cyrilzakka/clinical-trials huggingface dataset:
Rectal Cancer Surgery Without Mechanical Bowel Preparation

The aim of this controlled multicentric study is to assess rectal cancer surgery with sphincter preservation without pre operative mechanical bowel preparation

Preoperative mechanical bowel preparation (MBP) (i.e. including oral laxatives, retrograde enemas and/or oral diet before surgery) is the standard practice in colorectal surgery. The importance of MBP in preventing anastomotic leakage and infectious morbidity after elective colorectal surgery has been a dogma among surgeons for many years. The main reason is the belief that postoperative complications is related to septic bowel content. However, there is a paucity of scientific evidence demonstrating the efficacy of this practice in reducing morbidity. Moreover, potential disadvantages of MBP include the requirement for a longer preoperative duration of admission before surgery, its time consuming nature, being expensive and unpleasant for the patient and expose the early population to the particular risk of fluid and electrolyte imbalance .At least eight randomized clinical trials and two meta-analyses failed to show any superiority of MBP in colorectal surgery. On the contrary, they demonstrated that preparation might lead to an increased rate of septic complications. Such initial dates lead surgeons to re-evaluate their current clinical practice in colonic surgery. But to dates, these findings cannot finally be applied to rectal surgery because of insufficient dates. To date, no study about MBP was specifically devoted to rectal surgery. Moreover, it is currently admitted that the risk of septic complications following rectal resection, as a result of the well-known risk factors, is higher than after colonic preparation. It is the reason why most of the colorectal surgeons consider that a no preparation regimen in rectal cancer surgery could represent an additive risk factor for postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* patient with rectal cancer without any metastasesRectal excision with sphincter preservation with colorectal or coloanal anastomosis (with or without temporary ileostomy)

Exclusion Criteria:

* Stage IV disease
* Comorbidity with post operative infectious risk corticoids,immunodeficiency, Crohn's disease, ulcerative colitis ...)
* Abdominoperineal resection
* Emergency surgery
Mass in Motion Kids in the Clinical Setting

Mass in Motion Kids is a whole-of-community intervention in Fitchburg and New Bedford, Massachusetts that incorporates evidence-based interventions across multiple sectors and at multiple levels. The overall goal of the study is to examine the extent to which the comprehensive, systematic intervention reduces childhood obesity among underserved children.

The clinical intervention implements evidence-based interventions each city's federally-qualified community health center. Intervention components aim to improve primary and secondary prevention of childhood obesity and implement changes at four levels: clinician; parent-family; organizational; and environmental. We additionally provide training and educational materials to other pediatric clinicians in the two communities. The clinical intervention components include (1) advanced training on clinical quality improvement and obesity prevention, assessment, management; (2) computerized, point-of-care decision support tools for clinicians; (3) implementation of multi-disciplinary weight management programs within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating community health workers into the primary care and HWC teams; and (5) health center environmental changes to support behavior change modification.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 2-12 years
* Patient of the community's federally qualified health center
Integrated Smoking Cessation and Mood Management for ACS Patients

Quitting smoking following acute coronary syndrome can reduce mortality up to 50%. However, depression and smoking are highly co-morbid and depressed mood may interfere with cessation and independently predicts mortality. Thus, a single, integrated treatment for both smoking and depression could be highly effective in reducing post-acute coronary syndrome mortality. Behavioral Activation (BA) is a well established treatment for depression and has recently shown promise as a treatment for smoking cessation. The investigators systematically developed an intervention integrating gold standard smoking cessation counseling with existing BA based mood management techniques for post-ACS smokers; Behavioral Activation Treatment for Cardiac Smokers (BAT-CS).

Objective: For this R56 the investigators will conduct a vanguard trial to pilot all methods, materials, and systems for the later fully powered BAT-CS vs. attention control trial. The investigators will enroll up to 36 smokers with ACS and randomize them to 12 weeks of BAT-CS or an attention control (Health and Wellness Education). Both groups will be offered the nicotine patch if medically safe.


Eligibility Criteria:
Inclusion Criteria:

1. hospital inpatients with an ACS diagnosis documented in medical record,
2. smoked 1 or more cigarettes per day before being hospitalized,
3. age of 18-75,
4. English fluency,
5. lives within a 1 hour drive of the admitting hospital and has no plans to move away from the area for 1 year,
6. willing to consider quitting smoking at discharge,
7. has telephone, and
8. willing to consent to all study procedures.

Exclusion Criteria:

1. limited mental competency (i.e., Mini Mental Status Exam score ≤ 23);
2. presence of severe mental illness that would interfere with participation (e.g., schizophrenia) or suicidality;
3. expected discharge to hospice; and
4. currently attending counseling for depression or smoking cessation.
Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.

Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access.

All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity.

Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula.

During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access

Exclusion Criteria:

* Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks.
* Patient is expecting another solid organ transplant or a bone marrow transplant.
* Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb.
* Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.
Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis

The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.

The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin)administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for a similar period of time in patients with proximal venous thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive, symptomatic patients with a first or recurrent episode of acute proximal-vein thrombosis of the lower limbs.
* either sex and over 18 years of age
* referred to the Vascular Surgery Department of the hospital
* onset of symptoms less than 2 weeks
* documented by compression ultrasonography,

Exclusion Criteria:

* received heparin, low-molecular-weight heparin or oral anticoagulant therapy for more than 2 days for the present disease
* pulmonary embolism requiring thrombolytic therapy
* Need of surgical thrombectomy or vena cava interruption
* receiving oral anticoagulant treatment or antiplatelet agents for other conditions
* contraindication to anticoagulant treatment (active bleeding, severe blood pressure or allergy to the study drugs)
* platelet count lower than 100x103 /μl or hemoglobin concentration lower than 7 g/dl or history of heparin-associated thrombocytopenia
* severe renal failure necessitating dialysis
* pregnancy
* lumbar puncture within the previous 24 hours
Comparison of Conventional Lightwand Intubation Versus Video-laryngoscope Guided Lightwand Intubation in Simulated Cervical Spine-immobilized Patients

Among advanced intubation equipment for difficult intubation, a lighted stylet (lightwand) is a widely used equipment in cervical immobilized patients. However, a lightwand, which is used blind, is difficult to make midline positioning and can increase airway complications and hemodynamic changes. In contrast, videolaryngoscope can view vocal cord indirectly through camera, however, it requires cervical movement. Therefore, investigator hypothesized that the combined use of video-laryngoscope and lightwand for intubation can improve the efficacy of intubation compared to the use of lightwand alone in cervical immobilized patients.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 20- 80 yrs
2. Patients scheduled surgery under the general anesthesia

Exclusion Criteria:

1. Patient who has history of gastro-esophageal reflux disease, previous airway surgery, anatomical abnormality in the upper airway, or coagulopathy
2. Patients with body mass index \>35kg/m2, hemodynamic instability or loosening teeth
3. Patient who disagrees to participate this study or lacks decision-making ability, illiteracy, or foreigner
4. American Society of Anesthesiologists physical status ≥ 3
Use of a New Stapling Device in General Thoracic Surgery

The goal of this study was to test the safety and efficacy of this stapler in our general thoracic surgery practice.

A prospective study was conducted with 80 consecutive thoracic cases. Stapler usage data, intraoperative outcomes, and 30-day post-operative outcomes were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing planned VATS or open lung resection surgery (lobectomy or wedge resection)

Exclusion Criteria:

* Active bacterial or fungal infection
* Prior history of VATS or open lung surgery
* Use of staple line reinforcement material (buttress)
* Patients under the age of 18 on the date of the surgery
* Any female patient who is pregnant
* Scheduled concurrent surgical procedure other than lobectomy or wedge resection (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed)
HPV Self-Sampling for Cervical Cancer Screening Among Transgender Men and Transmasculine Individuals

The proposed study will examine the implementation of a Human Papillomavirus (HPV) self-sampling intervention for unscreened and under-screened transgender men and transmasculine individuals living in South Florida. The study will enroll participants to receive this cervical cancer screening intervention in community venues. The purpose of this study is to pilot the self-sampler for feasibility and acceptability within this underserved population.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as transgender male or as transmasculine

  * Assigned female sex at birth
  * English speaking
  * ages 25-65 years
  * report not having had a pap smear in the last three years
  * if age 30 and over, report not having a Pap smear/HPV co-test in the past 5 years

Exclusion Criteria:

* • Those who report having had a hysterectomy

  * Those who report having history of cervical cancer
  * Adults unable to consent
  * Those who are pregnant
  * Prisoners
Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life.

Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels.

Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.


Eligibility Criteria:
Inclusion Criteria:

* Term and late-preterm infants admitted to the regular care nursery of Robert Wood Johnson University Hospital will be eligible for the study

Exclusion Criteria:

* Infants suffering from genetic, chromosomal or surgical conditions will be excluded.
Study of Escitalopram in the Treatment of Specific Phobia

This pilot study is designed to assess the efficacy of escitalopram in the treatment of specific phobia in adult outpatients.

This double-blind placebo-controlled pilot trial study is designed to assess the efficacy of 12 weeks of escitalopram vs. placebo in the treatment of specific phobia in adult outpatients. It is hypothesized that escitalopram is safe and effective in the treatment of specific phobia.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* DSM-IV criteria for specific phobia according to the MINI
* For women of childbearing potential, a negative serum pregnancy test at screening
* Written informed consent

Exclusion Criteria:

* Any current primary DSM-IV diagnosis other than specific phobia
* History of DSM-IV substance abuse or dependence within the last months
* Lifetime history of bipolar I disorder, schizophrenia or other psychotic disorder, mental retardation, or other pervasive developmental disorder or cognitive disorder due to a general medical condition
* Suicide risk or serious suicide attempt within the last year
* Clinically significant laboratory or EKG abnormality or unstable medical condition
* For women of childbearing potential, unwillingness to use an acceptable form of contraception during the study
* Subjects needing concurrent use of psychotropic medications
Immediate Weight-bearing Verses Non-Weight-bearing After Foot & Ankle Surgery

The primary objective of this study is to determine whether immediate weight-bearing following foot and ankle surgery provides similar or superior results to the traditional non-weight-bearing post-operative course, while reducing the disuse atrophy and length of rehabilitation necessary to recover during the transition to weight-bearing following an extended course of non-weight-bearing. This will be done by way of clinical follow-up, serial radiographs and/or other appropriate imaging modalities, and patient reported outcomes by way of AOFAS and SF-36 surveys.

The study is a randomized 1:1, controlled trial, prospective in nature, where participants undergoing foot and ankle surgery will be randomly placed into one of two groups; an immediate weight-bearing group or a non-weight-bearing group. The patients will be randomly placed into the study group and control group if they meet all eligibility criteria.

This study will be conducted at 5 investigative clinic sites; West Penn Hospital, Forbes Regional Hospital, Jefferson Regional Hospital, Bethel Park Surgery Center, and Monroeville Surgery. Recruitment will stop when a minimum of 230 subjects are consented.

The study duration will require 7 visits to the clinic plus a surgery day therefore will require a pre-surgical visit/screening, surgery procedural day and six outpatient post-operative visits to the clinics. The entire follow up period will occur over 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 18 to 89 years
2. Undergoing foot and ankle surgery
3. Must be able to read and understand English and consent for themselves

Exclusion Criteria:

1. Diagnosed peripheral neuropathy
2. Diagnosed peripheral vascular disease
3. Documented infection to the surgical extremity
4. Previous surgery to the surgical limb
5. Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease which would predispose patients to poor healing and/or non-union
6. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment

In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy.

Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune checkpoint inhibitors (ICPI, notably anti-CTLA-4 and anti- PD1). The last ones can induce durable anti-tumoral responses in patients, even if metastases are present. Their mechanisms of action are focused on the activation of immune system in order to eliminate the tumor. ICPI, because of their mechanisms of action, target immune tolerance key components and can induce important immune toxicities (colitis, hepatitis, dermatitis, thyroiditis ...), leading to early discontinuation of treatment, severe or chronic morbidity, and can sometimes be lethal. It is of importance to detect patient at risk of irAEs, because of the increasing use of ICPI and the long- term response capacity in treated patients.


Eligibility Criteria:
Inclusion Criteria:

* patient with cancer, whatever initial tumoral histology and disease stage under ICPI treatment (anti-PD1 and/or anti-CTLA-4)
* age \> 18
* followed in oncology, pneumology, dermatology, gastroenterology departments of Amiens-Picardie University Hospital or Saint Quentin hospital
* who received verbal and written information, and signed the consent form for the study

Exclusion Criteria:

* non ICPI treated patients
* patient who received a first line of ICPI treatment
* patient who received or is receiving MEK inhibitors as a treatment (because of possible lower response to ICPI treatment when associated)
Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

This study evaluates the efficacy of clinical nutrition to treat lung neoplasms and breast carcinoma.We estimate there will be 480 patients accepted.120 patients will receive GLSE compound,120 patients will recrive Maitake mushroom extract compound,120 patients will recrive Rinseng compound,and 120 patients will be as blank countrol group.Efficacy Study of Clinical Nutrition to Treat Lung Neoplasms And Breast Carcinoma

GLSE compound、Maitake mushroom extract compound and Rinseng compound have different mechanism on enhancing immunity.This clinicaltrial compare them the immune effect in the progress of treating lung neoplasms and breast carcinoma.Within the 42 days,we will abide by the plan to evaluate the immunity enhancement by monitoring mmune effector molecules.

Eligibility Criteria:
Inclusion Criteria:

* lung cancer and breast cancer patients confirmed by surgery pathology;
* ECOG physical stamina score of 0\~3 points;
* Expected lifetime \> 3 months;
* Need to receive radiation and chemotherapy;
* Heart, liver and kidney function and blood picture is normal,WBC≥4×109/L, neutrophil count≥ 2 x 109 / L,platelet count≥100×109/L, hemoglobin≥100 g/L;
* To follow-up, good adherence

Exclusion Criteria:

* Allergic to text drug;
* Pregnancy or lactation women;
* Suffering from mental illness of not easy to control,
* Have serious mental or cognitive dysfunction;
* Can not comply with the experimental scheme or can't cooperate with the follow-up;
* The patients who are unfavorable to the subject.
A Study of RO4989991 in Patients With Allergic Rhinitis

This multi-center, randomized, observer-blinded, placebo-controlled study will evaluate the safety and tolerability of subcutaneous doses of RO4989991 in patients with allergic rhinitis who are otherwise healthy. The anticipated time on study treatment is 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-65 years of age, inclusively
* A history of allergic rhinitis diagnosed by a physician, but otherwise healthy
* A positive skin prick test to at least one standardized allergen at screening
* A body mass index (BMI) between 18 and 32 kg/m2, inclusively

Exclusion Criteria:

* History or presence of any respiratory disease or condition other than allergic rhinitis
* Use of prescription medication or herbal remedies within 14 days of dosing the study drug
* Use of over-the-counter (OTC) medications within 7 days of dosing the study drug
* Acute infection (including viral infections) 6 weeks (8 weeks for respiratory infections) preceding dosing or any ongoing chronic infection
* Positive test for human immunodeficiency virus (HIV) or hepatitis B or C
Remote Symptom Review in Patients With Implantable Diagnostic Holter

To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

Population of patients: Patients over 18 years old who require the implantation of an implantable diagnostic holter due to indications of syncope or atrial fibrillation, and who are willing to use an application installed on their phone to telematically send clinical symptoms that may occur during the active study period.

Design: Clinical, randomized, prospective, single-center study.

Investigational Device: BIOMONITOR III implantable cardiac holter and successive models with HOMEMONITORING remote monitoring system for constant monitoring of patient's cardiac signals. Installation of the Patient APP on the patient's phone for symptom transmission.

Overall Objective: To study the clinical and organizational benefit of implementing a methodology for monitoring patients receiving an implantable diagnostic BIOMONITOR III holter and successive models, consisting of remote review of alerts sent by the device via the HOME MONITORING remote monitoring platform and the transmission of relevant patient symptoms through the use of a specific application installable on the patient's phone. The efficiency of this methodology will be compared with a control group consisting of monitoring through the usual clinical practice of the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for implantation of a subcutaneous implantable holter due to syncope or cryptogenic stroke (atrial fibrillation detection)
* Patients over 18 years old.
* Patients who consent to the installation of a patient application for telematic submission of patient-related symptoms.
* Patients capable of using the patient application.

Exclusion Criteria:

* Patients over 80 years of age or, failing that, not able to use an application to send their symptoms.
* Life expectancy of less than 12 months for any reason.