cyrilzakka/clinical-trials huggingface dataset:
Nonsmokers Helping Smokers Quit

This study examines whether nonsmokers can be mobilized to help smokers quit. We will test, via mail campaign, whether targeting nonsmokers can be equally effective in increasing smokers' quit rate as targeting smokers directly. The hypothesis is that both targeted interventions will lead to a higher quit rate than a control group, which receives one set of self-help materials. Each of the targeted intervention groups receives 10 mailings. Smoking status of all three groups will be measured at 3 and 7 months post randomization.

This study examines the potential of enlisting nonsmokers to help smokers quit smoking. Nonsmokers are the majority of the society. If an intervention can be designed to mobilize nonsmokers to help smokers quit, then it has strong implications for increasing smoking cessation at the population level. The conventional approach in smoking cessation is to target smokers directly. This study aims to test whether targeting nonsmokers can be equally effective. The study employs a three arm randomized design, in which a smoker-nonsmoker pair in the same household will be randomized into one of the three groups. One group receives materials targeting the smoker in the household, one group receives materials targeting the nonsmoker, and the third group serve as a control group. The intervention consists of mailed materials which include postcards, informational materials, CDs, DVDs, coupons for cessation-related incentives such as nicotine patches, and links to secured websites. The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages.The mail campaign is augmented with brief phone calls to ensure receipt of mailings and to reinforce targeted messages. At 3 and 7 months post randomization, project staff contact all participants to assess their smoking status.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* A household with at least one smoker and one nonsmoker
* Valid contact information
* English proficiency, both speaking and reading

Exclusion Criteria:

* Insufficient contact information
A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
* For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
* For Caucasian subjects, self-reported European descent or white Latin-American descent.
* Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion Criteria:

* Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner\[s\] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Effective Management of Emotional Response to Generate Well-Being Post-HF Exacerbation

EMERGE is a PI-initiated feasibility study that aims to evaluate the accessibility, usability, effectiveness and relevance of an integrated psycho-behavioral intervention on heart failure patients in order to increase support, outreach and general well-being of these patients following hospitalization due to heart failure exacerbation.


Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients, age ≥ 18 hospitalized at Duke inpatient service because of heart failure
* NYHA Class ≥ II

Exclusion Criteria:

* Significant cognitive impairment, indicated as a mini-mental state exam (MMSE) total score of 23 or lower
* Lack of convenient internet access outside of hospital
* Alcohol or other drug dependence/abuse within past 90 days as evaluated by review of medical record and patient interview (SCID)
* Severe physical disability (visual, sensory or motor) that may interfere with study participation (assessment, online interactive learning)
* History or presence of psychoses, bipolar disorder, and/or severe personality disorders as evaluated by review of medical record and patient interview (SCID)
* Life-threatening co-morbidity with the likelihood of 50% mortality in one year
* Active suicidal ideations
* Female patients of childbearing potential
* Treatment with electroconvulsive therapy or transcranial magnetic stimulation within past 90 days
* Uncorrected hypothyroidism or hyperthyroidism
Yield of Colonoscopy in Children With Rectal Bleeding

description study of colonscopy in children with bleeding per rectum attending gastrointestinal endoscopic unit in assiut university children hospital from 2014-2019

Rectal bleeding is a source of anxiety for both children and parents and is frequently encountered clinical complaint in routine practice in pediatric patient . Lower gastrointestinal bleeding means bleeding from sites distal to the ligament of treitz and presents as rectal bleeding while passage of bright red blood from the rectum is called hematochezia.

The etiology of rectal bleeding is different in children than in adult according to age group which enables physicians to make appropriate differential diagnosis. There are several etiologies for rectal bleeding in pediatric practice ranging from mild condition requiring little or no treatment to severe and life-threating ones requiring immediate intervention. The etiologies include anal fissure, food allergy, infectious enterocolitis, Meckel'sdiverticulum, intussusceptions, volvulus, lymphonodular hyperplasia, inflammatory bowel disease, angiodysplasia, hemorrhoids, and hemolytic -uremic syndrome. Common causes of bleeding per rectum in children vary between studies . Once the bleeding is suspected to be coming from lower gastrointestinal tract it warrant an evaluation in all cases by proctosigmoidoscopy followed by colonoscopy .

Colonoscopy is the examination of choice for diagnosis and management of bleeding per rectum in children . The benefits of colonoscopy include identification of the site of bleeding regardless of the rate or presence of bleeding through visualization the entire length of the colon often include the distal ileum by possibility of endoscpic intervention and biopsy taking to make and confirm the diagnosis and follow up evaluation, so gastrointestinal endoscopy with biopsy is an essential tool for diagnosis of crohns disease and ulcerative colitis in children, as well as therapeutical intervention of colonoscopy by hemostasis, removing polyps, dilating stricture or decompressing the obstructed bowel .

Colonoscopy is considered a safe and low risk procedure. Complications of colonoscopy are rare and usually minor, as adverse effects of sedative medicine as (nausea,vomiting or allergies) can ocurr.

Bleeding after colonoscopy is usually minimal but may follow mucous biopsy or polypectomy, Perforation is very rare but it is the most serious complication of colonoscopy in children, it is usually related to polypectomy and can be successfully managed with surgical intervention. In case of infection in which cause the child will be given antibiotics.

Eligibility Criteria:
Inclusion Criteria:

* all children with rectal bleeding underwent colonoscopy

Exclusion Criteria:

* children underwent colonoscopy rather than rectal bleeding
Zero-fluoroscopic Navigation Versus Conventional Fluoroscopic Navigation for Double-chamber Pacemaker Implantation

This study is intended to compare the feasibility, safety and efficacy of Ensite-NavX zero-fluoroscopic navigation system to conventional fluoroscopic X-ray approach as to performing double-chamber pacemaker implantation.

Permanent pacemaker is a well-established treatment to treat patients with a wide range of heart rhythm disturbances.

Fluoroscopy is the imaging modality routinely used for cardiac device implantation and electrophysiological procedures.Due to the rising concern regarding the harmful effects of radiation exposure to both the patients and operation staffs, novel 3D mapping systems have been developed and implemented in electrophysiological procedure for the navigation of catheters inside the heart chambers.

Ensite NavX system can be used for cardiac imaging as a reliable and safe zero-fluoroscopy approach for implantation of single- or dual-chamber permanent pacemaker in patients. Our method offered a choice for some special population of patient in whom radiation exposure need to be avoided or in the extreme circumstances when the X-ray machine is out-of-order.

Eligibility Criteria:
Inclusion Criteria:

* Sick Sinus Syndrome
* complete Atrioventricular Block
* high degree second Degree Atrioventricular Block
* Bradycardia

Exclusion Criteria:

* pacemaker replacement
* severe structural cardiac malformations
* severe cardiac enlargement
* venous malformations
FFP Versus PCC in Intracranial Hemorrhage

The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.

Vitamin K antagonists in general and Coumadin in particular remains the most common form of outpatient anticoagulation in patients today. Despite the therapeutic benefits of these agents, bleeding in general and intracranial bleeding in particular are significant risks associated with these medications. Intracranial bleeding on oral anticoagulation agents are associated with a 20% increase in 30 day mortality versus non-anticoagulated controls, and rapid reversal of vitamin K antagonists in this population has been shown to have survival benefits.

Historically, vitamin K antagonists have been reversed using fresh frozen plasma (FFP) transfusions which, though effective, often incur delays due to the time required to obtain a type \& screen, thaw the product, and administer the product to the patient. In 2013, the FDA approved 4-factor prothrombin complex (PCC), a concentrate of factors II, VII, IX, X, protein C and protein S for use as a method for correcting vitamin K antagonist related coagulopathy. Though large, prospective randomized control trials have demonstrated efficacy and safety in a general population of all-comers bleeding, there is very little literature regarding the benefits of PCC versus FFP in the traumatic and spontaneous intracranial hemorrhage population.

Current standard of care in patients with traumatic and spontaneous intracranial hemorrhage who are on vitamin K antagonists is to reverse the effect of these agents with FFP or PCC. The choice of which agent to use is currently determined by both availability of each agent and surgeon preference. For this study, there will be an equal likelihood of either treatment being given.

The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.

Eligibility Criteria:
Inclusion Criteria:

* Coumadin use
* INR of 2.0 or higher on arrival at the study center
* Evidence on cranial imaging of spontaneous intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, traumatic subarachnoid hemorrhage, or traumatic intraparenchymal hemorrhage

Exclusion Criteria:

* Unable to obtain consent
* Estimated survival \<24 hours
* Hypersensitivity to 4 factor prothrombin complex concentrate
* Concomitant use of novel vitamin K antagonists
* Religious/social prohibition to receiving blood products
* Need for emergent, non-neurosurgical operative intervention
* Mechanical heart valves
EUS-FNA in the Pre-Operative Evaluation of Patients With Lung Cancer

This trial examines the role of EUS-FNA (Oesophageal Endoscopic Ultrasound with Fine Needle Aspiration) as an endoscopic technique for the mediastinal staging of patients with lung cancer.

Patients will be randomized to either conventional surgical technique or EUS-FNA.


Eligibility Criteria:
Inclusion Criteria:

* patients with histological or cytological proof of non small cell lung cancer (NSCLC) or with a high clinical suspicion for lung cancer (but without pathologically confirmed diagnosis from the bronchoscopy or CT guided transthoracal biopsies) in whom the next step is normally a diagnostic or therapeutic surgical intervention
* no distant metastases after routine clinical work up (PET is optional, not mandatory)
* provision of a written informed consent
* recent CT-scan of the thorax (\<28 days before randomization date)
* age 18 years or older
* clinically fit for surgery

Exclusion Criteria:

* proof of small cell lung cancer (SCLC) with CWU (bronchoscopy or CT guided transthoracal punction)
* stage IV NSCLC
* patients with a solitary pulmonary nodule (thus without enlarged mediastinal lymph nodes on CT and without mediastinal PET hot spots) : these do not require further mediastinal investigation
* former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
* other concomitant malignancies
* reasons for which the patient is unable to swallow the EUS-instrument (e.g. zenker diverticulum, unexplained esophageal stenosis)
* uncorrected coagulopathy
Smart Home-based Technology to Promote Functional Mobility Among Individuals With Parkinson's Disease

Many patients with Parkinson's disease suffer of gait disorder termed as "freezing of gait" (FOG). non-pharmacological approach such as applying external cues is effective in mitigating FOG events. The aim of this study is to test the feasibility and patients satisfaction from a first stage of technology development, designed to deliver automatically external cues to the patients in their homes.

People with Parkinson's disease (PwP) may experience severe difficulties in mobility that negatively affect their function and Quality of life. Freezing of gait, (FOG) is a brief and sudden inability to initiate walking or move forward, despite an intention to walk. Such episodes are often observed when PwP attempt to turn, cross a narrow space or negotiate obstacles. Rehabilitation interventions for FOG represent the most effective non-pharmacological approach to maintain functional independence and reduce the risk of falls. A key approach is the provision of external cues, defined as sensory stimuli, which facilitate gait initiation and continuation. These external cues are suggested to bypass the dysfunctional movement pathways in the basal ganglia and therefore, are considered effective in alleviating FOG. Cueing can be applied by different modalities; the most common are visual (e.g. spaced lines on the floor) and auditory (e.g. rhythmic metronome beats).

The term smart-home refers to a range of technologies that are designed for and deployed in individual residences, and are equipped with non-invasive, environmental, and physiological sensors. The concept of a "health smart-home" is a variation of smart-home with a focus on assistive technologies to enable the independence and wellness of residents, including the elderly and patients in supervised residences.

In this study, the investigators will be testing the first phase of developing a smart-home technology designed for patients coping with PD to use in their homes and aims to improve gait and assist in prevention of FOG. The aims of this exploratory study are to evaluate the 1) practical feasibility of the technology, 2) patient satisfaction and 3) the effect of the technology on gait. The device was developed by Selfit medical© and included application of light stripes (visual cues) and metronome beats (auditory cues) that are individually adjusted to the participant walking parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able to walk independently
* The patient report on daily episodes of FOG as indicated by question #2 in the new FOG questionnaire ("How frequently do you experience freezing episodes?").
* Score\>18 on the Telephone Version of the Mini-Mental State Examination (TMMSE)
* Intact hearing and vision by self-declaration

Exclusion criteria

• The patient suffer of any neurological condition other than Parkinson's disease.
Heart Rate Variability Biofeedback in Older Adults

Older adults will be randomly assigned to an active heart rate variability biofeedback condition and a "sham" control condition. Stress recovery measures and emotional and cognitive functioning will be assessed before and following the five-week intervention to assess potential changes from the intervention.

The goal of the current study is to compare heart rate variability biofeedback in an older adults study. The primary aims of the paper are to test whether there will be differences between HRV measurements pre- to post-intervention for HRV outcomes, stress recovery, and emotional and cognitive outcome measures. The investigators will implement an active HRVB condition and a control condition that utilizes methods developed by Yoo and colleagues. The "sham" control condition is designed to decrease the syncing of the baroreceptors and respiratory sinus arrhythmia and decrease heart rate oscillations. The target sample will be 50 older adults 65 years and older that will be randomized into the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speaker
* Able to provide informed consent
* 65 years or Older

Exclusion Criteria:

* Symptoms within the last year of a neurological disorder (e.g., dementia, stroke, epilepsy, traumatic brain injury with loss of consciousness in the last year, etc.).
* Conditions that might affect the biofeedback training (i.e., pacemakers, previous self-reported heart attack with hospitalization, self-reported coronary artery disease)
* Currently engaged in or have been previously trained in heart rate variability biofeedback.
* 3.3 or higher on the IQCODE.
* Currently prescribed and taking beta-blockers.
Clinical Evaluation of dCELL® Meniscus for Partial Replacement of the Meniscus

The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.

The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
* Must be a stable, well aligned knee with ligament laxity of Grade II or less
* Osteoarthritis \<grade 3 on the Kellgren Lawrence scale
* Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol

Exclusion Criteria:

* Body Mass Index (BMI) greater than 35 kg/m2
* Treatment with any investigational drug or device within two months prior to screening
* Patients presenting with abnormal degenerative osteoarthritis of the joint
* Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
* Patients using anticoagulants
* Patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening
* Patients with diabetes or cardiovascular disease which precludes elective surgery
* Patients with documented renal disease or metabolic bone disease
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor.

We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled.

Exclusion Criteria:

* Previous episodes of AF or flutter
* Uncontrolled diabetes mellitus
* Systemic mycotic infection
* Active tuberculosis
* Cushing's syndrome
* Psychotic mental disorder
* Herpes Simplex keratitis
* Serum creatinine exceeding 200 µg/ml
* Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.