cyrilzakka/clinical-trials huggingface dataset:
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners

The purpose of this study is to evaluate the efficacy of an adaptive web intervention (Partners Connect) on military spouse drinking behaviors (CPs) and service member help-seeking (SMs). The investigators want to identify for whom this intervention is most efficacious and on what drinking behaviors and mechanisms. The investigators hypothesize that the intervention will reduce concerned partner drinking and increase service member help-seeking, compared to website resources, and that phone-based CRAFT will increase help-seeking behaviors, compared to those who are guided via a CRAFT workbook.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age;
* be living together with their partner, with no plans to change that status in the next 2 months;
* not be in the military themselves (to reduce concerns about mandated reporting of alcohol use);
* score ≥4 on the AUDIT-C for females or ≥5 for males/other;
* respond yes to "Do you feel safe in your current relationship?" from the Partner Violence Screen;
* report not currently being in mental health or alcohol treatment (CP and SM)
* understand English fluently,
* be willing to try an online program to address risky drinking.

We require cohabitating CPs and SMs with no anticipated changes in the next two months to ensure close contact and opportunity to practice new skills, and those who would feel safe participating.

Exclusion Criteria:

* CPs in substance use treatment or their SM was in treatment in the last three months;
* does not feel safe in the current relationship;
* does not understand English fluently;
* has an impaired capacity (cognitive, visual, or hearing);
* is not cohabitating with their SM
Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients

The purpose of this study is to determine whether the telemedicine use in primary health care is effective in the accompaniment of stable coronary artery disease patients who were discharged from the tertiary health care clinics.

This study is a randomized non-inferiority trial for patients with chronic coronary artery disease from a tertiary hospital with outpatient discharge criteria. The purpose is to compare the use of telemedicine in the quality of care transition between tertiary care and primary care patients (intervention group), with patients who remain in the outpatient clinic of a tertiary hospital (control group).

Eligibility Criteria:
Inclusion Criteria:

* individuals with diagnosis of Coronary Artery Disease (CAD) in Canadian Cardiovascular Society (CCS)'s functional classification of angina Class I or II
* patients who did not submit hospitalization for cardiovascular disease in the last year

Exclusion Criteria:

* patients who were not followed up in the health service to at least one year
* unstable patients requiring adjustments of medications or who are performing some diagnostic evaluation at discharge outpatient
Compare Outcomes After High and Low Ligation of Inferior Mesenteric Artery in Colorectal Cancer

We aim comparing different outcomes between high and low tie ligation of inferior mesenteric artery in left colorectal cancer operable and elective surgeries.

Colon cancer represents a significant clinical surgical burden, accounting for approximately 10% of all cancer cases. It is assumed that it is the second leading cause of cancer-related deaths worldwide. Surgery and chemotherapy are considered the main lines of treatment.

Left colonic and rectal cancers represent approximately two-thirds of all colorectal malignancies. The mainstay of treatment is surgical resection, including tumor removal with adequate safety margins with adequate lymphadenectomy.

Several lifestyle factors contribute to the development of colorectal cancer, such as a high intake of processed meats and low intake of fruits and vegetables, a sedentary lifestyle, obesity, smoking, and excessive alcohol consumption.

In colon and rectal cancer surgery, the approach toward the inferior mesenteric artery (IMA) has always been debated among surgeons regarding the "high tie" and "low tie" techniques.

According to the consensus statement of definitions of anorectal Physiology and Rectal Cancer of the American Society of Colon and Rectal Surgeons (ASCRS), a low tie of the IMA is meant as a ligation after the origin of the left colic artery. In contrast, the high tie a ligation of the IMA at its aortic root.

High ligation of the IMA for rectal and left colonic cancers may improve lymph node yield rate, thus facilitating more accurate tumor staging and better oncological outcomes. Several studies have shown the importance of lymph node dissection up to the root of the IMA in terms of better survival and precise staging. The high ligation also enables tension-free colonic anastomosis during low anterior resection. However, high ligation of the IMA has been known to decrease blood flow to the anastomosis, increasing the risk of anastomotic leak.

In contrast, the low-ligation technique allows for adequate blood supply to the colon proximal to the anastomotic stoma during low anterior resection that might prevent vascular inefficiency of the anastomotic marginal colic arteries and decrease the risk of anastomotic leak, especially in elderly patients.

On the other hand, low ligation limits the opportunity for lymph node clearance at the origin of the IMA. This incomplete lymphatic clearance may decrease survival while increasing the possibility of metastasis and cancer recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Every elective patient diagnosed with left-side colon or rectal cancer will be included in our study.

Exclusion Criteria:

* Unfit patients with uncontrolled medical disease will be excluded. Patients with acute intestinal obstruction (emergency cases) and patients with extremes of age above 75 or pediatric ages will be excluded.
The Effects of Different Flow Settings on Lung Impedance

This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.

Background: High-flow nasal cannula (HFNC) is a device that can reduce the work of breathing (WOB) and improve oxygenation by providing a flow that matches or exceeds patient's peak inspiratory flow during tidal breathing. Despite its widespread use, there remains a lack of consensus regarding the optimal flow settings. Two new HFNC devices that can provide information regarding patient's peak tidal inspiratory flow breath by breath are recently available, which might help guide set and titrate the flow settings. This study aims to investigate the effects of different flow settings on lung impedance in a cohort of healthy volunteers by using the two new HFNC devices.

Methods: This prospective, randomized crossover trial will enroll adult healthy volunteers. Initially, the subject's peak inspiratory flow will be measured using a mask connected with a respiratory monitor. Subsequently, the volunteers will undergo HFNC treatment at different flow settings while their peak inspiratory flow will be continuously monitored. The primary outcome of this study is the lung aeration with different flow settings. Secondary outcomes include the lung aeration with different devices, subject's comfort at different flow settings, and the correlation between the subject's peak inspiratory flow measured by HFNC and by a mask connected with a respiratory monitor.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 21-65 years old

Exclusion Criteria:

* Chronic pulmonary diseases, including COPD, interstitial lung disease, cystic fibrosis, etc.
* Uncontrolled asthma;
* Pregnancy
* Subjects who have cold/flu symptoms (sore throat, runny nose, fever, chills, coughing)
* Nose abnormalities that can affect the functionality of the nasal prongs
Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients

Rationale: It is well known that distinctly abnormal blood potassium values can cause serious complications such as cardiac arrhythmias. Although potassium regulation is generally considered important, hardly any research has been done about potassium regulation in intensive care patients. The investigators hypothesize that different potassium target-values, within the as normal accepted range, may have different effects in critically ill patients.

Study design: A prospective trial comparing two different potassium target-values. Potassium will be tightly regulated with the already fully operational GRIP-II computer program.

Study population: 1200 adult patients admitted at the thoracic intensive care unit of the University Medical Center Groningen.

Intervention: Comparison between two variations of standard therapy: potassium target-value of 4.0 mmol/L versus 4.5 mmol/L.

Main study parameters/endpoints: The primary endpoint is the incidence of atrial fibrillation or atrial flutter from ICU-admission to hospital discharge. Secondary endpoints are serum levels of potassium and the other main electrolytes, renal function and renal potassium excretion, the relation with insulin and glucose, the cumulative fluid balance, (ICU) length of stay and mortality.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to the thoracic and surgical ICU of the University Medical Center Groningen.
* Computerized potassium regulation with GRIP-II

Exclusion Criteria:

* Patients who are not potassium regulated with GRIP-II (patients who take their own meals).
Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma

The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).

Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.

The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.

The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.

The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.

The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven with esophageal squamous cell cancer.
* Clinical N0 stage diagnosed by imaging examinations.
* Pathological T1b stage confirmed by endoscopic submucosal dissection.
* Age: 18-75.
* Tumor located at the thorax.
* Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Written informed consent.

Exclusion Criteria:

* Prior intervention treatment before endoscopic submucosal resection.
* Inability to accept any treatment component.
* Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
* Distant metastasis.
* The circumference of the lumen over 3/4
* Main tumor size \> 5cm assessed by endoscopy
* Inability to understand the informed consent.
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®

This is a multi-center, randomized, parallel arm, double-blind study with a total duration of subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed Natalizumab.

This is a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group study to assess the equivalence in efficacy and similarity in safety of biosimilar PB006 compared to Tysabri in patients with RRMS.

All eligible patients will be randomly assigned to one of two treatment groups in a 1:1 ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri at a dose of 300 mg at each intravenous (IV) infusion administered with every single one intravenous (IV) infusion administered every 4 weeks of either PB006 or Tysabri at a dose of 300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions. The End-of-Study Visit (visit 13, week 48) will be performed 4 weeks after the last infusion

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients (age ≥18 to 60 years), with relapsing-remitting multiple sclerosis (RRMS) defined by the 2010 revised McDonald criteria
* At least 1 documented relapse within the previous year and either ≥1 GdE T1-weighted brain lesions or ≥9 T2-weighted brain lesions at Screening
* Kurtzke Expanded Disability Status Scale (EDSS) score from 0 to 5 (inclusive) at Screening

Exclusion Criteria:

* Manifestation of multiple sclerosis (MS) other than relapsing-remitting multiple sclerosis (RRMS)
* Relapse within the 30 days prior Screening and until administration of the first dose of study drug
* Prior treatment with natalizumab, alemtuzumab, ocrelizumab, daclizumab, rituximab, cladribine, or other B- and T-cell targeting therapies
* Prior total lymphoid irradiation or bone marrow or organ transplantation
* Patients with John Cunningham Virus (JCV) index \>1.5 at Screening
* Past or current Progressive Multi-focal leukoencephalopathy (PML) diagnosis
* Severe renal function impairment as defined by serum creatinine values \>120 micromol per litre
Ventilation Knowledge and Skills Retention Using a Novel Tool, the Augmented Infant Resuscitator (AIR) Device as an Instant-feedback Tool

Babies born not breathing at birth require effective gentle ventilation to survive and avert organ damage if initial resuscitation steps such as drying, and stimulation are unsuccessful at facilitating breathing. Training of health workers to impart skills on ventilation is a way to prevent these adverse outcomes. Effective ventilation skills are typically acquired through training programs such as Helping Babies Breath (HBB). However, these ventilation skills quickly decay following training and current skills retention methods such as refresher courses are costly and there is a paucity of skilled human resources to effectively facilitate frequent HBB training courses. This raises the need to explore approaches that are independent of retraining for skills maintenance.

The investigators hypothesize that simulation enhanced HBB training followed by self-administered ventilation practice (SAVP) sessions with the Augmented Infant Resuscitator (AIR) as an electronic coach will result into ventilation skills retention over 12 months. SAVP allows participants to maintain practice and training to enhance skills retention.

The investigators will use a multi-methods approach. First, investigators will evaluate the effect of simulation enhanced HBB training and short self-administered practice with AIR device feedback on ventilation skills among undergraduate medical, nursing and midwifery students in Nigeria, Tanzania, and Uganda over a 12-month period. These short practice sessions will be conducted in skills labs. The investigators will equip each skills lab with at least 20 practice stations to enable increased number of students per unit time and reduce total required time in the skills labs for self-practice.

Second, the investigators will conduct focus group discussions with students before and after the intervention, to examine student experiences of simulation with SAVP vis-à-vis their expectations prior and post exposure.

Study design: This will be a 12-month cohort study among medical, nursing and midwifery students rotating in clinical disciplines. We will use a quasi-experimental design and measure ventilation skills before and after administration of a simulation enhanced HBB training plus SAVP with AIR as an intervention. The ventilation skills will also be measured prospectively every 4 months over a 12-month period in HBB scenario settings.

Eligibility Criteria:
Inclusion Criteria:

* Medicine students
* Nursing students
* Midwifery students
* Students at Mbarara University, Busitema University, Lira University, University of Jos

Exclusion Criteria:

* Students outside the participating institutions
* Students outside the Faculty of Medicine
The Effects of Sleep on Human Microbiota: Implications for Health and Disease

The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.


Eligibility Criteria:
Inclusion Criteria:

* Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.

Exclusion Criteria:

* Pregnant or breast-feeding women
* Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol
Virtual Reality in Plastic Surgery: Pain Control and Augmented Satisfaction

The study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

Patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. Patients will still get the standard lidocaine/novocaine numbing agent. Patients will be asked questions about their anxiety level and pain level. Heart rate and blood pressure will be monitored as measures of anxiety and pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for minor elective plastic surgery procedure
* Patients without cognitive, visual or hearing impairments

Exclusion Criteria:

* Patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
* Lesions that involve portions of the head or face that will prohibit the use of VR goggles
* Severe vertigo
* Patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (MRSA, VRE) were excluded.
* Patients who are pregnant
* Hearing or visually impaired
* Patients \<18 years old
Pharmacokinetics and Safety of Evogliptin in Subjects With Hepatic Dysfunction

The objective of the study is to compare the pharmacokinetics profiles and safety of Evogliptin in patients wit hepatic dysfunction versus healthy volunteers after single oral dose of Evogliptin

When the future evogliptin be administered to liver dysfunction patients, to investgate whether dose adjustment is necessary.

Eligibility Criteria:
Inclusion Criteria:

\<Hepatic Dysfunction\>

* At least 6 months with chronic liver disease (Regardless of cause hepatic dysfunction)
* Child-Pugh A or B

\<Healthy Control\>

* Subject has the following conditions: age ± 5 years, BMI ± 20%, same sex of each matched hepatic dysfunction subject

Exclusion Criteria:

\<Hepatic Dysfunction\>

* Child-Pugh C
* History of Liver transplant

\<Healthy Control\>

* History of chronic liver disorders
* Pregnant or lactating women
Self-Weighing: an Ecological Momentary Assessment

The primary objective of this study is to experimentally test the momentary and more distal psychological effects of daily self weighing as compared to an active control group.

Two significant public health problems, obesity and eating disorders, are prevalent during emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting, binge eating); both of which contribute to obesity. Because many emerging adults attend college, the college community represents a viable population for implementing interventions to prevent weight gain, while not triggering disordered eating.

A promising strategy for preventing weight gain during college is daily self-weighing, an example of behavioral self-monitoring, an evidence-based strategy for weight control. Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate progress in relation to a goal and modify behavior. Despite self-monitoring being recommended, some evidence suggests that self-monitoring strategies, self-weighing in particular, may have unintended psychological consequences; the concern being that negative mood states could precipitate disordered eating. Alternatively, other evidence suggests positive psychological outcomes related to daily self-weighing in young adults.

Technological advances have allowed for users to track personal health information in real time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged 18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is less known is individuals' psychological and behavioral response to self-monitoring. This original, important study will contribute to the fields of obesity and eating disorders and experimentally test the psychological effects of this daily weight-control intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Between the ages of 18 and 26
* UD student
* Owns a smart phone
* If participant does not currently have an eating disorder or has never had one in the past

Exclusion Criteria:

* If participant currently has an eating disorder or has had one in the past
* If participant answers "yes" to 3 or more items in SCOFF
Sprayshield as Adhesion Barrier System for Obese Patients

The application of SprayShield during a laparoscopic band removal (first surgical step) will be evaluated to see if the postoperative adhesions between the stomach, the left liver and the diaphragm are not severe, facilitating the surgical surgical step of a gastric bypass or a sleeve gastrectomy.

Monocenter and observational study on 20 obese patients, requiring removal of the gastric band for poor results (weight regain or insufficient weight-loss) or mechanical complications of the band ( slippage, esophageal dilation) and schedule for a second step surgery of gastric bypass or sleeve gastrectomy 2 months later.

Eligibility Criteria:
Inclusion Criteria:

* Obese male or female who would benefit from a gastric band removal and for whom a second surgical step with conversion to sleeve gastrectomy or bypass is scheduled

Exclusion Criteria:

* The patients having an ablation of ring motivated for an infectious complication