cyrilzakka/clinical-trials huggingface dataset:
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer

This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.

The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be men and women age 18+
* Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
* Any state of disease as described by AJCC v7 criteria
* Participants must have received and completed neoadjuvant chemotherapy

Exclusion Criteria:

* Participants who had other primary cancers prior to breast cancer
A Study of the Safety and Pharmacology Of PI3-Kinase Inhibitor GDC-0941 In Combination With Either Paclitaxel And Carboplatin (With or Without Bevacizumab) or Pemetrexed, Cisplatin, And Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics of oral (PO) GDC-0941 administered with one of three planned regimens: Arm A: paclitaxel and carboplatin in bevacizumab-ineligible NSCLC patients, Arm B: paclitaxel, carboplatin, and bevacizumab in bevacizumab-eligible NSCLC patients and Arm C: pemetrexed, cisplatin, and bevacizumab in bevacizumab-eligible, non-squamous NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented NSCLC with advanced disease (Stage IIIb not eligible for chemoradiotherapy or Stage IV or recurrent disease)
* Adequate organ function as assessed by laboratory tests
* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

* More than one anti-cancer regimen (chemotherapy or radiotherapy) for advanced NSCLC prior to initiation of study treatment
* Any adjuvant or neoadjuvant anti-cancer therapy within a specified timeframe prior to first study treatment
* History of Grade \>= 3 fasting hyperglycemia or diabetes requiring regular medication
* Active autoimmune disease, active infection requiring IV antibiotics, or other current uncontrolled illness
* History of clinically significant cardiac or pulmonary dysfunction
* History of malabsorption syndrome or other condition that would interfere with enteral absorption
* Clinically significant history of liver disease
* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
* Known brain metastases that are untreated, symptomatic, or require therapy
* Pregnancy, lactation, or breastfeeding
Metabolic Causes of Thrombosis in Type 2 Diabetes - Question 1

The purpose of this study is to learn more about why patients with diabetes have increased heart attacks, strokes and other illnesses due to blood clots causing blockage of a blood vessel. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM. Our hypothesis is that hyperglycemia, rather than hyperinsulinemia, is responsible for the dysregulation of fibrinolytic balance in diabetics.

This study will test the hypothesis that hyperglycemia will impair, while hyperinsulinemia will improve endothelial function and vascular fibrinolytic balance in type 2 DM. As discussed above, their roles in the increased prevalence of thrombotic events occurring in diabetics have not been defined. More recent data supports insulin as profibrinolytic and hyperglycemia to cause endothelial dysfunction. Conclusive studies are lacking in diabetic subjects. Furthermore, preliminary data from this lab indicates that in non-diabetic controls, hyperglycemia results in a prothrombotic state by increasing plasma PAI-1 and reducing tPA levels. The proposed protocol will study the separate and combined effects of hyperglycemia and hyperinsulinemia on endothelial function and fibrinolytic balance in Type 2 DM.

Eligibility Criteria:
Inclusion Criteria:

* 16 ( 8 female/ 8 male) Type 2 diabetic patients age 18-60 yrs
* 16 ( 8 female/ 8 male) Non-diabetic controls age and weight matched
* Body mass index 25-52 kgm2
* Female volunteers of childbearing potential: negative HCG pregnancy test
* Volunteers over 40 years old: normal baseline ECG
* For those with type 2 diabetes: HBA1C 6.5-10%

Exclusion Criteria:

* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
* Uncontrolled hypertension
* History of cerebrovascular incidents
* Pregnancy
* Subjects unable to give voluntary informed consent
* Subjects with a recent medical illness
* Subjects with known liver or kidney disease
* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
* Tobacco Use
The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction

It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA with different block level on propofol concentration during general anesthesia induction.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-II physical status,
* aged 40-60 yr,
* BMI 19-25 kg/m2,
* undergoing elective gastrointestinal surgery

Exclusion Criteria:

* patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.
Effects of α-linolenic Acid Supplementation on Hemostasis in Nondiabetic and Hypercholesterolemic Subjects

This study evaluates whether ALA intake alters total cholesterol and homeostatic factors and the relationship between these alteration and lipoprotein associated phospholipase A2 (Lp-PLA2) activity.

An 8-week, randomized, double-blind, placebo-controlled study was conducted with 86 nondiabetic and borderline-to-moderate hypercholesterolemic (200mg/dL ≤ serum cholesterol ≤ 300mg/dL) subjects, not taking any medications and supplements to affect lipid metabolism, platelet function and inflammation, divided into two groups: an α-linolenic acid (ALA) group \[1.2 g (two capsules) of perilla oil daily; 497 mg ALA\] and a placebo group (1.2 g of medium-chain triglyceride oil daily).

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agree to participate and sign in informed consent form
* Adults aged 40-70
* Nondiabetic and hypercholesterolemic subjects (serum cholesterol ≥ 200 mg/dL)

Exclusion Criteria:

* Subjects taking any medication or supplements known to affect lipid metabolism or platelet function, n-3 fatty acid supplementation or n-3 fatty acid-rich fish more than two times per week
* Following diseases: dyslipidemia, hypertension, diabetes, liver disease, renal disease, pancreatitis, cardiovascular disease, gastrointestinal disease, cancer, or any other disease requiring treatment
* Participation in clinical trials of any drug or supplement within 30 days prior to the participation of the study
* Pregnant or lactating women, alcoholic, mental patient
* Judged to be inappropriate for the study by the investigator after reviewing other reasons
Activity Restrictions After Inguinal Hernia Repair

This research is intended to be a pilot study to identify differences in outcomes for varied lifting and physical activity precautions following surgical repair of single-sided inguinal hernias. The researchers hypothesize that when given the autonomy to return to activity at the patient's discretion, convalescence will decrease in comparison to a control group given specific precautions to refrain from lifting and strenuous activity. Specific aims include differences in convalescence and surgical outcomes for each group, i.e. rates of complications, hernia recurrence, physical activity assessments pre and postop, and quality of life outcomes.

This study will evaluate lifting restrictions in the postoperative period after inguinal hernia repair. Patients will be consented to the study via in person and electronic methods. Patients will be asked to answer a questionnaire regarding their current pre-operative activity levels in order to establish a baseline. Patients will undergo surgery according to normal medical recommendations and patient preference. Patients will be randomized into one of two groups: a control group told to practice standard of care at Eastern Colorado VA with return to activity precautions (6 weeks for open surgery, 2 weeks for minimally invasive surgery) and a treatment group told to "return to activity as tolerated/comfortable and stop activity if pain present". Patients will be observed in post-operative clinics and asked clinical questions, as well as questionnaires to assess their surgical experience, when they returned to activity, and overall quality of life. Medical charts will be reviewed in order to compare differences in responses and behaviors between the two groups and these data points will be recorded in a password protected document for data analysis.

This study aims to identify if lengthy recommendations for convalescence after inguinal hernia surgery are necessary and determine the impact of allowing the individual patient to have some autonomy in a recommendation to return to physical activity based on their own comfort level. This study could provide the surgical community with a more structured response after this common surgical procedure, as well as potentially reduce convalescence times for individual patients, leading to less economic burden on the individual and the community with returning to work precautions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of unilateral inguinal hernia
* Must be undergoing surgery
* Must be able to consent

Exclusion Criteria:

* Bilateral inguinal hernia
* Recurrent inguinal hernia
* Surgery scheduled with additional concomitant procedures
Treatment Strategy for Rectal Cancer Patients With Complete Clinical Response

This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.

Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response from the year 2010 to 2018 were included. Sequential subjects were identified from a prospective maintained database in the Sun Yat-sen University Cancer Center. Clinical experts on rectal cancer from other 5 regional medical centers in China were also invited to participate, and provided data of cCR patients. Standardized forms for data collection were sanded to researchers in each center. Patients received radical resection will constituted our surgery group. Those refused surgery constituted the observation group who went on with the watch and wait approach. A propensity-score matched observational analysis will be used to compare the oncological outcome of these two groups.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response

Exclusion Criteria:

* history of a second primary malignancy.
European Multicenter Study Radiofrequency (RF) Versus Cryo in Atrioventricular Nodal Reentry Tachycardia (AVNRT)

In this randomized study, two energy sources for the ablation of AV nodal reentry tachycardia are compared: The standard technique of radiofrequency energy delivery is compared with the new approach of cryo-energy application.

The ablation of AV nodal reentry tachycardia with radiofrequency (RF) energy delivering catheters is a standard procedure and in experienced EP laboratories, the safety and efficacy of this approach is very high.

However, the potential complication of higher degree AV conduction block, requiring in some instances implantation of a pacemaker, is a major drawback of this approach.

We want to compare in this randomized study the safety and efficacy of standard RF ablation with the cryo-ablation technique. This relatively new technique is thought to offer more safety concerning higher degree AV conduction block.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Clinical diagnosis of AVNRT (ECG/patients history)
* Electrophysiologically confirmed (invasively assessed) diagnosis of AVNRT
* Written informed consent

Exclusion Criteria:

* Prior ablation for AVNRT
* Congenital heart disease interfering with the ablation method
* Prior cardiac surgery
* Medical or psychiatric disorder interfering with study protocol or data acquisition
* Exclusion of the patient by the study investigator
SPECT-CT Metabolic/Morphological Assessment of Cemented Hip Protheses

Single center, pilot, randomized, controlled clinical trial to assess metabolic and morphological images between two types of cemented stem prostheses in patients undergoing total hip arthroplasty surgery during a 2-year follow up period.

Single center, pilot, controlled clinical trial to assess metabolic and morphological images of patients undergoing total hip arthroplasty surgery randomized to the thick layer technique (Exeter hip stem model) or to the "French paradox" technique (Müller straight stem model).

Participants will be performed a plain radiography and a SPECT-CT at 3, 6, 12 and 24 months of the intervention. SPECT-CTs will be performed in addition to the usual medical care complementary imaging exams. The SPECT will require the administration of the 99mTechnetium-methylene diphosphonate (99mTc-MDP) radiopharmaceutical (useful to assess bone metabolism) and its combination with a CT scan (SPECT-CT) allows a combined metabolic and morphological study.

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years-old
* both genders
* patients undergoing a primary total hip arthroplasty surgery with implantation of a cemented prosthesis (Exeter hip stem model or Müller straight stem model)
* patients with a diagnosis of hip osteoarthritis, operated by the Orthopedic Surgery and Traumatology Department at the Bellvitge University Hospital
* patients who signed the written informed consent.

Exclusion Criteria:

* patients allergic to 99mTc-MDP radiopharmaceutical
* patients with claustrophobia
* patients with a background of an active septic process
* patients with a postoperative septic complication
* patients periprosthetic fracture or misalignment of the prosthetic component
* patients who have a total hip prosthetic implanted due to a subcapital femoral fracture
Efficacy of Retreatments With Intravitreal Bevacizumab

Choroidal neovascularization is a leading cause of visual loss in people older than 60 years and for its treatment there had been performed multicentric studies with Lucentis (Ranibizumab) with a significant improval of visual acuity. In our institution we evaluated efficacy of bevacizumab in several pathologies but we dont know what would be the results if we use the same dose several times. Our purpose was to determine the efficacy of bevacizumab for improve or stabilize visual acuity with two or more intravitreal inyections of bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* \* Any visual acuity

  * OCT: Central foveal thickness greater than 300 u or with evidence of subretinal fluid.
  * Active angiogram leakage

Exclusion Criteria:

* \* Basal Inflammatory disease

  * Endoftalmitis history
  * Lesions bigger than 5400 u or with scarring greater than 50% of lesion.
Microvascular Reactivity in Cardiac Surgery

Microcirculatory disturbance occurs most seriously during cardiopulmonary bypass (CPB) in cardiac surgery. If microvascular reactivity compensates for microcirculatory disturbance during CPB, tissue hypoxemia may be minimized. On the other hand, tissue hypoxemia may develop and lead to poor clinical outcomes. The primary aim of this study was to assess whether microvascular reactivity during CPB can predict major adverse events (MAE) within 30 days after cardiac surgery.

This prospective, observational, single-center study was conducted on 115 patients who underwent elective on-pump cardiac surgery. The vascular occlusion test (VOT) with near-infrared spectroscopy was performed five times for each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Sequential Organ Failure Assessment (SOFA) and Acute Physiologic and Chronic Health Evaluation (APACHE) II scores and the length of ventilator care, intensive care unit stay, and hospital stay were recorded. Postoperative MAE within 30 days after surgery was also recorded.

The VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor (INVOS® 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was placed on the thenar eminence and an automated tourniquet (A.T.S® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure. Baseline StO2, minimum StO2 during the 5-min inflation of the tourniquet, and maximum StO2 during deflation of the tourniquet were obtained. The occlusion slope and recovery slope were calculated based on the measured StO2 data. The occlusion slope, which is related to oxygen extraction, was defined as the slope of the StO2 descent to the lowest value. The recovery slope, which is related to microvascular reactivity, was calculated from the deflation of the tourniquet until the recovery of StO2 to the highest value.

Eligibility Criteria:
Inclusion Criteria:

* adult patients aged \>18 years
* elective on-pump cardiac surgery

Exclusion Criteria:

* pregnancy
* inability to tolerate VOT (e.g., patients with arm deformities, arteriovenous shunts, burns)adult patients aged \>18 years scheduled for elective on-pump cardiac surgery
* refusal to participate in the study
Fluid Responsiveness in Prone Patients

To assess fluid responsiveness in prone patient


Eligibility Criteria:
Inclusion Criteria:

* patients planed to prone position for treatment

Exclusion Criteria:

* no consent
* arrhythmia
* pregnancy
* pre existing pneumothorax
* pre existing fluid overload
* cannot insert arterial or central venous catheters
Nutritional and Metabolic Management of Toxidermia Patients Requiring Intensive Care (TEN Metabolism)

Retrospective observational cohort study including all patients admitted for toxidermia (Lyell syndrome, Stevens-Johnson Syndrome (SJS), or other extensive skin destruction) to the Burn unit of the adult ICU of the Lausanne burn center between 2006 and 2020.

Inclusion criteria: age \>18 years and admission to the burn-ICU for toxidermia whatever body surface affected.

Exclusion criteria: to have declined access to the medical record, a stay shorter than 24 hours, and major burns. The observation period will be limited to the first 31 days of the ICU stay.

All variables related to nutritional and metabolic management will be recorded

There are yet no description of the metabolic characteristics of patients admitted for Toxic epidermal necrolysis (TEN) or Stevens-Johnson Syndrome (SJS) which are a rare condition, often assimilated to major burns in terms of metabolic requirements. We will conduct a retrospective observational cohort study including all patients admitted for toxidermia (general term including TEN or Lyell syndrome, SJS, and other extensive skin destruction) to the Burn unit of the adult ICU of the Lausanne burn center between 2006 and 2020. The primary outcome will be compliance with the ICU's feeding protocol (feeding route, early start of enteral feeding, ), and secondary outcomes will include the adequacy of energy and protein delivery, and use of indirect calorimetry, and the comparison with both general and burn critically ill patients from prior studies in the ICU.

Inclusion criteria: age \>18 years and admission to the burn-ICU for toxidermia whatever body surface affected.

Exclusion criteria: to have declined access to the medical record, and a stay shorter than 24hours, and major burns. The observation period will be limited to the first 31 days of the ICU stay.

The recorded variables will include demographic characteristics, severity scores (SAPSII, SCORe of Toxic Epidermal Necrosis (SCORTEN for SJS/TEN), Nutrition risk screening (NRS) score), body surface area (BSA) affected by the disease, fluid intakes and balance (exudate volume estimation not included) of the first 10 days, body weight during the stay, renal function, length of mechanical ventilation and of ICU stay. Nutritional variables include the route of feeding, the 24hr energy prescription and delivery, protein, glucose, and lipid intakes, propofol, insulin, indirect calorimetry (IC) studies. Laboratory blood results include glucose, prealbumin, albumin, C-reactive protein (CRP), triglycerides, creatinine, and trace elements (Cu, Se, Zn).

Descriptive statistics: Wilcoxon rank test, while Chi2 test, changes over time with one-way ANOVA .

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* admission to the burn-ICU

Exclusion Criteria:

* declined access to the medical record
* stay shorter than 24hours