cyrilzakka/clinical-trials huggingface dataset:
Rural Smoking Cessation

Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

This is a SMART, where eligible rural people who smoke (RPWS) can be randomized up to two times to different resources/ways to help quit smoking. For each randomization, participants will use the assigned resources for 3 months, and partake in surveys at baseline, 1, and 3 months, during which they will be asked several questions related to use of resources, and smoking behavior. Carbon monoxide (CO) in exhaled breath will be collected at 3 months using iCO™ Smokerlyzer® (https://www.icoquit.com/us/) to determine biochemically confirmed abstinence.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years
* smoke ≥ 5 cigarettes per day
* daily access to their own iPhone/Android smartphone or tablet

Exclusion Criteria:

* past 30-day NRT use or contraindications listed on the NRT labels
* currently pregnant/breastfeeding
Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua

Allergic rhinitis (AR) is a common disease of nasal mucosa, affecting 10% to 40% of the population globally. Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR.Traditionally, AIT is divided into subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT). Artemisia annua is one of the most important allergen that is responsible for seasonal AR in China during July and October.

The trial is a randomized, double-blind, placebo-controlled, multicentred, phase III trial. 702 subjects with allergic rhinitis caused by Artemisia pollen were recruited and randomized to the immunotherapy group and placebo group.


Eligibility Criteria:
Inclusion Criteria:

* presence of seasonal rhinitis symptoms for over 2 years
* artemisia-specific immunoglobulin E (IgE) levels (ImmunoCAP) of class 3 or higher
* patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
* patients who are able to understand the information given and the consent and complete the daily record card.

Exclusion Criteria:

* patients with severe asthma, perennial allergic rhinitis, cancer or other serious diseases that are unfit to receive allergen immunotherapy
* patients who are taking β-antagonists or have taken systemic corticosteroids in last 4 weeks
* patients whose Humulus- or Artemisiifolia-specific immunoglobulin E (IgE) levels (ImmunoCAP) same as or higher than Artemisia-specific immunoglobulin E (IgE) level.
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 19 years old
* Unilateral or bilateral transtibial amputation
* Subject has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
* Currently using a standard carbon fiber or high temperature thermoplastic prosthetic socket.
* Residual limb is between 26-34 cm circumference with a liner (when measured 4cm proximal to distal end)
* Subject is eligible for standard carbon fiber or high temperature thermoplastic prosthetic socket if necessary.
* Must be able to ambulate at least 100 yards with or without an assistive device.
* Must be able to don and doff a prosthesis independently.
* Estimated life expectancy \> 1 year

Exclusion Criteria:

* Amputation \< 6 months prior to enrollment
* Residual limb less than (\<) 26cm and greater than (\>) 34cm circumference at the distal end.
* Body weight greater than (\>) 275lbs.
* Syme's amputations or total limb length over 30cm
* Some bulbous or irregular limb shapes
* Build height and circumference limitations
* Wounds or skin issues that preclude normal fit
* Unusual alignment of the socket or foot
* Alignment outside the capability of the Xtremity System.
* Planned for any major surgery within 6 months of enrollment.
* Subject is pregnant or breastfeeding
* Subject is incarcerated.
* Subject anticipates that the socket will frequently be subject to temperatures greater than 110 degrees F while in their possession.
* Subject anticipates that the socket will frequently be subject to direct sunlight
* Limb circumference at the mid-patella tendon exceeds the maximum circumference (see sizing chart in the instructions for use)
* Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
* Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre and post-treatment.
Vitamine D Treatment in Chronic Heart Failure

The investigators hypothesized that in vitamin D deficiency the 25-OH-D3 vitamin substitution improve the heart function in chronic heart failure.

Type of study: Controlled, randomized, double blind, placebo control

Number of patient: 300; 150 treated and 150 placebo controlled

Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month

Duration of study:1+1 year

Primary end points:

Survival rate, Ejection fraction by ultrasound, Brain natriuretic peptid,

Secondary end points:

Safety of D-vitamin supplementation, well being score, blood pressure, BMI Walking distant in 6 minutes

Visits:

Screening, Randomization, 1month, 2 month, 3 month, 6 month, 12 month, 24 month,


Eligibility Criteria:
Inclusion Criteria:

* NYHA II-IV
* vitamin D level between 10-30 ng/ml
* ejection fraction by ultrasound \< 40 %

Exclusion Criteria:

* blood calcium \> 2,6 mmol/l
* urinary calcium \> 0,1 mmol/body weight kg/die
* blood phosphorus \> 1,45 mmol/l
* nephrolithiasis in the history
* GFR \< 30 ml/min
* vitamin D injection in the last 6 month
* actual 1,25-OH2-D3 vitamin treatment
* Myocardial infarction or serious coronaria stenosis in the anamnesis uncontrolled atrial fibrillation
* serious valve disease
Brief, Scaleable Intervention for Coronavirus (COVID-19) Mental Health Sequelae in College Students

The major aim of this pilot study is to evaluate a brief coping skills intervention for college students, based on an evidence-based treatment and delivered remotely via 14 short daily videos. Participants will be 150 Rutgers undergraduates who are enrolled in Fall 2020. Participants in the experimental group (n=100) will receive 4 daily smartphone surveys assessing stress, affect, and other related factors for two weeks before, during, and after the 2-week coping skills intervention. Participants in the control group (n=50) will receive assessments over the same time period with no skills intervention. Both groups will be assessed weekly throughout the Fall semester to monitor the transition to the new semester and longer-term impact of the intervention. The control condition participants will have access to the skills videos at the end of the study.


Eligibility Criteria:
Inclusion Criteria

* Age 18 years or older
* Matriculated at Rutgers during Fall of 2020 (on campus and/or remote)
* Currently residing in the United States
* Willingness to follow study requirements, as evidenced by an ability to provide written informed consent and read, understand, and complete the study procedures
* iOS and Android smartphone compatible with MetricWire

Exclusion Criteria

* Non-English speaking
* Unable to understand or provide informed consent
Intermittent Oral Tube on Feeding Amount

The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

The study will last 15 days for each participant. The goal of this clinical trial is to compare the differences in feeding amount and nutritional status between ischemic stroke patients using Intermittent Oro-esophageal Tube and Nasogastric Tube. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will use Intermittent Oro esophageal Tube for enteral nutrition support, while the control group will use Nasogastric Tube. Researchers will compare changes in daily intake and nutritional status of two groups of patients before and after the study to see if Intermittent Oro-esophageal Tube can improve the feeding amount and nutritional status between ischemic stroke patients compared to Nasogastric Tube

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Meeting the diagnostic criteria for ischemic stroke .
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* No history of prior stroke.
* Stable vital signs.

Exclusion Criteria:

* Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
* Pregnant or nursing females.
Comparison Between IORT and Postoperative Radiotherapy in Breast Conserving Surgery

To compare the satisfaction with conserved breast, acute and chronic postoperative complications and tumor control between intraoperative radiotherapy(IORT) and traditional postoperative radiotherapy following breast-conserving surgery (BCS).


Eligibility Criteria:
Inclusion Criteria:

* Primary invasive breast cancer confirmed by pathology.
* Maximum tumor diameter ≤3.5cm.
* Clinical lymph nodes are negative.
* Single or multiple tumors are located on the same side of the nipple and in the same quadrant.
* ECOG status score ≤ 2.
* With informed Consents.

Exclusion Criteria:

* Previous history of breast cancer or other malignant tumors.
* Inflammatory breast cancer; 3. Previous radiotherapy history.
* Other diseases affecting radiotherapy, such as connective tissue disease, heart disease, lung disease and so on.
* Patients who are not going to have the axillary lymph node surgery (including SLN and ALND) were excluded.
Effects of Doxazosin Gastrointestinal Therapeutic System on Ambulatory Blood Pressure and Cardiovascular Risk Factors in Uncontrolled Hypertensive Patients

The primary objective was to determine the effects of the Gastrointestinal Therapeutic System (GITS) formulation of Doxazosin when used in combination therapy with the 5 major classes of antihypertensive agents as measure by 24-hour diastolic blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects were males or females ≥18 years of age with a diagnosis of primary essential hypertension and currently taking 1 or 2 individual antihypertensive agents
* Dosing for entry antihypertensive medication was at the accepted efficacious dose or the maximum tolerated dose and had to be stable for at least 4 weeks prior to study entry
* Subjects were required to have clinic sitting DBP ≥95 and ≤110 mmHg and SBP ≥140 and ≤180 mmHg as an average of 3 readings on their current antihypertensive therapy at visits 1 and 2

Exclusion Criteria:

Exclusion criteria included, but were not limited to:

* Subjects taking antihypertensive medications for other indications (i.e. arrhythrma, unstable angina, CHF, etc.)
* Orthostatic hypotension, defined as a decrease of at least 20 mmHg systolic or 1OmmHg diastolic pressure between sitting and standing blood pressures after 2 rmnutes, or known fluid depletion.
Effects of Two Home Ergonomics Programmes in Post-stroke Patients

The main objective of the clinical trial is to evaluate the effectiveness of two home ergonomics programmes, by reference to a control group, on functional capacity and quality of life in post-stroke patients.

For post-stroke patients, rehabilitation must address different aspects. When the resulting condition has become established, treatment should take the form of a mixed intervention model, incorporating preventive, rehabilitational and compensatory or adaptive approaches, aimed at enhancing the patient's performance within the environment. Physiotherapy and occupational therapy are key disciplines in the composition of multi- and inter-disciplinary teams for the care of stroke patients. In this clinical trial we evaluate the effectiveness of two programmes of ergonomic intervention in the home, with respect to levels of functionality (performance of activities of daily living) and the quality of life of post-stroke patients, by reference to a control group.

Eligibility Criteria:
Inclusion Criteria:

* stroke diagnosed 6-24 months previously
* aged over 18 years
* ability to speak and understand Portuguese.

Exclusion Criteria:

* severe cognitive deficit
* severe aphasia
* other associated neurological disease
* musculoskeletal pathology
* drug or alcohol abuse.
An Education Initiative to Reduce Stigma Towards Sex Workers and Sexual Minorities Among Nursing Students

Background: Sex workers and sexual minorities (SWSM) often encounter barriers when accessing healthcare services due to social stigma and discrimination. In Hong Kong, stigma and prejudice exist among nurses and nursing students toward SWSM.

Aims: This education initiative aims to improve the knowledge, attitudes, and clinical competence of nursing students in caring for SWSM.

Methods: This pilot study will employ a one-group pre-and post-test design. Convenience sampling will be used to recruit 52 nursing students from the clinical phase of the Bachelor of Nursing program at the School of Nursing and Health Studies of Hong Kong Metropolitan University, as well as nursing students from other local universities. The intervention will consist of a four-session one-day workshop based on social cognitive theory and interpersonal contact theory. The workshop will cover various topics, including terminologies, human rights, stigma and discrimination in healthcare settings, contact with SWSM, and skills building. The primary outcome measure will include participants' attitudes toward SWSM. Secondary outcome measures included their knowledge and clinical competence. These outcome measurements will be assessed at baseline (T0) and after the intervention (T1) and three months follow up (T2). Additionally, focus group discussions will be carried out to explore participants' experiences of the intervention.

Discussion: Findings from this study could contribute to the existing knowledge on stigma surrounding SWSM in Hong Kong and its impact on healthcare. The intervention is expected to increase the knowledge, attitudes, and skills of nursing students in providing care for SWSM. By promoting non-judgmental and equitable care, the research aims to contribute to the overall well-being and health outcomes of SWSM. These results will inform future nursing education curricula and clinical practice, facilitating the development of more inclusive and patient-centered care for marginalized populations in Hong Kong and beyond.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years of age or above;
* studying in the clinical phase (i.e., year 3 to year 5);
* are able to speak, read, and write Cantonese or Putonghua;
* are willing to participate in the study and share their experience of the education initiative with the research group;
* have informed consent to participate in the study.

Exclusion Criteria:

* Those who have completed a similar workshop or discussion of sex workers and sexual minorities in previous nursing education will be excluded from this study.
Iatrogenic Chronotropic Incompetence and Exercise Tolerance in Heart Failure

Patients with CHF benefit from heart rate lowering, and the investigators have previously demonstrated that this does not adversely affect exercise tolerance. In a pacemaker population we also have shown that preventing heart rate lowering is detrimental in terms of symptoms and prognosis.

The aim of the study is to therefore to establish whether heart rate limitation in patients with heart failure has a negative impact on exercise capacity. If the investigators establish that this is not the case, physicians will be able to confidently prescribe heart rate lowering agents, and programme pacemakers to allow bradycardia without the concern that there will be detrimental effects of symptom.


Eligibility Criteria:
Inclusion Criteria:

* Able to walk on a treadmill Able to provide consent Heart failure (or not) depending upon the arm. Patients with atrial fibrillation to have had an AV node ablation (or very slow response to AF)

Exclusion Criteria:

* Cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.
Study in Healthy Volunteers to Investigate the Effects of Quinidine on the Pharmacokinetics of NKTR-118

Study in healthy volunteers to investigate the effects of Quinidine on the Pharmacokinetics of NKTR-118

A Randomized, 2-Part, Crossover, Single Center Study to Evaluate Effect of Quinidine on the Pharmacokinetics of NKTR-118 and the Concomitant Effect of Quinidine and NKTR-118 on Morphine-induced Miosis

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study-specific procedures.
* Male and female (nonchildbearing potential, nonlactating) healthy volunteers aged 18 to 55 years inclusive, with suitable veins for cannulation or repeated venipuncture.
* Female volunteers must be nonpregnant and nonlactating. Women of childbearing potential must have negative pregnancy test (screening and admission) and be using a highly-effective form of birth control for 3 months before enrollment.
* Male volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the IP. The female partner should use contraception during this period.
* Volunteers must have a BMI between 18 and 30 kg/m2, inclusive, and weigh at least 50 kg.

Exclusion Criteria:

* Any clinically significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine) which, may put the volunteer at risk of participation in the study, or influence of the ADME of drugs.
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP.
* Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results as judged by the Investigator.
* History (personal or family) of torsades de pointes, any other polymorphic ventricular tachycardia, long QT syndrome, sudden death or Brugada syndrome, or personal history of sustained (greater than 30 s) monomorphic ventricular tachycardia.
* Abnormal vital signs, after 10 minutes supine rest as defined in protocol.
Enteral vs. Oral Nutrition After Pancreatoduodenectomy

Patients suffering from pancreas cancer as well as patients with chronic pancreatitis or requiring pancreas surgery often are in a compromised nutritional status. Nutritional support should therefore be started early during the postoperative course to prevent further malnutrition, as it is an important risk factor to develop complications. Recently, several studies have shown that early enteral nutrition (EEN) could shorten length of stay, reduce postoperative infections and mortality, and decrease costs when compared with total parenteral nutrition (TPN) in gastrointestinal cancer surgery. After pancreatoduodenectomy (PD), EEN has been shown to reduce early and late complications, infections, and readmission rates. It is nevertheless currently not clear if EEN improves the short-term outcomes after PD compared to oral nutrition.

The primary objective of the study is to assess the impact of EEN on postoperative morbidity after PD, according to the Comprehensive Complication Index. Secondary objectives are to assess the impact of EEN on major postoperative complications, according to Clavien classification, specific complications, length of stay, readmission rates, quality of life, metabolic stress and nutritional response after PD.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for elective open pancreatoduodenectomy.
* Patient ≥18 years old.
* Patient at nutritional risk, i.e., with Nutrition Risk Screening (NRS) ≥3.
* Signed informed consent.

Exclusion Criteria:

* Patient not able to give informed consent as documented by signature of consent form (e.g., vulnerable patients).
* Enteral feeding already initiated preoperatively.
* Language barrier.
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders (i.e., eating disorders and bipolar disorders), or dementia.
Emotion Endophenotypes in Schizophrenia

Schizophrenia is an invalidating psychiatric illness with a strong genetic component characterized by abnormal processing of emotional information. This alteration in emotion processing has been described in acute as well as in remission phases of the illness. It has also been found in healthy relatives of patients with schizophrenia and in subjects at high risk of psychosis. Thus, alterations in emotional information processing are not only linked to the prognosis but can also be considered as a marker of vulnerability of schizophrenia. In addition, schizophrenia patients differ from healthy controls in neural activity in brain regions implicated in emotions processing. However, interpretation of findings in patients is limited by confounding factors, such as antipsychotic treatments or alterations due to the course of illness. Also, there is no data concerning genetic factors (polymorphisms or gene expression) underlying these patterns of cerebral activation in emotion information processing.

So, the main objective of this study is to compare the cerebral activity of schizophrenia patients to that of healthy siblings and healthy controls in an emotional processing task.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participant, right-handed, aged from 18 to 45 years old
* Haven given their written consent
* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders version 5) diagnosis of schizophrenia
* Remitted phase (criteria of Andreasen)
* Stable doses of antipsychotics during the last 6 weeks
* No severe somatic illness
* Normal clinical exam
* Inscription to the social security

Exclusion Criteria:

* Women in genitally active period without contraception
* Women pregnant or breast feeding
* Participants presenting a severe somatic /neurologic condition
* Present/history in the last year of alcohol or drug abuse
* Participating in another clinical study or still in period of exclusion of a previous clinical trial
* Contraindication to an MRI test (metallic foreign body, pacemaker, heart valve, chirurgical clip, claustrophobia...)