cyrilzakka/clinical-trials huggingface dataset:
Wear Measurement of Opposing Enamel to Milled Resin Matrix Ceramic Versus Bulk Fill Resin Composite After 2 Years

This clinical trial conducted to measure the amount of wear of opposing enamel to indirect milled resin matrix ceramic versus direct bulk fill resin composite intraorally using Digital Scanner after two years of using

Indirect milled resin matrix ceramic overlay versus direct bulk fill resin composite overlay was utilized in a clinical trial to compare the amount of enamel wear on endodontically treated molars using a Panda P2 digital scanner and Geomagic Control X 3D software. After one and two years, measurements of enamel wear were taken.

Eligibility Criteria:
Inclusion Criteria:

* ● Patients with non vital badly decayed posterior teeth.

  * 18 -55years.
  * Males or Females.
  * Good oral hygiene.
  * Co-operative patients approving to participate in the study

Exclusion Criteria:

* High caries index.

  * Severe medical complications.
  * Pregnancy.
  * Allergic history concerning methacrylates Disabilities.
  * Heavy smoking.
  * Xerostomia.
  * Lack of compliance.
  * Evidence of parafunctional habits.
  * Temporomandibular joint disorders.
Prehospital Telemedical Support in Acute Stroke

The aim of the study is to investigate the quality of prehospital emergency care in acute stroke, when paramedics are supported telemedically by an EMS physician.

Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of suspected acute stroke (including intracranial hemorrhage), the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is obtained. The tele-EMS physician has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, neurological diagnosis, general diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Eligibility Criteria:
Inclusion Criteria:

* suspected acute stroke
* verbal consent for teleconsultation obtained or patient is not able to consent due to the severity of the emergency

Exclusion Criteria:

* no suspected stroke
* patient refuses consent
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

The bunionectomy was performed under regional anesthesia and propofol sedation. Perioperative anesthesia was standardized for all participants. Upon completion of surgery, designated study personnel ensured continued eligibility per the selection criteria of the protocol.

After an appropriate period of time following bunionectomy, participants who had a pain intensity score of ≥ 40 mm on a 100 mm visual analog scale (VAS) and moderate or severe pain intensity per the categorical pain intensity scale were eligible for randomization, in equal numbers, into 1 of 5 treatment arms. In order to maintain the single-blind nature of the study, all participants were dosed with study drug (active and/or placebo) every 6 hours.

Eligibility Criteria:
Inclusion Criteria:

- Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.

Exclusion Criteria:

* Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
* Allergic reaction to study medications
* Pregnant or breastfeeding females
* Clinically significant lab abnormalities at screening
* Positive hepatitis testing at screening
* Clinically significant or uncontrolled medical disorders or illness at screening
* Active malignancy or chemotherapy
* Any history of drug or alcohol abuse/addiction
* Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
* History of major depressive episode or major psychiatric disorder
* Current systemic corticosteroid therapy
* Inability to refrain from smoking during or alcohol during stay at investigative site
Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Planned diagnostic coronary or peripheral artery angiography
* T2DM
* CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
* Statin naive, or not on statin treatment for at least 14 days
* Withdrawal metformin or aminophylline for 48h before angiography
* Total iodixanol volume

Exclusion Criteria:

* Hypersensitivity to iodine-containing compounds and statins
* Type 1 diabetes mellitus
* Ketoacidosis
* Lactic acidosis
* CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR\<30ml/min per 1.73m2)
* STEMI
* NYHA class IV or hemodynamic instability
* Administration of any iodinated CM within 14 days before randomization
* LDL-C\<1.82mmol/L（70mg/dL）
* Hepatic dysfunction (ALT 3 times greater than upper normal limit)
* Thyreoid insufficiency
* renal artery Stenosis(unilateral \>70％ or bilateral stenosis\>50％)
Tele-based Resisted Exercise for COPD

The present study aims to investigate the effect of six weeks tele-based resisted exercises on cardiopulmonary function, quality of life, muscle strength and functioanl performance among patients with chronic obstructive pulmonary disease. In addition, the effect of different forms of exercise instruction (i.e., booklet and video) was also investigated.

Background and Purpose: Chronic obstructive pulmonary disease (COPD) is the 3rd global cause of deaths. Pulmonary rehabilitation (PR) is the standard treatment for this disease. However, the dropout rate remains high (33-50%) because of traffic issues and patients' low mobility. Therefore, telerehabilitation seems to be a better way to deliver PR. Using videos to deliver PR is not only easy to manipulate on the cellphone or ipad, but also improve patients' attention and compliance. Thus, the aim of this study is to assess whether tailor-made PR video rehabilitation program improves patients' quality of life (QoL), muscle strengths, cardiopulmonary functions, and compliance.

Methods: This is a quasi-experimental study. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. They voluntarily choose to participate in control group, booklet group or video groups to conduct 6-week tele-based resisted exercise program. Patients in control group received conventional intervention and exercise instruction booklet. Participants in booklet and video groups additionally received a COPD exercise package with 2 elastic bands in different weight (4 ponds and 8 ponds). Participants in booklet group received the exercise instructed in education booklet with words and pictures. Patients in video group received exercise instructed using YouTube videos. Both participants in booklet and video groups were asked to record their rating of perceived exertion (RPE) scores. A physical therapist would weekly contact them to monitor and modify the exercise intensity using their RPE scores. The videos included 5-minute breathing reeducation, 20-minute interval strengthening exercise and 5-minute education animation. All patients were assessed the performance of spirometry, cardiopulmonary exercise test (CPET), questionnaires about symptoms, QoL, muscle strengths and distances of 6-minute walk test (6MWT) before intervention, after intervention and after 6-week follow-up.

Eligibility Criteria:
Inclusion Criteria:

* COPD
* Be medically stable
* Ability to use a smartphone and applications (LINE and Youtube)
* Access to the internet
* Have visual and auditory impairments corrected with assistive devices

Exclusion Criteria:

* Other respiratory disease as main complaint other than COPD
* Exacerbations within 4 weeks
* Had enrolled PR programs within the last 6 months
* Unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
* Unstable medical conditions
* Any comorbidities which precluded exercise training
The Effect of Combined Spinal-Epidural Analgesia on the Success of External Cephalic Version (ECV) for Breech Position

We aim to answer the clinical question: Does combined spinal-epidural analgesia improve the success rate of external cephalic version? We hypothesize that neuraxial analgesia (spinal or epidural analgesia) during version for breech presentation increases successful fetal rotation and decreases the incidence of Cesarean delivery for malpresentation.

At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. Cesarean delivery, the safer option for the baby, however, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications.

Obstetricians perform versions after 36 weeks gestational age with a reportable success rate of 30-80%. The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Pain relief is most commonly provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.

Although the use of neuraxial analgesia and anesthesia techniques improve maternal pain and satisfaction, there is conflicting evidence if they improve the success rate of version procedures. The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."

We propose to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural analgesia on the success rate of external version for breech fetal position and the subsequent incidence of vaginal vs. Cesarean delivery as a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* 18-55 years of age
* Female
* Pregnant
* Breech Presentation
* Greater than 36 Weeks gestation
* Version Procedure

Exclusion Criteria:

* Under 18 or over 55 years of age
Change of Nasalance After Tonsillectomy in Thai Adult

The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai adults.


Eligibility Criteria:
Inclusion Criteria:

* Thai adults age over 18 years who were perform bilateral tonsillectomy
* The pathological are not malignancy

Exclusion Criteria:

* Craniofacial anomalies
* Neurological problems
* History of Peritonsillar abscess
* Performed other operation beside tonsillectomy
* Can't read Thais
* Visual problem that effect reading
* Nasal disease that cause nasal obstruction
Comparing Liquid Versus Solid Forms of Sugars and Whey Protein

To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men.

Three randomized cross-over design experiments were used to compare the effect of solid and liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/ 50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment 3 on healthy normal weight males . The controls were water (experiment 1 and 3) and calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin (sweet control, experiment 2). Subjective average appetite was measured by visual analogue scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment consumptions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy lean males with BMI between 18- 24.9 kg/m2 and an age range of 19 to 28 years were recruited for the three experiments.

Exclusion Criteria:

* Diabetics (fasting blood glucose ≥ 7.0 mmol/L), smokers, breakfast skippers or dieters were excluded from the experiments. Individuals under medications or with a history of liver or kidney disease and major medical or surgical event within the last six months were excluded.
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions

Open-label, Phase 2, single treatment arm, 3 cohorts


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease. Cohort C locally advanced or metastatic solid tumor.
* Progression of disease on or after a platinum-based chemotherapy regimen (Cohorts A and B) or after standard of care (Cohort C)
* EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B) or NRG1 or ERBB family gene fusions (Cohort C)
* Measurable disease according to RECIST v.1.1
* ECOG performance status of 0 or 1
* Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
* Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
* Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
* Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
* Platelet count ≥ 100,000/μL
* No evidence of second or third degree atrioventricular block
* No clinically significant arrhythmia (i.e.; pauses of \> 4 seconds, VT of any duration, SVT \> 4 beats/minute)
* QRS interval ≤ 110 ms
* QTcF interval of \< 450 ms
* PR interval ≤ 200 ms
* Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides)

Key Exclusion Criteria:

* Another known activating oncogene driver mutation
* (Cohorts A and B Only) Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
* (Cohorts A and B Only) Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
* Investigational therapy administered within the 28 days or 5 half lives
* Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
* Immunotherapy within 21 days
* Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
* Untreated and/or symptomatic CNS malignancies (primary or metastatic);
* Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
* Personal or familial history of Long QT Syndrome
* NYHA class III or IV or LVEF \< 55%
* Myocardial infarction, severe or unstable angina within 6 months
* History of TdP, ventricular arrhythmia
* Significant thrombotic or embolic events within 3 months
* Uncontrolled or severe cardiovascular disease
* Concurrent malignancy expected to require treatment within 2 years or interfere with study outcomes
* History of severe allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition as tarloxotinib
* Known HIV infection or active Hepatitis B or C
The Study of Irinotecan Plus Epirubicin as the Second-line Chemoregime for Advanced Gastric Cancer

This study is to determine the response rate and safety profile of irinotecan plus epirubicin as the second-line chemotherapy for advanced gastric cancer and fully evaluate the feasibility and effectiveness of the regime.

The main purposes: to determine the progression-free survival (PFS) and overall survival (OS) of gastric cancer patients given irinotecan + epirubicin as second-line treatment, who are at Stage IV with disease progressed or recurred after first-line chemotherapy failed, ,

The Secondary purposes: to determine disease control rate (Disease Control Rate, DCR), the objective response rate (Object Response rate, ORR) and the Quality of life (Quality Of Life, QOL)

Eligibility Criteria:
Inclusion criteria:

* Aged between 18 to 70 years
* The pathologically confirmed gastric adenocarcinoma and the failure of first-line chemotherapy
* Measurable lesions outside the stomach
* ECOG(Eastern Cooperative Oncology Group ) score between 0 to 1
* Expected survival time of at least 3 months
* Subjects receiving treatment for other damage caused has been restored, which it accepted the nitroso or mitomycin interval\> 6 weeks, the acceptance of other cytotoxic drugs, radiotherapy or surgery\> = 4 weeks, and the wound has completely healed. No bleeding, no nervous system transferred
* Blood and organ function was normal

Exclusion criteria:

* Comorbid with other malignant tumors
* Pregnant and lactating women
* with the disease of endangering patient's safety and affecting the completion of the study
* Patients suffering from high blood pressure by antihypertensive treatment cannot control (systolic blood pressure\> 140mmhg, diastolic blood pressure\> 90mmhg,) there is more than Class I and Class I arrhythmia coronary heart disease, with more than Class I heart dysfunction
* Major organ failure, such as decompensated heart and lung failure, liver failure, renal failure and patients with intestinal obstruction ipate in other clinical trials of patients in the past four weeks
* Participated in clinical trials with other drugs or using other drugs during past 4 weeks
* Lesions which can't be measured such as pleural effusion, ascites, peritoneal cancer lesions, diffuse liver and bone metastases violation, brain metastasis
A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
* All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
* Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 \[COVID 19\] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires

Exclusion Criteria:

* Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
* Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
* Participant previously received a coronavirus vaccine
* Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study