cyrilzakka/clinical-trials huggingface dataset:
CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

Many people smoke cigarettes and use e-cigarettes, and have a hard time stopping. Nicotine replacement therapy medications, such as nicotine patches and lozenges, have been shown to help people quit e-cigarette use. The purpose of the present study is to see how well nicotine patches and lozenges help people quit both smoking and vaping, and to determine if higher doses of the medication work best.

Tobacco use is a leading cause of cancer death and disability in the US, thus tobacco control remains an important public health priority. Alternative tobacco products have grown popular in the past decade, including electronic cigarettes (e-cigarettes; vaping). E-cigarettes were initially marketed as an alternative to or means for smoking cessation and became popular amongst those currently smoking. Recent estimates suggest that 54% of those who vape are currently smoking (i.e., dual use). Despite this, there is a lack of empirically tested interventions for dual use cessation among the general adult population. In a prior pilot study, investigators found preliminary evidence that a standard dose of nicotine replacement therapy (NRT; 21mg patch+4mg lozenge) was sufficient at helping exclusive e-cigarette users quit vaping. However, dual users (individuals who smoke cigarettes and use e-cigarettes) did not respond similarly. The proposed project aims to compare three doses of NRT (21mg patch+4mg lozenge; 21+14mg patch + 4mg lozenges; 21+21mg patch + 4mg lozenges) with a sample of dual users who wish to quit smoking and vaping use in order to understand more about how NRT can help dual users quit tobacco.

Eligibility Criteria:
Inclusion Criteria:

* Age 18yrs +
* Daily nicotine-containing e-cigarette user (25+ days per previous month)
* E-cigarette use 5+ times/day
* E-cigarette use \> 1year
* Smoking \>1 cigarette on 5-7 days per week
* Interest in quitting smoking and e-cigarette within the next month (\>7 on 10-point scale)
* Willingness to use NRT
* Able to receive text messages/email
* Mailing address in South Carolina.

Exclusion Criteria:

* Medical conditions contraindicated to NRT use (including pregnancy, past month myocardial infarction, current cardiac arrhythmia, current angina, uncontrolled vascular disease, or medical conditions in which consumption of phenylalanine is contraindicated)
* Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications
* Those who vape non-nicotine substances
* Individuals unable to consent (e.g. significant cognitive deficit, non-English speaking).
Study Comparing Graft Function in Renal Allograft Recepients Receiving Reduced or Standard Dose CsA With Sirolimus

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months were evaluated also.

This study evaluated renal graft function (based on calcuated creatinine clearance) 12 months after kidney transplantation in patients receiving either a regimen of reduced dose or standard dose cyclosporine (CsA) in combination with sirolimus and corticosteroids. The incidence of acute graft rejection at 6 and 12 months following transplantation and patient and graft survival at 12 months after transplantation were evaluated also.

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 years of age
* End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric, living-unrelated or living-related mismatched donor
* Patients with a secondary transplant must have maintained their primary graft for at least 6 months

Exclusion Criteria:

* Planned antibody induction therapy
* Multiple organ transplants
* Patients at a high risk of acute rejection
Changes in Microbiome and Metabolites Regarding Physical Activity in Middle-aged Korean Women

This study aimed to examine the effect of physical activity (PA) on health through changes in multi-omics biomarkers during 6 months of exercise intervention.

This study aimed to examine the effect of physical activity (PA) on health through changes in multi-omics biomarkers during 6 months of exercise intervention. Twenty-seven healthy middle-aged women were recruited and 14 subjects completed the exercise intervention. A total of three blood and stool samples were collected at 3-month intervals. The amount of PA was measured with an accelerometer. Clinical variables were used, including blood pressure, grip strength, flexibility, and blood glucose levels and lipid markers obtained from laboratory tests. The concentration of blood metabolites was measured by targeted metabolomics. Fecal microbiome data were obtained by 16S rRNA gene amplicon sequencing. During the second half period (period 2), Coronavirus disease 2019 (COVID-19) occurred and spread out in Korea, and PA decreased compared with the first half period (period 1). Blood pressure, hemoglobin A1c (HbA1c), and low-density lipoprotein cholesterol (LDL-C) decreased in period 1 and tended to increase again during period 2. Forty metabolites were changed significantly during period 1, and investigators found that 6 of them were correlated with changes in blood pressure, HbA1c, and LDL-C via network analysis. Our results may suggest the relationship between changes in biomarkers at multi-omics levels during exercise and a message that reduced PA due to COVID-19 can adversely affect health.

Eligibility Criteria:
Inclusion Criteria:

* age 40 - 59 (middled aged women)
* Those who have no difficulties in daily living
* Those who engage in sedentary activities most of the day
* Willing to commit throughout the study

Exclusion Criteria:

* Antibiotics medication in the last month.
* Those who are in the treatment of the following diseases: Liver disease, Neurological disease, Respiratory disease, Tumors, Psychiatric disorders, Angina, Myocardial infarction, and Stroke
Intensive Faciltiation of Swallowing in Patients With Severe Dysphagia After Acquired Brain Injury

This study is a randomized controlled trial (RCT). Patients after severe acquired brain injury (ABI) were randomised in addition to the individual daily rehabilitation program to intensive Facial Oral Tract Therapy (F.O.T.T.®) (intervention group) or unspecific treatment: washing face, brushing teeth, without facilitating swallowing (control group).

The duration of the intervention period was 15 working days (3 weeks). The intervention in both groups was twice a day.

The F.O.T.T.® approach uses structured tactile input and facilitation techniques in meaningful everyday life context, aiming for improving function in the face and oral tract that is as normal as possible. The goal is maximum participation in daily life. The treatment encourages learning of helpful functional movements or patterns of movement for safe swallowing, protection of airway, oral hygiene, eating, drinking, breathing, voice and articulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with dysphagia caused by severe ABI

Exclusion Criteria:

* congenital brain damage, psychiatric diagnosis, history of head and neck cancer, agitated behaviour, need for tracheostomy tube
Blood Test to Measure DNA Damage in Blood

To check the radiosensitivity level in individual patients based on their DNA damage level.


Eligibility Criteria:
Inclusion Criteria:

* prostate cancer diagnosis
* undergoing radiotherapy
* agree to participate in study

Exclusion Criteria:

* not willing to participate
* not undergoing radiotherapy
Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have had a cryptogenic stroke within the last 270 days
* Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
* Subjects willing to participate in follow-up visits

Exclusion Criteria:

* Subjects with intracardiac thrombus or tumor
* Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
* Subjects with left ventricular aneurysm or akinesis
* Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
* Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
* Subjects with contraindication to aspirin or Clopidogrel therapy
* Pregnant or desire to become pregnant within the next year
Group Alcohol Interventions for College Men

The objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention.

Although research suggests that sexual assault interventions based on Bystander and Social Norms theory help to reduce sexual assault among college men, these programs do not completely eliminate sexual assault and their effects tend to fade over time. Unfortunately, there is minimal research on whether (1) decreasing alcohol use concurrently decreases sexual assault perpetration among college men and (2) whether alcohol interventions can be incorporated into existing sexual assault programs for college men (i.e., Bystander/Social Norms programs). Therefore, the objective of the proposed project is to conduct a randomized controlled trial (RCT) comparing sexual assault perpetration and related outcomes (i.e., bystander behavior; rape myth acceptance) for men who receive a group alcohol intervention only to men who receive a group integrated alcohol and sexual assault intervention. Specifically, the alcohol only intervention will consist of the Brief Alcohol Screening and Intervention for College Students (BASICS), an empirically-supported intervention for college student drinking. The integrated alcohol and sexual assault intervention, which we have termed Ohio University's Combined Alcohol and Normative Intervention program (OU CAN), will be modeled after BASICS and empirically-supported Bystander and Social Norms interventions for sexual assault. The current study will recruit 100 college men who are sanctioned by their university to receive an alcohol intervention for violating a campus alcohol policy: by definition an indicated and at-risk population for sexual assault perpetration. Men will be followed for 6 months to determine the effects of the intervention on sexual assault perpetration and other primary outcomes (e.g., bystander behavior).

Eligibility Criteria:
Inclusion Criteria:

* Must be 18 or older; must be an Ohio University student; must be male; must be sanctioned to receive an alcohol intervention by Ohio University

Exclusion Criteria:

* Under the age of 18
I-gel Plus Supraglottic Airway Device for Surgical Procedures in Prone Position

I-gel Plus is a novel supraglottic airway device that has been evaluated in various studies with high success and low complication rates. Feasibility of supraglottic airway devices (SGA) in patients undergoing surgery in prone position has been demonstrated in some pilot studies and case series; however, the evidence is still limited. It is currently uncertain, if the i-gel Plus facilitates appropriate ventilation in individuals undergoing elective surgery in prone position.

The primary aim of this single-center non-inferior study is to assess the leak fraction of the i-gel Plus in patients undergoing surgery in prone position and to compare it with data from an existing prospective control cohort in patients undergoing surgery in supine position. Secondary aims are to investigate the oropharyngeal seal pressure and other secondary outcome parameters and to compare them with the control cohort.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduling for elective surgery in prone position
* Planned airway management using a SGA
* Adult patients (age 18-89 years)
* ASA physical status 1-3

Exclusion Criteria:

* Pregnant or breastfeeding women
* Non-fasted patients
* Increased risk of aspiration or other contraindications for supraglottic mask ventilation
* Shared airway or intracavity open surgery
* Body mass index (BMI) \&amp;gt;35 kg/m2
* Inability to understand or sign informed consent
Autonomic Cardiovascular Control for Elderly Surgery Patients

The purpose of this study is to study aspects of autonomic cardiovascular control and the level of stress hormones and inflammatory markers in saliva or serum, in elderly patients exposed to elective, major abdominal surgery, with or without postoperative delirium, to explore the hypothesis that delirium may be the result of aberrant stress responses.

Patients admitted for elective, major, abdominal surgery will be tested with a head-up tilting to 20 degrees for 15 minutes preoperatively and again on the second postoperative day. Haemodynamic variables will be registered by the device TaskForceMonitor which monitors heart rate (HR), electrocardiography (ECG), blood pressure and stroke volume continuously and non-invasively.

Background variables (including demographics, comorbidity and simple cognitive tests) and daily variables (including delirium assessments) will be registered.

Blood and saliva samples will be drawn preoperatively and postoperatively to measure levels of stress hormones and inflammatory markers.

Eligibility Criteria:
Inclusion Criteria:

* Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital

Exclusion Criteria:

* Absence of a valid informed consent or assent, or consent from a legal proxy
* Patients with atrial fibrillation or a pacemaker rhythm
* Polyneuropathy
* Current treatment with beta-blockers, calcium-blockers or cholinesterase inhibitors
* Competing research project
Immunotherapy in Upper Tract Urothelial Carcinoma

Upper-tract urothelial carcinoma (UTUC) is a rare tumor. Standard treatment of localized disease is most often radical nephroureterectomy.

In advanced/metastatic disease, treatments follow the standards for urothelial carcinoma including platinum-based chemotherapy and anti-PD(L)1 (Programmed death (ligand) 1) immunotherapy, with no regard as to the primary disease site (bladder or upper tract). Given the rarity of UTUC, efficacy data in the UTUC subgroup of advanced urothelial carcinoma is scarce.

UTUC show distinct pahological and molecular features, including higher prevalence of microsatellite instability and of abnormalities in the FGFR (fibroblast growth factor receptors) gene family. These specific features may impact outcomes of immunotherapy in advanced/metastatic UTUC.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and more
* Diagnosis of urothelial carcinoma (with or without variant histology)
* Advanced/metastatic disease not amenable to local treatment with curative intent
* Treatment with an anti-PD-(L)1 monoclonal antibody initiated between 2016 and 2022

Exclusion Criteria:

* Patient's opposition to this research
* Urothelial carcinoma of bladder or urethral primary site
* Non-urothelial tumor
* Maintenance immunotherapy initiated without disease progression
Dry Needling Versus Conventional Physical Therapy in Patients With Plantar Fasciitis

The purpose of this research is to compare patient outcomes following treatment of plantar fasciitis with conventional physical therapy (stretching, strengthening, ultrasound, manual therapy, and cryotherapy) and conventional physical therapy plus dry needling. Physical therapists commonly use conventional physical therapy techniques and dry needling to treat plantar fasciitis, and this study is attempting to find out if the addition of dry needling to conventional physical therapy is more effective than conventional physical therapy alone.

Patients with plantar fasciitis will be randomly assigned to receive 1-2 treatments per week for 4 weeks of either: (1) Dry Needling and conventional physical therapy, or the (2) Conventional physical therapy (stretching, strengthening, ultrasound, manual therapy, and cryotherapy)

Eligibility Criteria:
Inclusion Criteria:

1. Report of at least 3 months of heel pain
2. Patient has not had physical therapy, massage therapy, chiropractic treatment, or injections for plantar heel pain in the least 4 weeks.
3. Diagnosis of plantar heel pain with ALL of the following positive clinical signs:

   * "First---step" pain upon weight bearing in the morning OR after sitting for a period of time
   * Pain localized over the medial calcaneal tubercle
   * Increased pain with extended walking OR standing \>15 minutes
4. Plantar heel pain greater than or equal to 2/10 (NPRS 0-10 Scale)

Exclusion Criteria:

1. Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. History of previous surgery to the tibia, fibula, ankle joint, or foot.
3. History of arthrosis or arthritis of the ankle and/or foot.
4. History of significant ankle and/or foot instability.
5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

   * Muscle weakness involving a major lower extremity muscle group
   * Diminished lower extremity patella or Achilles tendon reflexes
   * Diminished / absent sensation in any lower extremity dermatome
6. Involvement in litigation or worker's compensation regarding their foot pain.
7. Any condition that might contraindicate the use of electro---needling
8. The patient is pregnant
Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial

The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

* BMI\<35 Kg/m2,
* Important comorbidities
Sound Check-Correlation Between Transperineal and Digital Cervical Exam in 3rd Trimester Pregnancy

The primary purpose of this study is to compare the accuracy of the Butterfly iQ pocket ultrasound with the digital cervical examination in the third trimester cervix. The secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.

Patients in the 3rd trimester that require a digital cervical exam (DCE) for assessment of labor will be approached. After informed consent is obtained, one of two study investigators will perform a transperineal ultrasound (TPUS) using the glove-covered Butterfly iQ+ probe. The Butterfly iQ+ does not have a transperineal probe or setting, therefore, the "bladder" preset setting will be used. The "bladder" setting has been predetermined to provide the best cervical images. This pocket ultrasound is FDA-approved and is the standard of care for point of care ultrasounds in many institutions and is already used in our department. The TPUS will be performed by 1 of the 2 investigators with digital calipers. There will be 3 measurements: dilation, effacement, and station. The dilation measurements with be made from the inside margins of the cervix . Effacement will be measured by marking the thinnest and most easily imaged lip of the cervix. Zero station will be assumed to be 5 cm above the perineum, with distances from 6-10 cm corresponding to -1 to -5 station clinically. An independent, blinded examiner will then perform a traditional digital cervical exam, which will be recorded in EPIC. The study investigators will be blinded to the DCE measurement until the end of the study. The patient will act as their own control. Additionally, the investigators will collect EGA, race, ethnicity, age, BMI, and indication for assessment of the cervix.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery.

Exclusion Criteria:

* Second trimester (less than 28 weeks)
* BMI\>50
* Does not wish to participate
OCS Liver PROTECT Continued Access Protocol

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

A prospective, single arm, continued access protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers having one or more of the following characteristics:

1. Donor age equal to or greater than 40 years old, or
2. Expected cross clamp time of 6 hours or greater, or
3. Donor after circulatory death (DCD) with age less than or equal to 55 years; or
4. Steatotic lever \>0% and less than or equal to 40% at time of retrieval, based on pre-retrieval histology)

A maximum of 21 sites will enroll up to 184 transplanted liver recipients. The primary effectiveness endpoint will be the incidence of Early Allograft Dysfunction (EAD) or primary non-function.

All recipients will be followed for 24 months from the date of transplantation (some of which will be post-market).

Eligibility Criteria:
Recipient Inclusion Criteria:

* Registered primary liver transplant candidate, male or female
* Age ≥ 18 years
* Signed (1) written informed consent document and (2) authorization to use and disclose protected health information

Exclusion Criteria:

* Acute, fulminant liver failure
* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of \> 3 mg/dl for \> 2 weeks and/or requiring hemodialysis
* Multi-organ transplant
* Ventilator dependent
* Dependent on \> 1 IV inotrope to maintain hemodynamics

Donor Inclusion Criteria

* Donor age ≥ 40 years, or
* Expected cross-clamp time ≥ 6 hours, or
* Donor after circulatory death (DCD) with age ≤ 55 years, or
* Steatotic liver \> 0% and ≤ 40% macrosteatosis at time of retrieval

Donor Exclusion Criteria

* Living donors
* Liver intended for split transplants
* Positive serology (HIV, Hepatitis B surface antigen \& Hepatitis C)
* Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
* Donor livers with macrosteatosis of \> 40% based on retrieval biopsy readout.