cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors of Disease-free Survival After Complete Pathological Response to Neoadjuvant Radiotherapy in Rectal Adenocarcinoma

Many data suggest that patients with low rectal adenocarcinoma who achieved ypT0N0 status have improved survival and disease-free survival (DFS) compared to all other stages however only few data are available regarding the specific prognosis factors of this subgroup. This retrospective multicentric study aimed to predict the prognosis of patients with complete pathological response after neoadjuvant treatment.


Eligibility Criteria:
Inclusion Criteria

* patients with a histologically proven low rectal adenocarcinoma,
* no previous or synchronous colorectal disease,
* UICC stage I-III patients who underwent neoadjuvant chemoradiotherapy or chemotherapy,
* followed by total mesorectal excision (TME), and
* a complete pathological response defined as ypT0N0

Exclusion Criteria:

- all patients with metastatic tumors or missing data
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older

The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.

The investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer treatment. The DA was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women.

Phase I :

- The investigators will obtain and incorporate additional feedback on the DA from women 70 years or older who were diagnosed with breast cancer \> 6 months ago, their family members, and clinicians, so that the DA can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer.

Phase II

- The investigators plan to test the efficacy of the revised DA in a randomized control trial (RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or less breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Phase I

  * Patient age ≥ 70 yrs
  * Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer \>6 months ago but \<2 years ago
  * Caregiver age \>21 years
  * English speaking
* Phase II

  * Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer
  * Women newly diagnosed with breast cancer on the day of surgical consult

Exclusion Criteria:

* Phase I

  * Patient Age \< 70 years
  * Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
  * Signs of Dementia
  * Score \>10 on the Orientation-Memory-Concentration (OMC) test
  * Non-English Speaking;
  * Caregiver age \< 21 years
  * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
* Phase II

  * Women with a history of breast cancer (invasive and non-invasive)
  * Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor
  * Signs of Dementia
  * Score \>10 on the OMC test (indicative of dementia).
  * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality

Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).


Eligibility Criteria:
Inclusion Criteria:

Patients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging.

* Age range of 18-60 years
* Cirrhosis as diagnosed by histology or clinical, laboratory and USG (UltraSonography) findings,
* Upper GI bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices

Exclusion Criteria:

* Age \>60 years
* Chronic renal disease
* Pregnancy and peripartum cardiomyopathy
* Hypertension
* Coronary artery disease
* Valvular heart disease
* Sick sinus syndrome/ Pacemaker
* Cardiac rhythm disorder
* Hypothyroidism
* Hyperthyroidism
* Portal vein thrombosis
* Transjugular intrahepatic porto systemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males
Walking Aid and Locomotion Knowledge in Emergency Rooms (WALKER 1) for Elderly People

Older adults have higher rates of emergency department admissions when compared to their younger counterparts. Mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. Walking aids can be used to improve mobility and prevent falls. According to international guidelines, they must be available in Geriatric Emergency Department. This study aims to evaluate the effectiveness of a program of training and provision of walking aids (WA), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.

A randomized clinical trial will be carried out in the emergency department of Hospital Sírio-Libanês. Participants will be randomized and allocated into three intervention groups, as follows: A) Walking aid group; B) Walking aid and telemonitoring group; C) Control group. Patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces (Life Space Assessment), gait speed, muscle strength, functionality (Barthel Index, Katz index, and Lawton-Brody Scale), quality of life (Euro Quality of Life Instrument-5D), fear of falling (Falls Efficacy Scale International), history of falls, cognition (10-Point Cognitive Screener) and mood (15-point Geriatric Depression Scale) before the intervention. Gait time and fear of falling will be assessed again after the intervention. Finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 months after discharge from the geriatric emergency department through a telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Admitted to the Geriatric Emergency Department of Hospital Sírio-Libanês
* Willing and able to give informed consent
* Least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months).

Exclusion Criteria:

* Altered level of conscience
* need for supplemental oxygen (≥3L/min)
* respiratory distress
* hemodynamic instability
* postural instability with a tendency to fall backward
* cognitive impairment that limits the use of walking aids
* hospitalization after Emergency Department evaluation
* Delirium
Adequate Additional Bronchial Cuff Volume to Achieve Blood-tight Seal After Air-tight Seal in Double Lumen Tube

The purpose of this study is to find the adequate additional bronchial cuff volume after achievement of air-tight seal, that can achieve blood-tight seal(preventing leakage of blood through cuff) in double lumen tube


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thoracic surgery under left lower decubitus position, using left sided double lumen tube
* patient's left main bronchus size adequate for 35Fr, 37 Fr, 39 Fr double lumen tube

Exclusion Criteria:

* dislocation or great movement of double lumen tube depth
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.

Patients undergoing Cesarean delivery (C-Section) with a body mass index of 30 or less will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery. It is unknown what the best dose for the usual medicine used for this purpose (an antibiotic medicine called cefazolin). Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level. These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in normal weight women undergoing c-sections.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Body mass index (BMI) of 30 or less, as calculated from the height and weight at the first prenatal visit
3. Undergoing cesarean delivery

Exclusion Criteria:

1. BMI greater than 30.
2. Not undergoing Cesarean delivery.
3. Age less than 18 years.
4. Pre-existing infection.
5. Allergy to cephalosporin medications or a history of an anaphylactic reaction to penicillin.
6. Cesarean delivery being performed under emergent circumstances
LEAVE Safe With DOACs

Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.

Patients first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* New prescription of DOAC within 4 days of consent OR continued DOAC use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with DOAC prescription within 4 days of consent
* Fluency in English, Portuguese, or Spanish

Exclusion Criteria:

* Currently hospitalized with inpatient status (as opposed to observation status)
* Age \< 18
* Prisoners
* Pregnant patients (medications are contraindicated)
Endoscopic Full Thickness Resection With Laparoscopic Assistance

The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.

The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.

Eligibility Criteria:
Inclusion Criteria:

* Gastric subepithelial tumor
* Invasion of muscularis propria on Endoscopic ultrasound
* Tumor size 1.5cm-5cm or increasing size during follow-up

Exclusion Criteria:

* Bleeding tendency,
* Inappropriate condition for surgery with general anesthesia
* Refuse to be enrolled to study
ECMO: Optimization of Its Use

To create a local registry for ECMO patients.

To create a local registry of retrospective and prospective patients on ECMO at Spectrum Health, Butterworth campus in order to optimize the use of ECMO therapy and to create algorithms to estimate the prognosis. ECMO patients will be compared to a control group of patients. Patient mortality will be assessed in-house, at 48 hours, 3 months, and 1 year after the start of ECMO therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* requiring ECMO. For the control,Patients without ECMO admited to ICU.

Exclusion Criteria:

* Age\<18
* Known prisoner of the state
Patient Perceptions of Robotic, Endoscopic and Open Thyroid Surgery

Robotic thyroid surgery offers certain improvements in cosmesis and postoperative recovery. The study aimed to describe patients' concerns in choosing surgical approach and how these attitudes affect preferences for robotic thyroidectomy (RT), endoscopic thyroidectomy (ET) and conventional open thyroidectomy (OT), with the long-term goal of promoting RT.

Patients admitted for surgical treatment for thyroid disease, after sufficient counselling on the main differences and traits among open, endoscopic and robotic approach completed an anonymous questionnaire. Size of incision, cost, postoperative recovery, postoperative hospitalization, operation duration and absence of the anterior neck incision were respectively assessed the degree of importance when patients chose the surgical approach in thyroid disease. In addition, patients underwent RT and ET rated their satisfaction in terms of scars and cosmesis.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent thyroid surgery and were willing to complete the questionnaire

Exclusion Criteria:

* The completeness of the questionnaire was less than 80%
* Drop of follow-up
Transcranial Direct Current Stimulation (tDCS) in Human Subjects With PTSD Receiving an Exposure-based, Behavioral Therapy

The primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tDCS), a noninvasive brain stimulation technique, when delivered in combination with Written Exposure Therapy (WET), for posttraumatic stress disorder posttraumatic stress disorder (PTSD).

While the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with PTSD. Towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tDCS) vs. a sham condition in a sample of 40 adults with PTSD receiving 5 weekly sessions of Written Exposure Therapy (WET), an exposure-based, behavioral psychotherapy for PTSD.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals between the ages of 18 and 65 years old at time of screening.
2. PTSD diagnosis as assessed by the Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
3. Able to write, read, and speak English

Exclusion Criteria:

1. History of epilepsy or seizures.
2. History of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., Stroke, Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Alzheimer's, Dementia, Parkinson's, and/or Huntington's).
3. History of skin condition (e.g., eczema, psoriasis) where electrodes will be applied.
4. Electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump).
5. Metallic objects other than dental appliances/fillings near the site of stimulation
6. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement).
7. Current moderate or severe substance use disorder.
8. Suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment.
9. Change in anticonvulsive or benzodiazepine medication regimen in the past month.
10. History of adverse effects to previous tDCS or other brain stimulation technique.
11. Concurrent engagement in another brain simulation technique or trauma-related psychotherapy for PTSD.
12. Currently pregnant or breastfeeding.
Epoetin Alfa in Treating Chemotherapy-Related Anemia in Women With Stage I, Stage II, or Stage III Breast Cancer

RATIONALE: Epoetin alfa may stimulate red blood cell production to treat patients who have anemia following chemotherapy.

PURPOSE: Phase IV trial to study the effectiveness of epoetin alfa in treating chemotherapy-related anemia in women who have stage I, stage II, or stage III breast cancer.

OBJECTIVES: I. Determine the effectiveness and safety of epoetin alfa in patients receiving adjuvant chemotherapy for stage I, II, or III breast cancer. II. Determine the clinical outcomes in these patients receiving this drug.

OUTLINE: This is a multicenter study. Patients receive epoetin alfa subcutaneously once weekly for up to 24 weeks in the absence of unacceptable toxicity. Quality of life is assessed at baseline, at week 13, and at study completion.

PROJECTED ACCRUAL: A maximum of 2,500 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I, II, or III breast cancer Planned adjuvant anthracycline-based chemotherapy with or without a taxane for 3-6 months Hemoglobin 10-14 g/dL (independent of transfusion) No anemia due to factors other than cancer/chemotherapy (i.e., iron, cyanocobalamin, or folate deficiency; hemolysis; gastrointestinal bleeding; or myelodysplastic syndrome) Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 9 months Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled or severe cardiovascular disease No myocardial infarction within the past 6 months No uncontrolled hypertension No congestive heart failure Other: No hypersensitivity to mammalian cell-derived products No hypersensitivity to human albumin Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior epoetin alfa or any investigational forms of erythropoietin (e.g., gene-activated erythropoietin or novel erythropoiesis- stimulating protein) No transfusion within the past 30 days No other concurrent epoetin alfa Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent investigational drugs No other concurrent treatments for anemia
A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers

This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers


Eligibility Criteria:
Inclusion Criteria (subset):

* Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
* Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
* If not a menopausal female or surgically sterile male or female, subjects must be willing to practice at least one of the in the CSP described highly effective methods of birth control for at least a (partner's) menstrual cycle before and for 3 months after study drug administration.
* For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dose:

  * hysteroscopic sterilization;
  * bilateral tubal ligation or bilateral salpingectomy;
  * hysterectomy;
  * bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 2 years prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per PI or designee judgment.

Exclusion Criteria (subset):

* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
* History of any illness that, in the opinion of the PI or designee, that could affect the action, absorption, or disposition of MIV-711 or may confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems (first, second, or third degree heart blocks, bundle branch block, or incomplete block, atrial fibrillation and/or paroxysmal atrial fibrillation, sick sinus syndrome or prolonged QTc interval), inappropriate sinus bradycardia, deviant ECG morphology or exercise related cardiac events.
* Unable to refrain from or anticipates the use of:

  * Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dose and throughout the study. Medication listed as part of acceptable birth control methods will be allowed.
  * Any drugs known to be inducers of CYP enzymes for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug.
  * Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
  * Hormone replacement therapy will also be allowed.
  * Subjects on a stable dose (at least 3 months) of thyroid medication will be allowed.
* An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.