cyrilzakka/clinical-trials huggingface dataset:
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment

The aim of the present study is to understand the influence that marginal/subgingival restorations exert on the surrounding periodontal tissues. Even though proximal restorations are routine in everyday clinical practice, few information is available as to whether or not they may have a detrimental effect on the supracrestal tissue attachment.


Eligibility Criteria:
Inclusion Criteria:

* an age range 18-70 years
* a good general health
* the ability to understand the phases of the trial and to stick to them for the whole length of the study
* the ability of will to release a written informed consent
* presence of a marginal cavity or a 2mm subgingival cavity
* presence of a cavity subgingival \> 2mm

Exclusion Criteria:

* PPD\>4mm
* patients affected by active periodontal disease
* patients smoking more than 10 cigarettes/pipes per day
Reliability and Validity of the Chinese Version of the Neonatal Sleep-Wake Assessment Tool

Sleep assessment of newborns in China is often neglected by medical staff, but sleep is related to the stability of vital signs and future neurobehavioral development. In order to understand the sleep quality of Chinese newborns and to protect their sleep during work, the neonatal sleep-wake assessment tool was translated into Chinese, revised, and tested for reliability and validity, in order to provide a reference for clinical staff to choose the timing of care.


Eligibility Criteria:
Inclusion Criteria:

* The clinical definition of a newborn was met.

Exclusion Criteria:

* A state of persistent convulsions
Sentinel Lymph Node Biopsy in Patients With Breast Cancer After Neoadjuvant Therapy

The aim of this study is to create clear indications for Sentinel Lymph Node Biopsy (SLNB) or Axillary Dissection (AD) in women with breast carcinoma after neoadjuvant therapy by studying the false negative rate of SLNB.

The main object of the study is to evaluate, whether sentinel lymph node biopsy (SLNB) at women with breast cancer after neoadjuvant therapy is a method with a high false-negative rate. Patients will be classified into groups according to histological findings during SLNB, clinical and ultrasonography (USG) findings in the axilla. The aim of this study is to create clear indications for SLNB or axillary dissection (AD). In case of extension of SLNB indications, there will be a decrease in morbidity after surgical therapy when compared to AD, which will mean a profit for the patients.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of breast carcinoma confirmed by biopsy
* neoadjuvant therapy
* examination of axillary lymph nodes clinically and by ultrasound
* surgical therapy after neoadjuvant therapy

Exclusion Criteria:

* inflammatory breast carcinoma
* incomplete neoadjuvant therapy
* previous sentinel lymph node biopsy performed on the same side of the body
* disagreement with participation in the study
* other malignities influencing the treatment of breast carcinoma
* distant metastases
Cycled Light and Crying of Preterm Infants

This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.


Eligibility Criteria:
Inclusion Criteria:

* very preterm infants (≤ 32 0/7 weeks gestational age, GA)

Exclusion Criteria:

* major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound
* retinopathy of prematurity grade III and IV
* congenital malformations
* small for gestational age (birth weight \< 3rd percentile)
* prenatal infections
* intrauterine drug exposure
Feather Edge Versus Deep Chamfer Finish Line Marginal Design in Complete Coverage Bruxzir Zirconia Crowns

Evaluation of patient satisfaction, color difference, marginal integrity and survival of Bruxzir Zirconia complete coverage crowns with feather edge versus deep chamfer finish line marginal design.

(Randomised Controlled Trial)


Eligibility Criteria:
Inclusion Criteria:

* 19-50 years.
* Males or females.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Patients younger than 19 years old
* Disabilities
* Systemic diseases or severe medically compromised
* Lack of compliance of the patient contributed in the study
tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Cerebellar ataxia
* Ages: 18 to 65 years;
* Gender: Both;
* Score ≥ 3 and \< 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia

Exclusion Criteria:

* Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests;
* Pacemaker;
* History of seizures;
* Metallic implants in the head or neck;
* Medication change during the period of study
Evaluation the Effectiveness of Ru-Yi-Jin-Huang Powder for the Radiation-induced Dermatitis.

Radiation-induced dermatitis is the most common complication of radiotherapy for cancer treatment. However, there is no satisfactory management to deal with the problem. Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin diseases but lack of evidence to support efficacy. The aim of this trial is to evaluate the effectiveness of Ru-Yi-Jin-Huang Powder for radiation-induced dermatitis.

The common management of head and neck cancer are concurrent chemoradiotherapy (CCRT) after surgical section. Radiation-induced dermatitis is the most common complication of radiotherapy for cancer, affecting approximately 95 percent of patients receiving radiotherapy. The skin changes include erythema, edema, pigment changes, hair loss, and dry or moist desquamation. It may cause xerostomia, hard food taking, severe infection to delay the completion of course of treatment. Although, there are lots of topical drug to deal with radiation dermatitis, there is no best way to manage the skin problems. Ru-Yi-Jin-Huang Powder is one of most common topical TCM drug to treat skin ulcer, joint swelling or other infective or inflammatory diseases. Some study showed that Ru-Yi-Jin-Huang Powder can be used to decrease edema or swelling, pain relief, decrease phlebitis or mumps. However, there is no related evidence to support Ru-Yi-Jin-Huang Powder for radiation dermatitis. Thus, the aim of the study is to evaluate the effectiveness of Ru-Yi-Jin-Huang Powder for radiation-induced dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* stage 3 or 4 of head and neck cancer or nasopharyngeal cancer with pathological confirmed malignancy undergoing concurrent chemoradiotherapy more than 20 times or radiation dermatitis \> CTCAE grade 2.
* more than 18 years old.
* VAS score \> 6 with poor response to narcotics.
* estimated survival time of \> 6 months.
* be suitable for TCM topical treatment after evaluation by TCM physicians.
* willingness to joint this trial and sign consent form of study.

Exclusion Criteria:

* non-head and neck cancer or have not receive CCRT.
* not be suitable for Ru-Yi-Jin-Huang topical treatment after TCM physicians evaluation.
* history of allergy to TCM topical use.
* poor conscious to answer questionnaires.
* pregnancy.
* KPS \< 30.
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses ofAZD2551

The purpose of this study is to determine how well tolerated and safe AZD2551 is at different dose levels in healthy, non-smoking males. It will also investigate how quickly AZD2551 is absorbed into and cleared by the body


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed, written and dated informed consent prior to any study specific procedures
* Be willing to use barrier methods of contraception unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods
* Have a body mass index between 18 and 30 kg/m2 inclusive and weight at least 50kg and no more than 100kg

Exclusion Criteria:

* Use of any prescribed or non-prescribed medication during the two weeks prior to the administration of study drug
* History or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
* Any impairment of kidney function or laboratory results for markers of kidney function that are outside the reference range and considered clinically significant
* Underlying musculoskeletal symptoms of unknown origin, subjects with shoulder girdle musculoskeletal symptoms or Dupuytrens syndrome
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.

This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function

Eligibility Criteria:
Key Inclusion Criteria:

1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.
2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
3. Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to Visit 1.
4. A post-bronchodilator FEV1/FVC of \<0.70 and post-bronchodilator FEV1 of \<50% predicted normal value at Visit 2.
5. A pre-bronchodilator PIF of \<50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit 2.
6. Current or former smokers with history of at least 10 pack-years of cigarette smoking.

Key Exclusion Criteria:

1. Current diagnosis of asthma, in the opinion of the Investigator.
2. Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
3. A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization (Visit 3).
4. Need for mechanical ventilation within 3 months prior to Visit 1.
Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children

Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.

The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.


Eligibility Criteria:
Inclusion Criteria:

* patients under the age of 17
* pleural fluid depth of at least 15mm, confirmed by ultrasound
* at least one of the following severity criteria :

  1. fever continuing 48h after starting correct antibiotherapy
  2. respiratory distress
  3. mediastinal displacement on the chest X-ray

Exclusion Criteria:

* previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
* congenital pulmonary disorders with lung function impairment
* chronic pulmonary disease associated with lung function impairment
* hemodynamic instability
* congenital immunodeficiency disease
* secondary immune deficiency induced
* hemostasis disorder (contraindication of thrombolytic therapy)
* pregnancy or breastfeeding patient
Hypothermia's Effect on Hepatitis B Vaccination

The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.

Despite the current research on Hypoxic Ischemic Encephalopathy (HIE), and the known effects of hypothermia on acute immune response, the effect of the hypothermia protocol for HIE on the efficacy of the Hepatitis B vaccine is still unknown. We plan to measure anti-hepatitis B surface antibodies at intervals prior, during, and after the primary Hepatitis B vaccine schedule for individuals with HIE to see if there is any effect on efficacy due to the Hypothermia protocol.

Eligibility Criteria:
Inclusion Criteria:

* \> 34 weeks' gestation at birth as measured by best obstetrical estimates
* \> 1500 grams birth weight
* Clinical signs of asphyxia or documented periods of hypoxic ischemia with no cyanotic cardiac malformations and no known congenital infections.
* Documented period of hypoxic ischemia:
* Venous Cord gas pH \< 7.0 or initial newborn blood gas pH \< 7.1
* Base deficit \> 13 on venous cord gas or initial newborn blood gas
* Apgar score \< 5 at 10 minutes
* Prolonged, sustained fetal bradycardia (HR \<80) for \> 15 minutes in utero by doppler or fetal heart rate monitoring
* Need for continued resuscitation after 5 minutes (bag-valve mask ventilation with/or without chest compressions) due to the absence of respiratory effort
* Documented postnatal oxygen saturation \< 70% or PaO2 \< 35 for \> 20 minutes by 2 ABGs, not due to cyanotic heart disease, accompanied by hypotension (mean BP\< 35), cardiac arrest with chest compressions, or hemorrhage (requiring 20cc/kg volume replacement)
* Parental willingness for infant to receive Hepatitis B vaccine.

Exclusion Criteria:

- Positive maternal Hepatitis B status during pregnancy
Combined Sensitivity and Specificity of Cortical Lesions and Central Vein Sign for MS Diagnosis and Differential Diagnosis

This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.

CLs and LCLs may be detected at 3 Tesla (T) MRI by using dedicated sequences. 3D Double inversion recovery (DIR), Phase-Sensitive Inversion Recovery (PSIR), Magnetization Prepared - RApid Gradient Echo (MPRAGE) and Magnetization Prepared - 2- RApid Gradient Echo (MP2RAGE) have all shown variable sensitivity to CLs and LCLs. The central vein sign (CVS, i.e. the detection of a central vessel in a focal lesion) has been recently proposed as a biomarker for distinguishing between MS and not and not MS. Both the presence of CL and CVs brings high sensitivity and specificity in distinguishing MS from not MS patients; whether their combination achieves higher sensitivity and specificity to MS diagnosis and differential diagnosis is to date not know. This study investigates the specificity/sensitivity of the combined presence of cortical lesions (CLs)/leuco-cortical lesions (LCLs) and central veins sign (CVs) for multiple sclerosis (MS) diagnosis and differential diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and MRI data of patients with MS or MS mimics (migraine, vasculitis, diabetes, neuromyelitis optica spectrum disorder)
* MRI data must have been collected at 3T between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection) and DIR/PSIR/MP2RAGE (eventually also high spatial resolution MPRAGE) for cortical lesion detection

Exclusion Criteria:

* Unavailability of institutional informed consent
* Unclear diagnosis
* Other neurological or psychiatric diseases.
Characteristics of Patients With COVID-19 in Meta State, Colombia

This observational study aims to collect detailed clinical information on confirmed or suspected patients of COVID-19 treated in hospitals from Meta State, Colombia. The objectives are:

1. To establish the characteristics of patients and healthcare workers treated with COVID-19.
2. To assess previous predisposing morbidity.
3. To detail clinical factors associated with complications.
4. To profile clinical indicators for severity and outcomes.

Hospital database and clinical charts in an electronic format of patients with suspected or confirmed COVID-19 will be reviewed to include in the study. Multiple centers from the eastern Colombian prairies caring for this population will participate to provide an understanding of the behavior of the epidemic and accurate clinical comprehension of the disease. Healthcare centers involved in providing an evaluation of patients infected with SARS-CoV-2 will be invited to participate.

The study will focus on the routine or new treatment strategies provided and a large population of patients analyzed would be desirable. It will allow identifying the most relevant factors associated with clinical outcomes, complications, and prognosis, with an appropriate statistical methodology for the analysis of observational nature.

Variables of individuals assisted will be recorded as well as the end results, such as baseline characteristics of individuals and disease, and main outcomes such as mortality, need for ICU attention, mechanical ventilation, and length of stay.

These results will be used to promote an improvement in the quality of care and individual and cluster decisions in the region.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to participant institutions with respiratory symptoms or diagnosed as compatible with COVID-19.

Exclusion Criteria:

* None.
Novel Cardiac Rehabilitation in Patients Heart Failure and Preserved Ejection Fraction

Patients with HFpEF suffer from exercise intolerance, increased risk for hospitalization and mortality, and poor QOL. Unlike patients with HFrEF, no drug or device therapies appear to be consistently beneficial in treating these problems. However, increasing evidence suggests that exercise training is effective for both partially reversing exercise intolerance and improving quality of life in these patients. Most such trials to date have been conducted in controlled research setting, versus integrating these patients in to a standard CR program. Also, since functional capacity is related to outcomes in these patients, exercise strategies aimed at further improving fitness are warranted. One such strategy is using higher intensity interval training (HIIT) in the CR setting, a strategy shown to be effective in patients with other types of CVD. This project is designed to test the feasibility of incorporating these patients into the CR setting, and training them using a methodology (i.e., HIIT) already shown to yield (in other patients with CVD) greater gains in fitness when compared to what was achieved using standard MCT alone.


Eligibility Criteria:
Inclusion Criteria:

1. NYHA class II or III symptoms
2. Referred by physician to CR with echocardiographic evidence of HFpEF defined as an ejection fraction ≥ 50 % and moderate to severe (grade II-III) diastolic dysfunction.
3. ≥ 50 years of age
4. Free of orthopedic or other medical problems that would limit participation in CR
5. Peak VO2 on baseline cardiopulmonary exercise test (CPX) \< 24 mL/kg/min in men and \<21 mL/kg/min in women

Exclusion Criteria:

1. Systolic dysfunction, per ejection fraction \< 50%; those with mild (grade I) diastolic dysfunction
2. Initial clinical responses observed during first 3 visits in CR or baseline exercise test that would preclude participation in study over-all (e.g., new onset/troublesome arrhythmia that warrants further investigation) or undergoing HIIT (e.g., claudication, balance issue)
3. Patients with exercise induced angina during CR or CPX testing or ST segment depression representative of myocardial ischemia during CPX testing
4. Pregnant or planning to become pregnant
5. Any patient recently hospitalized for heart failure will have to wait at least 2 weeks before starting CR, or until clinically stable per physician(whichever time period is greater)
6. Atrial fibrillation
Effectiveness of Ketamine Treatment for Three Consecutive Days in Depression

Inclusion criteria: 1. patient over 20 years old with depression diagnosed by a psychiatrist and MADRS \>= 25 scores; 2. failed to improve by at least optimal dosage of two antidepressants for four weeks and one psychotherapy. Patients and outcome assessors will be blinded from intervention the patients have.

Participants will be randomized into two groups that are intervention (ketamine 0.5 mg/kg IV drip in 40 minutes) and control (midazolam 0.045 mg/kg IV drip in 40 minutes) groups. Participants will administer ketamine/midazolam once daily for three consecutive days. They will be evaluate MADRS changing, vital signs, dissociative symptoms, CGI, and quality of life (EQ-5D-5L) during the treatment, at 1 week and 4 weeks after treatment completion.


Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* depression was diagnosed by a psychiatrist and having MADRS \>= 25
* depression treated with 2 optimal dosage of antidepressants for 4 weeks and one psychotherapy
* stable dosage of current medications for 4 weeks
* fluently Thai

Exclusion Criteria:

* secondary depression
* PTSD
* current pregnancy
* history of increased intracranial hemorrhage, increased intracranial pressure, severe head injury, abnormal thyroid function, angina, heart failure, arrhythmia, aneurysm, uncontrolled hypertension, chronic lower tract respiratory disease, myasthenia gravis, glaucoma, dementia, acute porphyria, or cystitic (within 3 months prior to recruitment)
* allergy to ketamine or midazolam
* history of substance use disorder within 1 year prior to recruitment
* history of psychosis within 3 months
* history of bipolar disorder
* BMI over 35
* frail medical condition
* currently ECT or TMS