cyrilzakka/clinical-trials huggingface dataset:
Optimal Surgical Approach for Early-Stage Breast Cancer in Chinese Patients Aged ≤ 40 Years: a Cohort Study

The optimal surgical treatment option (BCS+RT versus MAST) for young patients with early-stage breast cancer remains debated. The present study aims to explore trends in surgical management and compare survival outcomes between BCS+RT and MAST in young patients with early-stage breast cancer, ultimately providing optimal treatment strategies for Asian populations.

This study is a unique addition to the current research on young women with early-stage breast cancer, aiming to compare the survival outcomes between BCS+RT and MAST, providing valuable insights into their effectiveness for this group of patients. This study enrolled patients at West China Hospital, Sichuan University. Kaplan-Meier analyses with the log-rank test were applied to compare the locoregional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), breast cancer-specific survival (BCSS), and overall survival (OS). Cox multivariate hazard regression was employed to assess hazard ratios (HRs) between the two groups for survival outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40 years.
* Pathological diagnosis of invasive breast cancer.
* Undergoing Breast-Conserving Surgery (BCS) with Radiotherapy (RT) or Mastectomy (MAST).
* Availability of detailed clinical information, including:

Tumor (T) stage. Node (N) stage. Clinical stage. Hormone receptor status. Endocrine therapy details. Targeted therapy details.

Exclusion Criteria:

* Male patients.
* Patients with distant metastatic disease.
* Patients with bilateral breast cancer.
* Patients not undergoing surgery.
* Follow-up time of less than 1 month.
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
* EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
* Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Has a life expectancy of greater than 12 weeks
* Has adequate organ function

Exclusion Criteria:

* Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
* Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
* EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
* Has had other active malignancies within 5 years or at the same time
* Has uncontrolled pleural effusion、pericardial effusion or ascites
Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty

Hip fractures incidence grows rapidly with the aging of the population. After indicated surgical treatment, hip fracture patients experience high rates of postoperative complications, postoperative delirium (PD), postoperative cognitive dysfunction (POCD), leading to poor postoperative recovery during hospitalization, which can cause disability, distress for both patients and their families, are associated with other medical complications and account for significant additional health care costs. We currently use dexmedetomidine in elderly patients with hip fractures undergoing hip hemi-arthroplasty in order to improve postoperative recovery and prevent and treating PD and POCD.

Dexmedetomidine is a drug used for sedation in critically ill patients that provides some pain relief and controls the bodies response to stress. The sedation produced by dexmedetomidine appears more similar to natural sleep than any other drug used for anesthesia and postoperative sedation. Data suggesting that dexmedetomidine can prevent delirium following cardiac surgery and the developing understanding of the causes of PD and POCD suggest that dexmedetomidine will be particularly effective.


Eligibility Criteria:
Inclusion criteria

* Age \> 75years old
* Patients with femoral neck fractures
* Undergoing hip hemi-arthroplasty surgery
* American Society of Anesthesiologists (ASA) physical status II-IV
* MoCA being more than 23

Exclusion Criteria

* Patient refusal to participate in the study
* Patient refusal or failure of regional block
* allergic to local anesthetics or general anesthetics
* history of opioid dependence
* contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
* current severe psychiatric disease or alcoholism or drug dependence
* severe visual or auditory disorder
Effects of Avenanthramide-enriched Oats on Inflammation

The objective of this randomized, double-blinded, placebo-controlled, parallel trial is to determine whether consuming avenanthramide-enriched oats daily for 8 weeks on can improve biomarkers of inflammation in older, obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Men \& postmenopausal women, age 50 years and over
* BMI 30-36 kg/m2
* waist:hip ratio \> 0.8 for women, \> 0.9 for men

Exclusion Criteria:

* Cigarette smoking and/or nicotine replacement use
* Individuals taking estrogen
* Use of cholesterol-lowering medications
* Use of blood pressure-lowering medications
* Regular use of any stomach acid-lowering medications, laxatives (including fiber supplements) or anti-diarrheal medications(prescription or over-the-counter \[OTC\])
* Cardiovascular (heart) disease
* Gastrointestinal disease
* Kidney disease
* Endocrine disease: including diabetes, untreated thyroid disease
* Rheumatoid arthritis
* Active treatment for any type of cancer, except basal cell carcinoma, within 1 year prior to study admission
* Systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 95 mmHg
* Regular use of oral steroids
* Regular daily intake of ≥ 2 alcoholic drinks
* Strict vegetarians
* No dietary supplements, including those containing any vitamins, minerals, herbs, plant concentrates (including garlic, gingko, St. John's wort) homeopathic remedies, probiotics, or fish oil (including cod liver oil), for one month prior to study admission
Effect of Pollen Extract on Urinary Incontinence

Study with food supplement to assess the eficacy of pollen extract on Urinary Incontinence


Eligibility Criteria:
Inclusion Criteria:

* Moderate, severe or very severe urinary incontinence, according to the severity index Incontinence Severity Index (ISI) \* of Sandvik
* Healthy patients from 18 to 75 years of age
* Normal cytology in the last year and normal urological culture at inclusión
* Negative result in urine culture and normal vaginal canal (no evidence of dysplasia and / or infection)
* External vaginal area (vestibule and introitus) free of wounds or bleeding

Exclusion Criteria:

* Surgery for urinary incontinence
* Acute or recurrent infections of the urinary tract or genital infections (herpes or candida) in the last 3 months
* Malignant neoplasm or history of neoplasia in the last 5 years
* Concomitant disease such as a cardiac disorder, uncontrolled type I or II diabetes, lupus porphyria, relevant neurological disorders, any disease that in the opinion of the doctor could interfere with the treatment or resolution of the disease
* Anticoagulant alteration or thromboembolic alteration or taking anticoagulant drugs one week before treatment or during treatment for possible drug interaction (to allow inclusion, temporary cessation of use at the discretion of the doctor)
* History of immunosuppression or immunodeficiency (including HIV infection or AIDS) or use of immunosuppressive medications
* Hormonal imbalance, related to the thyroid, hypophysis or androgen not controlled
* Having a significant alteration in the areas under treatment or inflammatory alterations including but not limited to lacerations, abrasions or ulcers prior to treatment (time of resolution at the discretion of the doctor) or during treatment
* Dysplastic nevus in the treatment área
* Prolapse grade II according to the classification of the "Pelvic Organ Prolapse Quantification (ICS-POP-Q) System"
* Kegel exercises or electrostimulation at least 30 days before the start of treatment are not allowed
Diabetes Risk Education and Communication Trial

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. This pilot study will develop and evaluate the Diabetes Risk Education and Communication Trial (DiRECT) intervention, which communicates information about diabetes risk and treatment options for preventing diabetes among primary care patients with prediabetes. Given that 38% of U.S. adults have prediabetes, this project has large potential to impact public health by developing a scalable intervention to promote the use of evidence-based treatments that lower diabetes risk in this population.

Landmark clinical trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for preventing diabetes among adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used in practice and little existing research has focused on approaches for promoting their use.

This novel intervention, delivered by medical assistants before patients' routinely scheduled office visits, consists of the following 3 components intended to promote initiation of ILI and metformin: 1) a prediabetes decision aid focused on diabetes risk and treatment options for preventing diabetes; 2) a "think aloud" exercise; and 3) formulating a preliminary treatment plan. Previous studies report that medical assistants can improve uptake of some preventive health services in primary care, which may also be true for ILI and metformin.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obesity
* documentation of prediabetes in medical chart or
* A1c 5.7-6.4

Exclusion Criteria:

* Age \< 18; individuals who are not yet adults (infants, children, teenagers)
* Patient's primary care physician did not provide permission to participate in the study
* Pregnancy status: current or planned pregnancy during study period
* Serum creatinine \>1.4mg/dL in women and \>1.5mg/dL in men
* Patients that are blind, deaf, or otherwise unable to review study materials
* Prior diagnosis of diabetes mellitus type 1 or type 2 or on antidiabetic medication
* Diagnosis of post-surgical hypoinsulinemia
* Diagnosis of dementia
* Uncontrolled hypertension (≥160/100 mm Hg)
* No office visit in past 12 months
Food Effect Study of BMS-984923 in Healthy Older Adult Volunteers

This project is developing a novel disease-modifying compound for Alzheimer's disease (AD).

The primary objective of this study is to evaluate for an effect of food consumption on the pharmacokinetics profile of BMS984923. Safety and tolerability is also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men or women between the ages of 50 and 80 years, inclusive
* No history of cognitive impairment
* Capable of providing written informed consent and willing to comply with all study requirements and procedures
* Participant is not pregnant, lactating, or of childbearing potential

Exclusion Criteria:

* Body mass index (BMI) \>38 kg/m2 or body weight \<50 kg.
* Significant cerebrovascular disease
* Any significant neurologic disease
* A current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM V) diagnosis of active major depression, schizophrenia or bipolar disorder
* Clinically significant or unstable medical condition
* Any disorder or medication that could interfere with the absorption, distribution, metabolism or excretion of drugs
* History of cholecystectomy
* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B (seropositive for hepatitis B surface antigen \[HbsAg\] or anti-hepatitis C virus \[HCV\] antibody).
* Use of psychoactive medications
* Use of medications with potential drug-drug interactions
* Use of another investigational agent
* Clinically significant abnormalities in screening laboratories
* Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale
* Acceptable Geriatric Depression Scale (GDS) score
The Role of Ghost Ileostomy in Laparoscopic Rectal Resection

To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a prospective randomized controlled study comparing 2 groups of patients undergoing anterior resection of the rectum laparoscopically. In the first group of patients at the end of the procedure was always performed a Ghost Ileostomy while in the second group no protective stoma was built at the end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Surgical Indication for Laparoscopic Anterior Rectal Resection
* Medium risk of anastomotic leakage

Exclusion Criteria:

* High risk of anastomotic leakage
* Lower risk of anastomotic leakage
* Advanced neoplasia (T4)
* Indication for inter-sphincteric resection hydro-pneumatic test of the anastomosis tightness showed positive for air leak
* Surgical procedure intraoperatively modified from the standard laparoscopic anterior rectal resection
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis

The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent to participate in this study in accordance with local regulations
2. Have a confirmed diagnosis of cystic fibrosis (positive sweat chloride value ≥ 60 mEq/L) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with the CF phenotype)
3. Be aged \> 6 years old
4. Have FEV1 \>40 % and \< 90% predicted
5. Be able to perform all the techniques necessary to measure lung function

Exclusion Criteria:

1. Investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
2. Be considered "terminally ill" or eligible for lung transplantation
3. Have had a lung transplant
4. Be using nebulized hypertonic saline in the 4 weeks prior to visit 1
5. Have had a significant episode of hemoptysis (\>60 mL) in the three months prior to enrolment
6. Have had a myocardial infarction in the three months prior to enrolment
7. Have had a cerebral vascular accident in the three months prior to enrolment
8. Have had major ocular surgery in the three months prior to enrolment
9. Have had major abdominal, chest or brain surgery in the three months prior to enrolment
10. Have a known cerebral, aortic or abdominal aneurysm
11. Be breast feeding or pregnant, or plan to become pregnant while in the study
12. Be using an unreliable form of contraception (female subjects at risk of pregnancy only)
13. Be participating in another investigative drug study, parallel to, or within 4 weeks of visit 0
14. Have a known allergy to mannitol
15. Be using beta blockers
16. Have uncontrolled hypertension - systolic BP \> 190 and / or diastolic BP \> 100
17. Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
18. Be 'Mannitol Tolerance Test positive'

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Delta Shock Index in Predicting Massive Transfusion

Background: To determine the performance of delta shock index (ΔSI), a change in shock index (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need for massive transfusion (MT) among adult trauma patients with stable blood pressure.

Methods: This study included data from all trauma patients aged 20 years and above who were hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered trauma database of the hospital. Only patients who were transferred by emergency medical service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n = 7,875). The odds ratios with 95% confidence intervals for associated patient conditions and the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the patient's probability of receiving MT.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were transferred by emergency medical service (EMS) from the field of accident and had a stable blood pressure (SBP ≥ 90 mmHg) at the ER were included

Exclusion Criteria:

* Patients who were transferred from other hospitals or arrived by private vehicles.
* Patients who had incomplete data
* Patients who had an unstable blood pressure (SBP \< 90 mmHg) upon arrival at the ER were also excluded
Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes

To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation

The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.

Eligibility Criteria:
Inclusion Criteria:

* elective implantation of LAVD (Heartmate II),
* written informed consent to the study
* Patients with health insurance

Exclusion Criteria:

* treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
* Pregnancy or breastfeeding
* Juridical Protection
Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL

The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).

The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed,CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
* In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
* ECOG performance status of 0-2 at study entry
* Laboratory test results within these ranges: ANC \<=1500/μL, Platelet count \<= 100,000/μL. Patients with ANC \<1500/μL or plt \<100,000/μL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible.
* creatinine clearance of \>60 mL/min as determined by the Cockcroft-Gault calculation.
* Total bilirubin \<= 2X upper limit laboratory normal (ULN). Patients with non-clinically significant elevations of bilirubin due to Gilbert's disease are not required to meet these criteria.
* Serum transaminases AST (SGOT) and ALT (SGPT) \<=5x ULN, Serum alkaline phosphatase ≤5 X ULN.
* Disease free of prior malignancies for ≥ 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma "in situ" of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery).
* Patients may have received prior therapy with bendamustine or lenalidomide, but must not have disease that is refractory to bendamustine or lenalidomide.
* Prior therapy with rituximab is permitted, even in the setting of rituximab refractory disease.

Exclusion Criteria:

* Has received \>5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
* Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
* Prior history or current evidence of central nervous system or leptomeningeal involvement.
* Use of any other experimental drug or therapy within 28 days of baseline.
* Known hypersensitivity to thalidomide.
* The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
* Known to be positive for HIV or infectious hepatitis, type B or C.
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

The purpose of this study is to determine the safety and efficacy of ospemifene in postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain associated with sexual activity.


Eligibility Criteria:
Inclusion Criteria:

* Naturally or surgically menopausal
* Moderate or severe symptoms of vaginal atrophy
* 5% or fewer superficial cells in maturation index of vaginal smear
* Vaginal pH greater than 5.0
* Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion Criteria:

* Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
* Current vaginal infection requiring medication
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

* Previous participation in any other ospemifene study