cyrilzakka/clinical-trials huggingface dataset:
The Effects of Dexmedetomidine on Microcirculation and Surgical Outcomes After Cardiac Surgeries

Cardiac surgery with cardiopulmonary bypass (CPB) provokes a systemic inflammatory response that can often lead to dysfunction of major organs. Activation of the contact system, endotoxemia, surgical trauma, and ischemic reperfusion injury are all possible triggers of inflammation. Previous studies demonstrated that pro-inflammatory cytokines play an important role during this process. However, very little is known about the susceptibility of the splanchnic organs to ischemic reperfusion injury. Although the incidence of intestinal complications reported to be low, the in-hospital mortality in these patients was high at 15% to 63%.

Dexmedetomidine, a highly selective α2-adrenergic agonist, can reduce the consumption of other sedative and antinociceptive drugs and provide sufficient sedative effects with minimal respiratory side effects. In addition, dexmedetomidine gradually has gained popularity in the field of critical care. Preemptive administration of dexmedetomidine has shown to be protective against inflammation, intestinal, renal, and myocardial injuries in animal and human studies. Dexmedetomidine is also used as an anesthetic adjuvant during surgery to offer good perioperative hemodynamic stability and an intraoperative anesthetic-sparing effect. Perioperative use of dexmedetomidine can reduce intestinal and hepatic injury after hepatectomy with inflow occlusion under general anesthesia. However, whether or not it can exert protective effects on the above-mentioned organs, especially intestine, after cardiac surgery remains unclear. The aim of this study is to evaluate the effects of dexmedetomidine on intestinal, hepatic, and other organ injury in patients receiving cardiac surgery with CPB.

In this double-blinded randomized controlled study, serum diamine oxidase activity, which is a sensitive and specific marker for the detection of intestinal injury, is taken as the primary endpoint. Other parameters reflecting the functions of liver (AST/ALT), lung (lung injury score and CC-16), kidney (BUN/Cre), and heart (CK-MB/Troponin T), the biomarker of endothelial injury (endocan) will also be determined. Besides, microcirculation parameters measured with Cytocam® and near-infrared spectroscopy (NIRS) will be used to estimate the protective effect of dexmedetomidine on microcirculation. The variables will be collected perioperatively and will be followed up for 3 days after the surgery. Clinical outcome parameters will be followed up for 3 months after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Non-emergent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* left ventricle ejection fraction \< 40%
* acute myocardial infarction within 3 months
* angina within 48 hours before surgery
* COPD
* previous history of inflammatory bowel disease
* diarrhea within 7 days before surgery
* previous cardiac surgery
* receiving non-pharmacological cardiac supportive management
* previous pulmonary embolism
* previous deep vein thrombosis
* allergic to dexmedetomidine
* refractory bradycardia (HR \< 60/min )
HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

A phase Ib, dose escalation, multiple dose trial with HuMax-IL8 in patients with metastatic or unresectable, locally advanced malignant solid tumors.

All human subjects with a diagnosis of incurable solid tumors are eligible for the dose-escalation phase of this study. This study consists of two phases, the dose-escalation phase and the expansion phase. Subjects will be treated with the study treatment until any off-treatment criteria are met. The safety and efficacy will be assessed until the end of treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at the time of disease progression if the patient has a progression between end of treatment and 52 weeks. The patients will be followed up for overall survival until the study closure. The study will be closed when all enrolled patients have been followed up for at least 52 weeks or have died.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
* Patients may have measurable or non-measurable but evaluable disease.
* Patients with surgically resected metastatic disease at high risk of relapse are also eligible.
* Patients must have completed or had disease progression on at least one prior line of disease-appropriate therapy for metastatic disease, or not be candidates for therapy of proven efficacy for their disease.
* Patients must have recovered (grade 1 or baseline) from any clinically significant toxicity associated with prior therapy
* Age ≥ 18 years. .
* ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).
* Patients must have normal organ and hematologic function therapy
* Patients must have baseline pulse oximetry \> 90% on room air

Exclusion Criteria:

* Pregnant women or women presently breast-feeding
* Concurrent treatment for cancer
* Chronic hepatitis B or C infection.
* Any significant disease that, in the opinion of the investigator, may impair the patient's tolerance of study treatment.
* Significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
* Active autoimmune diseases requiring treatment or a history of autoimmune disease.
* Concurrent use of systemic steroids
* Patients who are receiving any other investigational agents
* Patients with untreated central nervous system metastases or local treatment of brain metastases
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agent used in study.
* Serious or uncontrolled intercurrent illness
* HIV-positive patients are ineligible
* Patients unwilling to use adequate contraception

Other protocol defined inclusion/exclusion criteria could apply
Ability to Awaken in Nonmonosymptomatic Enuresis

To evaluate the effect of controlling lower urinary tract symptoms (LUTS) with anticholinergics on improving the ability to awaken (AA) in children with nonmonosymptomatic enuresis and evaluate the potential implication of improved AA for treatment response prediction.

Nocturnal enuresis is associated with three main etiologies, including nocturnal polyuria secondary to abnormal anti-diuretic hormone levels, low bladder capacity related to lower urinary tract dysfunction, and sleep disorders causing problems in arousal. Among them, the association between enuresis and lower urinary tract symptoms (LUTS) has gained importance. If these two conditions coexist, the diagnosis is nonmonosymptomatic enuresis (NME). The reported prevalence of LUTS among enuretic patients ranges widely from 21% to 99%. Moreover, it was reported that spontaneous resolution can be prolonged, and some cases of NME are likely to become refractory if treated like monosymptomatic enuresis (ME) cases. A possible explanation for this may be the presence of bladder dysfunction that is not addressed properly by the standard treatment of ME. However, this explanation is only speculative.

By showing a paradoxical increase in light sleep and higher cortical arousal index in enuretic children with reduced bladder capacity, one of the reason for impaired ability to awaken (AA) in enuretic patients may lie in the chronic stimulation of the bladder. This kind of bladder dysfunction leading to an abnormal bladder-brain dialogue has been further elaborated by an experiment showing brain dysfunction in the ventrolateral periaqueductal gray matter as a result of the experimental reduction of the bladder capacity. If this is true for enuretic children, we may be able to improve arousal (improved AA) by increasing their bladder capacity.

Based on this hypothesis, the present study aimed to evaluate to the effects of anticholinergic therapy with standard urotherapy on improvement of AA and show the effect of improved AA on treatment response in children with NME.

Eligibility Criteria:
Inclusion Criteria:

* primary nonmonosymptomatic enuresis who received initial anticholinergic therapy

Exclusion Criteria:

* any urological abnormalities including neuropathic bladder
PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA

This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to Alopecia Areata (AA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.
* At least 25% hair loss due to alopecia areata
* Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)
* Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy
* Signed informed consent
* Stable regimen for other medications before and during the study

Exclusion Criteria:

* Other significant medical conditions
* Occupational or recreational noise exposure
* History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy
* HbA1c \> or = 7.5% at Screening
* Recurrent or disseminated Herpes Zoster
* Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months
* Active or latent (insufficiently treated) Hepatitis
* Active or latent (insufficiently treated) TB
* Concomitant medications associated with peripheral neurologic or hearing loss
* Protocol specific laboratory abnormalities
Trachoma Amelioration in Northern Amhara (TANA)

The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.

The proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions:

Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments.

Specific Aim 2. To determine whether children form a core group for the transmission of trachoma.

Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment.

Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality.

Specific Aim 5. To determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.

Eligibility Criteria:
Inclusion Criteria:

• All residents residing in the state-teams which are randomly selected for this study.

Exclusion Criteria:

* Pregnant women
* Children under 6 months of age
* All those who are allergic to macrolides or azalides
* Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.
Community Interventional Trial (CITFOMIST)

The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011.

The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital

Exclusion Criteria:

* Those taking vitamin D supplements
* Those with underlying disease affecting bone health
* Those taking medication affecting bone metabolism
* Those taking fortified products on a regular basis
* Those following special diets
Serum METRNL Concentration in Type 2 Diabetes

The investigators measured serum METRNL levels in newly diagnosed patients with type 2 diabetes (T2DM) compared with normal glucose tolerance or prediabetes and explored the correlations between its serum levels and various metabolic parameters


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have not been diagnosed diabetes mellitus

Exclusion Criteria:

* Person with diabetes who were treated with oral hypoglycemic agent or insulin
* Individuals with type 1 diabetes, gestational diabetes, active hepatitis/liver cirrhosis, chronic renal failure on hemodialysis, congestive heart failure, or other known major disease
Preventive Intervention in Nursery School Teachers

Childcare in nursery schools has been shown to be associated with an elevated prevalence of neck, shoulder, arm and low back disorders. The current evidence suggests that exercises seem to be the only effective preventive intervention. Thus the purpose of this study is to determine the effectiveness of an extension-oriented exercise program in preventing low back/neck pain and functional disability in nursery school teachers. In addition, the investigators also sought to identify the occurrence of musculoskeletal complaints in this category of workers.

Seventy-one nursery school teachers working in nine school buildings were randomly divided into two groups, with each school as a unit of randomization. All the teachers in both groups received an ergonomic brochure; teachers in the experimental group also received an extension-oriented exercise program, conducted by a physical therapist. Data were collected at baseline and at a two-month follow-up. The primary outcome measure recorded was the level of disability (Roland Morris Disability Questionnaire and Oswestry Disability Index), while secondary outcome measures included LBP and neck pain presence (Pain Drawing) and intensity (Visual Analogue Scale). At follow-up, a significant improvement was registered in the experimental group for all the outcomes evaluated. In conclusion a six-session extension-oriented exercise program proved decisive in preventing low back and neck complaints and in reducing consequent LBP functional disability among nursery school teachers.

Eligibility Criteria:
Inclusion Criteria:

The study population was composed by all the 71 nursery school teachers, employed at the town hall of Forlì, that worked in nine different school buildings similar in size and furniture. As provided for by the Italian law (Emilia-Romagna Regional Law No. 1 of January 10, 2000 - art. 32, followed by the Directive of July 25, 2001), teachers had the same working schedule and the same workload in terms of teacher/children ratio depending on children age.

Exclusion Criteria:

* medical history of serious injury
* spinal surgery
* malignant pathology
Kidney and Intestinal Markers for Early Detection of Organ Injury After Endovascular Aortic Repair

This study aims to investigate the predictive value of novel biomarkers and contrast-enhanced ultrasonography for early detection of abdominal end-organ (kidney and intestinum) hypoperfusion and ischemia in patients undergoing endovascular aortic repair (EVAR) for aortic aneurysm or dissection. In this context, patients will be monitored for renal biomarkers (TIMP-2, IGFBP7) and intestinal biomarkers (plasmatic intestinal fatty acid binding protein (i-FABP)) and local tissue perfusion will be assessed using contrast-enhanced ultrasonography (CEUS).

The ultimate goal of this study is an early identification of patients developing one or both of these complications, which may facilitate a timely intervention to improve outcome.


Eligibility Criteria:
Inclusion Criteria:

* Existence of an aortic aneurysm with need of repair as indicated by the treating vascular surgeon
* Aortic stenting involving the origin of both mesenteric (i.e. superior and inferior mesenteric arteries) and kidney arteries
* Central line is present to perform repeated blood collections
* Written informed consent is obtained.

Exclusion Criteria:

* Pre-existing severe liver or kidney injury (defined as spontaneous international normalized ratio (INR) \>2 or creatinine \>2 mg/dl or renal-replacement therapy in the pre-operative course.)
* Known allergy to ultrasound contrast media (exclusion for the CEUS but not for marker evaluation)
* Anemia with hemoglobin concentration \< 7g/dl
* Patients \< 18 years of age
* Patients not able to give written informed consent
A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery

The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have occurred.

The purpose of the present study is to establish the efficacy of the technique of intravenous regional analgesia with a forearm tourniquet using reduced doses of lidocaine.

Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly. A conventional Biers block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area.

A mini-Biers block in which the tourniquet is placed on the forearm, has been shown to be a safe and effective way of anesthesia to perform hand and wrist surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions.

Intravenous regional anesthesia (IVRA) or Bier's Block is a simple and effective but underused anesthetic technique for hand and wrist surgery, This technique, introduced by Dr.August Bier in1908, provides complete anesthesia as well as a bloodless field during surgery.

Traditionally, an upper arm tourniquet has been used to sequester the local anesthetic and to create a bloodless Surgical field. Major complications after IVRA with an upper arm tourniquet are rare but are mostly related to local anesthetic systemic toxicity after release of the tourniquet.

Use of a forearm tourniquet has been introduced in 1978 and comes with the big advantage of lower (non-toxic) local anesthetic dosage requirement to produce a good quality of analgesia.

Consequently, there is no minimal tourniquet inflation time after forearm IVRA. In addition ,it has been postulated that sensory onset time after forearm IVRA may be shorter than after upper arm IVRA. With these two features forearm IVRA may be the ideal anesthetic technique for short surgery of hand and wrist.

Eligibility Criteria:
Inclusion Criteria:

* Patients of American Society of Anesthesiologists (ASA) physical status I to II.
* Both sexes.
* ≥ 21 to 65 years.
* scheduled for elective hand and wrist surgeries.

Exclusion Criteria:

* American society of Anesthesiologists (ASA) physical status ≥3 or BMI ≥40
* Patients will do bilateral hand surgery
* Local site infection.
* Allergy to local anesthetics.
* Patient refusal
* Patients with pre-existing myopathy or neuropathy on the operating limb.
* Patients with significant cognitive dysfunction.
* Chronic analgesic abuser patients.