cyrilzakka/clinical-trials huggingface dataset:
Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure

Controlled exercise training is a valuable therapeutic addition to pharmacological treatment in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac remodeling and improving functional capacity. Despite the mechanism underlying its benefits might be multifactorial, a sustained improvement in autonomic balance is usually attributed as a major effect. Nevertheless, not all eligible subjects show the same response to exercise, probably due to several differences in the subpopulations enrolled. The investigators hypothesize that some Heart Rate Variability indexes could be valid tools to optimize the selection and follow-up of chronic heart failure patients to training

Forty subjects followed in a University Heart Failure Management Program were prospectively included. All patients were evaluated before the randomization and after 24 weeks from enrollment. The investigators performed a detailed anamnesis and complete physical examination, Doppler echocardiography, Stress Testing, 6-minute walk test, heart rate variability analysis, and quality of life test. Patients were randomized either to a training group: performing a supervised training program, or a control group receiving usual care. All patients received an optimal pharmacologic treatment including diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers and beta-adrenergic blocking agents. All patients included in the training group attended a supervised program 3-days/week during 24 weeks (68-74 sessions). Physical aerobic training appears to impart beneficial changes in autonomic control of patients with chronic heart failure through both parasympathetic and sympathetic control of hear rate. These effects produce changes in several Heart Rate Variability indices as HF and rMSSD related with parasympathetic tone.

Eligibility Criteria:
Inclusion Criteria:

* subjects followed in a University Heart Failure Management Program
* maintained sinus rhythm
* New York Heart Association Functional Class (NYHA) I to III and
* LVEF≤40% documented by echocardiogram
* optimal pharmacologic treatment

Exclusion Criteria:

* history of stroke, myocardial infarction or extended anterior myocardial scar
* revascularization procedures or recurrent angina within previous 3 months
* orthopedic impairment
* alcohol or drug abuse;
* implant of pacemaker or cardioverter-defibrillator (AICD);
* frequently ventricular dysrhythmias,
* atrial flutter or fibrillation
* insulin-dependent diabetes mellitus;
* severe chronic obstructive pulmonary disease or renal dysfunction
* comorbid non-cardiac disease limiting short term survival
* previous enrollment in an ET program
* subjects at great propensity for noncompliance
The Effect of GLP-1 Receptor Agonist on Bone Metabolism in Patients With Diabetes Mellitus

Through an one-year follow-up, to explore the effect of GLP-1 receptor agonist on bone metabolism in patients with diabetes.

This study is a single-center observational study. After the patients were enrolled according to the standard of admission and exclusion, on the basis of the original scheme, GLP-1 receptor agonists were added and followed up for one year. The indexes of bone metabolism and body fat were measured at several time points (3 months, 6 months, 9 months and 12 months after treatment). Bone mineral density (BMD) was measured at several time points (6 months and 12 months after treatment) to explore the effect of GLP-1 receptor agonists on bone metabolism in patients with diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed patients with diabetes
2. HbA1c≥7.5%；
3. Willing to sign a written informed consent form and abide by the research plan

Exclusion Criteria:

1. Any of the following drugs or treatments were used within one month before screening: treated with GLP-1RA, GLP-1 analogues, DPP-4 inhibitors, or any other enterotropic insulin analogue
2. Long-term intravenous, oral and intra-articular administration of corticosteroids within 2 months before screening (more than 7 days in a row)
3. Use of weight control drugs or surgery that can lead to weight instability within the first 2 months of screening, or are currently in the weight loss plan and are not in the maintenance stage
4. History of acute and chronic pancreatitis; history of myeloid C cell carcinoma, MEN (multiple endocrine tumors) 2A or 2B syndrome, or related family history
5. There is a clinically significant abnormal gastric emptying.
6. Screening of any organ system tumors that have been treated or untreated within the previous 5 years
7. Underwent coronary angioplasty, coronary stent implantation and coronary artery bypass surgery within 6 months before selection, resulting in negligent compensatory heart failure (New York Heart Association NYHA classification III and IV), stroke or transient ischemic attack, unstable angina pectoris, myocardial infarction, persistent and clinically significant arrhythmias.
8. Acute metabolic complications occurred within 6 months before screening. （9）Before screening, any laboratory test index meets the following criteria: glutamic pyruvic transaminase \> 2.5 times or aspartate oxaloacetic transaminase \> 2.5 times; eGFR \< 45ml \< 45ml hand minmax 1.73m2; fasting triglyceride \> 5.64mmol/L
Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer

RATIONALE: The use of a nicotine inhaler may help decrease appetite and relieve "hunger pain" (an intense craving for food) in patients with malignant bowel obstruction caused by cancer.

PURPOSE: This randomized clinical trial is studying the side effects and how well a nicotine inhaler works in treating "hunger pain" in patients with malignant bowel obstruction caused by cancer.

OBJECTIVES:

* Determine whether patients with malignant bowel obstruction due to incurable cancer utilize a potential therapy for "hunger pain."
* Determine, preliminarily, the efficacy and toxicity of nicotine in treating "hunger pain" in these patients.
* Determine whether nicotine results in a decline in circulating ghrelin (for patients enrolled at the Mayo Rochester Clinic only).
* Evaluate hormonal changes in patients treated with nicotine (for patients enrolled at the Mayo Rochester Clinic only).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter, pilot study. Patients are stratified according to vomiting status within the past 24 hours (yes vs no) and use of narcotics (yes vs no). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive a nicotine inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity .
* Arm II: Patients receive a placebo inhaler to use as needed for "hunger pain." Treatment continues for up to 48 hours in the absence of unacceptable toxicity.

After 48 hours, patients in arm I may continue nicotine therapy off study. Patients in arm II who are not surgical candidates may cross over to treatment with the nicotine inhaler off study.

Blood and spot urine samples are collected at baseline and after 48 hours from patients enrolled at the Mayo Rochester Clinic. Blood samples are analyzed to evaluate circulating hormone (e.g., ghrelin, leptin) concentrations. Urine samples are analyzed to evaluate nicotine and nicotine metabolite concentrations.

Global quality of life is assessed at baseline and after 48 hours. "Hunger pain" is assessed at baseline.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of any incurable malignancy
* Presence of malignant bowel obstruction
* Must be on strict "nothing per os" (NPO) status over the next 48 hours

  * Ice chips allowed
* Acknowledges that "hunger pain" is a problem

PATIENT CHARACTERISTICS:

* Mentally competent
* No history of life-threatening arrhythmia
* No severe or worsening angina
* No accelerated hypertension
* No known hypersensitivity to nicotine
* Not pregnant or nursing
* Negative pregnancy test

PRIOR CONCURRENT THERAPY:

* Concurrent short-term use of dexamethasone or other hormonal therapy or symptom control strategy allowed
Erector Spinae Plane Block vs Quadratus Lumborum Block for Laparoscopic Nephrectomy

Ultrasound (US) guided Quadratus Lumborum Block (QLB) is performed at the level of the 12th rib, in the parasagittal oblique plane, at the L1-L2 level. As there are modifications of the block generally local anesthetic is given between quadratus lumborum (QL) and psoas major (PM) muscles (Anterior QLB). The QLB provides a sensory block between T7 - L1. Therefore, QLBs are used to provide postoperative analgesia for abdominal, obstetric, gynecologic, and urologic surgeries.

US-guided erector spinae plane block (ESPB) is performed at the level of the T11 transverse process. After visualization of the erector spinae (ES) muscle and the transverse process, local anesthetic is injected under the ES muscle. ESPB provides a sensory block of the anterior, posterior, and lateral thoracic and abdominal walls accordingly it's used for postoperative analgesia after thoracal wall repairs, thoracotomies, percutaneous nephrolithotomies, nephrectomies, and ventral hernia repairs.

This study aims to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

Nephrectomy for renal transplantation is a commonly performed procedure. The laparoscopic live donor nephrectomy (LLDN) is associated with many benefits and has become the gold standard for kidney retrieval surgery. As compared to open donor nephrectomy (ODN), LLDN has been shown to have less post-operative pain, shorter hospital stays, and faster recovery. Even though LLDN is less traumatic, some patients undergoing laparoscopic live donor nephrectomy still suffer significant postoperative pain require parenteral opioids, and have a risk for chronic pain.

The postoperative pain mechanism of LLDN is multifactorial - port pain, pain caused by incisions to retrieve the kidney, pelvic organ nociception, diaphragmatic irritation, and discomfort of a urinary catheter. Opioids, epidural anesthesia, Transversus Abdominal Plane (TAP) Block, and local infiltration of local anesthetics are used to prevent postoperative pain after LLDN.

In this study, the investigators aim to compare the effectiveness of US-guided ESPB and QLB on postoperative pain control after laparoscopic nephrectomy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I-II
* Scheduled for living donor laparoscopic nephrectomy under general anesthesia

Exclusion Criteria:

* history of bleeding diathesis,
* receiving anticoagulant treatment,
* known local anesthetics and opioid allergy,
* infection of the skin at the site of the needle puncture,
* pregnancy or lactation,
* patients who refuse the procedure or participation in the study
Differential Effects of Vasopressin and Oxytocin on Attention Control

The main aim of the present study is to investigate whether intranasal vasopressin (20IU) and oxytocin (24IU) have differential effects on attention control in a social-emotional saccade/antisaccade eye-tracking paradigm.

Previous studies have demonstrated intranasal vasopressin and oxytocin's divergent effects on social behavior and emotion processing such as empathy and negative emotion processing, however, it remains unclear whether vasopressin and oxytocin treatment would have differential effects on attention processing to social stimuli. Based on the previous registered studies (ClinicalTrials.gov ID: NCT04493554 and NCT03486925) from our group using a validated emotional anti-saccade task with social stimuli (emotional faces) and non-social stimuli (oval shape) have separately explored intranasal vasopressin and oxytocin's modulatory effects on attention processing, the present study aims to conduct a secondary analysis of the previously acquired data to directly compare vasopressin and oxytocin's effects on attention control to social emotional stimuli. To this end data from subjects who underwent intranasal oxytocin administration (n = 33; NCT03486925) will be compared with data from subjects who underwent intranasal vasopressin or placebo administration (n = 39, or 45 respectively; NCT04493554). To further control for non-treatment related factors the intranasal placebo groups from the previous studies (ClinicalTrials.gov ID: NCT04493554 and NCT03486925) will be compared with respect to primary and secondary outcome measures of the trial, in particular general and emotion-specific effects on attentional control.

Eligibility Criteria:
Inclusion Criteria:

* Male, healthy participants
* Non smokers

Exclusion Criteria:

* Previous or current medical, psychiatric, neurological disorder
* Regular medication
* Use of any psychoactive substances in the 24 hours before experiment
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start

Within a research network of Head Start centers in Massachusetts, an efficacy trial of a stepped-care intervention (SCI) to address maternal depression, using intervention components that both prevent depression and help those in major depressive episode (MDE) engage with care, will be conducted. Both the prevention and engagement components of the model have strong, supportive randomized trial evidence for both their efficacy and safety; but they have yet to be synthesized and tested within a coordinated intervention, applicable to a broad population base. Stepped-care interventions are commonly used in mental health service projects, in which the intensity or type of service is calibrated to the severity of illness.

This research study is a community-based efficacy trial (n=388) of a stepped-care model intervention to strengthen the capacity of Head Start to address parental depression and related adversities. Head Start mothers with symptoms of depressed mood or anhedonia, and their Head Start children, are enrolled across 12 Head Start centers.

The research study aims to improve developmental outcomes for Head Start children by delivering stepped care intervention that incorporates depression prevention and linkage to formal mental health care to mothers. Mothers with low baseline depressive symptoms are offered a problem-solving intervention while mothers with greater symptoms are offered engagement sessions to link them to formal mental health services. At each problem-solving session participant's symptoms are assessed and if the symptoms meet pre-specified 'step-up' criteria, they are converted to Engagement sessions.

Over 12 months, the intervention's effect will be assessed on a series of outcome measures for mothers; mechanisms by which maternal depression is theorized to impact young children; and child outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Mother of a 0 to 5-year-old Head Start child
* Mother speaks English or Spanish

Exclusion Criteria:

* Mother with suicidal ideation
* Mother with cognitive limitation
Association Between Natural Hypoglycemic Foods and Blood Sugar Level: A Pilot Study

Type 2 diabetes patients often do not reach desired control of glycemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives: to evaluate whether proposing a choice of spices and foods products with hypoglycemic effect to diabetic patients can help better control diabetes.

Diabetic type II patients would be encouraged to eat what they like within a list of food products with hypoglycemic effect, at a similar dosage and preparation mode than the one in the reference clinical trials.

This pilot project will be conducted as a randomized controlled trial with 2 arms over 12 weeks: 1. training patients about hypoglycemic spices and foods alongside their usual anti-diabetic treatment, versus usual anti-diabetic treatment alone.

Expected results: Confirmation of the hypothesis that daily consuming spices and foods with hypoglycemic effect to diabetic patients can help better control diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with poorly controlled glycemia, i.e. at least one of the following measurements:

  1. Fasting plasma glucose (FPG) values ≥ 7.0 mmol/L (126 mg/dl), or 2-h post-load plasma glucose ≥ 11.1 mmol/L (200 mg/dl), or HbA1c \> 6.5% (48 mmol/mol); or a random blood glucose ≥ 11.1 mmol/L (200 mg/ dl), despite ≥ 3 months usual care (lifestyle + medication if applicable).

Exclusion criteria:

1. Severe and unstable complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc...
2. Patients with rapid insulin,
3. Any health condition that requires urgent attention,
4. Patients with a cognitive or sensory impairment that may prevent conducting the interview,
5. HbA1c \> 11.5%
6. Pregnant women
Multidetector Computed Tomography (MDCT) Evaluation of Obstructive Jaundice: A Cross-sectional Study From a Tertiary Hospital of Nepal

This study was done to evaluate the diagnostic statistics of MDCT and its features in the assessment of obstructive jaundice in reference to surgical or histopathological diagnosis.

We did a cross-sectional study among 30 participants of obstructive jaundice at BP Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal. The sensitivity and the Negative predictive value of MDCT for non-neoplastic cause to detect obstructive jaundice were 100% (95% CI 79.41-100.00) and 100% (95% CI 75.29-100.00), while the specificity and the Positive predictive value for neoplastic cause to detect obstructive jaundice were 100% (95% CI: 79.41-100.00) and 100% (95% CI: 75.29-100.00). Similarly, the accuracy for either non-neoplastic or neoplastic cause was 96.67% (95% CI: 82.78-99.92). The most common cause for obstructive jaundice was choledocholithiasis (33.34%) followed by cholangiocarcinoma (20%), ampullary carcinoma (13.33%) and choledochal cyst (13.33%). The diagnostic accuracy of individual etiology of common causes of obstructive jaundice ranged from 82.78 to 100%. Biliary obstruction was most frequently observed in the periampullary region (83.33%), followed by the proximal common bile duct (6.67%), hilar region (6.67%), and intrahepatic region (3.33%).The MDCT could serve as the initial, cost-effective, easily available, and time-efficient imaging modality for diagnosing various causes of obstructive jaundice. It can differentiate non-neoplastic from neoplastic causes of obstructive jaundice.

Eligibility Criteria:
Inclusion Criteria:

* Any patient referred for CT scan with findings suggestive of obstructive jaundice with pertinent Histopathological and post-surgical findings .

Exclusion Criteria:

* Patients with contraindications for contrast-enhanced CT, those with non-obstructive cases of jaundice, and patients experiencing recurrent malignancy causing obstructive jaundice.
Patient Engagement Program for Stroke - Pilot Study

Currently there is a lot of literatures on stroke rehabilitation and post-discharge therapy. However, there are few evidence based guidelines on patient engagement after stroke in the post-rehabilitation community phase. There is evidence from stroke studies that stroke patients with mild to moderate disability, discharged early from an acute hospital unit can be rehabilitated in the community by an interdisciplinary stroke rehabilitation team and attain similar functional outcomes when compared to patients receiving in-patient rehabilitation. There is strong evidence that additional hospital based outpatient therapy improves short term functional outcomes compared to routine care over short term. Although meta-analyses have examined the efficacy of self management education programs, the interpretation of such reviews is limited by heterogeneity in populations and interventions and the limited range of outcomes measured. Few randomized controlled trials have found a reduction in health service utilization, such as incidences of hospitalization (in patients with chronic lung disease, heart disease, stroke and arthritis) as a direct outcome of attending an education program. For self-management support to be effective and sustainable in the community, it is postulated that initiatives simultaneously focus on supporting patients to engage in self management and equipping health care professionals with the necessary resources to assist them.

This is a randomized controlled pilot study of a post discharge community based patient engagement program for stroke patients discharged with a new carer after a period of in-hospital rehabilitation. Potential cases are identified within 2 weeks after admission into rehabilitation wards and randomized into either intervention group or usual care (control) group. Patients undergo the usual pre-discharge planning while in ward with predischarge assessment carried out by an independent (blinded) assessor. The control group are referred to receive the usual post-discharge community and rehabilitation backup. The intervention group has access to a special telephone hotline, home visits by team member within 1 week after discharge, patient diary to record home monitoring and back up of a specialist lead patient engagement clinic located in Kowloon Hospital. After 12 weeks, another home visit will be arranged for a repeat assessment by an independent (blinded) assessor. The outcomes to be measured include service parameters such as unplanned medical readmissions, AED attendances, length of stay at acute and rehabilitation units. Patient related parameters such as mortality, institutionalization, functional outcomes, mood, quality of life and complications will be measured as well as a carer strain and satisfaction survey.

Eligibility Criteria:
Inclusion Criteria:

* A stroke patient being discharged from a rehabilitation unit planned to be discharged to community with new carer

Exclusion Criteria:

* plan to enter institution within 3 months of discharge