cyrilzakka/clinical-trials huggingface dataset:
Microbiome and Papillary Thyroid Microcarcinoma

It has been shown that gut microbiome and microbiome metabolism can regulate or control the initiation of a cancer process. To the best of the investigators knowledge, no study has directly shown the relationship of the thyroid microcarcinoma to the human microbiome. In this work, the aim is to detect the microbiome in peripheral blood in a patient with a thyroid gland carcinoma, and to correlate it with the disease, compared to the microbiome of a group of patients who did not find another thyroid gland carcinoma

Measurements of biological markers and tumor cell motility may be useful in predicting early whether a papillary thyroid microcarcinoma (PTMC) will develop to invasive carcinoma. Ideally, patients at high risk of progression may undergo immediate surgery instead of active surveillance and those with a very low likelihood of tumor progression may be included in an active surveillance protocol. Future research should focus on the development of new predictive early markers of papillary thyroid carcinoma during patient follow-up. From the above, it is clear the need to develop a new marker that raises the suspicion of possible thyroid microcarcinoma, if it is not preoperatively detected by the needle biopsy method and the patient has the indication for surgery for another benign thyroid disease. To date, there are no absolute biological and clinical parameters distinguishing a low risk from a high risk PTMC. If the fine needle aspiration shows stage V and VI Bethesda classification, and there is a high suspicion of PTMC, then questions such as the extent of the surgery, lobectomy or total thyroidectomy are beginning to be raised. The next dilemma is lymphadenectomy. The dilemma is greater if there are enlarged cervical lymph nodes (diameter over 1 cm in diameter of the small axis) and subsequently micromestases are confirmed. Another entity is when the cervical lymph nodes are not pathologically enlarged. This clinical situation is often emphasized as 60-80% of PTMC patients have metastases. By correlating a possible difference in the microbiome of a participants peripheral blood preoperatively, together with the imaging data, there may have been another marker of early PTMC detection and patient management planning respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are going to have surgery for some thyroid disease, benign or malignant

Exclusion Criteria:

* Recent, less than 3 months, infection of any system
* Receiving antibiotic or antiviral medication in the previous trimester
* Patient with chronic virus or bacterial infection
* Patient with dermatological disease
Bovine Colostrum for Prophylaxis Against Recurrent Urinary Tract Infection in Children

Prebiotics as bovine colostrum are considered as a valuable supplement in the prevention of upper respiratory tract infections, gastrointestinal tract infections and neonatal sepsis. It contains many bioactive substances, such as immunoglobulins, lactoferrin, lysozyme, lactoperoxidase, and other growth factors.There is a lack of research on the use of prebiotics for prophylaxis against recurrent urinary tract infection (UTI) in children.In this era of increasing bacterial resistance to antimicrobial therapy, bovine colostrum can offer an approach for prophylaxis against UTI in these patients.We aim at this trial to evaluate the efficacy and safety of bovine colostrum as a prebiotic for prophylaxis against recurrent urinary tract infection in children.

This prospective,randomized, placebo-controlled pilot study will enroll a total of sixty children diagnosed with recurrent UTI and following up in Pediatric Nephrology Clinic at Children's Hospital at Ain Shams University. Participants' parents will sign an informed consent statement prior to inclusion in the study. Children fulfilling the eligibility criteria, whether they are already on antibiotic prophylaxis for UTI or not, will be randomly assigned (1:1), using a computer-generated list into one of two groups: Experimental group receiving oral Bovine colostrum sachets daily for 1 month (n=30)\& Control group receiving oral placebo sachets daily for the same duration(n=30).

* Patient demographics, clinical symptoms suggestive of UTI, medication history, any risk factors for UTI, and clinical examination will be obtained at baseline.These will be followed up monthly for 6 months after the beginning of the study either during clinic visits or via telephone calls.
* Urine analysis (UA) will be done at base line, and monthly for 6 months. However if symptoms suggestive of UTI, UA will be requested.
* Urine culture at base line and with the appearance of symptoms or presence of pyuria in the urine analysis defined by \> 10 WBC /HPF.

Eligibility Criteria:
Inclusion Criteria:

* Documented recurrent UTI proven by positive urine culture. Recurrent UTI will be defined according to NICE guidelines as any of the following:

  1. 2 or more episodes of UTI with acute pyelonephritis.
  2. 1 episode of UTI with acute pyelonephritis plus 1 or more episode of UTI with cystitis.
  3. 3 or more episodes of UTI with cystitis.

Exclusion Criteria:

1. Allergy or hypersensitivity to the prescribed prebiotic.
2. Presence of any endo-urinary device (ureteral stent).
3. Presence of urinary stones
Argatroban Monitoring in Critically Ill Patients: Evaluation of a Novel Ecarin-based Bedside Test

Argatroban is a parenteral direct Thrombininhibitor used for anticoagulation in patients suffering from heparin induced thrombocytopenia (HIT). There is increasing evidence suggesting that the activated partial thromboplastine time (aPTT), which is recommended for dosage monitoring, correlates poorly with serum argatroban concentration in critically ill patients. Therefore it may be badly suited to determine the correct dosing. Ecarin based tests have been proven to be effective in determining effects of direct thrombin inhibitors. The investigators now plan to evaluate a novel, rotational thrombelastometric, ecarin based bedside test for its ability to measure the effect of argatroban in critically ill patients. So far an excellent correlation of a similar test could be shown in spiked plasma of healthy adults. According to the manufacturer the ECA-Test is able to detect direct thrombininhibitors. However to our knowledge neither the ECA-Test nor other ecarin-based thrombelastometric tests have been studied in critically ill patients treated with argatroban. The investigators therefore seek to investigate the correlation of the ECA-Test (ClotPro®) with the serum argatroban concentration.


Eligibility Criteria:
Inclusion Criteria:

* Continuous infusion of Argatroban in routine clinical use according to local standard of care
* Expected length of stay at ICU \> 4 days
* 18 years

Exclusion Criteria:

* Heparin infusion in the last fourhours
A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain

Patients who fulfilled inclusion criteria and consented to participate received either treatment as usual at the clinic, or were enrolled in a group-therapy based intervention, the multi-disciplinary pain intervention, led by a Medical doctor, physiotherapist and psychologist at the clinic.

The Department of Pain Management and Research at Oslo University Hospital is Norway's largest outpatient pain clinic. It treats around one thousand new patients annually suffering from chronic pain of all aetiologies. Many of the patients receive interdisciplinary care based on a biopsychosocial framework, by at least two health care providers (physician, physiotherapist, psychologist, occupational therapist and/or nurse).

Participants were recruited through referrals from primary or secondary care, which were identified by an established interdisciplinary team. Patients found potentially eligible for the study were contacted by the research team and consulted with a research physician. Patients who fulfilled the inclusion criteria were invited to participate in the study and signed a consent form. Patients who declined to participate and non-eligible patients received usual care.

Inclusion criteria were 1) age 18 or more; 2) pain in at least three out of five bodily regions (defined as the four quadrants and axially); 3) pain persisting three months or more; 4) the patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills); 5) no other medical condition could better explain the symptoms.

Subjects were randomised either to treatment as usual or a group-based multidisciplinary pain intervention (the MUD-PI).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Pain in at least three out of five bodily regions (defined as the four quadrants and axially)
* Pain persisting three months or more
* The patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills
* No other medical condition could better explain the symptoms.
Do Oral Steroid Dose Packs Predict How Well Epidural Steroid Injections Will Work?

The purpose of this observational study is to show whether a standard oral steroid dose pack can be used as a screening tool to assess the effectiveness of a subsequent epidural steroid injection (ESI). If an oral steroid does not give a patient significant temporary relief of pain from a herniated lumbar disc then an epidural steroid injection will not either. Therefore the risk and expense associated from the interventional pain management procedure for those patients could be avoided and other treatment modalities pursued.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Diagnosed by participating physicians during the study enrollment period as having intervertebral disk herniation and persistent symptoms with or without some nonoperative treatment for at least 4 weeks
* Radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations)
* Evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise-positive between 30° and 70°) or a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution)
* Undergone either MRI or CT scan showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms
* Patients with multiple herniations can be included if only one of the herniations is considered symptomatic
* Preenrollment nonprocedural care can include: education/counseling, physical therapy, chiropractic therapy, anti-inflammatory medications, opioid analgesics, adjuvant analgesics such as anticonvulsants and antidepressants

Exclusion Criteria:

* Prior lumbar surgery
* Cauda equina syndrome
* Vertebral fractures
* Spine infection or tumor
* Severe motor deficit
* Inflammatory spondyloarthropathy
* Pregnancy
* Cardiac or pulmonary comorbid conditions contraindicating interventional procedures
* Diabetes
* Inability/unwillingness to have spinal injections
Effect of Systematic Medication Review in Elderly Patients Admitted to an Orthopedic Department

Elderly patients have a higher risk of experiencing adverse drug events due to an age related increase in morbidity and medication use. Inappropriate or wrong medication use among elderly patients acutely admitted to hospitals is assumed to result in earlier contact to general practitioner, emergency departments and re-admissions if not corrected during hospital admission. It is therefore our hypothesis that a systematic medication review conducted by pharmacists and physicians specialized in pharmacology will increase time to first unscheduled physician contact (general practitioner, emergency departments, ambulatory care and re-admissions) after discharge from hospital from an average of 21days to 25 days. Further, the following secondary outcome parameters will be measured at discharge and within 3-month follow-up:

* length of in-hospital stay
* number of contacts to general practitioner 30 days after discharge, that resulted in medication changes
* number of re-admissions at 3-month
* number of death at 3-month
* number of contact to primary health care at 3-month
* patients self-experienced quality of health(EQ-5D) 3-month


Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* expected admission time of more than 24 hours
* acute admission

Exclusion Criteria:

* Psychotic patients
* Moribund patients
* Suicidal patients
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
* Signs and symptoms consistent with infection
* Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

Exclusion Criteria:

* Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
* Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
* Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
Prevention of Depressive Relapse by Means of Physical Exercise and Lifestyle

Depression treatments including physical activity and sleep management has been shown to relieve depressive symptoms among participants suffering depressive episodes. This study evaluates the potential of these methods as prevention of depressive relapse or recurrence


Eligibility Criteria:
Inclusion Criteria:

* A history of at least one episode of Major Depression.
* If medicating - Taking a stable (since one month) and therapeutic dosage of antidepressant medication
* Being able to read and write Swedish
* Having access to the internet

Exclusion Criteria:

* Fulfilling the criteria for Major depression
* Bipolar disorder
* Psychosis
* Substance abuse
* Suicidality
* Currently in psychotherapy
The Changes of Tissue Oxygen Saturation Under Spinal Anesthesia

Neuraxial anesthesia affords a less interventional way to desensitization of the lower body for surgical procedures. After introduction of neuraxial anesthesia, vasodilatation of body part below the anesthetic level is theoretically appeared as the sympathetic nerve efferent is blocked. The vasodilatation effect is related to hypotension, hypothermia, shivering and the response of volume redistribution. It is believed that vasodilatation leads to better regional tissue perfusion and better regional tissue oxygenation. Previous reports of laser doppler flowmetry and thermography showed their effectiveness on monitoring blocked level but they were not easily available in the operation room. Recently Near-infrared spectroscopy(NIRS) demonstrates real-time tissue oxygen saturation(rSO2) which is applied generally in non-invasive brain oximeter. We use NIRS in spinal anesthesia to monitor the tissue oxygenation change over the upper and lower limbs during the induction of neuraxial anesthesia.

In patients who were planned to receive an operation with intrathecal anesthesia, NIRS (INVOS Cerebral Oximeter Model 5100B; Somanetics, Troy, MI, USA) with two adhesive patches was used to monitor rSO2. One patch was applied over the biceps brachii muscle,(the body part above the anaesthetic level), and the other patch was applied over the medial side of the gastrocnemius muscle of the non-surgical leg,(the body part below the anaesthetic level). In both extremities, rSO2 was monitored continuously and recorded every minute from before intrathecal bupivacaine injection until 15 min after injection. Isobaric bupivacaine 0.5% 10-15 mg was injected intrathecally and the level of anaesthesia was examined 10 min later by loss of cold sensation to alcohol swab by an anaesthetist not involved in the study. the changes of rSO2 of upper and lower extrimities were recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* patients who receive operations under spinal anesthesia

Exclusion Criteria:

* neurological, cardiovascular diseases
Accuracy of Pulse Oximeters in Profound Hypoxia

The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in good general health with no evidence of any medical problems.
* Subject is fluent in both written and spoken English.
* Subject provided written informed consent and is willing to comply with the study procedures.
* Subject is willing to have their skin color assessed.

Exclusion Criteria:

* Subject is obese with a BMI over 30.
* Subject has a known history of heart disease, lung disease, kidney or liver disease.
* Subject has asthma, sleep apnea, or uses a CPAP.
* Subject has diabetes.
* Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
* Subject has any other serious system illness.
* Subject is a current smoker.
* Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
* Subject has a history of fainting or vasovagal response.
* Subject has a sensitivity to local anesthesia.
* Subject has Raynaud's disease.
* Subject has unacceptable collateral circulation based on an exam by the investigator.
* Subject is pregnant, lactating, or trying to get pregnant.
* Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
* Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.
Anatomo-radiological Study of the Ankle's Lateral Ligament

Subtalar instability is found in 30% of cases following a severe ankle sprain. Treatment is conditioned by subtalar involvement, so detection is essential. There is no consensus on the ligament anatomy of the subtalar region, making precise diagnosis of subtalar ligament damage difficult. The aim of this study is to provide a detailed description of the anatomy of the subtalar ligaments of interest, followed by a detailed radiological description (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with no history of sprain on studied ankle

Exclusion Criteria:

* Sprain on studied ankle
Efficacy and Safety for Different Regimen of VTE Pharmacoprophylaxis Among Severely Burn Patients

This study aims to assess the feasibility and safety of VTE prophylaxis for 3 modality regimens (Unfractionated heparin 5000 U SQ q8 hours, Enoxaparin 40 mg SQ q24 hours or Enoxaparin 30 mg SQ q12 hours) in adult patients (≥18 y/o) with severely burn injuries (BSA≥20%) by measuring the bleeding incidence and VTE events.

This is a pilot , randomized control trial-Open label, prospective trial in tertiary academic hospitals for patient admitted to burn ICU for at least 24 hours of injury or transferred from other hospital(s) within 7 days of injury. Each patient admitted meets the inclusion criteria will be randomize by block randomization to either receive heparin 5000 units S.C. TID, enoxaparin 40 mg S.C. OD, or Enoxaparin 30 mg S.C. BID. VTE prophylaxis should be started within 36 hours of injury, if the patient is transferred from another facility, VTE prophylaxis should be started immediately unless contraindicated. All patients should undergo diagnostic ultrasound at baseline ( before starting the prophylaxis) to assess any presence of DVT and as clinically indicated for clinical suspicion for VTE thereafter until discharge, an urgent spiral CTA chest will be requested on clinical suspicion for PE. Anti Xa factor will be monitored at day 3, and weekly thereafter until discharge unless there is active bleeding or high clinical suspicion for bleeding. Will follow-up patient until discharge from ICU, developed VTE requiring treatment (switch to treatment dose), developed HIT or death.

Eligibility Criteria:
Inclusion Criteria:

* Burn ICU admitted adult patients, age ≥ 18 years old.
* Body Mass Index of 18.5 to \< 40 kg/m2.
* TBSA of 20% or more.

Exclusion Criteria:

* VTE history.
* Death within 24 hours of injury.
* Burn injuries combined with trauma requiring withholding pharmacoprophylaxis more than 48 hours.
* Coagulopathy (INR \> 1.7, PTT\> 2 times upper normal limit, platelet \< 50k mm3)
* Patient with positive baseline US for VTE.
* Heparin induced thrombocytopenia (HIT).
* Active bleeding.
* Patients with CrCl of 30 ml/min or less.
* Patients using anticoagulation treatment dose for other indications.
Aviptidil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)

This study looks at the safety and effectiveness of Aviptidil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptidil plus current standard of care (SOC), or with placebo plus current SOC.

This is a treatment trial of the ACTIV-3b/TESICO master protocol (NCT04843761) to evaluate the safety and efficacy of Aviptidil at improving outcomes for patients with acute respiratory failure related to COVID-19.

This protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol.

This protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

The protocol is for a Phase 3 study.

Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.

This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for Aviptidil versus placebo with use of the ordinal outcome. The planned sample size is 320 participants. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.

Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) at enrollment. Other agent-specific stratification factors may be considered.

An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

Eligibility Criteria:
Inclusion Criteria:

Refer to the master protocol (NCT04843761)

Exclusion Criteria:

Refer to the master protocol (NCT04843761)

Additional Exclusion Criteria:

* Refractory hypotension
* Severe diarrhea
* Current C. difficile infection
* Pregnancy or current breast-feeding
* End-stage liver disease