cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Smoking Cessation Program in a Community Health System

Research efforts are needed to increase tobacco cessation support and to improve tobacco cessation efficacy. In addition, strategies must be identified to increase access to smoking cessation support and to develop processes to integrate smoking cessation into treatment plans for cancer patients.

The Cancer Patient Tobacco Questionnaire (C-TUQ) survey tool will be used to address the primary and secondary outcome measures. This tool is publicly available on the National Cancer Institutes Grid-Enabled Measures website and was developed by NCI and the American Association for Cancer Research. This tool is a 22-item self-report survey designed to capture information about tobacco use by cancer patients and cancer survivors. Comparisons will be made for those patients that enroll in the structured smoking cessation program versus those patients that have opted to quit on their own.

Primary:

To determine the effectiveness of an intensive structured smoking cessation program (education and support) provided by a tobacco cessation trained specialist versus unassisted smoking cessation quitting methods (no support, patients have opted to stop on their own) in cancer patients seen in a community health care system

Secondary:

* Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking with professional support
* Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support, participants choosing to stop smoking on their own.
* Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.

Eligibility Criteria:
Inclusion Criteria:

Any Gender

* Over 18 years of age
* Able to read and understand English
* Able to sign the informed consent form
* A current cigarette smoker defined as smoking within 30 days
* Diagnosed with cancer and wants to quit smoking

Exclusion Criteria:

* • Individuals with Dementia

  * ECOG Performance Status 3-4
  * Survival prognosis less than 12 months
  * Currently participating in a smoking cessation program that is not provided by Virtua
  * Individuals who do not want to quit smoking
  * Pregnant Women
Shared Oral Care - Improving Oral Care in Institutionalized Elderly in Aalborg Municipality

Background:

Nationally and internationally, more people over the age of 65 and especially an increase of people over the age of 80 enter nursing homes with natural dentition and complex prostheses and bridges than previous generations. Furthermore, there is an increased incidence of dental diseases in the elderly. This is leading to increased and different oral care needs. There is a large discrepancy between the elderly who need help with oral hygiene and the elderly who actually receive help. In order to improve the oral hygiene competencies of healthcare professionals at nursing homes, it is necessary to increase their education and improve organizational strategies.

Hypothesis:

The Intervention Shared Oral Care improves the elderlys bleeding and plaque index after 6 months.

Study type:

An intervention study.

A cluster randomization of 14 nursing homes in Aalborg municipality is carried out.

Outcome Measures:

Change in mucosal-plaque score (MPS) index

Change in Oral Related Quality of life

Outcome Measure Time Frame:

Change in mucosal-plaque score index measured at 0, 3 and 6 months.

Change in Oral Related Quality of life measured at 0 and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Elderly living in nursing homes in Aalborg Municipality Having one or more natural dentition

Exclusion Criteria:

* no natural dentition
Dose Response Effect of Probiotics for the Prevention of Antibiotic-associated Diarrhea in Chinese Adults

The purpose of this study is to determine the dose response effect of probiotic capsules for the prevention of antibiotic-associated diarrhea (AAD).


Eligibility Criteria:
Inclusion Criteria:

* age 30-70 years
* initiating antibiotic therapy
* informed consent

Exclusion Criteria:

* current diarrhea
* life threatening illness
* habitual probiotic use
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be men or non-pregnant women at least 18 years of age
* Patients who present with a gastric or duodenal ulcer

Exclusion Criteria:

* Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation
* Patients presenting with active bleeding and/or NBVV at 2 or more separate sites
* Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases
A Study of LY3871801 in Healthy Participants

The main purpose of this study is to compare the amount of LY3871801 that gets into the blood stream and how long it takes the body to get rid of it, when given as crystalline freebase tablet (test) and as a solid dispersion oral suspension (reference) in healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3871801 will also be evaluated. The study may last up to approximately 15 days excluding the 28 days of screening period.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
* Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 40.0 kilograms per meter squared (kg/m²)
* Participants not of childbearing potential

Exclusion Criteria:

* Have known allergies to LY3871801, related compounds or any components of the formulation, or history of significant atopy.
* Have an abnormal blood pressure and/or pulse rate, deemed to be clinically significant by the investigator
* Have used or intend to use prescription or nonprescription medication (including dietary supplements, vitamins, herbal supplements, and/or alternative medicines) within 7 days prior to dosing
* History of drug or alcohol abuse in the past 2 years and/or regularly use known drugs of abuse
* Are unwilling to stop alcohol consumption 24 hours prior to admission and while resident at the clinical research unit (CRU).
* Smoke more than 10 cigarettes per day (or the equivalent, including electronic cigarettes) or are unable to abide by the CRU smoking restrictions.
Effects of Glutamine in Ischemic Heart Disease Patients Following Cardiopulmonary Bypass

The purpose of this study is to determine whether perioperative glutamine administration possess protective properties on internal organs (heart and gut) in patients with coronary atherosclerosis, operated under cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with coronary artery disease operated on under cardiopulmonary bypass

Exclusion Criteria:

* Ejection fraction\<40%
* Viral hepatitis
* Liver cirrhosis
* Cholecystitis
* Pancreatitis
* Chronic severe gastrointestinal disease
* Surgery on gastrointestinal tract in patient's medical history
Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

The purpose of this study is to examine the difference in perioperative pain after shoulder surgery with a standard bupivacaine nerve block compared to liposomal bupivacaine enhanced nerve block alone in TSA and ARCR. Data will be compared using VAS scores and opiate consumption between the two groups. The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Arthroscopic rotator cuff repair (ARCR) and shoulder arthroplasty (TSA) provide excellent clinical outcomes but are often associated with significant postoperative pain, frequently managed with oral opioid medication. Orthopedic surgeons prescribe approximately 32 unused pills per shoulder surgery and are the third largest prescribers of opiates in the USA. It is incumbent upon the orthopedic community to identify postoperative pain management methods which reduce the need for narcotic medication following shoulder procedures as a means to mitigate the impact of orthopedic procedures on this epidemic.

The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is an accepted approach for managing surgical pain and reducing opiate use but requires peer reviewed protocols to gain wider acceptance.

Interscalene nerve block with bupivacaine remains a gold standard for peri-operative analgesia, but is associated with significant rebound pain due to the short duration of the local anesthetics. Recent studies have demonstrated that the addition of a liposomal bupivacaine field block may lower pain and enhance patient satisfaction throughout the first postoperative week. Liposomal bupivacaine has recently received FDA approval for ISB, but the data regarding its efficacy in nerve blocks is sparse.

The purpose of this pilot study is to determine if liposomal bupivacaine-enhanced interscalene nerve blocks can be used to improve peri-operative pain control methods, limit narcotic use, and provide appropriate postoperative analgesia compared to standard bupivacaine blocks. Primary and secondary outcome measures will be collected as number of opiates taken and self-reported VAS pain scores over a 14 day postoperative period, respectively.

The hypothesis of this study is that an interscalene nerve block with liposomal bupivacaine will decrease both postoperative VAS pain scores and total narcotic consumption when compared to a standard bupivacaine interscalene nerve block alone.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

* Pregnant
* Documented drug of alcohol abuse
* Active narcotic use prior to surgery
* Neurological deficit
* Allergy to amide anesthetics
* Not cleared by primary care physician
* Hydrocodone or oxycodone intolerance
* Enrollment in another clinical trial or past cognitive or mental health status that interferes with study
Translocator Protein PET/CT in Various TSPO-Related Disease

To evaluate the potential usefulness of 18F-DPA714/FDPA positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various TSPO-related disease patients.

Subjects with various Tau-related disease patients underwent 18F-DPA714/FDPA PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-DPA714/FDPA PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled TSPO PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Optical Imaging For Assessment of Foot Perfusion

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.

This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic. SFDI is a non-contact optical imaging technology that measures tissue functional (blood volume, tissue oxygen saturation) and structural information (scattering index) across a large field of view. Our hypothesis is that SFDI parameters can eventually become a quantitative tool to assess foot health and identify patients at risk for ulcer formation. This phase of the study is designed to correlate SFDI outputs to current clinical risk categories

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Pregnant/lactating women
* Rheumatoid arthritis
Fexofenadine in Patients With Active Rheumatoid Arthritis

Rheumatoid arthritis (RA) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. Fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of TNF-α signalling


Eligibility Criteria:
Inclusion Criteria

* Moderate to severe RA (disease activity score-28 joints: DAS-28 \> 3.2) were recruited.
* Age between 18 - 60 years having active disease according to the diagnosis of an experienced rheumatologist, being under treatment with disease-modifying anti-rheumatic drugs (DMARDs), not receiving cytokine inhibitors
* Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.

Exclusion Criteria:

* History of biological DMARDS.
* History/presence of acute heart disease, liver and kidney diseases, COPD
* Intolerance or allergy to fexofenadine or methotrexate
* Alcohol abuse
* Any changes in using medication (changing the dosage or type of medicines
* Receive hormone replacement therapy, warfarin, and other anticoagulants
Intranasal Civamide for Episodic Cluster Headache

This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).


Eligibility Criteria:
* At least 2 year history of episodic cluster headache (meeting IHS criteria)
* At least 2 previous episodes
* Expected duration of cluster period is at least 6 weeks but not longer than 24 weeks
* At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment
Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.

A PET study using \[11c\]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.

This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.

Eligibility Criteria:
* Inclusion criteria:

  * Healthy male subjects
  * Age: 18-55 years
  * No history of physical, neurological or mental illness
* Exclusion criteria

  * History of claustrophobia or inability to lie still in the PET camera for at least 2 hours
  * Cardiac pacemakers or metal implants in the body that contraindicate MRI scan.
  * History of regular alcohol consumption (weekly intake \>21 units) within the previous six months.
Infant & Toddler Short Gut Feeding Outcomes Study

The purpose of this study is to better understand why children with short gut develop feeding problems.

We seek to identify characteristics of our patients' histories that are associated with feeding problems in the context of availability of early prophylactic occupational therapy. We plan to review our most recent four years' experience in children with short gut syndrome with onset in early infancy who initially required home parenteral nutrition to identify risk factors or clusters of risk factors associated with food aversion.

Eligibility Criteria:
Inclusion Criteria:

* Patients seen in home-TPN clinic since July of 2008 with:
* Intestinal failure
* Short gut
* Onset \< 3 months of age
* Received home parenteral nutrition following initial hospital discharge
* Less than 7 years of age at time of study
* Must have at least 1 parent/legal guradian willing to participate in the study

Exclusion Criteria:

* Not seen in home TPN clinic
* Short gut with onset \>3 months
* No parents/legal guradians willing to participate in the study
Minimally Invasive Distal Chevron in Comparison to the Reverdin-Isham Osteotomy for Hallux Valgus Correction

This study analyses the Reverdin Isham procedure, which is the most popular minimally invasive surgical hallux valgus correction method and the minimally invasive chevron osteotomy, representing the standard technique of open surgery. It is hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

Multiple different surgical techniques have been established for hallux valgus surgery so far, each technique with its unique advantages and limitations. The distal chevron method is widely accepted as a surgical method for correcting mild to moderate hallux valgus deformities. Numerous publications presenting the radiological outcome of this surgical technique and the clinical outcome by means of well established score systems have been published and make this technique, today's benchmark in hallux surgery.

Due to scarring and decreased range of motion of the greater toe joint after open surgery and increasing patients' demands several minimally invasive techniques have been brought to public in the last few years. These techniques claim minor soft tissue damage and reduced surgical time. The efficiency and stability of correction, as well as the clinical outcome of these techniques have been discussed controversially. However, most studies present data from minimally invasive surgery without specific differentiation of the type of surgery and in regard to the clinical and radiological outcome.

Recently a prospective randomized study comparing the open versus the minimally invasive chevron technique has been published presenting data with comparable clinical and radiological outcome.

Given the above-mentioned lack of evidence it was the aim of the study to compare the results of two different minimally invasive techniques. The investigators analyzed the Reverdin Isham procedure, which is known as the technique, that made minimally invasive hallux surgery popular and the minimally invasive chevron osteotomy. It was hypothesized that the two techniques would show significant differences in regard to radiological outcome (Hypothesis 1), clinical outcome (Hypothesis 2) and development of radiological recurrence (Hypothesis 3).

Eligibility Criteria:
Inclusion Criteria:

* patients after minimally invasive distal Chevron osteotomy for hallux valgus deformity with a Minimum follow up of 24 months
* patients with informed written consent for being analyzed
* patients, of whom radiographs are available from preoperative throughout the follow-up time of 24 months

Exclusion Criteria:

* patients under 18 years of age
* pregnant patients, or women below the age of 50 ys, of whom the pregnancy status is not clear
* patients with mental illness or patients, who cannot follow the required postoperative Treatment or controls
* patients, who refuse to participate
* patients, who are assigned to other clinical studies
Study Evaluating Safety and Efficacy of UCART Targeting CS1 in Patients With Relapsed/Refractory Multiple Myeloma (MELANI-01)

This is a Phase I, FIH, open-label, dose escalation study evaluating Safety and Efficacy of UCART targeting CS1 in patients with Relapsed or Refractory Multiple Myeloma (MM). The purpose of this study is to evaluate the safety and clinical activity of UCARTCS1A and to determine the Maximum Tolerated Dose (MTD).


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of active multiple myeloma (as defined by International Myeloma Working Group \[IMWG\] criteria) who have relapsed/refractory disease after and have received at least 3 prior lines of prior therapy.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1;
* No previous treatment with investigational gene targeting CS1 or chimeric antigen receptor therapy targeting CS1
* Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within the screening period.
* Other criteria may apply.

Exclusion Criteria:

* Previous treatment with investigational gene therapy targeting CS1 or chimeric antigen receptor therapy targeting CS1;
* Any cellular therapy (other than autologous or allogenic HSCT) within 60 days prior to enrollment;
* Prior treatment with rituximab or other anti-CD20 therapy within 3 months
* Any known active or uncontrolled infection
* Autologous hematopoietic stem cell transplantation (HSCT) within 12 weeks prior to enrollment; any cellular therapy (other than autologous) within 60 days prior to enrollment; prior allogeneic HSCT.
* Seropositive for Hepatitis C virus or positive for Hepatitis B surface antigen or core antibody.
* Presence of active and clinically relevant central nervous system disorder, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or organic brain syndrome.
Sequential Therapy With WLL/Inhaling GM-CSF for Autoimmune Pulmonary Alveolar Proteinosis

The purpose of the study is to evaluate the effectiveness of the sequential therapy with whole lung Lavage (WLL)/inhaling granulocyte-macrophage colony stimulating factor, compared to WLL only, for adult patients with severe autoimmune pulmonary alveolar proteinosis in China over a two-year period.


Eligibility Criteria:
Inclusion Criteria:

* Comfirmed diagnosis of autoimmune pulmonary alveolar proteinosis
* Disease severity score (DSS) is 4-5

Exclusion Criteria:

* The acute respiratory infection
* Heart failure (such as cardiogenic pulmonary edema)
* The serious liver and kidney dysfunction (creatinine or ALT were equal to or more than 2 times of the upper limit of normal range);
* Pregnancy;
* The patients with hereditary and secondary factors (inhalation of dust, hematological diseases, autoimmune diseases, etc.);
* DSS is 1-3;
* The patient is allergic to the drugs that be used in our research;
* The patients with poor compliance, or suffering from mental illness;
* The patients have not signed informed consent;
* They were treated with whole lung lavage or regular GM-CSF therapy (treatment for more than 2 weeks) within 3 months before the enrollment.