cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

Using Nicorette® gum 2 mg, 4 mg and Nicorette® patch 5 mg/16 h, 10 mg/16 h, 15 mg/16 h to alleviate nicotine cravings and withdrawal symptoms and assist smoking cessation in smoking hospital physicians and staff who are motivated to quit. During the study, brief telephone consultation and SMS are provided as behavioral supports.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, aged 18 years or older
* Normal dental status and chewing ability for nicotine gum users; normal skin without excessive hair growth on tested areas for nicotine patch users
* Current daily smoker for at least two years
* Have a carbon monoxide (CO) level of at least 10 parts per million (ppm) after at least 15 smoke-free minutes
* Be motivated to stop smoking with the help of nicotine gum or patch treatment.
* Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the trial
* Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Current use of other tobacco-containing products e.g. snuff, chewing tobacco, cigars, or pipes.
* Use of any other stop-smoking products (nicotine or non-nicotine) or treatment (hypnosis, acupuncture, etc) during the study i.e. during the last 6-month period.
* Unstable angina pectoris or myocardial infarction during the previous 3 months.
* Pregnancy, lactation or intended pregnancy.
* Any major metabolic disease, clinically important renal, hepatic disease.
* Suspected alcohol or drug abuse.
* Participation in other clinical trials in the previous three months, or during study participation.
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
Shoulder Pain and Scapular Endurance

Objective: This study aimed to investigate the effects of regular exercising on scapular muscle endurance and shoulder pain in young individuals.

Methods: Participants' clinical and sociodemographic properties recorded, scapular muscle endurance assessed with Scapular Muscular Endurance (SME) test, and shoulder pain severity questioned using the Visual Analogue Scale.

Background: Serratus Anterior and Trapezius muscles are the most important stabilizers of the scapulothoracic joint. The inadequate endurance of these muscles plays an important role in the decreased neuromuscular performance.

Objective: This study aimed to investigate the effects of regular exercising on scapular muscle endurance and shoulder pain in young individuals.

Methods: Participants' clinical and sociodemographic properties recorded, scapular muscle endurance assessed with Scapular Muscular Endurance (SME) test, and shoulder pain severity questioned using the Visual Analogue Scale.

Eligibility Criteria:
Inclusion Criteria:

for exercise group;

* between 17-25 years ages
* who were using the fitness center by their preference (not professional)
* had active sporting life (not professional)
* who were regularly exercising

for sedentary group;

* between 17-25 years ages
* who had sedentary life style

Exclusion Criteria:

for boths group;

* Individuals who had surgical stabilization,
* who had previous shoulder complex fractures
* who had positive impingement test results
* who had systemic diseases
* who had neurological and orthopedic problems
Effect of Xenogeneic Collagen Matrix on the Peri-implant Tissues of Immediate Implants.

The present clinical trial will try to demonstrate the efficacy of stable xenogeneic collagen matrix in maintaining the vestibular coronal soft tissue volume and the stabilization of mid-buccal margin position in immediate post-extraccion sockets compared with the use of autogenous connective tissue grafts.


Eligibility Criteria:
Inclusion Criteria:

1. Adequate oral hygiene (21).
2. Sufficient interocclusal space (≥6 mm) to place a provisional crown without occlusion.
3. Presence of adjacent teeth. Only one tooth gap.
4. Presence of soft tissue and cortical buccal bone of the tooth to be extracted according to the classification of Elian et al. 2007
5. Adequate bone quantity in the apical region of the tooth to be extracted (assessed on the CBCT).

Exclusion Criteria:

1. Patients with medical conditions that affect bone and soft tissue metabolism.
2. Uncontrolled endocrine disorders.
3. Alcohol and drug abuse.
4. Previous history of immunodeficiency syndromes.
5. Patients who smoke\> 10 cigarettes a day.
6. Active periodontal disease.
7. Absence of a tooth adjacent to the tooth to be treated.
8. Oral lesions of the untreated mucosa.
9. Recent previous history (\<6 months) of local radiotherapy or chemotherapy.
10. Bruxism or severe parafunctions.
11. Pregnant patients.
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.


Eligibility Criteria:
Inclusion Criteria:

Critical limb ischemia RC 4-6

Lesions in superficial femoral artery and popliteal artery (p1 -p2)

Target vessel 4-8mm

At least I 1 vessel runoff to the foot

Age \>18 years

Exclusion Criteria:

Pregnancy

Patient disapproval

Age \<18 years
A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction

The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?

Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. However, some studies have shown that oral misoprostol can be continued into active labour. In the Cochrane review on labour induction, those whose augmentation was continued with misoprostol (M/M protocol) had 42% less CSs than those who changed to oxytocin (M/Ox protocol; 15% vs 26%). This misoprostol-only protocol would be simpler and probably more acceptable to women. However, these two protocols have never been directly compared. We propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.

Eligibility Criteria:
Inclusion Criteria:

* • Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not

  * Women age ≥18 years
  * Signed informed consent form
  * Undergone cervical ripening with misoprostol if cervix initially unfavourable
  * Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s

Exclusion Criteria:

* Women with previous caesarean births
* Those unable to give informed consent
* Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins)
* Multiple pregnancy
* History of allergy to misoprostol
* Adequate uterine activity
* Pre- induction Ruptured amniotic membranes
* Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)
Skin Microbiome of Chinese Population Cohort Study

This observational study aims to investigate the relationship between public health and the skin microbiome in the province of Zhejiang. Due to the lack of current research on the skin microbiome, the following general questions will be investigated in this study: 1) What connection exists between dietary practices and facial skin microbiome? 2) How do people's lifestyle routines affect the facial skin microbiome? 3) What effects does the altered living environment have on people's facial skin microbiomes? 4) How do the seasons affect people's facial skin microbiomes?

Every 3 to 4 months, the participants' facial skin microbiota samples will be taken, and they will be asked to complete a survey.


Eligibility Criteria:
Inclusion Criteria:

* ages from 15 to 50.

Exclusion Criteria:

* a severe medical history, including a history of surgery or medication, or serious illnesses such as cancer, liver disease, kidney disease, or craniocerebral trauma.
* recent medical treatment (topical antibiotics, corticosteroids, and other anti-inflammatory drugs within 4 weeks, and systemic antibiotics, corticosteroids, and other immunosuppressive drugs within 6 months)
Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.

Respiratory failure in term newborns is associated with significant morbidity and mortality, despite maximal conventional therapy. Neonates with pulmonary hypertension have been treated with iNO, a selective pulmonary vasodilator. This multicenter, double-masked placebo-controlled randomized trial tested whether iNO would reduce the risk of death and/or the initiation of extracorporeal membrane oxygenation (ECMO) in a prospectively defined cohort of term or near-term neonates with hypoxic respiratory failure unresponsive to conventional therapy. The sample size was based on a reduction of the primary event (death or ECMO) from 50 percent to 30 percent; 90 percent power; and a two-tailed Type I error of 0.05.

Infants were evaluated at baseline for pulmonary, cardiac, bleeding status, and therapies received. Those who were greater than 34 wks gestation and 14 days old or less and required assisted ventilation with an OI (mean airway pressure x FiO2 divided by the PaO2 x 100) greater than 25 were eligible. They were randomly assigned to receive iNO at 20 ppm or 100 percent oxygen as a control. Infants whose PaO2 increased by less than 20 mm Hg after 30 minutes were studied at 80ppm iNO or control gas.; MetHg and NO2 concentrations were monitored regularly. Management, including surfactant administration, included prospectively defined criteria for study gas response, escalation, reinitiation, and weaning. The maximum total time on study gas was 336 hrs (after 240 hrs, the INO concentration was required to be no more than 5 ppm). Patients were followed to death, discharge, or 120 days and evaluated at 18-24 mos by a masked certified examiner.

Eligibility Criteria:
Inclusion Criteria:

* Greater than 34 wks gestational age
* One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia
* Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart
* Indwelling arterial line
* Echocardiography before randomization
* Parental consent

Exclusion Criteria:

* Congenital diaphragmatic hernia
* Known congenital heart disease
* Decision not to provide full therapy
The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients

Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (\> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.


Eligibility Criteria:
Inclusion Criteria: Volunteers with Cystic Fibrosis and lung disease with chest hemiperímetro ≥ 37 cm. Exclusion Criteria: Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (\> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used.
A Study of Preferences for the First-Line Treatment of Advanced/Metastatic Non-Small Cell Lung Cancer

The purpose of this observational study is to determine participants' preferences for outcomes associated with first-line treatment of advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) using a discrete-choice experiment (DCE).


Eligibility Criteria:
Inclusion Criteria:

The following is the inclusion criteria for pretest interviews and final online survey.

Participants:

* Must be 18 years of age or older
* Must be a US resident.
* Lung cancer participants with a physician diagnosis of NSCLC. Global Perspectives will be involved to suggest alternative strategies to a physician-confirmed diagnosis to ensure that actual cancer participants are recruited.

Exclusion Criteria:

* Not applicable

Other protocol-defined inclusion/exclusion criteria apply
The Flocked Swab and the Traditional Fiber Swab for the Diagnosis of the Herpes Simplex Epithelial Keratitis

The purpose of this study is to compare a corneal sampling realized by a flocked swab (flocked swab regular 519CS01) with a sampling by traditional fiber swab (Copan regular swab 164KS01 in polyester). Their impact on the sensibility of the viral culture in the Herpes simplex epithelial keratitis will be the primary objective of this study.

In our center, the flocked swabs became an important tool in the corneal sampling for viral keratitis, replacing rightly or wrongly the former traditional fibers swab. No research was specifically designed to study the corneal taking with these swabs. Nevertheless, numerous reasons would motivate it, because of the peculiarities in ophthalmology: the corneal sampling has to be made with the slit lamp rather than in a macroscopic manner; the corneal lesion are often millimetre-length and confined; the histology of the cornea is unique and compares only imperfectly with other structures of the human body like the nasal mucosa. In these circumstances, the properties of the stalk (rigidity, length) and of its extremity (roughness, textures, absorbance) can influence the quality of the sampling and the final result of the culture.

Eligibility Criteria:
Inclusion Criteria:

* Slit lamp signs at the initial examination that are compatible with an Herpes simplex epithelial keratitis (Herpes simplex dendrite, herpes simplex geographic ulcer)

Exclusion Criteria:

* Topical or systemic antiviral Therapy during the last 14 days Patient with Herpes simplex stromal keratitis without epithelial involvement Herpetic lesion outside the cornea
The Efficiency and Gingival Health Status of Hall Versus SDF Techniques in the Management of Carious Primary Molars

PICO question:

In Comparison to the hall technique , will silver diamine fluoride have equalvent gingival health status in treatment of carious primary molars?

population: children suffering from caries . intervention : silver diamine fluoride. comparison: hall technique outcome:

Primary outcome:

Gingival health measurement device modified gingival index, measurement unit score(0-1-2)

Secondary outcomes:

1. Oral hygiene measurement device modified plaque index , measurement unit score (0-1-2)
2. Time of Treatment measurement device digital chronometer, measurement unit minutes

Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

Eligibility Criteria:
Inclusion Criteria:

* Age: From 4 to 6 years
* Clinical diagnosis of tooth with caries in primary molars within enamel or dentin without pulp disease

Exclusion Criteria:

* Tooth with signs and symptoms of pulp necrosis
* Tooth with Root caries
* Tooth with Spontaneous pain
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

To determine if a manual blood loss can be detected using the non-invasive blood monitor.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteer
* between 18 to 50 years of age
* weight between 157 to 220 lbs

Exclusion Criteria:

* unstable or untreated cardia disease
* alcohol consumption in 24 hours prior to screening
* tobacco use in 4 hours prior to screening
* pregnancy
* infection
* Hemoglobin \< 12.5 g/dL at time of procedure
Predicting Acute Kidney Injury After Coronary Artery Bypass Graft

Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.

Acute kidney injury (AKI) after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome. There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully. The investigators attempt to evaluate the influence of preoperative medication, preoperative albumin level, uric acid concentration, NL ratio, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft. Preoperative and postoperative diastolic dysfunction may be associated with postoperative AKI. In addition, preoperative neutrophil-lymphocyte ratio (NLR) which has been reported to be a marked for systemic inflammation and was associated with prognosis in cardiac patients undergoing coronary artery bypass graft or percutaneous coronary intervention. This preoperative or immediate postoperative NLR might be able to predict AKI after coronary artery bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center

Exclusion Criteria:

* lack of postoperative creatinine or urine output data
* patients who expired within 24hours after surgery
Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes

Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years and above
* Have diagnosis of type 2 diabetes mellitus
* Provided informed consent
* Have near-field communication (NFC) compatible phones
* Able to engage in light physical activity (e.g., walking)

Exclusion Criteria:

* Significant cognitive impairment
* Other conditions that may preclude participants from wearing CGM devices
Pediatric Study for Appropriate Dose of Ritonavir Boosted Lopinavir in Thai HIV-infected Children (PEARL)

To compare the safety and efficacy of low-dose versus standard dose lopinavir/ritonavir containing HAART regimen in virological suppress, HIV RNA viral load \< 50 copies/ml at 48 week


Eligibility Criteria:
Inclusion Criteria:

1. HIV infection children age \< 18 years old
2. Currently on PI regimens
3. HIV RNA viral load \< 50 copies/ml at screening
4. BW 25-50 kg
5. Written informed consent

Exclusion Criteria:

1. Relevant history or current condition of PI resistance, plasma HIV RNA \> 1000 copies/ml after received the PI regimens for at least 6 months
2. On rifampin, nevirapine, efavirenz which have drug interaction with lopinavir
3. On double boosted protease inhibitors