cyrilzakka/clinical-trials huggingface dataset:
Bulk-fill With Different Technique Three-year Clinical Performance

The current study will be intended to evaluate and compare three-year clinical performance of class II bulk-fill resin composite restorations placed with different techniques.

Fifty patients with proximal carious lesion in permanent molars were included in the study. A total eighty class II cavities were restored with one of the following bulk-fill resin composite with their adhesive systems (n=20) Filtek™ Bulk Fill, Heated Filtek™ Bulk Fill, G-aenial™ BULK Injectable or Sonicfill3. Double blinded randomized clinical trial with survival and clinical quality were evaluated at baseline, after 12 , 24 and 36months using modified FDI(Fédération dentaire internationale) World Dental Federation criteria

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Good oral hygienic
* Patient aging 18-35 year
* Patient available for follow-up visits compound class II (mesio-occlusal or disto-occlusal)
* Carious lesion in the external and middle third of dentin thickness
* ICDAS (International caries detection and assessment system) 4 or 5 that diagnosed clinically and radiographically.
* Maxillary or mandibular first or second molars
* Tooth with antagonist and adjacent mesial and distal tooth contact,
* Normal response to a vitality test.

Exclusion Criteria:

* Poor oral hygiene
* Severe or chronic periodontitis
* Heavy bruxism
* Occlusion fewer than 20 teeth
* Sensitivity to resin-based material.
* Patients with orthodontic treatment
* Patients on pregnancy or lactation
* chronic use of anti-inflammatory drugs, analgesic, and/or psychotropic drugs
* Patient potentially unable to attend recall visits
* Teeth would need direct pulp capping or
* Teeth act as abutment for fixed or removable prosthesis.
Vitamin D3 - Omega3 - Home Exercise - HeALTHy Aging and Longevity Cohort

The DO-HEALTH trial will be extended into the cohort including the collection on life style factors such as diet, quality of life and physical activity, as well as health-related data on co-morbid conditions as well as a standardized assessment of multiple organ functions, physical, cognitive and mental function using surveys and standardized health assessments.

The DO-HEALTH cohort will be a continuation of the trial without intervention and will elucidate longterm determinants of healthy, active and independent aging in European community-dwelling older adults. The main emphasize of the cohort will be to determine the risk factors, to quantify the incidence and to describe the trajectories of incident frailty, impaired mobility, loss of independence and age related morbidity (e.g. heart arrhythmia, type 2 diabetes, falls, fractures).

Additionally, the cohort will continue to investigate the primary endpoints of the original trial like the risk and incidence of injurious falls (bone); functional decline (muscle); high blood pressure (cardiovascular); cognitive decline (brain); and the rate of any infection (immunity). Moreover, the cohort will include and extend key secondary and exploratory endpoints of the original trial such as incidence and prevalence of anemia, sarcopenia, cardiovascular diseases, type 2 diabetes and cancer.

Eligibility Criteria:
Inclusion Criteria:

* Former participation in the DO-HEALTH clinical trial study

Exclusion Criteria:

* Inability or unwillingness to give written informed consent
* Medical condition that would make the results of the tests/assessments unreliable and/or would put too much burden to the participant, and/or leads to safety concerns.
Comparison of Coronally Advanced Flap and Semilunar Incision Vestibular Technique for Multiple Gingival Recessions in Maxillary Teeth - A Randomized Controlled Trial

Comparison of Coronally advanced flap with semilunar vestibular incision technique for root coverage in patients with multiple gingival recession in maxillary teeth.

the subjects attending the OPD department of periodontology, IGIDS and patients will be selected based on inclusion criteria, informed consent to be obtained from the patients,

Randomization process:

1. Patient to be selected for one of the two procedures by simple random sampling (Lottery method)
2. Baseline value will be recorded by a calibrated examiner other than the operator
3. The procedure is performed by the operator ( primary investigator)
4. Post op values to be recorded by the calibrated examiner.

Patient to be reviewed at 3 and 6 months Results will be dicussed

Eligibility Criteria:
Inclusion Criteria:

* Males and females subjects of 20-50 years.
* Patients with multiple gingival recession (2-4 teeth) of class I \& II in maxillary teeth.
* Patients with well aligned teeth

Exclusion Criteria:

* Patients with class III \&IV gingival recession in maxillary teeth
* Recession in relation to molars
* Patients with systemic diseases
* Medically compromised patients
* Patient with history of smoking
* Patients with erosion and root caries
Robotic-assisted Left Hemicolectomy for Left Colon Cancer

The main goal of this study is to clarify if Robotic-assisted surgery could become the standard approach in patients undergoing left colonic resection.

Patient candidates to left colonic resection were randomly assigned to Robotic(RAL) or laparoscopic(LL) approach. The surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital days. Long-term morbidity, quality of life, and 5-year survival have also been evaluated

Robotic-assisted Left Hemicolectomy as advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve compare to laparoscopic approach. Our experience found that operational flexibility was advantage without surgeon's position exchange.

Eligibility Criteria:
Inclusion Criteria:

Colon cancer adenocarcinoma The tumor located between the descending colon and the right 1/3 of transverse colon Tumors T3,Т4а,b N0-2 Tolerance of chemotherapy ECOG 0-2

Exclusion Criteria:

With distant metastases Tumors T1-2 Complications of tumor Women during Pregnancy
Rectal Misoprostol in Women Undergoing Myomectomy for Intraoperative Blood Loss: A Randomized Placebo-controlled Study

Comparison of efficacy of rectal misoprostol for reduction amount of blood loss in women undergoing myomectomy, both open and laparoscopic approach

According to development of reproductive technology to assist infertile women, rate of myomectomy increases. During this operation, surgeons would deal with hypervascular masses with raw surfaces that tend to bleeding. Interventions to diminish bleeding were studied such as using misoprostol, vasopressin, transamenic acid along with mechanical intervention such as tourniquet and uterine artery ligation. But in Rajavithi hospital, such procedures aren't generally used because of fewer cases and also lacks of supporting data. Misoprostol, used in gynecologic patients for a long time with a wide safety margin acts at prostaglandin receptors of myometrium to stimulate contraction that constricts uterine vessels that lead to decreasing amount of bleeding during the operation. This led to the experimental study of rectal misoprostol administered at 15 - 30 minutes prior the operation to decrease blood loss and also blood transfusion rates. Our study also gather data about adverse effect that subject experienced after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Patient provisionally diagnosed with leiomyoma of uterus with less than 10 cm diameter
* Patient undergoing myomectomy, both open and laparoscopic approach
* Patient aged 25 - 50 years
* Patient able to give free and informed consent and who agrees to participate bu signing the consent form
* Patient able to speak and understand Thai
* Patient able to complete the questionnaire

Exclusion Criteria:

* Patient who was pathologically diagnosed apart from leiomyoma
* Patient with leiomyoma FIGO type 0
* Patient who has medical conditions that increase bleeding tendency, such as thrombocytopenia, coagulopathy, renal insufficiency, uncontrolled diabetes mellitus, taking antiplatelets or anticoagulants less than 7 days prior the surgery
* Patient who takes prostaglandin analogs and/or antagonists (NSAIDS) less than 7 days prior the surgery.
* Patient who may take higher risks of misoprostol adverse effect such as hypertension, ischemic heart disease, glaucoma, asthma
* Patient who had and allergic reaction to misoprostol or vitamin B6
Mixed Urinary Incontinence Symptoms Before and After Treatment With Botox and Bulkamid

This study compares mixed urinary incontinence symptoms before and after a combined treatment with Botox and Bulkamid. Eligible for the study are adult females with a mixed urinary incontinence, having both urgency urinary symptoms and stress urinary symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥ 18 years.
2. Clinically diagnosed therapy-refractory mixed urinary incontinence (MUI) based on cough test, urodynamic evaluation, 3-day micturition diary, incontinence-questionnaire with visual analog scales for SUI and UUI.
3. All criteria for the indication to treat patient with Botox are met.
4. All criteria for the indication to treat patient with Bulkamid are met.
5. Participant has given informed consent

Exclusion Criteria:

1. All contraindications for Bulkamid or Botox
2. Previous treatment with Botulinum toxin (within last 3 months)
3. Previous treatment with Bulkamid or other bulking agent (within last 3 months)
4. Participant is pregnant or lactating
5. Current urinary tract infection (in which case this has to be treated first before patient might be included)
6. Residual urine of \> 100 ml
Anesthesia Induction With Intravenous Bolus or Continuous Infusion of Remimazolam

Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.

In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)


Eligibility Criteria:
Inclusion Criteria:

* Adults 19 years of age or older undergoing surgery under general anesthesia
* ASA I-III

Exclusion Criteria:

* Intraoperative regional blocks (e.g. spinal anesthesia, epidural anesthesia, peripheral nerve block)
* Liver resection or liver transplantation
* Cardiopulmonary bypass
* Uncontrolled HTN (SBP ≧180 mmHg, or ≧160 in patients taking antihypertensive drugs)
* Uncontrolled DM (HbA1c antihypertensive drugs ≧9.0%)
* Total bilirubin ≧3.0 mg/ml or AST or ALS ≧2.5 times the upper limit of normal
* Serum creatinine ≧2.0 mg/ml or ESRD on dialysis
* COPD in need of treatment
* Patients who are expected to have difficulty in tracheal extubation immediately after surgery for postoperative lung management
* Resistance to benzodiazepines
* Hypersensitivity to benzodiazepines, remifentanil, fentanyl citrate, rocuronium, sugammadex, flumazenil, or other anesthetic drugs
* Myasthenia gravis or myasthenic syndrome
* Myocardial infarction, transient ischemic attack, stroke, newly diagnosed coronary artery disease, percutaneous coronary intervention, or coronary artery bypass graft within 6 months
* Implantation of rate-responsive cardiac pacemaker with bioelectrical impedance sensor
* Organic brain disorder, or other neurologic diseases that cannot adequately measure EEG (BIS)
* Severe allergic diseases
* Cognitive impairment that makes it impossible to understand the instructions and informed consent of this study
Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists

Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

End points:

End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.


Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome (ROME III criteria)
* age 18-65 years

Exclusion Criteria:

* medication: antidepressants or H1-receptor antagonists
* pregnancy, breast feeding
* co-morbidity: severe kidney- and/or liver disease
Open Label Study Assessing Effectiveness Of Amlodipine/Atorvastatin In Subjects With Hypertension and Dyslipidaemia

To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their governing guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are above target LDL-C and BP who are eligible for treatment

Exclusion Criteria:

* High liver enzymes
Pilot Study Evaluating the Use of a New Device for Transanal Irrigation in Patient With Bowel Disorders

The study descripted of efficacy of IryPump®R Set in term of success of the procedure at each irrigation


Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years old,
2. Patient having signed an informed consent
3. Patient having neurologic or non neurologic bowel disorders, being initiated to TAI and practicing TAI with Peristeen® for the management of her/his bowel disorders, for at least 6 weeks, with satisfying results.
4. Patient practicing TAI on the basis of 1 procedure/ week as a minimum or more frequently
5. Patient capable to perform the procedure of transanal irrigation himself or with the help of a caregiver
6. Patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
7. Patient agrees to test IryPump® Set R for a time corresponding to 5 consecutive irrigations and a maximum of 4 weeks.
8. Patient covered by social security

Exclusion Criteria:

1. Patient with bowel obstruction
2. Patient already participating in another clinical study or who have previously participated in this investigation,
3. Pregnant or breast-feeding woman
A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds

Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.


Eligibility Criteria:
Inclusion Criteria:

* Has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
* Wound has not healed after using at least one other type of advanced wound care treatment
* Wound size is between 1 and 100 cm2
* Patient has adequate circulation, as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is free of infection and absence of osteomyelitis.

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Has a known allergy to porcine products
* Has an allergy or sensitivity to any type of collagen
* Unable or unwilling to receive porcine collagen
* Wound is infected or there is presence of osteomyelitis
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol
Prospective Clinical Study of PCV and PCV-VG in Patients Undergoing Bariatric Surgery

This study compares the two mechanical ventilation strategies in obese patients undergoing bariatric surgery: pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG). This is a randomized controlled trial with a sample size of 100 patients whose body mass index(BMI) is over 30kg/m².

With the development of economy and changing of life style, obesity is becoming a common phenomenon. More and more obese patients are undergoing bariatric surgery every year.

Obesity results in a series of physiological changes particularly the respiratory system. The decrease of lung compliance and the limited total lung capacity, vital capacity, functional residual capacity are all contributed to intraoperative hypoxemia and postoperative lung complications. Presently study mainly discuss lung protective ventilation strategies from four aspects: tidal volume,ventilation modes,positive end-expiratory pressures and lung recruitment maneuvers.

This prospective study will compare two ventilation modes in obese patients undergoing bariatric surgery:pressure-controlled ventilation(PCV) and pressure-controlled ventilation volume-guaranteed（PCV-VG).

The total of 100 patients will be divided into two groups randomly. The patients will be ventilated with PCV or PCV-VG modes plus positive end expiratory pressure (PEEP) of 5cmH2O throughout the whole operation.

The respiratory and hemodynamic parameters in six time points will be recorded, and the postoperative chest computerized tomography (CT) will be checked to identify the postoperative lung complications.

Eligibility Criteria:
Inclusion Criteria:

* BMI≥30kg/m²
* ASA classification II-III
* Bariatric surgery

Exclusion Criteria:

* Patients combined restrictive or obstructive lung diseases,pneumonia, bullae of lung ; patients after pneumonectomy
* Patients combined with other severe internal medicine diseases
* duration of pregnancy or suckling
Changing Technique of Abdominal Wall Closure (PHACPA)

Implementing guidelines of EHS for abdominal wall closure in all specialities of a General Hospital. Migrating from large stitch technique to short stitch technique.

Surgeons will receive instruction about new techniques of closure of the abdomen and will practice in models and receive a certification previously to implement in their surgical practice the new technique.

Results will be monitorised and compared with previous cohort of patients. A protocol of closure will be implemented. Patients without risk factors will receive a laparotomy closure with "short stitch" technique and patients with risk factor for developing incisional hernia or burst abdomen and aditional profilactic suprafascial mesh.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated on by laparotomy

Exclusion Criteria:

* Previous mesh
* Concomitant hernia repair
Intranasal Ketamine as a Sedative for Venipuncture

Randomized clinical trial, controlled, double-blind, parallel two-arm.

Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.

Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
* Aged 3 months to 12 years;
* Requiring venipuncture independent research.

Exclusion Criteria:

* Severe neurological sequelae;
* Patients who need immediate venipuncture at risk;
* Presence of active nosebleeds;
* Patients using drugs sedative and analgesic continuos;
* Children who have experienced clinical change with ketamine.
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.

Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year.

The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.

The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.

Eligibility Criteria:
Inclusion Criteria:

Clinical

1. Patients with angina or silent ischemia and documented ischemia
2. Patients who are eligible for intracoronary stenting
3. Age \> 18 years

Angiographic

1. De novo lesion CTO
2. Reference vessel size 2.5 mm by visual estimation
3. At least one CTO lesions located in proximal or mid epicardial coronary artery. (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)

CTO definition: TIMI flow 0 and estimated duration over 3 months The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion

1. Angiographically defined total occlusion over 3 months
2. If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy
2. Pregnant state
3. Three vessel CTO
4. Known hypersensitivity or contra-indication to contrast agent and heparin
5. ST-elevation acute myocardial infarction requiring primary stenting
6. Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
7. Hematological disease
8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
9. Renal dysfunction, creatinine more than 2.0
10. Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
11. Left ventricular ejection fraction
12. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
13. Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).