cyrilzakka/clinical-trials huggingface dataset:
Team-based Financial Incentives for Smoking Cessation

The purpose of this study is to identify the effectiveness of team-base financial incentives for increasing long-term smoking cessation among employees at St. Paul's Hospital, Korea.

About 70% of smokers report that they want to quit, but annually 2 to 3% of smokers succeed. Smoking-cessation programs and pharmacologic therapies have been proven effective in helping smokers quit, but only a few smokers are enrolled in those programs.

Financial incentives may contribute to reinforce smoking cessation among workers through the following pathways: (1) increasing the number of tobacco users who participate in cessation effort; (2) increasing the number of tobacco user who initiate an attempt to quit; and (3) increasing the number of tobacco users who sustain a successful quit effort. Moreover, there is a number of advantages to offering smoking cessation support in the workplace, including the accessibility of the target population, the availability of occupational health support and the potential for peer pressure and peer support. In addition, team-based approach for smoking cessation could likely make use of new or existing cessation support resources offered within the workplace.

This study is a clinical trial of team-based financial incentives for smoking cessation among a sample of 60 smokers, who are health care workers from St. Paul's Hospital in Korea. Smokers will be given a usual care (counseling, education and coverage of prescription drugs) plus a package of financial incentives for self-reported and biochemically validated smoking cessation (urine or saliva cotinine). All incentives will be provided to each team at 6 months post-quit date.

Eligibility Criteria:
Inclusion Criteria:

* Employees of St. Paul's Hospital at work sites in Korea
* Current smoker who report having smoked at least 5 cigarettes per day for the prior 12 months
* Age 18 or older

Exclusion Criteria:

* Age 17 or younger
* Unwilling to quit smoking
* Smoker who does not want to be enrolled in this trial
* Planning to leave St. Paul's hospital within the next 12 months
Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte

This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I - III
* Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest
* Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area
* Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study
* Willing and able to read, understand and sign the Informed Consent Form
* Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions

Exclusion Criteria:

* Any laser treatment on neck and/or chest within 12 months
* Any topical treatment on neck and/or chest within 6 months
* Pregnant and/or breastfeeding
* Infection, dermatitis or a rash in the treatment area
* Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders
* History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing
* History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
* Having a known anticoagulative condition or taking anticoagulation medications
* History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen
* Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
* History of radiation to the head, neck and/or upper chest
* Undergoing systemic chemotherapy for the treatment of cancer
* Systemic use of isotretinoin (Accutane®) within 6 months
* Any use of gold therapy
* Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
* Current smoker or history of smoking within 12 months of study
* Participation in a study of another device or drug within 6 months
* As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines

Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.

For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or older) who underwent FB

Exclusion Criteria:

* concurrent treatment with antibiotics or systemic corticosteroid
Tissue Oxygen Index and Pulsatility Index in Orthopedic Surgery: a NIRS and TCD Pilot Trial

Cerebral microemboli (ME) are frequently generated during major orthopaedic surgery. The primary objective of this study was applying novel transcranial Doppler (TCD) ultrasound software algorithm to quantify (ME load/15 minutes) and qualify (particulate vs. gaseous) ME, detected as high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs) before and after orthopaedic surgery.


Eligibility Criteria:
Inclusion Criteria:

* hip prosthesis
* knee prosthesis
* shoulder prosthesis
* spine surgery

Exclusion Criteria:

* severe valvular heart defect
* acute neurological disorder
Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per season. Even mild traumatic brain injury, including concussion, can cause long-term cognitive problems that affect a person's ability to perform daily activities and to return to school or work. Far more concerning is the mounting body of evidence that concussions are not just transient injuries - but have cumulative effects. It has been well established in animal models that progesterone has neuroprotective benefits. Animal studies using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral outcomes. To date, there have been no studies to assess whether or not progesterone will be effective for the treatment of concussions. This double-blind placebo controlled trial will assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize that athletes treated with progesterone will have faster resolution of their concussive symptoms. The investigators believe this study may be the first clinical trial to show an effective treatment for concussion.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a concussion
* A 18 years or older
* Diagnosis \< 24 hours from injury
* Consent obtained prior to concussion

Exclusion Criteria:

* Pregnant
* Active breast or reproductive organ cancers
* Allergy to peanuts
* History of or current thrombophlebitis or venous thromboembolic disorder
* Females taking birth control
* Known hypersensitivity or prior adverse reaction to progesterone
* Known liver disease
Comparison of Ultrasound-guided Corticosteroid Injection Versus Corticosteroid Injection and Hydrodissection for Carpal Tunnel Syndrome

The objective of this study is to investigate the effect of ultrasound guided steroid injection versus ultrasound guided steroid hydrodissection to treat patients with CTS.

This study was a prospective, randomized clinical trial. Patients with CTS were randomly treated with sonographically guided corticosteroid injection (group A); sonographically guided hydrodissection and corticosteroid injection (group B).

Boston Carpal tunnel questionnaire, nerve conduction studies and VAS pain score were performed on initial visit and after 6 weeks and 12 weeks .

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of CTS The diagnosis of CTS was confirmed by electrophysiological tests.

Exclusion Criteria:

presence of thenar atrophy any accompanying orthopedic or neurologic disorders that could mimic CTS such as cervical radiculopathy, polyneuropathy, proximal median nerve entrapment, or thoracic outlet syndrome prior steroid injection into the affected carpal tunnel within 6 months or ever received carpal tunnel surgery history of distal radius fracture pregnancy or lactation regular use of systemic NSAIDs ,corticosteroids or diuretics known allergy to corticosteroids and local anesthetics. impaired cognitive function

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Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, age 18-65 years at consent.
* History of serious burn injury
* Pruritus (itchiness) prior to the initial screening visit and during the screening period
* Judged to be in good health in the investigator's opinion.

Key Exclusion Criteria:

* Prior treatment with study drug or similar drug
* Pruritus (itchiness) due to another reason besides burn injury/ healing.
* Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject.
* History of hypersensitivity to study drug or any of its components.
* Currently pregnant or male partner of pregnant female.
* Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.
Quality of Life and Behavioral Change of Retired Persons

Researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. It begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. Frailty is multifactorial. It is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. This state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change.

The Longevity Pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well.

This study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching.

The study will be carried out on healthy volunteers, retired.

The main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions.

Eligibility Criteria:
Inclusion Criteria:

* Man or Woman;
* Retired;
* Having the desire to change his/her lifestyle;
* Agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment).
* Having signed the informed consent form;
* Social insured;

Exclusion Criteria:

* Presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect;
* Subject participating in another clinical study or in period of exclusion from another study;
* Subject deprived of liberty;
* Subject under judicial protection measure;
* Whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;.
Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.

Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.

Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.

Eligibility Criteria:
Inclusion Criteria:

* Any kind of malignancy
* Gastrointestinal bleeding in the last 48 hours
* Referred to emergency endoscopy

Exclusion Criteria:

* under 18 years old
* bleeding from non malignant lesions
* previous endoscopic treatment with another method done in the last 48h
Effect of Home-fortification With Sprinkles in Hematologic and Nutritional Status in Preschool Children in Medellín

Objective: To acquire the local scientific evidence, to evaluate the effects of micronutrient Sprinkles™ powder, both the nutritional status and haematological values in the vulnerable preschool population, to corroborate the reported benefits of the experiences in other countries.

Question: Will it improve the nutritional status and hematological levels after the home fortification with Sprinkles in children of two child care centres in the city of Medellin, in 2013?

Hypothesis: At the end of intervention, hematologic levels and anthropometric indicators will be better in the intervention group with Sprinkles, compared with the placebo group.

Design: Randomized clinical trial, triple-blind and placebo-controlled.

Participants: Two groups of 50 children each, aged between 5 and 59 months, not anemic or with severe malnourished, full-time assistants to two children's centres that have the same alimentation menu.

Intervention: The daily diet will be supplemented with sprinkles in one of the children's centres and will be compared anthropometric and hematological values before and after with a group receiving the same diet with placebo.

Outcome measures: Nutritional status (anthropometric measures) and haematological values (hemoglobin, ferritin, transferrin and folate).


Eligibility Criteria:
Inclusion Criteria:

* Assistance to children's centres full day (8 hours).
* Age 5 to 59 months.

Exclusion Criteria:

* Anemia (hemoglobin less than 11 g / dl).
* Current supplementation with a product formulated by a health professional as a part of a nutritional recovery.
* Denial for informed consent signing by parents or legal guardians.
* Diagnosis of severe acute malnutrition by anthropometric measurements.
Voice, Dyspnea and Acute Respiratory Failure

Breathing is an automatic vital function that has the peculiarity of being controllable voluntary for actions other than breathing. Speech production is a characteristic example of use of the respiratory system for nonrespiratory purposes. A healthy respiratory system is necessary for speech to be adequately produced and modulated. In patients with respiratory diseases, it becomes difficult to interfere with an automatic control of breathing that is intensely active to compensate for the respiratory deficience. Speech production is impeded, and, reciprocally, speech can generate dyspnea. This study explores the hypothesis that longitudinal changes in speech characteristics will parallel the clinical evolution of acute respiratory episodes. The aim is to validate such changes as prognostic indicators, in the perspective of future telemedicine applications. The hypothesis tested is that of an association between :

* vocal abnormalities at inclusion (assessed in relation to known data within a normal population (database of holy subjects already constituted) and the initial clinical severity (assessed according to the usual clinical and gasometric criteria):
* the evolution of vocal abnormalities during the stay and the clinical evolution.

In the conceptual framework describe in the "brief summary" section of this document, this observational longitudinal monocentric study will include consecutive patients admitted in a specialised respiratory medicine ward for acute respiratory episodes. Any such episode will be considered be it "de novo" or complicating an underlying chronic respiratory disease. Vocal recordings will be performed daily, and will be analysed according to standard in the fields. Clinical parameters will also be recorded daily (vital signs, treatment intensity, outcome -including requirement for treatment intensification, transfer to the ICU, death, discharge to rehabilitation facility, discharge to home). The clinical follow-up and the vocal follow-up will be confronted to determine if voice analysis has an intrinsic prognostic value, alone, or in combination with clinical signs.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalised in the Pitié-Salpêtrière Pneumology Department with an acute respiratory illness (pneumonia of any cause, COVID pneumonia depending on the epidemic context, COPD decompensation, etc);
* whose condition allows conversational exchanges with the nursing staff within the framework of usual care;
* adults, not protected;
* understand and speak French fluently;
* affiliated to the social security system;
* having read and understood the information leaflet;
* do not object to the use of their data;

Exclusion Criteria:

* a clinical condition on admission that is too severe to allow the patient to answer the usual questions of the anamnestic and clinical examination
* patients with uncorrected hearing problems
* patients with neurological, otorhinolaryngological or psychiatric pathology
Early Usage of Bakri Ballon in Managing Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is the top reason for maternal deaths in China. The four major causes of PPH include uterine atony, genital tract laceration, placenta factors and systemic medical disorders (including inherited and acquired coagulopathy). Management of PPH contains the application of uterotonic agents, using hemostasis agents, transfusion of blood component products, conservative procedures (intrauterine packing or balloon tamponade, compression sutures, vascular ligation and uterine artery embolization using sponges), and even hysterectomy.

The Bakri Balloon has attained its efficacy and popularity ever since it was invented by Doctor YN. Bakri. Although it is recommended by many countries as a routine procedure for PPH management, the Bakri Balloon is not yet a first choice in China due to lack in clinical data of preventive usage.

The aim of this study is to prove the efficacy and safety of the Bakri Balloon in early management of PPH.

Data of 472 patients from 20 different hospitals had a Bakri balloon tamponade. Enrolled patients would follow the next process: assessment of blood loss intrapartum and 2 hours postpartum; laying the Bakri Balloon; assessment of blood loss, uterine contraction and complications after Bakri Balloon tamponade; further conservative surgical measures (uterine placation (B-lynch suture), arterial embolization; artery ligation; cervical cerclage) or even hysterectomy if necessary; recording the puerperium infection and involution of uterus.

Data were analyzed by SPSS 20.0 database. The results were expressed as mean ± standard deviations or median with interquartile range. Differences between groups were assessed by Student's unpaired t test, Mann-Whitney U test, or Chi-square test as appropriate. Correlation analysis was performed using the Spearman rank correlation method. To identify independent relationships and adjust the effects of covariates, multiple linear regression analyses were performed. P values of \<0.05 were considered significant.

Eligibility Criteria:
Inclusion Criteria:

* Women with vaginal or cesarean delivery;
* PPH caused by: Uterine Atony, Placenta Factors, Coagulation disorders, Hematological disorders, Hepatic diseases, Obstetric DIC;
* Not reacting well to continuous uterine massage or uterotonic agents including oxytocin (0.04IU/L ivgtt to a maximum of 60IU), Hemabate (250-500ug im) and Duratocin (100ug iv);

  * Without other conservative surgical treatment(uterine compression suture, internal arterial embolism; vascular ligation);
* Signing the informed consents;

Exclusion Criteria:

* Has undergone or will undergo conservative surgical treatment(uterine compression suture, international arterial embolism; artery ligation);
* Impaired soft birth canal injury;
* Untreated uterine deformity;
* Definite indication for uterectomy.
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME.

The primary endpoint will be assessed at Year 1; additional secondary endpoints for efficacy will be assessed at Years 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent prior to participation in the study.
2. Treatment-naïve diabetic macular edema, with vision loss and center involvement (if present) diagnosed within 9 months of screening.
3. BCVA ETDRS letter score between 78 and 25 (-20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye.
4. CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center.
5. Decrease in vision determined by the Investigator to be primarily the result of DME.
6. Type 1 or Type 2 diabetes mellitus and a HbA1c of ≤12%.
7. Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

1. Macular edema in the Study Eye considered to be secondary to a cause other than DME.
2. Active iris or angle neovascularization or neovascular glaucoma in the Study Eye.
3. High-risk proliferative diabetic retinopathy characteristics in the Study Eye.
4. History of Pan-retinal Photocoagulation (PRP) laser in the Study Eye within 3 months of screening.
5. Tractional retinal detachment in the Study Eye.
6. Active retinal disease other than the condition under investigation in the Study Eye.
7. Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study (e.g., vitreomacular traction, epiretinal membrane).
8. Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.
9. Any prior use of an approved or investigational treatment for DME in the Study Eye (e.g., anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
10. Women who are pregnant or lactating or intending to become pregnant during the study.
11. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest.
12. Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
13. History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
14. Other protocol-specified exclusion criteria may apply.