cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Sodium Bicarbonate Buffered Anaesthetic Solution on Pain During Injection

This study will test the effectiveness of addition of Sodium Bicarbonate as a buffering agent to the anaesthetic solution on minimizing the pain of injection and increasing the onset time and potency of the anaesthetic solution in children

27 healthy cooperative children will be enrolled in the study after taking their guardians' informed consent.

The study design will be a split mouth design where each patient will be received buffered anaesthetic solution (8.4% sodium bicarbonate will be added to the anaesthetic solution in ratio 1:19) in one side and conventional anaesthetic solution (4% articaine HCL with 1:1000000 epinephrine) in the other side.

The pain during injection for each patient in both sides will be then compared using objective and subjective methods.

The onset time of the anaesthesia in both sides will also be compared for each patient using Transcutaneous electric nerve stimulator device (TENS)

The results will be collected and mentioned.

Eligibility Criteria:
Inclusion Criteria:

* Age range from 5 - 7 years.
* Children free of any systemic disease or special health care need (ASA I).
* No previous bad dental experience.
* Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
* Patients whom their lower primary molars bilaterally are indicated for pulpotomy.
* Patients whom their parents will give consent to participate.
* Patients who give multiple reliable responses while using the transcutaneous electric nerve stimulator device.

Exclusion Criteria:

* Active sites of pathosis in area of injection that could affect anaesthetic assessment.
* History of allergy to local anaesthesia.
* Root resorption affecting more than one third of the root length.
* Fractured crowns due to trauma.
* Clinical signs and symptoms of pulp degeneration such as swelling or sinus tracts
* Radiographic evidence of periapical or interradicular radiolucency
* Non restorable crowns.
* Signs of mobility.
* Ankylosed roots.
Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants

This is a 2-part, open label, fixed-sequence study to evaluate the potential drug interaction between ALXN2050 and fluconazole (Part 1), and between ALXN2050 and rifampin (Part 2) in healthy adult participants. Part 1 will be a 2-period, fixed-sequence study. Part 2 will be a single-period, fixed-sequence study.


Eligibility Criteria:
Key Inclusion Criteria:

* Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
* Body mass index within the range 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

Key Exclusion Criteria:

* History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* History of significant multiple and/or severe allergies.
* Any previous procedure that could alter absorption or excretion of orally administered drugs.
* Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
* Body temperature ≥ 38.0°Celsius, at Screening or prior to the first dose of study intervention.
* History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine user or smoker or a positive cotinine test at Screening.
* Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma

With an estimated \> 2 million women with undetected breast cancer in the United States, the need for improved early detection is imperative. Early diagnosis for these women is key to minimizing quality life-years lost to disease and optimizing success of treatment. Evidence now exists supporting the finding that systemic spread is an early event in the natural history of breast cancer, manifested as a release of single cancer cells from the incident, clinically undetectable tumor, which circulate through the bloodstream and deposit within remote tissues. Reliable and accurate detection of these circulating tumor cells (CTCs) is now possible with a simple peripheral venous blood draw. This study hypothesizes that women with CTCs and no other signs of malignancy have clinically undetectable disease.

This study will attempt to validate this technology as a breast cancer screening test and acquire data to determine the clinical validity and utility of this proposed screening methodology on a relatively young, ethnically diverse population who are eligible military health care beneficiaries. Furthermore, this study will attempt to bank identified CTCs in order to perform additional molecular analyses in the future. The specific aims are to develop a simple, reliable, cost-effective, and clinically relevant breast cancer screening test in order to identify subclinical disease early in its natural history in subjects at risk of progression to clinically apparent disease over the ensuing decade. The ultimate goal is to decrease the treatment-related morbidity and cause-specific mortality of breast cancer. An experienced team devoted to the care of patients with breast disease has been assembled to achieve this goal.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age or older
* Mentally competent and willing to provide written informed consent prior to entering the study
* Military healthcare beneficiary
* Undergoing a diagnostic or therapeutic procedure (biopsy, lumpectomy, mastectomy) in the breast clinic or operating room.
* Present to the CBCP and willing to be followed at the CBCP during the course of treatment and follow-up

Exclusion Criteria:

* Prior history of invasive carcinoma
* Presence of clinically-apparent metastatic disease
* Participants with known human immunodeficiency virus (HIV), any history of hepatitis, prion-mediated disease, drug resistant tuberculosis or other infectious disease presenting a significant risk to personnel handling tissue or blood-derived products shall be excluded from participation
* Participants with pre-existing coagulopathies or all other conditions, for whom invasive biopsy or surgery is medically contraindicated
Real World Study of Efficacy and Safety of Atezolizumab Plus Chemotherapy in Chinese Patients With ES-SCLC

The study is a prospective,multi-center,single arm,real world study to evaluate safety and performance of Atezolizumab plus chemotherapy in patients with extensive-stage small-cell lung cancer,and also to explore potential biomarkers for Immune-related Adverse Events.

In 2018,the results of IMpower 133 were reported on WCLC.Meanwhile,the data was published in NEJM.Atezolizumab combined with carboplatin and etoposide for extensive stage small cell lung cancer was recommended as the first by NCCN guidelines quickly.

Atezolizumab plus chemotherapy was approved by NMPA on Feb 13,2020,making Atezolizumab for 1L ES-SCLC in China.

Real world study can reflect the efficacy and safety of treatment in clinical practice.Based on the research of public database,the prospective cohort study had been reported,but the study based on Chinese patients still left weak point.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
* No prior systemic treatment for ES-SCLC
* 18-80 years old, or more than 10 months of expected natural survival;
* Eastern Cooperative Oncology Group performance status of 0 or 1 or 2
* Measurable disease, as defined by RECIST v1.1 Adequate hematologic and end organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
* The subject must be willing and able to participate in the study procedures and to understand and sign the informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or 6 months after the final dose chemotherapy. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.

Patients or family members cannot understand the conditions and goals of this study.

The subject has an estimated life expectancy of less than 10 months The subject is unable or unwilling to comply with the study requirements or follow-up schedule
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

The current research is designed to investigate the analgesic efficacy of intravenous ibuprofen on the postoperative analgesic requirements, pain intensity and other recovery parameters.

The patients will be given general anaesthesia. Anaesthesia will be induced by propofol 1-2 mg/kg, and fentanyl 1-2 µg/kg. Endotracheal intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane in oxygen - air mixture. Transversus abdominis plane block will be performed at the end of the operation. A postoperative analgesic regimen according to group allocation will be started.

Eligibility Criteria:
Inclusion Criteria:

* American Society of anaesthesiologists physical status I to III.
* Open abdominal hysterectomy operations

Exclusion Criteria:

* History of gastrointestinal bleeding.
* History of intracranial haemorrhage.
* Pregnancy and lactation.
* Taking angiotensin converting enzyme(ACE) inhibitors or anticoagulation drugs.
* Asthmatic, hepatic,renal or heart failure.
* Abnormal platelet count.
Testing the Efficacy of Two Behavioral Interventions at Recalibrating Physician Heuristics in Trauma Triage

The objective of this study is to compare the efficacy of two behavioral interventions at recalibrating physician heuristics.

Treatment at trauma centers improves outcomes for patients with moderate-to-severe injuries. Accordingly, professional organizations, state authorities, and the federal government have endorsed the systematic triage and transfer of these patients to trauma centers either directly from the field or after evaluation at a non-trauma center. Nonetheless, between 30 to 40% of patients with moderate-to-severe injuries still only receive treatment at non-trauma centers, so-called under-triage. Most of this under-triage occurs because of physician decisions (rather than first-responder decisions). Existing efforts to change physician decision making focus primarily on knowledge of clinical practice guidelines and attitudes towards the guidelines. These strategies ignores the growing consensus that decision making reflects both knowledge as well as intuitive judgments (heuristics). Heuristics, mental short cuts based on pattern recognition, drive the majority of decision making. The investigators have developed two separate behavioral interventions to recalibrate physician heuristics in trauma triage, and will compare the effect of these interventions, an educational program, and no intervention on physician performance on a virtual simulation.

Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine physicians who work at a non-trauma center.
* Emergency medicine physicians who work at a Level III/IV trauma center.

Exclusion Criteria:

* Emergency medicine physicians who work only at a Level I/II trauma center.
* Emergency medicine physicians who do not practice in the US.
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Males and Females with a condition of general good health.
* Must be willing to participate in all study-related procedures.

Exclusion Criteria:

* History of significant sensitivity to any drug.
* Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives.
* A requirement for medications, vitamins and/or herbal supplements during the study.
* Pregnant or breast-feeding.
* History of drug or alcohol abuse.
* Positive Hepatitis or HIV test.
* History of certain medical conditions or any uncontrolled medical illness.
* History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption.
* Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.
Management of Symptomatic Uterine Fibroids in Pregnancy by Laparotomic Myomectomy: a Prospective Cohort Study

The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.


Eligibility Criteria:
Inclusion Criteria:

* The large and giant size of UFs, which prevent the proper continuation of pregnancy and/or occupy the entire small and large pelvis, as well as invade and/or occupy the abdominal cavity.
* Circulatory disorders, evidenced by necrosis of the UFs.
* Atypical localization of UFs (cervical, isthmic, intraligamentary, etc.), which caused pelvic organ dysfunction (dysuric phenomena, tenesmus, impediment to the act of defecation, pelvic pain).

Exclusion Criteria:

* Refusal of LPTM by the patient.
* Absence of urgent indication for LPTM during pregnancy.
PET Study of Non-Motor Symptoms of Parkinson Disease

This research plan is focused on neurochemical positron emission tomography (PET) studies of Parkinson disease (PD). PD is the most common neurodegenerative movement disorder, and considerable progress has been made in understanding and treating the "typical" movement abnormalities of resting tremor, bradykinesia and rigidity. These cardinal PD features are all initially responsive to dopamine replacement therapy, and have been investigated intensively with respect to their relationships to degeneration of the nigrostriatal dopamine projection. More recently, increased attention has focused on the "non-motor" clinical aspects of PD, including cognitive, mood, chronobiological and peripheral autonomic defects. These clinical features are less reliably affected by dopaminergic therapy, and are likely to be associated with other, non-dopaminergic neural degenerations. Indeed, detailed postmortem assessments of PD brain reveal substantial neuronal losses in a variety of chemically-defined neurons, including brainstem serotonin and norepinephrine neurons and basal forebrain cholinergic neurons. Projects in the proposal will focus on dementia, depression, sleep-apnea and dysautonomia in PD patients, employing PET measures of presynaptic dopaminergic, serotoninergic and cholinergic CNS neurons and of peripheral sympathetic neurons. Results of the investigations may identify associations of non-motor PD signs and symptoms with the non-dopaminergic neuronal losses. These findings will establish additional therapeutic targets for symptomatic, but also for potential neuroprotective PD therapies. In addition, a majority of patients will be characterized with all 3 CNS PET measures. The availability of multiple markers of distinct neuronal populations involved in PD neurodegeneration will permit exploratory analyses to assess whether the degenerations are correlated (possibly manifestations of a common pathophysiology) or apparently independent (possibly a manifestation of multiple PD subtypes or pathophysiologies). Ultimately, better understanding of these non-motor features will be essential to developing future treatments that address the entire PD patient.

Participating subjects may be eligible for one or more of the sub-projects that may have a focus on cognition, mood, sleep or autonomic symptoms.

Eligibility Criteria:
Inclusion Criteria:

* age 50 and above (40 for Normal Control population)
* diagnosed with PD
* Hoehn \& Yahr 1-4,

Exclusion Criteria:

* other disorders which may resemble PD
* unstable medical conditions
* significant neurological or psychiatric disorders
* taking certain medications such as acetylcholinesterase inhibitors, neuroleptics, psychostimulants, tricyclic antidepressants,
* contraindication to MRI (pacemakers, metal in eye, etc)
* recent exposure to significant amount of ionizing radiation
* pregnancy
Systematic Symptom Identification With Disease Specific PROM to Assess Symptoms of Chronic GVHD in Outpatient Care in Patients Post HSCT

A two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed PROM (Lee Symptom Scale) longitudinally with a 12 month follow up in outpatient care in patients post HSCT to assess symptoms of chronic GVHD (n= 30).

A prospective, non-randomized, feasibility study examining a systematic approach to symptom management using PROMs with 12 months of follow up in hematological outpatient clinic

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years old
* Approximately 3 months post HSCT (they will be included before HSCT, but the intervention will begin at 3 moths).
* Patients included needs to be able to manage a computer to receive and respond to collect PRO data.

Exclusion Criteria:

* Patients who do not understand, read and speak Danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.
Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty

Postoperative Cognitive Disorders (POCD) are common in hospitalized people \> 60 year old, especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain.

In this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic patients scheduled to primary hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* patient scheduled to primary hip arthroplasty,
* orthopedic procedure under spinal anesthesia.

Exclusion Criteria:

* patients younger than 18 y.o.,
* surgery under general anesthesia,
* patients who refused to participate in the study.
Corellation of Mutations, TILs and Age in Breast Cancer

Age may pertain to different tumor genotype characteristics which may interfere with treatment efficacy and prognosis. The investigators investigated the distribution and prognostic effect of mutations (mut) and tumor infiltrating lymphocyte (TILs) in young and elderly early breast cancer patients (pts).


Eligibility Criteria:
Inclusion Criteria:

* women with early breast cancer \<35 years old or \>65 years old

Exclusion Criteria:

* NA
Dietary Intervention and Vascular Function

It is well established that diet plays an important role in both the development and progression of heart disease. Different types of dietary fat have varying effects on heart disease risk factors. The elasticity of an individual's blood vessels is strongly associated with heart disease risk and recent evidence suggests that dietary manipulation may influence elasticity of the blood vessels with dietary fat (including saturated, monounsaturated and polyunsaturated fatty acids) as a potentially important modulator. Substantial evidence exists on the effects of monounsaturated fats (type of fatty acids mainly found in olive and rapeseed oil), n-6 polyunsaturated fats (type of polyunsaturated fatty acids found in vegetable oils) and saturated fat (found mainly in animal derived products) on lipid levels. However, the influence of these dietary fats on the elasticity of blood vessels remains unclear.The main purpose of the DIVAS study is to determine the effects of the substitution of saturated fats with either n-6 polyunsaturated or monounsaturated fats on blood vessel elasticity and to determine the effects of these different dietary fats on other risk factors for heart disease including lipoproteins and inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

Adults should have a relative risk (RR) of \> 1.5 of developing cardiovascular disease (CVD) based on presenting with at least one recognised risk factor for CVD:

* total cholesterol (TC) \> 6.0 mmol/l
* HDL cholesterol (HDLC) ≤ 1.0 mmol/l male, ≤ 1.3 mmol/l female
* Glucose ≥ 6 mmol/l
* Stage 1 hypertension or above i.e. a systolic BP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg
* BMI 28-35 kg/m2
* waist \>102 cm male or \> 84 cm female
* Adults with a first degree relative with either a history of premature CVD - age of onset younger than 55 y in fathers, sons or brothers or younger than 65 y in mothers, daughters or sisters, or type 2 diabetes.

Exclusion Criteria:

* having suffered a myocardial infarction/stroke in the past 12 months
* diabetic (diagnosed or fasting glucose \> 7 mmol/l) or suffer from other endocrine disorders
* suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
* on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* no history of alcohol abuse
* planning or on a weight reducing regime
* taking any fish oil, fatty acid or vitamin and mineral supplements
* pregnant, lactating or planning a pregnancy
* smokers
Berberis Vulgaris Consumption and Blood Pressure

The aim of this study is to investigate the effect of barberry consumption on systolic and diastolic blood pressure, serum lipids, and inflammatory status. The study will involve cases having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment. Seventy people will be randomized into two groups, including intervention (barberry) or placebo groups.

Before and after of 8 week intervention, 24-hour ambulatory blood pressure monitoring will be done and fasting venous blood sample will be taken to measure plasma lipids. In addition, 24-hour urine will be collected to measure its sodium content and estimate sodium intake.


Eligibility Criteria:
Inclusion Criteria:

* willingness to participate in the study
* age between 20-65 years
* having elevated BP (129/ \< 85) and known hypertensive patients on medical treatment
* at least one other classical cardiovascular disease risk factors, including hyperlipidemia or diabetes mellitus

Exclusion Criteria:

* Unwillingness to continue participation
* BMI\> 30
* patients on nitrates
* high doses of statins consumption (Atorvastatin\>40 mg/day or Rosuvastatin\>20 mg/day)
* consumption of vitamins or minerals supplements during past month
* Chronic kidney disease stage 4 or 5