cyrilzakka/clinical-trials huggingface dataset:
Nature Sounds as a Pain and Anxiety Reducing Strategy in Patients Undergoing Breast Core Biopsy

Patients will be randomly assigned to one of two groups: the group exposed to NS, or the standard care group exposed to supportive dialogue. Patients assigned to the former group will be exposed to continuous NS throughout the CNB procedure.

For stereotactic biopsies, the experiment consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient positioning and breast compression is complete, (2) One 2-min local anesthesia administration period during which the skin is injected with local anesthetic and an incision is made to insert the biopsy needle into the breast occurs ("stressor 1"), (3) One 2-minute post local anesthesia administration period during which imaging is obtained to confirm the position of the needle with respect to the target, (4) One 1-minute sampling period when the breast tissue is sampled ('stressor 2"), (5) One 2-minute post-CNB period, during which adequacy of obtained samples is confirmed and the need for additional sampling determined, and (6) One 2-minute period during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.

For ultrasound biopsies, the experiment also consists of six different parts: (1) A baseline 5 min biopsy planning period during which only imaging occurs after patient is positioning, (2) One 2-min local anesthesia administration period during which local anesthesia is given at the site of biopsy and a skin incision performed ("stressor 1"), (3) One post local anesthesia administration period during which intra-procedure imaging and confirmation of adequate targeting occurs, (4) One 1-minute first-pass sampling period ('stressor 2") during which the biopsy device is advanced to the target for the first time and fired to acquire the first tissue sample, and (5) One 2-minute post-CNB period, following the first needle pass while sample adequacy is visually assessed and additional intra-procedure imaging occurs, (6) One 2-minute post-CNB period, during which a biopsy marker clip is deployed and pressure dressing placed on the biopsy site.

The total time for a single site CNB is approximately 30 minutes when performed under US-guidance, and 30-45 minutes when performed under stereotactic guidance. The added physiological recordings for this experiment are not expected to significantly prolong the duration of CNB procedures.

Eligibility Criteria:
Inclusion Criteria:

* 1) ≥ 21 years old
* 2) present for CNB
* 3) to be able to read and speak English
* 4) provide written informed consent.

Exclusion Criteria:

-
Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)

the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.

The present study was carried out on 84 children. Children were recruited based on certain inclusion criteria after signing a written informed consent by their parents. They were divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the child rinsed for 1 minute and plaque samples were collected from the child before and after rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed with garlic with lime extract and group (IV) the children rinsed with pomegranate extract mouth rinse with the same procedures. .child satisfaction was measured using 5-point pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5. Very poor).

All the plaque samples were collected and put in sterile test tubes containing thioglycolate as a transport media. They transferred to the microbiology laboratory within half an hour after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at 37°C. Number of bacterial colonies were counted by hand-held digital colony counter.

Eligibility Criteria:
Inclusion Criteria:• Age 5-8 years.

* No history of systemic disease.
* Patients didn't received antibiotics for at least 3 months before and during the study

Exclusion Criteria:• Children who can't expectorate completely or brush their teeth on their own.

* Fixed or removable orthodontic appliances.
* Children with intra oral abscess, oral lesions or gingival diseases.
* Parental consent was not acquired
Gastric Volume in Elderly Patients Undergoing Staged Bilateral Total Knee Arthroplasty

In the past, some guidelines advised no oral intake for at least 8 hours before any surgery, However, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting.

The perioperative fasting guidelines of the European Society of Anaesthesiology focus on preoperative carbohydrates. They hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. Nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited.

Some factors have been known to influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics.

In the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee.

In the present study, the investigators will evaluate the effect of old age, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years
* American Society of Anesthesiologists physical status classification 1, 2, and 3
* Body mass index \< 35 kg/cm2
* Patients administered carbohydrate-containing fluid 2 hours prior to surgery

Exclusion Criteria:

* Previous surgery of the upper gastrointestinal tract
* Achalasia
* Diabetes
Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency

The goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life (QoL), symptoms due to estrogen deficiency, and bone health in women with premature ovarian insufficiency (POI).

The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol (E2), Follicle-Stimulating Hormone (FSH), Luteinizing hormone (LH), total Testosterone (T), Estrone (E1), E1 sulfate (E1S), and Sex Hormone Binding Globulin (SHBG). Bone mineral density (BMD) will be measured using dual-energy X-ray absorptiometry. Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound (TVS), treatment-related adverse events (AEs) and treatment-emergent AEs monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patients with karyotypically normal spontaneous POI diagnosed before the age of 40. POI as defined by: change in menstrual function (oligomenorrhea and/or amenorrhea for at least 4 months), elevated serum follicle stimulating hormone (FSH ≥ 25 IU/L with 4 to 6 weeks interval)
* Between 18-45 years of age
* Use of standard-dose estradiol HRT (Estradiol 2 mg+ Dydrogesterone10 mg) for at least the last 12 months
* Signed informed consent before inclusion in the study

Exclusion Criteria:

* Any contraindication to HRT per the current drug labels. These could include, but are not limited to: history of venous thromboembolism, estrogen-sensitive cancer history, regular cigarette smoking and history of or active liver disease, bleeding from the genital tract of unknown origin, etc.
* POI due to cytotoxic chemotherapy or radiation therapy, surgery
* Diseases that may be associated with hot flashes (such as pheochromocytoma, hyperthyroidism, medullary carcinoma of the thyroid, acromegaly, pancreatic islet-cell tumors, renal cell carcinoma, carcinoid syndrome, systemic mast cell disease, neurological flushing, emotional flushing, spinal cord injury)
* Taking medications that can also cause hot flashes (such as Tamoxifen, Raloxifene, Tricyclic antidepressants, Monoamine oxidase inhibitors, Calcium channel blockers, Depo leuprolide, Clomiphene, Serotonin uptake inhibitors)
* Severe somatic conditions (uncontrolled hypertension, kidney disease, liver disease, etc.)
* Diseases with impaired thyroid and adrenal gland function
* Refusal to participate
Outcomes of Patients With Heart Failure Hospitalized in an Internal Medicine Unit

In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017).

The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge.

Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.


Eligibility Criteria:
Inclusion criteria:

- Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure

Exclusion criteria:

- Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation
Cortical Resections in Drug Resistant Epilepsy

The aim of the study is to evaluate safety and efficacy of epilepsy surgery in the form of cortical resections in patients with refractory epilepsy and to review outcomes of resection procedures in focal epilepsy.

Nearly one-third of epilepsy patients are refractory/resistant to medical treatment . Refractory or drug-resistant epilepsy is defined as resistance to treatment with two appropriately chosen and tolerated antiepileptic drugs (AED) . Nevertheless, epilepsy surgery is an effective alternative treatment for some patients as it suggests seizure freedom . During the past 3 decades, surgery has found more acceptance as an option for drug-resistant epilepsy . Developments made in surgical techniques (cortical resections) have significantly increased the effectiveness and safety of these techniques; as such techniques have been demonstrated to improve seizure control/freedom outcomes and enhanced quality of life in patients . Neuro imaging developments with the introduction of positron emission tomography (PET), magnetic resonance imaging (MRI), functional MRI, single-photon emission computed tomography (SPECT), and magneto encephalography, electroencephalography and neuronavigation have facilitated the presurgical evaluation of patients, thus providing the lesion-directed surgeries more possible , also reducing the number and severity of complications . Complications of epilepsy surgery including failure to stop seizures and neuropsychological, psychosocial, or psychiatric impairment are still difficult to define, and there is no universal consensus in this regard .

This technique characterized by :

• Once the epilepsy focus is located by using interpretation and collection of data from functional MRI, EEG long term video and clinical findings, the specific surgery involved in treatment is decided on. The type of surgery depends on the location of the seizure focal point. Surgeries for epilepsy treatment include, but are not limited to, the following types: temporal lobe resection, ground temporal and extra temporal resection, parietal resection, occipital resection, frontal resection, extra temporal resection.

Eligibility Criteria:
Inclusion Criteria:

* All patients with focal epilepsy who are refractory to medical treatment.
* Patients accept surgical maneuver

Exclusion Criteria:

* Epileptic patients responding to medical treatment.
* Patients refusing surgical intervention.
* Patients unfit for brain surgery.
* Multi focal or generalized seizures.
Do Nanobubbles Improve Joint Hypoxia?

Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to new treatment approaches in the future.


Eligibility Criteria:
Inclusion Criteria:

* • Participant is willing and able to give informed consent for participation in the study.

  * Male or Female, aged 18 years or above.
  * Fulfil American College of Rheumatology/European League Against Rheumatism criteria (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria or fulfil Classification Criteria for Psoriatic Arthritis 2006 (CASPAR).
  * Selected joint for biopsy must be minimum Grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum Grade 3 synovial thickening for small joint (metacarpophalangeal).
  * Women of child bearing potential who are willing to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the study.

Exclusion Criteria:

* • Currently on oxygen therapy.

  * Current enrolment in any other clinical study involving an investigational study treatment.
  * Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
  * Intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit.
  * Oral corticosteroid \> 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit.
  * Oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit.
  * Oral non-steroidal anti-inflammatory drugs (including aspirin \> 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit.
  * Disease modifying anti-rheumatic drugs (DMARDs) dose not stable for at least 4 weeks prior to baseline visit.
  * History of septic arthritis.
  * Participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants. Oral anti-platelet agents are permitted.
  * History of haemophilia.
Minimally Invasive Techniques Or Surgery In the Diagnosis of Sarcoidosis

The purpose of this study is to evaluate the yield of endoscopic guided fine needle aspirations (by means of transoesophageal endoscopic ultrasound : EUS-FNA or transbronchial endoscopic ultrasound : EBUS-TBNA) in patients with a clinical suspicion for sarcoidosis stage I-II; but in whom the preceding bronchoscopy did not result in a qualifying diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 y
* Suspicion of thoracic sarcoidosis and need for tissue confirmation
* Recent (\<6 weeks) RX and CT-thorax (HRCT not compulsory)
* Fit for bronchoscopy (with or without EBB, TBB, TBNA), esophagoscopy and surgery
* Written informed consent

Exclusion Criteria:

* Patients with obvious other organ involvement allowing "simple and safe" biopsy
* Lofgren syndrome
* Pregnancy
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
* Chronic hepatitis B infected patient with positive HBeAg at screening
* Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
* HBV DNA more than 1x10\^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
* Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
* Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
* Patient given a written consent voluntarily

Exclusion Criteria:

* Have uncompensated liver disease
* Serum creatinine \> ULN x 1.5
* Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
* Had a previous liver or bone marrow transplant
* Are currently taking any immunosuppressant or any possible immune modulatory drugs
* Women who are pregnant or breastfeeding
* Woman or man who plans a birth for study duration
* Any experience of severe adverse drug reaction or any medical history of severe allergic disease
* Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
* Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
* Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
* Patient with any present malignant tumor except liver or its history
* Other inappropriate patient in discretion of investigator
Ultrasonographic Assessment of Neck Vessels as Predictors of Spinal Anesthesia Induced Hypotension in Elderly

Spinal anesthesia induces sympathetic blockade and venodilation, thus reducing venous return and the cardiac output. Therefore, assessment of intravascular volume deficit before anesthesia might predict a critical decrease in blood pressure after anesthesia.

Recently, ultrasonographic evaluation of the internal jugular vein (IJV) has been used to reflect intravascular volume status and fluid and as a predictor of hypotension after induction of general anesthesia.

Carotid intima-media thickness (CIMT) has been used to predict atherosclerosis-related events, such as stroke, myocardial infarction, peripheral artery disease, and hypotension after induction of anesthesia with a cut-off value of 0.65 mm of CIMT as a threshold level.

This study aims to evaluate the ability of preoperative Ultrasonographic assessment of the internal jugular vein (IJV) and Carotid intima-media thickness (CIMT) to predict spinal anesthesia induced hypotension (SAIH).

Participants will be elderly patients (above 60 years), ASA I-II-III, scheduled for elective surgeries under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>60 years)
* ASA I-II-III
* Patients scheduled for elective surgeries under spinal anesthesia.

Exclusion Criteria:

* Operations which will last for less than 15 minutes.
* Deep vein thrombosis in the upper extremities.
* History of radiotherapy or neck surgery.
* Previous sonographic data show tricuspid or mitral regurgitation or a very distended right atrium and ventricle.
* Patients with history of valvular or carotid artery surgery, arrhythmia, heart failure.
* Being unable to lie in a supine position for the necessary measurements.
* Technical limitations to imaging of the IJV and carotid artery.
LIght Sedation Pressure Support

Sedation may have many drawbacks in ICU patients: cardiovascular, neurologic, muscular.

Light sedation and Pressure Support ventilation is feasible in ARDS patients. However spontaneous breathing can lead to high transpulmonary pressure.

The goal of the study is to measure transpulmonary pressure before sedation decrease and after stabilization. The main endpoint is transpulmonary pressure less than 24 cmH2O.


Eligibility Criteria:
Inclusion Criteria:

* ARDS (Berlin definition)
* social insurance

Exclusion Criteria:

* neuromuscular disorders
* pregnancy
* need for muscular paralysis
* need for deep neurosedation
* more than 24hrs of artificial ventilation
* cystic fibrosis
The Norwegian Vitamin Trial (NORVIT)

The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease

Observational studies have demonstrated that elevated levels of plasma total homocysteine is a risk factor for cardiovascular disease. The purpose of this trial is to evaluate the efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in patients who have experienced an acute myocardial infarction.

This controlled, double-blind, multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization. Participants will be randomized, in a two-by-two factorial design, to receive one of the following four treatments: A, folic acid 0.8 mg plus vitamin B12 0.4 mg and vitamin B6 40 mg per day; B, folic acid 0.8 mg plus vitamin B12 0.4 mg per day; C, vitamin B6 40 mg per day; D, placebo.

The primary end point during 3.5 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction within 7 days prior to randomization
* Men and women aged 30-85 years
* Written informed consent

Exclusion Criteria:

* Coexisting disease that shortens expected survival to less than 4 years
* Ongoing treatment with B vitamins
* Expected poor compliance
Effect of Communication Board on Functional Communication of Children With Cerebral Palsy

My aim of the research is to compare the effect of traditional therapy with the AAC device and identify if the AAC device is more effective for CP children than traditional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Children of both genders with Cerebral Palsy age group 8 years-12 years
* Children with Cerebral Palsy having mild to moderate cognitive impairment and communication impairment
* Children with comorbid conditions (epilepsy, microcephalia)
* Children with physical abilities of functional Pointing, One Step Command
* Following, Vocalization, and Imitation.

Exclusion Criteria:

* Children with comorbid conditions (visual impairment, hearing impairment