

* Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent

Exclusion Criteria:

* Insufficient knowledge of German Severe cognitive impairment Obesity (BMI \> 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims
Predictive Value of Tumor Vascular Normalization Scoring in HER-2 Positive Breast Cancer

This study aims to evaluate the predictive value of the tumor vascular normalization score for the efficacy of neoadjuvant therapy in HER-2-positive breast cancer and explore its potential as a predictive biomarker. Through longitudinal observation of HER-2-positive breast cancer patients receiving standard treatment, we will analyze the correlation between vascular normalization scores and treatment responses (including objective response rate \[ORR\] and pathological complete response \[pCR\]) to optimize individualized therapeutic strategies. Additionally, an exploratory investigation will assess the impact of ginsenoside-containing formulations (e.g., Jinxing Capsule, Shenyi Capsule, Yiqi Jianpi Oral Liquid) on tumor vasculature and neoadjuvant therapy outcomes in HER-2-positive breast cancer, providing scientific insights for complementary therapeutic interventions.


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients aged ≥18 years planned for neoadjuvant therapy.
* Histopathologically confirmed HER2-positive status (IHC 3+ or IHC 2+ with positive FISH confirmation).
* Mentally competent, no psychiatric disorders, with good compliance to treatment and follow-up.
* Voluntarily participate and provide written informed consent.

Exclusion Criteria:

* HER2-negative breast cancer.
* Pregnant, planning pregnancy, or lactating women.
* History of allergic predisposition or known/suspected allergy to study drugs.
* Participation in other clinical trials within the past 4 weeks or planned enrollment.
* Other conditions deemed ineligible by the investigator.
Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis

Traditional antiviral treatments, including systemic acyclovir, have shown effectiveness in resolving keratitis but can also lead to complications, including ocular surface toxicity and the development of acyclovir-resistant strains of HSV. Topical ganciclovir 0.15% ophthalmic gel presents a safer alternative for managing herpetic keratitis, offering effective viral suppression with minimal toxicity. This study aims to compare the efficacy and safety of topical ganciclovir versus systemic acyclovir in treating herpetic keratitis, providing valuable insights into optimal management strategies for this condition


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with herpetic keratitis

Exclusion Criteria:

* Patients with known allergies to ganciclovir or acyclovir
* Severe ocular surface disease
* Those who have previously received antiviral therapy for herpetic keratitis within the last month
Effect of Left Posterior Pericardiotomy for the Prevention of POAF

This study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. Eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.

Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (CABG), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. There is evidence that pericardial effusion can trigger the occurence of POAF. Therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of POAF after CABG.

Patients who are planned to undergo off-pump CABG will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. Secondary outcomes will include early clinical outcomes and hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* patients who are planned to undergo coronary artery bypass grafting
* patients aged ≥19 years

Exclusion Criteria:

* patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures)
* patients who undergo coronary artery bypass grafting using cardiopulmonary bypass
* patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation
* patients who have a history of cardiac surgery
* patients who have a history of pericardial disease
* patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy
* patients who refuse to participate in this study
Skin Care for Cancer Patients: A Product Satisfaction Survey

This study is being done because the investigators would like to evaluate product satisfaction of three test products (product A, product B, product C) that are available at any drug store. This will be done by measuring any changes in the subjects' answers to the Skindex-16 questionnaire at two time points (at screening and baseline visit and at follow-up visit) and by evaluating their responses to the product satisfaction survey that will be given to them by a study coordinator.

The primary objective of this study is to evaluate product satisfaction of the following test articles A, B, and C: Lindi Skin soothing balm (product A), Lindi Skin face serum (product B), and Lindi Skin face wash (product C). This will be done by measuring change in Skindex-16 questionnaire at two time points (baseline and follow-up visits) and by evaluating responses to the investigator administered product satisfaction survey.

The secondary objective of this study is to see if there is any correlation between product satisfaction and grade of skin toxicity based on NCI-CTCAE v.3.0 scale.

Participants in this study will be patients seen at the Northwestern University SERIES clinic or Lurie Cancer Center who are receiving chemotherapeutic and or radiation treatments. Subjects who choose to participate complete a Skindex16 questionnaire, and will after consenting to participate, be given all three test articles A, B, and C to use daily for one month. (These test articles are currently marketed products classified by the FDA as cosmetics).

At the return visit, 1 month after baseline visit, the participant will be asked to return the test articles and complete an investigator administered product satisfaction questionnaire for each test article used. 100 participants will be surveyed. Subjects will be telephoned to check for product compliance after 1 week and 2 week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who have the willingness and ability to understand and provide informed consent to participate in the study and are able to communicate with the investigator.
* Subjects who are seen in the SERIES clinic or Lurie Cancer Center and who are receiving chemotherapy and/or radiation treatment for malignancy
* Subjects who have grade \<2 skin toxicity based on NCI-CTCAE v3.0 scale.
* Subjects who are routine cosmetics users

Exclusion Criteria:

* Under 18 years of age.
* Known allergy to any of the ingredients in the assigned products (Appendix C).
* Subjects who have grade 2,3,4 skin toxicity based on NCI-CTCAE v3.0 scale.
* Subjects who are pregnant, breast feeding, or those who are planning on becoming pregnant during test period.
* Subjects who use multiple topical agents on study areas
Efficacy and Tolerance Study on the Use of the In-exsufflator in the Hospitalized Elderly

The mechanical in-exsufflator (MI-E) is a medical device used to facilitate coughing when the patients' cough is not efficient. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular disorders however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.

Background: One of the most frequent reasons for hospital admission of older adults are respiratory disorders. Physiological aging processes decrease respiratory muscle strength and can reduce the efficacity of cough. The mechanical in-exsufflator (MI-E) is a medical device used to help coughing. Studies have shown positive results in helping airway clearance in children and adults with neuromuscular pathologies however there is lack of evidence in older populations. This study's aim is to evaluate the feasibility of the MI-E in older adults. The hypothesis is that the use of MI-E in older adults is feasible.

Methods: Feasibility will be evaluated by outcomes such as the discomfort of each session (use of a numerical scale of discomfort from 0 to 10) and the relief felt before and after each session (use of a modified Borg scale to quantify dyspnea). Two sessions a day of MI-E will be done for a total of four sessions. Furthermore, other outcomes shall be used, before and after each session, such as vital signs (heart and respiratory rate, blood pressure and oxygen saturation), auscultation as well as the measure of cough peak flow.

Discussion: The protocol of this study is the first to evaluate the use of MI-E in hospitalized older adults by the measure of discomfort and relief. In regard to literature on the use of MI-E in patients suffering from neuromuscular pathologies and on the effects of aging on the respiratory system, the hypothesis of the study seems justified. On top of bringing physical benefits to the patient, the study will pave the way for other randomized controlled studies.

Eligibility Criteria:
Inclusion Criteria:

* patient hospitalize in Intensive Care Unit or Pulmonary Unit,
* having airway clearance problem associated with mucus hypersecretion,
* peak expiratory flow (PEF) \<280 l/min,
* medical indication for respiratory physical therapy.

Exclusion Criteria:

* contraindication to use of MI-E device (ex. bronchospasm, immediate follow-up to surgery of airway system, chest or abdominal region, untreated pneumothorax, hemodynamic failure, etc.),
* refuse to participate,
* pregnant,
* breastfeeding,
* insufficient cognitive status.
Ashwagandha for Cognitive Dysfunction

This is a 1:1 randomized double blinded placebo controlled trial. • To determine if ashwagandha can improve cognitive dysfunction when compared with placebo in patients undergoing chemotherapy for cancer.

Patients are eligible if they are currently undergoing chemotherapy or treatment with chemotherapy in the past year and state that they notice thinking or memory problems. Patients will be given FACT-Cog PCI (Version 3). Patients that score less than 63, a score that reflects moderate to severe cognitive problems, are confirmed eligible. Subjects will be randomized 1:1 in blocks of 4.

Thyroid hormone testing will be conducted at baseline and at the end of week 6 for patients with a history of thyroid disease.

Patients will receive ashwagandha 350 mg po BID or placebo. The investigators and participants will be blinded to group assignment.

Endpoint testing including the FACT-Cog PCI and total score, Hopkins verbal learning test, trail making test (abstraction and executive function), and Mini Mental Status Exam (MMSE) will be administered at baseline and after 9 weeks of treatment. Six months after stopping the study, patients will receive a link to a REDCap database to complete the FACT-Cog and state whether they used ashwagandha once they completed the study.

Active study participation will be for 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and older
2. English speaking
3. Currently undergoing chemotherapy or treatment with chemotherapy in the past year
4. Self-reported memory loss, attention, visual-spatial functioning, reasoning, or information processing or cognitive changes in the first 2 cycles of chemotherapy and score \< 63 on the FACT-Cog PCI
5. Able to follow instructions for testing and comply with testing
6. Able to swallow pills

Exclusion Criteria:

1. Undergoing treatment for any hormone dependent cancer
2. Planned surgical treatment
3. History of pre-existing dementia, untreated depression, psychiatric disorder, prior brain radiation or brain injury
4. History of hypotension
5. Active autoimmune disease
6. Brain metastasis
7. Taking any drugs daily that would alter cognition
8. Concurrent use of benzodiazepenes or other sedatives
9. Concurrent use of supplements that can cause sedation such as 5-HTP, calamus, California poppy, hops, Jamaican dogwood, kava, St.John's Wort, skullcap, valerian, yerba mansa
10. Currently taking hypoglycemic medications
11. History of substance abuse
12. Current or recent diagnosis of stomach ulcer or gastritis
Dynaloc for Treatment of Femoral Neck Fractures

A prospective, randomized study comparing the effectiveness of a new system, Dynaloc compared with three cancellous screws, for osteosynthesis of femoral neck fractures


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women (see age specifications below) with subcapital femoral neck fractures (stable or unstable) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
* Patients between 50 and 69 years of age with any Garden type femoral neck fracture
* Patients older than 70 years of age with femoral neck fractures Garden type I and II
* Patients older than 70 years of age with a femoral neck fracture Garden types III and IV and contraindication to hemiarthroplasty.
* Operative treatment within 4 days (i.e., 72 hours) of presenting to the emergency room.
* Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
* Anticipated medical optimalization of the patient for operative fixation of the hip.
* Provision of informed consent by patient or proxy.
* Low energy fracture (defined as a fall from standing height).
* No other major trauma.

Exclusion Criteria:

* Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
* Retained hardware around the affected hip.
* Abnormal opposite hip making end-point evaluation impossible
* Infection around the hip (i.e., soft tissue or bone).
* Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget's disease, renal osteodystrophy).
* Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors).
* Patients with Parkinson's disease (or dementia or other neurological deficit) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
* Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
Diagnostic, Risk Stratification and Prognostic Value of Novel Biomarkers in Patients With Heart Failure

The objective of this work is to investigate and then to sequence new biomarkers in the blood of patients with heart failure, and study their diagnostic, risk stratification and prognostic value.

Blood samples (plasma or serum) for heart failure patients presenting dyspnea or edema and with increased NT-proBNP. The objective of this work is to investigate and then to sequence new proteins or microRNAs in the blood of these patients for diagnostic, risk stratification and prognostic purpose.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years of age
2. Symptomatic (NYHA class II-IV) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level)
3. Hospital admission, Emergency Department visit, or outpatient diuretic escalation of therapy for destabilized HF at least once in the 6 months prior to enrollment

Exclusion Criteria:

1. Life expectancy \<1 year due to causes other than HF such as advanced cancer
2. Cardiac transplantation or revascularization indicated or expected within 6 months
3. Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 L (when diagnosed as standard of care)
4. Subject unable or unwilling to provide written informed consent
5. Coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
6. Progressive neurological disease
7. Pregnancy
Efficacy and Safety of Fibrin Sealant (FS) VH S/D-APR for Hemostasis and Wound Healing in Endoscopic Browlift

The primary objective is to evaluate the safety and efficacy of Artiss (Fibrin Sealant) in reducing the incidence of early postoperative bruising and swelling.


Eligibility Criteria:
Inclusion Criteria:

* Subjects planned for endoscopic browlift, subjects who read, understand and sign the written informed consent, healthy female or male subjects, 18-75 years old, and subjects who are able and willing to comply with the protocal requirements

Exclusion Criteria:

* Subjects who had previous browlift, subjects indicated for concurrent facial surgeries, subjects considered to be active smokers, subjects with ecchymosis/edema on day 0, significant laboratory abnormalities, subjects with known bleeding or coagulation disorders, subjects treated with anti-coagulants.
Efficacy and Safety Study of CC-4047 (Pomalidomide) to Treat Advanced Soft Tissue Sarcoma

The purpose of the study is to determine the safety and efficacy of single agent CC-4047 (pomalidomide) in patients with advanced soft tissue sarcomas who have relapsed or are refractory to prior anticancer therapy.


Eligibility Criteria:
Inclusion Criteria:

* Must be \> 18 years of age
* Must have histologically confirmed soft tissue sarcoma
* Must have locally recurrent unresectable, or metastatic soft tissue sarcoma, and have failed or relapsed after a minimum of one and a maximum of 3 prior systemic anticancer therapy regimens
* Must have measurable or evaluable disease determined as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Must have documented disease progression (PD) determined as per RECIST criteria within 3 months prior to study enrollment
* Must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Pregnant or lactating females
* Prior therapy with thalidomide or lenalidomide
* Prior use of experimental/investigational drug therapy \< 3 months prior to treatment initiation
* Prior chemotherapy, biologic or immunotherapy \< 3 weeks prior to treatment initiation
* Prior radiotherapy \< 3 weeks prior to treatment initiation
* Prior major surgery \< 3 weeks prior to treatment initiation
* Absolute neutrophil count (ANC) \< 1.5 x 109 cells/L
* Platelet count \< 100 x 109cells/L
* Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvate transaminase (ALT/SGPT) \> 3.0 x upper limit of normal (ULN) or \> 5.0 x ULN in the presence of demonstrable liver metastases
* Known active central nervous system (CNS) metastases