cyrilzakka/clinical-trials huggingface dataset:
Pathways to Advance Targeted and Helpful Serious Illness Conversations (PATH-SIC)

The purpose of this study is to increase serious illness conversations (SICs) about patients goals and preferences regarding their healthcare between patients with cancer and their oncology clinicians and improved care provided near the end of life.

The objective of this study is to implement an intervention in a pragmatic randomized controlled trial that uses cancer treatment pathways data to identify patients appropriate for serious illness conversations (SICs) and applies "nudges" to patients and their oncology clinicians to increase SICs and improve end of life (EOL) outcomes.

Identified participants and clinicians will be randomized into 1 or 4 groups.

* Nudge to patient and clinician
* Nudge to patient only
* Nudge to clinician only
* No nudge.

The expected enrollment is approximately 800 participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are aged 18 years or older, reach one of the poor prognosis nodes identified and have an upcoming appointment at one of the following Dana Farber Cancer Institute oncology clinics (including Longwood and Chestnut Hill locations)
* Breast Oncology Clinic
* Gastrointestinal Oncology Clinic
* Genitourinary Oncology Clinic
* Gynecologic Oncology Clinic
* Thoracic Oncology Clinic

Exclusion Criteria:

* Patients with an SIC documented in the Advance Care Planning module of the electronic health record in the 6 months prior to reaching a poor prognosis node
* Patients who have previously been randomized in this trial (e.g., the patient is encountering a poor-prognosis node for the second time during the trial period)
The Immediate Effect of an Osteopathic Manual Treatment on Blood Pressure in Adults With Hypertension - a Pilot Study.

The aim of this study was to determine if 4 manual osteopathic treatment techniques; Spinal manipulation, stretch intrathoracic fascia, sternum recoil and cranial base release has an immediate effect on blood pressure (BP) in hypertensive adults.

30 hypertensive adults (age=50.76±8.66 years, height= 1.75±0.082 m, weight=89.5±19.08 kg), were randomly assigned into one of two equally sized groups; a non- intervention and an intervention group in which patients received 4 manual techniques. Outcome measures included systolic- and diastolic BP pre-treatment and post-treatment 1-,5-, and 10-minutes. Two-way mixed ANOVA was used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-60 years old.
* Primary hypertension.
* Hypertension not more than grade 2, defined as: Systolic BP from 135-174 mmHg and diastolic BP from 85-104 mmHg.

Exclusion Criteria:

* Hypertension grade 3, defined as: Systolic BP from \>175 mmHg and diastolic BP \>105 mmHg, due to high risk of developing stroke, apoplexy and myocardial infarct.
* Positive hepato-jugular-reflux test, as a safety-test, to test pathological conditions of the heart.
* History of liver, kidney or known heart diseases, diagnosed by family physician as these conditions can contribute to secondary hypertension.
* Presence of contraindications for manual treatment, such as (but not limited to); infections, neurological symptoms, inflammation, haemophilia, ankylosis, prosthesis, pregnancy, cancer, osteoporosis, trauma and the use of blood-thinning medicines or corticosteroids.
Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD

Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.


Eligibility Criteria:
Inclusion Criteria:

* CKD 3-4 Age 18-80

Exclusion Criteria:

* Recent MI, CVA, malignancy active infection active inflammation High calcium already on Viatmin D therapy
Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy

Robotic-assisted thoracoscopic surgery (RTS) segmentectomy is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). In RTS-segmentectomy, dissection and sealing procedures are performed by either staplers or energy devices.

Staplers, the current standard of care, have been associated with higher operating costs compared to energy devices for open lobectomy, RTS lobectomy and minimally invasive segmentectomy. However, there is a lack of prospective research evaluating the costs of the two methods for lung dissection and vessel sealing in RTS-segmentectomy.

This prospective trial seeks to determine whether it is feasible to conduct a randomized controlled trial evaluating the costs of the Signia stapler versus Vessel Sealer Extend energy device in RTS-segmentectomy for NSCLC. If this trial is feasible, we will be able to conduct a full-scale trial to compare costs and health outcomes, providing an economic evaluation that will inform hospital decision makers and clinicians in Canada.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 120 years at time of consent
* Ability to speak and understand English
* Clinical stage I, II or IIIa NSCLC
* Candidate for RTS segmentectomy, as determined by the operating surgeon

Exclusion Criteria:

* Anticoagulation with inability to cease anticoagulant therapy prior to surgery
* Incurable coagulopathy
* Systemic vascular disease or vasculitis
* Not a candidate for RTS segmentectomy
Safe Use of Heparin Sodium in Patients With Chronic Renal Failure.

The Heparin form a complex with a plasma protein, antithrombin III (ATIII), which is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. Moreover, heparin and other proteases ATIII inactivate the clotting cascade, especially the anti-activated factor X. The end result of these actions is the inhibition of biochemical training and synthesis of certain clotting factors that activators of critical functions in the genesis of a blood clot. Patients with chronic renal failure (CRF) who use the treatment of hemodialysis need a system of anticoagulation with the direct thrombin inhibitor and / or heparinóides to prevent thrombosis.

Based on clinical studies, to control the level of plasma heparin in patients with CRF is essential. Evidence of clotting as APTT, TP, ACT and proof of the activity of anti-factor Xa should be used as a substrate of protection for those patients on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age above 18 years;
* Patients who agree to participate in the study and signed the free and informed consent (attached);
* Insufficient patients in chronic renal dialysis scheme (3 times per week);
* Low Chronic Renal indication of anticoagulant during dialysis.

Exclusion Criteria:

* Not agree to the terms described in informed consent;
* Patients with sensitivity to heparin sodium;
* Volunteer search with hypersensitivity to benzyl alcohol;
* Patients with a history of bleeding or change in blood clotting that can aggravate or terminate the clinical picture, such as tables of gastric ulcer;
* Patients with a history of peptic ulcer;
* Patients with cancer of any etiology, because of the possibility of compromising the function of the variable coagulation;
* Patients in a period of pregnancy and postpartum;
* Individuals with genetic abnormality of clotting system;
* Patients polytraumatized;
* Patients in use of glucocorticoids for at least 1 month;
* Patients in use of other anticoagulants;
* Patients with high rate of bleeding;
* Patients undergo any surgery performed less than 15 days because of the risk of the formation of hematomas at the site of surgery;
* Patients in use of drugs that affect the hemostasis;
* In addition to these, clinical characteristics that the medical criteria, can interfere with the study.
Long Term Effect of Buspirone on Esophageal Function and Esophageal Symptoms in Patients With Systematic Sclerosis (SSc)

Esophagus is commonly affected in Systemic Sclerosis (SSc) and esophageal function is compromised in about 75% of patients. Previous studies have shown that buspirone, an orally available 5-HT1A (serotonin 1a receptor agonist), enhances esophageal motility in healthy volunteers. Recently, the investigators observed that a single dose of buspirone (10mg) improves lower esophageal sphincter (LES) function in patients with SSc and esophageal involvement .

Objectives: To evaluate the effect of continuous administration of buspirone on esophageal dysfunction and related symptoms in SSc using high resolution manometry (HRM).

Systemic sclerosis (SSc) is a chronic autoimmune disease affecting the skin and other organs especially the gastrointestinal tract. Esophageal involvement occurs in up to 90% of SSc patients. Symptoms of esophageal disease are due to gastroesophageal reflux disease (GERD) and esophageal motor dysfunction. Thus, heartburn, regurgitation and dysphagia have been reported by 80% of SSc patients.

The gold standard method for the assessment and detection of esophageal dysmotility in SSc patients is manometry. High-resolution manometry (HRM) is the most accurate tool to assess esophageal motility using multiple closely spaced (\<2cm) pressure sensors, assessment of esophageal motility is more sensitive ,and allows a better assessment of LES and of the whole esophagus.

Buspirone, an orally available 5-HT1A receptor agonist, exerts a beneficial acute effect on esophageal motor dysfunction and LES pressure and may enhances an important role in improvement of esophageal symptoms in SSc patients. Thus, the investigators will conduct a study to evaluate the putative beneficial long-term effect of buspirone i) on esophageal motor dysfunction and ii) on esophageal symptoms in symptomatic SSc patients.

Eligibility Criteria:
Inclusion Criteria:

* SSc patients with esophageal symptoms

Exclusion Criteria:

* none
A Crossover Study on the Blinding Effect of a New Pragmatic Placebo Needle

Placebo needle is a useful tool to assess the efficacy of acupuncture. Investigators have applied a new kind of placebo needle in large scale acupuncture clinical trials, which named as pragmatic placebo needle. Compared with other placebo needles used in acupuncture trials, this pragmatic placebo needle shows several advantages: the outlook closer to traditional acupuncture needles, no restriction to needle depth of true needle, simple to manipulate and more economical. However, its blinding effect is not yet validated. The primary objective of this trial is to validate the blinding effect of the new pragmatic placebo needle; the secondary objective is to explore factors influencing the blinding effect of the placebo needles.

blinding refers to subject blinding

Eligibility Criteria:
Inclusion Criteria:

* 18-74 years old;
* with a basic capacity of listening, speaking, reading and writing in Chinese;
* volunteer to join this research and sign the informed consent.

Exclusion Criteria:

* with acute or chronic pain;
* taking analgesics or drugs inducing abnormal sensation;
* with diseases of sensory disturbance or sensory loss;
* with alcohol or drug abuse history;
* serious cardiovascular, cerebral, hepatic, renal, hematopoietic, hemorrhagic or psychiatric diseases;
* diabetes mellitus or dermatological disease;
* women in pregnancy or lactation period;
* cardiac pacemaker carrier, metal allergy or severe needle phobia.
Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant

Polyomavirus BK nephropathy is a serious complication after renal transplantation leading to graft loss in 40% of cases. Since no virustatic drug exists, the investigators want to study the best way to manage viral invasion by changing the immunosuppressive treatment comparing two treatment schemes. The investigators hypothesis is that switching to an mTOR-based scheme is superior to a general decrease of a calcineurin inhibitor (CNI)-based scheme. The study will be performed as a prospective, randomized, parallel group comparison.

The study group (n=62) will be switched from CNI to everolimus while the control group (n=62) will get a general reduction of the CNI-based immunosuppression. Follow-up and duration of intervention per patient will be 24 months, duration of the trial 72 months including 4 years of recruitment.

Eligibility Criteria:
Inclusion Criteria:

* preceding renal transplantation
* functioning graft with a permanent creatinine clearance of more than 25mL/min
* biopsy-confirmed polyoma BK virus nephropathy
* age over 18 years old

Exclusion Criteria:

* allergy or non-tolerance of the study medication everolimus
* pregnancy
A Phase I Open Label Dose Escalation Study for the Safety and Tolerability of AZD2171 in Solid Tumors in Japan

A Phase I open label dose escalation study to assess the safety and tolerability of AZD2171 following single and multiple oral doses in patients in Japan with advanced solid malignancies. In addition there will be an expanded cohort multi-centre study phase with NSCLC patient and CRC patients


Eligibility Criteria:
Inclusion Criteria:

* advanced solid tumors
* life expectancy is 12 weeks or longer

Exclusion Criteria:

* patient with uncontrolled brain metastases
* patient with inappropriate laboratory test values
* patient with poorly controlled hypertension
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.


Eligibility Criteria:
Inclusion Criteria:

* Declaration of consent signed
* Minimum age 18 years
* localised prostate carcinoma
* planned DVRP with bilateral lymphadenectomy

Exclusion Criteria:

* patient's lack of capacity to consent
* ORP
* no planned PLND
* metastatic prostate cancer
* ASA status \>3
A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer

This study will evaluate the efficacy and safety of intravenous Herceptin in patients with metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The anticipated time on study treatment is until disease progression.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* metastatic urothelial cancer;
* disease progression during or after 1 prior platinum-based chemotherapy;
* measurable disease;
* HER2 overexpression (IHC \[2+\] or \[3+\]).

Exclusion Criteria:

* concomitant chemotherapy or immunotherapy;
* active or uncontrolled infection;
* solely CNS metastases;
* clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;
* co-existing malignancies diagnosed within last 5 years, except basal cell cancer or cervical cancer in situ.
Effect of Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes in Children

Emergence agitation (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.

The high incidence of EA and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. Dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. It provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. It also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance P release. The study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on EA in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 2-7 years old
2. American Society of Anesthesiologists（ASA） score of I or II
3. Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane

Exclusion Criteria:

1. Emergency surgery
2. were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
3. had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
4. intellectual disability, or neurological illness with agitation-like symptoms
5. weighed more than 50 kg
6. were allergic to dexmedetomidine
7. The use of sedative or analgesic medications before surgery
Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest

The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.


Eligibility Criteria:
Inclusion Criteria:

* patients present with a complex defect after tumor resection
* all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital.
* patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap.

Exclusion Criteria:

* pre-existing nerve deficits
* pregnant women
Decision Aid in Veterans With Posttraumatic Stress Disorder

The purpose of this study is to examine the effects of a decision aid on veterans with posttraumatic stress disorder (PTSD) presenting for care. The investigators' primary hypothesis is that patients assigned to use the decision aid will demonstrate improved quality of decisions regarding PTSD treatment relative to patients assigned to usual care. Improved decision quality will be examined by assessing patient's knowledge of treatments, evaluation of the risk and benefits, ability to arrive at a decision, and certainty about that decision. The investigators' secondary hypothesis is that patients assigned to the decision aid will be more satisfied with their care and more compliant with their care compared to patients assigned to receive usual care. The investigators will also determine whether patients assigned to the decision aid, relative to patients assigned to usual care, are more likely to receive evidence-based treatments for PTSD and experience reductions in PTSD symptoms.

Posttraumatic stress is a severe and often disabling condition affecting millions of veterans. Within VA, significant staffing and financial resources are devoted to the mission of treating PTSD and the anticipated need for treatment is expected to accelerate as veterans return from the Iraq war.

Research has identified a number of successful strategies for the treatment of PTSD, including both psychotherapy and pharmacology. Several treatments, including group psychotherapy and benzodiazepines have demonstrated a lack of efficacy in the treatment of PTSD. Despite this knowledge, many veterans with PTSD do not receive an evidence-based treatment and may even receive a treatment known to not be effective. Among the group of proven effective treatments, the patient time commitment and adverse effects differ considerably. Patients with PTSD are often ill informed about the available treatments, and there has been little formal effort aimed at matching the patients' preferences to a specific treatment.

We propose to conduct a clinical trial of a decision aid for veterans with PTSD. Decision aids are standardized, evidence-based tools to help patients choose between two or more preference-sensitive, clinically acceptable options when there is no clear "best" option. Decision aids are designed to provide patients with detailed balanced information about all the viable treatment options. In addition, they seek to assist the patient in clarifying their own values and preferences such that the patient may choose among the available treatment options.

We believe that the use of a decision aid, compared to treatment as usual, will result in a more patient-centered approach that ultimately will increase the likelihood of the patient receiving evidence based care, both of which are priority goals of VHA.

Eligibility Criteria:
Inclusion Criteria:

* Veterans who meet criteria for Posttraumatic Stress Disorder on the Posttraumatic Stress Disorder Checklist (PCL).

Exclusion Criteria:

* Patients must not have active substance abuse.
* Patients must not have received VA PTSD treatment within the last 12 months.