cyrilzakka/clinical-trials huggingface dataset:
Acupuncture for Lumbar Spinal Stenosis

Acupuncture is widely used to manage chronic low back pain. Mounting evidence suggests the beneficial effects of acupuncture for mitigating chronic low back pain with acceptable minor adverse events. However, little information exists regarding the effects and safety of acupuncture for degenerative lumbar spinal stenosis, one of the spinal disorders that present chronic low back and leg pain.

The investigators aimed to assess the overall effectiveness, safety, and feasibility of acupuncture in combination with usual care (as opposed to usual care alone) for patients with symptomatic degenerative lumbar spinal stenosis.

The hypotheses of this study are as follows:

1. A set of acupuncture sessions in combination with usual care can provide greater functional improvements than usual care alone .
2. A set of acupuncture sessions in combination with usual care can provide greater pain reduction than usual care alone .

The study aims to include 50 participants (25 in the acupuncture group and 25 in the usual care group).


Eligibility Criteria:
Inclusion Criteria:

* Aged over 40
* Pain or bothersomeness of lower back or leg began at least three months ago (with at least 40 of pain or bothersomeness visual analogue intensity at the time of recruitment; 0 refers to no pain or bothersomeness and 100 to worst pain or bothersomeness imaginable)
* Clinical features of lumbar spinal stenosis, including neurological claudication or postural symptom changes
* Lumbar spinal stenosis confirmed by radiologic examination (e.g., computed tomography or magnetic resonance imaging) within the last two years
* Willingness to participate in the study

Exclusion Criteria:

* Congenital spinal stenosis
* Other spinal deformities, including spinal fractures and infections
* Participants who have received spinal surgeries, such as laminectomy, spinal fusion, and discectomy, due to lumbar spinal stenosis or other spinal diseases
* Other surgeries which might influence clinical features of lumbar spinal stenosis (e.g., total hip/knee replacements)
* Comorbid conditions which might interfere with the participant's active participation in the study (i.e., poorly controlled hypertension, poorly controlled diabetes mellitus, severe coronary artery disease, unstable asthma, cognitive function disorders, and other disabling conditions that interfere with self-ambulation, such as severe hip or knee arthritis)
* Past/present history of malignancy
* Began a new intervention for the management of lumbar spinal stenosis within the last one month
* Cauda equine syndrome (progressive lower extremity muscle weakness, loss of bowel/bladder control, and/or perianal numbness) and other urgent conditions which require immediate surgery
* Other conditions not appropriate for study participation
Characterization of Antibacterial Antibodies in Patients With Cystic Fibrosis

Most of the cystic fibrosis (CF) patients are or have been pulmonary colonized with bacteria such as Pseudomonas aeruginosa or Staphylococcus aureus. Aim of this study is to detect virulence factor neutralizing antibodies in the sera of the study population followed by B cell repertoire analyses to design B cell-derived neutralizing monoclonal antibodies. The functionality of neutralizing antibodies rests on inhibition of virulence factors by binding of crucial epitopes rather than merely the induction of opsonization. Focusing on patients with bacterial colonization/chronic infections or a history of an acute infection in the past, will increase the likelihood for identification of serum with neutralizing activity as in vivo antigen contact is a prerequisite for antibody development and maturation. Since virulence factors are essential for infection, dissemination and tissue damage, inhibition of these factors by developed neutralizing antibodies might contribute to a favorable outcome of life-threatening infections.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Ability to give consent
* Normal vital signs including:
* Blood pressure systolic value 150 - 100 mmHg, diastolic value \< 90 mmHg
* Respiratory rate \< 20/min
* Oxygen saturation \>92%
* Heart rate 50 - 110/min
* Body temperature \<38°C

Exclusion Criteria:

* Cytopenia (leukocytes \< 1.500/µl, thrombocytes \< 50.000/µl, Hemoglobin \< 12 g/dl)
* Heart disease or pulmonary hypertension
* Body weight \<50 kg (exclusion of blood sampling for B cell isolation)
* Blood donation, larger blood loss and/or major surgery in the last 8 (male) or 12 (female) weeks
* Any decline of the general state of health in the last 3 month including weight loss \> 2kg, pulmonal exacerbation or increased impairment of pulmonary function (FEV1 \< 50%)
Effect of Tai Chi Chuan on Autonomic Nervous Modulation in Aged Subjects

Since Tai Chi Chuan (TCC) training has been shown to be beneficial to the cardiopulmonary function of the subject, TCC might have a beneficial effect on the pulmonary function, autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects.

Tai Chi Chuan (TCC) is a traditional Oriental conditioning exercise or calisthenics that is believed by many people around the world to be good for the health. The frequently claimed reason for this merit of TCC is that it can improve the cardiopulmonary function and immunity of the subject who practice it continuously. TCC has been shown to delay the decline of aerobic power, improve the cardiopulmonary function, balance and strength of the subjects. One study has demonstrated that TCC could reduce tension, anxiety, and mood disturbance. However, few studies have examined the effect of TCC on the blood lipid profile and immunity of the TCC practitioners. Another study reported that 12-week programme of regular TCC exercise enhanced functional mobility, personal health expectations, and regulatory T cell function. It has also been shown that an appropriate combination of TCC exercise program with diabetic medication might improve both glucose metabolism and immunity in type 2 diabetic patients. Since TCC training has been shown to be beneficial to the cardiopulmonary function of the subject, TCC may also have an effect on the blood lipid profile and immunity of the subjects. We hypothesize that TCC might have a beneficial effect on the pulmonary function, autonomic nervous modulation, lipid profile, and cytokines production in the aged subjects. Thus, the aim of this study was to examine whether or not TCC have these effects in the aged subjects.

Eligibility Criteria:
Inclusion Criteria:

* All subjects included in this study had normal lifestyles, and were capable of daily activities without limitations.

Exclusion Criteria:

* Subjects who had major cardiopulmonary disease or were on regular medicine for diabetes mellitus, hypertension, renal or liver disease were not included in the study.
Effect of Negative Wound Pressure on P.S

This study will compare the NPWT using the NPD to the conventional wound dressing and specifically evaluating (i) reduction of wound surface area and depth, (ii) removal of slough and formation of granulation tissue

Initial debridement of slough and necrotic tissue was performed in all patients at the time of admission and before their being allocated in a group.

it's 3 groups:

Group (A): conventional dressing :

acting by:preventing pus, the findings from the review indicate that decreasing frictional forces transmitted to the patient's skin is achieved by use of a dressing with an outer surface made from a low friction material.

The surface of the PU will be cleaned with normal saline and packed with sterilised gauze to cover the wound. Dressing changes will be performed once or twice daily depending on the soakage of the dressing.

.

Group (B), negative pressure wound therapy using the electronic-vac :

It is believed that the negative pressure assists in removal of interstitial fluid, decreasing oedema, increasing blood flow and reducing tissue bacterial levels, in addition, mechanical deformation of cells is thought to result in protein and matrix molecule synthesis, which increases the rate of cell proliferation and granulation tissue formation, this , in turn , may promote healing .

We will place a nonadherent contact layer, such as Xeroform between prepared wound bed and foam then applying a contact dressing with sealling using an adhesive drape. The dressing will be connected to the machine through tubing that was connected to the canister. Continuous pressure of 200 mm Hg will be applied. The dressing will be changed three times a week Group (C), negative pressure wound therapy using the Romo-vac: The NPD will be applied as a bedside procedure with a low-power continuous suction apparatus. We will Place nonadherent contact layer, such as Xeroform between prepared wound bed and contact dressing with sealling using an adhesive drape. The dressing will be connected to the Romo-vac which applying pressure of-60 to -125 mm Hg. The Romo-vac will be recharged every 5-6 hours and the dressing will be changed three times a week or earlier if there is a soakage/leakage

Eligibility Criteria:
Inclusion Criteria:

Stages three and four PU as defined by the National Pressure Ulcer Advisory Panel (NPUAP).

Exclusion Criteria:

* wound with necrotic tissue unlikely to tolerate debridement. Exposed Vessels, Nerves and or organs. Active bleeding. Ischemic limb. Opening into body cavity
Non-invasive Blood Pressure (BP) Monitoring Compared to A-Line BP Monitoring

Blood pressure cuffs (NIBP) are slowly replacing intra-arterial (IABP) measurement as the standard of care in the medical intensive care unit. There is little data to support this clinical normalization of deviance. This study aims to correlate NIBP with IABP.

It has become standard practice in inpatient and intensive care settings to monitor systolic, diastolic and mean arterial blood pressure by oscillometric technique. Several studies have confirmed the accuracy and precision of the oscillometric technique in ambulatory patients at both the level of the brachial and radial arteries. Multiple clinical research studies have demonstrated that when blood pressures (systolic, diastolic and mean arterial pressures) determined by non-invasive blood pressure monitors (NIBP) from various manufacturers are compared to direct invasive arterial pressure monitors, the two values are on average within 5 mm Hg of each other. There is limited data in critically ill patients. To date, there are no studies evaluating the accuracy or precision of these devices in intensive care patients for alternative sites (calf, thigh). In addition, there are no large clinical studies evaluating oscillometric NIBP monitoring in a complex medical intensive care population with varying hemodynamics. The goal of this study is to validate the oscillometric technique in measurement of blood pressure in the calf and thigh regions when compared to a gold standard. We may also be able to evaluate more specifically which situations for our patient population the blood pressure will be accurately portrayed as compared with the arterial pressure tracing. It has possible clinical value in either validating non-invasive blood pressure monitoring and eliminating/decreasing the need for invasive arterial blood pressure monitoring. Our hypothesis is that NIBP in the medical intensive care patients is highly variable and not a reliable means of arterial blood pressure monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Arterial blood pressure line

Exclusion Criteria:

* Lack of arms and legs for cuff pressures
* Medical or surgical indication that might prevent use of blood pressure cuffs
Evaluation of an Intervention Model for Family Crisis and Support

To learn more about how a family treatment program helps people after brain injury. Specifically, do families feel better and function better after going through the program, and do patients feel better and function better after going through the program.

To evaluate the efficacy of a structured outpatient family intervention program (BIFI) on family members' emotional well being, life satisfaction, needs, and family functioning; and to evaluate the impact of the BIFI on the emotional well being, life satisfaction, functional independence, vocational status, and neurobehavioral functioning of persons with acquired brain injury (ABI).

Eligibility Criteria:
Inclusion Criteria:

* Family members/caregiver friends and persons with acquired brain injury (ABI) who are at least three months postinjury. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.

Exclusion Criteria:

* Families including individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators.
* Individuals under 18 years of age.
Minimum Alveolar Concentrations of Sevoflurane for Maintaining Bispectral Index Below 50 in Morbidly Obese Patients

the target of this study is to assess the minimum alveolar concentration of sevoflurane to maintain theBispectral Index below 50.The minimum alveolar concentration (MAC) for maintaining Bispectral Index below 50 (MACBIS50) of sevoflurane has been reported previously in adult with Body Mass Index ( BMI) \< 40 to be 0.97 and in enfant to be 2.83%, However, there is no study assessed theBispectral Index below 50 (MACBIS50 ) in morbidly obese patient (BMI \> 40). The first aim of our study is to assess the MACBIS50 of sevoflurane in morbidly obese patients BMI 40 - 70 using the Continuous Reassessment Method (CRM) in 80 % of patients.

After ethical committee approval and written informed consent, 30 morbidly obese adult patients , BMI 40- 70Kg/m², ASA physical status 1 and 2 , aged 18-49 yr, , undergoing elective bariatric surgery under general anesthesia using sevoflurane, were included in this study.

Monitoring consisted of noninvasive blood pressure, Electrocardiogram (ECG) , pulse oximetry, and BIS. All subjects received a standard dose of 2 mcg/kg fentanyl approximately 20 min before induction of general anesthesia. a standard BIS® monitor strip was applied before fentanyl administration and induction of general anesthesia. Induction was performed in all patients with 2m/kg propofol, 0.2 mg/kg cisatracuruim, followed by direct laryngoscopy and tracheal intubation. Therefore, when BIS reached \> 65 , sevoflurane was started immediately at the predetermined dose.

The endtidal sevoflurane concentration was adjusted with starting dose for the first cohort patients 1% and maintained for 10 min to ensure equilibration with the cerebral anesthetic partial pressure followed by a 1-min assessment of BIS taken at 10-s intervals. Briefly, a first dose is given to the first patient and the next doses are given according to the following rule: if the subject responds positively (BIS\<50), the dose is decreased one step for the next subject, and conversely, if the subject does not respond (BIS\>50), the dose is increased one step. The dose adjustment is 0.2% for sevoflurane. The CRM is used to calculate the dose adjustment for every cohort with the number of patients for every cohort .

Eligibility Criteria:
Inclusion Criteria:

* morbidly obese patient
* BMI 40-70
* age : 20-40 year

Exclusion Criteria:

* Age\< 20 and \> 40
* BMI \< 40 and \> 70
* comorbidity
Nursing Intervention for the Reduction of Anxiety During the Process of Primary Total Hip Arthroplasty Within the Optimized Recovery Program.

Osteoarthrosis (OA) is a chronic, degenerative disease characterized by joint wear and tear. It is a major cause of pain, disability and decreased quality of life. Total hip arthroplasty (THA) and total knee arthroplasty (TKA) represent an effective alternative for the treatment and pain control of patients with osteoarthritis. The "fast-track" program is translated as enhanced recovery or fast-track, and consists of the active participation of patients in their own recovery and immediate post-surgical mobilization, thanks to preoperative education through an educational workshop, the type of analgesia used and the empowerment of the patient in his or her own recovery.

The problem of anxiety in the surgical patient and the role of nurses in it has been widely studied for some decades, as shown in the scientific literature. Our experience as professionals of a hospital unit of orthopedic surgery and traumatology shows us the reality of this situation and the investigators find that when discharging patients who have undergone surgery and are discharged after 24 hours, the patient almost globally manifests a series of expressions, behaviors or behaviors that are related to anxious behavior, a completely natural human response of a patient who does not know what he is going to face. This leads us to detect a need to reinforce the information provided at discharge and the accompaniment during the first weeks after discharge.

Anxiety is a complex reaction to potentially dangerous situations or stimuli. It is an alarm signal that triggers a series of responses to cope with the situation. Anxiety is an emotional response that encompasses unpleasant cognitive aspects and physiological alterations that manifest themselves with high nervousness and even motor alterations.

Surgery is perceived by the patient as an important stress factor that can translate into nervousness and anxiety. Anxiety is almost always present during surgery, to a greater or lesser degree, both preoperatively and postoperatively.

Several studies have shown that good preoperative information reduces preoperative and postoperative anxiety. Patients need information about their process since dispelling their doubts will minimize anxiety. Currently there is very little information on anxiety during the whole surgical process. Therefore, in the present project the investigators propose to carry out a research study to analyze whether nursing intervention has beneficial results in the surgical patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled with signed consent for primary hip arthroplasty surgery, age over 18 years, patients who agree to participate in the study.

Exclusion Criteria:

* Patients who are discharged to a social-health center, patients with cognitive or mental disorders, patients who cannot read or write.
Bortezomib in Treating Patients With Recurrent Glioma

Phase I trial to study the effectiveness of bortezomib in treating patients who have recurrent glioma. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth

OBJECTIVES:

I. Determine the maximum tolerated dose of bortezomib with or without anticonvulsant drugs known to be metabolized by the P450 hepatic enzyme complex in patients with recurrent glioma.

II. Determine the biologic activity of this drug by measuring proteasome 20S activity in these patients.

III. Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on biologic activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to concurrent anticonvulsant drug use (phenytoin, carbamazepine, phenobarbital, primidone, or felbamate vs gabapentin, lamotrigine, valproic acid, or no anticonvulsant drugs).

Patients receive bortezomib IV over 3-5 seconds twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of bortezomib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated with bortezomib at the MTD. Patients are followed every 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed progressive or recurrent malignant glioma

  * Anaplastic astrocytoma
  * Anaplastic oligodendroglioma
  * Glioblastoma multiforme
* Prior low-grade gliomas that have progressed to high-grade after therapy allowed
* Measurable disease by MRI or CT scan
* Performance status - Karnofsky 60-100%
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* Transaminases no greater than 4 times upper limit of normal
* Creatinine no greater than 1.7 mg/dL
* Mini mental score at least 15
* No concurrent serious infection or other medical illness that would preclude study participation
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
* No more than 1 prior chemotherapy regimen
* At least 3 months since prior radiotherapy and recovered
* No other concurrent investigational agents
Clinical Outcomes and Costs of 4-Week Versus 6-Week Bloodwork for Patients on Hemodialysis

The objective of this quality improvement study was to determine the effect of an institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets for patients on chronic hemodialysis.

Rationale \& Objective: Routine bloodwork for patients on hemodialysis has both financial and opportunity costs, but there is little data on how the frequency of measurement affects patient outcomes. Our objective was to determine the effect of changing from routine bloodwork at four-week intervals to six-week intervals on the achievement of anemia and chronic kidney disease-mineral and bone disorder (CKD-MBD) targets.

Study Design: Retrospective interrupted time series from June 1, 2012 to December 31, 2015.

Setting \& Participants: Tertiary hospital in Ontario, Canada, that provides hemodialysis to 350-400 adult patients.

Quality Improvement Activities: Institution-wide switch of routine bloodwork from four-week intervals to six-week intervals on March 24, 2014.

Outcomes: Proportion of patients who achieved recommended hemoglobin and phosphate targets. In a 252-day sub-analysis, we also calculated the cost-savings attributable to a change in laboratory testing frequency for hemoglobin, ferritin, iron saturation, calcium, and phosphate.

Analytical Approach: Statistical Process Control to analyze variation in the clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all patients who received chronic hemodialysis at the Kingston Health Sciences Center regional hemodialysis program

Exclusion Criteria:

* none
D-chiro-inositol and Endometrial Thickness

Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.


Eligibility Criteria:
Inclusion Criteria:

- altered endometrial thickness

Exclusion Criteria:

* patients with cancer
* patients under hormonal treatments (progestogens and/or estrogens)
* patients supplemented with inositols