cyrilzakka/clinical-trials huggingface dataset:
Nicotine Replacement Therapy Sampling for Smokers in the Community

The aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community.


Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents aged 18 years or above
2. Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
3. Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
4. Able to communicate in and read Chinese
5. Have a local contact number

Exclusion Criteria:

1. Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
2. Pregnant or breastfeeding
3. Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks
Pre-malignant States to Hematologic Malignancies in Firefighters

The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.

Firefighters from the Charlotte Fire Department, ages 40-49 and with at least 5 years on the job experience will be offered consent for this study. Consented and eligible participants will have labs collected at the Baseline visit to evaluate for CHIP and monoclonal gammopathy. Buccal swabs (also collected at Baseline) and any remaining blood from the Baseline labs will be collected from participants who consent to collection and banking of their samples for future research. Participants will also complete the Firefighter History Assessment at Baseline.

If clonal hematopoiesis (CHIP) results are interpreted by the investigator as abnormal, the participant will be given a clinical referral if indicated for discussion of diagnosis, potential further diagnostic tests, and implications per standard CHIP management guidelines. If monoclonal gammopathy or other (concerning) abnormality of the complete blood count is detected, the participant will be provided a referral for a clinic visit for diagnostic assessments and followed up per standard of care.

If the participant proceeds with the referral and diagnostic work-up, the final diagnosis (if any) resulting from the initial diagnostic assessment(s) will be collected

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent and HIPAA authorization for release of personal health information.
2. Age ≥ 40-49 years at the time of consent (self-reported)
3. Ability of the participant to understand and comply with study procedures for the entire length of the study
4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)

Exclusion Criteria:

Anyone with a current diagnosis of a hematologic malignancy will be excluded.
Predictability of Preoperative Carotid Artery Corrected Flow Time for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section

The purpose of this study was to investigate the incidence of hypotension after spinal anesthesia in patients undergoing cesarean section as predicted by preoperative carotid artery corrected flow time measured by Doppler ultrasound. Before entering the operation room, Two inspectors perform two measurements of carotid artery corrected blood flow time respectively, and an average of the four measurements is calculated and analyzed. At this time, the patient's posture is supine, and the head is turned about 30 degrees to the left. Corrected blood flow time (FTc) is measured using carotid ultrasound as previously described by Blehar and colleagues. Corrected blood flow time is calculated by Bazett's formular and Wodey's formular by evaluating a single cycle after several successive cycles have reached a stable and acceptable quality level.

The occurrence of hypotension is recorded from the spinal anesthetic injection until the fetus is delivered.

The definition of hypotension after spinal anesthesia is that the systolic blood pressure drops to 80 mmHg, less than 75% of the baseline value, or even if it does not meet the former criteria, symptoms that are consistent with hypotension (dizziness, dizziness, dyspnea, nausea or vomiting).


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated singleton full-term parturients undergoing cesarean delivery
* age 20\~40
* ASA class 1\~3

Exclusion Criteria:

* Emergency surgery
* Placenta previa
* Preeclampsia or Preeclampsia
* Cardiovascular or cerebrovascular disease
* Morbid obesity with a body mass index (BMI) of 40 kg / m2 or higher
* Gestational age \<36 or ≥ 41 weeks
* Contraindications to spinal anesthesia
* Carotid stenosis\> 50% (angiography, CT angiography, MR angiography, or duplex ultrasonography)
* Basal systolic blood pressure\> 160 mmHg
* The preoperative examination revealed that the electrocardiogram was not normal sinus rhythm
* Chronic kidney disease (eGFR \<60 mL / min / 1.73 m2)
* If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)
The Effectiveness of Health Advice and Occupational Health Intervention on Work Ability

Study hypotheses were 1) Classification of the risk of sickness absence can be made with questionnaires addressing self-rated health problems; 2) Occupational health intervention of the employees at 'High Risk´ of sickness absence is more effective than usual care in controlling sickness absence; 3) Health advice intervention of the employees at 'Increased Risk´ of sickness absence is more effective than usual care in controlling sickness absence; 4) The interventions are cost-effective use of resources from the societal perspective.

The study design is a longitudinal cohort study with two embedded randomised trials. The risk of sickness absence is classified on the basis of self-administered questionnaires, on the basis of a priori defined cut-off limits. Two randomised trials are performed in the subgroups of 'High Risk´ and 'Increased Risk´ of sickness absence. The study is performed within one corporation in Finland. All employees with permanent job and age between 18 and 60 years are invited to participate.

The worker's own occupational nurses and physicians execute the occupational health program for workers at 'High Risk´ for sickness absence. The employees in the "High Risk" intervention group receive a personal feedback of their health survey results in a letter, in which they are also invited to a consultation at the OHS. The main purpose of the consultation, during which the individual findings of the health survey are available for the OHS professionals, is the construction of an action plan, and if appropriate, referral to a medical specialist, or psychologist. The employees in the 'High Risk´ control group receive care as usual.

The intervention for workers at 'Increased Risk´ for sickness absence is executed as medical counselling over the telephone. The employees in the 'Increased Risk´ intervention group receive a personal feedback of their questionnaire results in a letter, in which they were also invited to call the phone advice centre in order to receive medical advice. The employees in the 'Increased Risk´ control group receive care as usual.

Sickness absence data is obtained from the employer's records, the baseline covering the one-year period before the intervention and the follow-up covering the one-year period after the intervention. Sickness absences are obtained without medical diagnoses. The study participants also fill in a health questionnaire including, among other questions, healthcare utilization variables at the one-year follow-up.

We will carry out an intention to treat analysis. We will use analysis of covariance (ANCOVA) to analyse sickness absence outcomes at 12 months, with corresponding baseline values and risk / treatment group as covariates. Economic evaluation will be performed alongside the randomised controlled trial within the 'High Risk´ group.

Eligibility Criteria:
Inclusion Criteria:

* Permanent job
* Age 18 to 60 years

Exclusion Criteria:

* Pension granted
NEW DAY: Nutrition, Exercise, Weight Loss, Diabetes And You

This clinical trial examines whether the addition of individual sessions of a motivational intervention to a state-of-the art behavioral group weight loss intervention for overweight women with Type 2 diabetes improves the weight losses and glycemic control outcomes.

The multi-disciplinary behavioral, group-based intervention focuses on dietary and exercise changes, with group meetings over an 18-month period. Participants are assessed at 6-month intervals (for a total of 18 months) to examine the impact of the interventions on body weight and blood sugar control (primary outcomes), as well as on blood pressure, cholesterol, quality of life and attitudes (secondary outcomes). All enrolled participants receive group-based weight loss intervention. Half the women enrolled also receive several individual sessions of motivational interviewing and the other half of enrolled women receive the same number of individual sessions of health education, which focus on issues relevant to women (e.g., mammography, sleep hygiene, menopause, etc).

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 27 - 50
* Type 2 diabetes currently treated with oral medications
* Ability to walk for exercise

Exclusion Criteria:

* Use of insulin
* Current pregnancy
* Presence of debilitating disease, psychotic condition or any other condition that might interfere with participation
* Failure to complete self monitoring diary for 1 week
* Plans to move out of the area in the upcoming 18 months
Social Media and Risk Reduction Teaching-Enhanced Reach

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).

The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and breastfeeding (BF) within a population of pregnant Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients.

The study will randomize 2,000 pregnant women, when they reach 34 weeks gestation, to one of four mHealth prenatal/postnatal messaging combinations of safe sleep and breastfeeding practices.

Eligibility Criteria:
Inclusion Criteria:

* Must be client at a WIC center participating in study.
* Must be pregnant and less than 34 weeks gestation
* Must speak English or Spanish
* Must live in the United States
* Must have texting capabilities via mobile phone
* Must plan to live in same household as infant after birth.

Exclusion Criteria:

* A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning.
* Meets the definition of a minor according to applicable state law.
Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects

Included participants who have a stable HT who intend to practice RJ

Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.

Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with or without diagnosed hypertension intending to fast Ramadan.

Exclusion Criteria :

* Age \< 30 years old
* Adult patient with or without diagnosed hypertension not intending to fast Ramadan.
Regulatory TYKERB® Tablets PMS

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information TYKERB® is a registered trademark of the GlaxoSmithKline group of companies.

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of TYKERB® tablets administered in Korean patients according to the prescribing information

TYKERB® tablets will be administered with capecitabine for HER2 overexpressing advanced or metastatic breast cancer treatment or with letrozole for the treatment of postmenopausal women with hormone receptor positive metastatic breast cancer that overexpresses the HER2 as described the prescribing information of TYKERB® tablets

Eligibility Criteria:
All subjects must satisfy the following criteria at PMS entry according to MFDS PMS regulation:

* Subjects with indication in the locally approved prescribing information
* Subjects with no contraindication according to the prescribing information
Determination of Biological Activity of Enriched Serum Following TOTUM-448 Consumption

Dietary intakes of saturated fatty acids remain well above nutritional recommendations for most European countries. This may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. The hypothesis of this study is that TOTUM-448 promotes the normal function of hepatocytes in a mild inflammatory context. To determine the cellular and molecular effects of TOTUM-448, circulating bioactive molecules after TOTUM-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by Clinic'n'Cell.


Eligibility Criteria:
Main Inclusion Criteria:

* Lipid profile within reference values
* Glycemia \< 100mg/dL
* Normal hepatic function
* Normal blood formulation
* Normal renal function
* BMI between 20 and 28kg/m2
* Non smoker or occasional smoker

Main Exclusion Criteria:

* All types of vaccination within one month
* Alcohol intakes superior to World Health Organization recommendations
* Ongoing pharmacological, dietary supplement and/or probiotic treatment
* Consumption of enriched functional foods or dietary supplements within two weeks of inclusion
* Any known disease
* Allergy to ingredients of the study product
* With dietary habits incompatible with the study conduct
Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)

This study is being done to find out if a non-invasive Magnetic Resonance Imaging (MRI) examination of the kidneys may be helpful for diagnosing lupus nephritis in patients with systemic lupus erythematosus (SLE).

Participation involves having a kidney MRI that will take between 30 to 60 minutes. Participants may have 1-4 kidney MRIs over a 6-month time period.

The primary objective of this research is to evaluate the best techniques for magnetic resonance imaging (MRI) of the kidneys in patients with lupus nephritis. This research is being done to evaluate a minimally-invasive method for assessing kidney inflammation and kidney damage in patients with lupus nephritis. Both kidneys will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults over the age of 18 who have been diagnosed with SLE and are able to undergo a kidney MRI.

Exclusion Criteria:

* The participant cannot take part in the study if they have any contraindications to MRI as specified by the current clinical MRI screening protocols including: metallic foreign objects within the body, programmable shunt/shunt, epidural or Swan Ganz catheter, ear or cochlear implant, eye implant, aneurysm clip, pacemaker/wires, internal defibrillator, tissue expander, recent stent placement, blood vessel coil, tracheostomy, stimulator/wires, infusion pump, penile prosthesis, intra-uterine device (IUD), surgical clips, bullets/pellets/bullet ball (BB), medication patch, tattoo, artificial limb, history of welding or metal fragments in eyes, pregnancy, claustrophobia, requirement of conscious sedation or anesthesia, colonoscopy procedure in the last 8 weeks.
* Any patient that is receiving renal dialysis.
* Any patient that has undergone a renal transplant.
Massage Therapy and the Well-Being of Police Officers

This study is intend to show the positive impact that massage therapy can have on the lives of police officers. The study will demonstrate how regular treatment can change sleeping quality, stress levels and mental health. It will also investigate the impact that police work can have on the body.


Eligibility Criteria:
Inclusion Criteria:

* Police Officers preferable working on the street within the St. John's area

Exclusion Criteria:

* Civilians
Clinical Evaluation of Effectiveness and Safety of Dietary Supplement Potensa in Men With Erectile Dysfunction

This is a randomized, double blind, placebo-controlled, comparative, prospective study (clinical evaluation) of the effectiveness and safety of dietary supplement Potensa in men with mild to moderate erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Men, 18 years of age or older;
* Patients diagnosed with "erectile dysfunctions" of various pathogenesis, typical form without complications;
* Ability to read and understand informed consent in order to participate in the study;
* Ability to follow study's conditions.

Exclusion Criteria:

* Oncological illnesses, except those in complete remission for at least 5 years;
* Conditions that may require emergency or planned hospitalization in the next 6 months;
* Extragenital endocrine conditions (hormonally active) (thyroid, adrenal glands, pituitary, hypothalamus);
* Surgeries on sex organ within 1 year of the screening;
* Any surgeries within 3 months of the screening;
* Psychiatric illnesses;
* Diabetes mellitus;
* Cryptorchidism
* Taking other dietary supplements that can affect erectile dysfunction within 1 month of participating in the study;
* High risk of non-compliance.
A Study of a Long-Acting r-Factor 7a (Factor VIIa) in Adult Men With Hemophilia A or B

The purpose of the current Phase 1/2a single dose, dose-escalating study is to evaluate the acute safety, pharmacokinetics (PK) and pharmacodynamics (PD) properties of MOD-5014 in adult subjects with moderate/severe congenital hemophilia A or B. This will be a single-dose, open label, dose-escalating study. Each dose cohort will be concluded by a safety review, following which escalation to the next dose cohort will be approved.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate or severe congenital Hemophilia A or B with or without inhibitors

Exclusion Criteria:

* Diagnosis of any coagulation disorder other than Hemophilia A or B
* Receipt of any immunomodulatory therapy within 3 months prior to screening, with the exception of Hepatitis C or HIV therapy
* Have had, within one month prior to study drug administration, a major surgical procedure (e.g. orthopedic, abdominal) or have an elective surgery planned within the study period
* Use of any anticoagulant for arterial/venous obstructions and/or atrial fibrillation within 7 days prior to first study drug administration
* Malignancy within past 5 years (excluding non-melanoma skin cancer)
Evaluation of Cardiopulmonary Parameters in Individuals With Asthma

The aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.

It is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. Detailed investigation will be provided with this research.

Eligibility Criteria:
Inclusion Criteria:

* No respiratory, cardiovascular and metabolic diseases
* Regular non-smoker

Exclusion Criteria:

* Non-consenting
* Pregnant women
ProPBM : A Modified Patient Blood Management Protocol

The introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.

Patient blood management (PBM), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome.

PBM relies on three corresponding aspects:

1. Optimising haemopoiesis,
2. Minimising bleeding and blood loss
3. Harnessing and optimising physiological tolerance of anaemia.

Therefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics
* Major surgery defined as either Intrabdominal surgery or main joint surgery, Risk of blood loss \>15% blood volume
* Aged between 18 to 80 years of age
* The patient must be willing and able to provide written informed consent for the study

Exclusion Criteria:

* Allergy or known sensitivity to parenteral iron
* Hypersensitivity to the active substance, Iron(III) Isomaltoside or any of its excipients listed in the summary of product characteristics
* Patients with iron overload
Impact of Pycnogenol® on Gingival Inflammation

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

Polyphenols are natural compounds produced by plants that have various functions, such as defence against microbial pathogens or protection against UV light. Based on their antioxidant activity, a soothing or preventive effect of polyphenols on various inflammatory diseases has been suspected. There is evidence of an anti-inflammatory effect of polyphenols in manifest periodontitis as well as antibacterial properties of these compounds. In addition, it is discussed that dietary polyphenols intervene in mechanisms involved in the pathophysiology of arteriosclerotic changes and their progression.

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of a polyphenol-containing Maritime Pine (Pinus pinaster) bark extract (Pycnogenol®) on clinical signs of gingival inflammation in a cohort of periodontal aftercare patients

Eligibility Criteria:
Inclusion Criteria:

* number of teeth ≥ 10
* age ≥ 35 ≤ 90 years
* body mass index (BMI) ≥ 20 ≤ 30
* history of periodontal disease and inclusion in a regular scheme of supportive periodontal therapy (regularly repeated subgingival biofilm removal 2-4 x/year)
* minimum of 10% probing sites displaying bleeding on probing

Exclusion Criteria:

* manifestation of inflammatory oral mucosal diseases other than gingivitis
* xerostomia (stimulated salivary flow ≤ 0.1 ml/minute)
* inability to perform regular oral home care
* inability to follow the study protocol due to intellectual or physical handicaps
* history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years
* current pregnancy
* acute infections such as HIV
* manifestation of metabolic bone disease
* use of antibiotics and/or anti-inflammatory medications within 4 weeks prior to screening.
* current orthodontic therapy