cyrilzakka/clinical-trials huggingface dataset:
Effects of Combined Physical-cognitive Training on Cognitive Function in MCI

The present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. It is hypothesized that: 1) the combined physical-cognitive training program will be superior to the physical and cognitive training program alone; and 2) the degree of cognitive improvement will be positively correlated with the improvement of plasma BDNF and mitochondrial function.

Recent research suggests that the benefits of combined physical-cognitive training may be greater than either physical or cognitive training alone. Nevertheless, this synergistic effect has been demonstrated mainly in cognitively intact older adults. Studies examining the effects of combined physical-cognitive training in older adults with MCI are scarce and show mixed results. Moreover, few studies have determined the effects of the combined training on peripheral brain-derived neurotrophic factor (BDNF) and mitochondrial function. Thus, the present study aims to investigate the effects of combined physical-cognitive training on cognitive function as well as peripheral BDNF level and mitochondrial function of individuals with MCI. The present study will provide insight into the interplay among the training program, peripheral BDNF concentration, mitochondrial function, and cognitive function. Importantly, the findings will have clinical implication regarding the training program that is feasible and effective in improving cognitive function of older adults with MCI which ultimately will have great impact on public health as this population is at high risk of progression to AD.

Eligibility Criteria:
Inclusion Criteria:

* meet criteria for mNCD (mild neurocognitive disorders), previously known as MCI, based on the recent DSM-V (Diagnostic Statistical Manual-V) criteria
* comprehend instructions and willing to participate
* able to comply with the study schedule and procedures
* not taking any medications for their cognition and not planning to start medications during the study trial

Exclusion Criteria:

* presence of medical conditions that would be unsafe to exercise
* diagnosed with other neurological conditions (e.g. Parkinson's disease, Stroke, Multiple Sclerosis, AD) that affect cognition and mobility
* presence of depressive symptoms
* presence of acute or/and chronic disease that could not be controlled (e.g. Arthritis, Asthma, Hypertension, Diabetes mellitus, Coronary artery disease)
* exercise regularly (at least 30 min/day, 3 days/week)
Feasibility Study of BMAC Enhanced CABG

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years and ability to understand the planned treatment.
* Patients with ischemic congestive heart failure requiring by pass surgery
* Congestive heart failure with ejection fraction ≤ 40%.
* Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.
* Serum creatinine \< 3.0 or no dialysis.
* NYHA performance status ≥ 3.
* Negative pregnancy test (in women with childbearing potential).
* Subject has read and signed the IRB approved Informed Consent form
* Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT \<1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR\<1.6 at the time of randomization/surgery

Exclusion Criteria:

* Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
* History of Prior Radiation Exposure for oncological treatment.
* History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
* History of abnormal Bleeding or Clotting.
* History of Liver Cirrhosis.
* Acute Myocardial Infarction \< 4 weeks from treatment date.
* Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free.
* Active clinical infection being treated by antibiotics within one week of enrollment
* Terminal renal failure with existing dependence on dialysis
* Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
* Unable to have 250cc bone marrow harvested.
* Medical risk that precludes anesthesia or ASA Class 5
* History of ventricular arrhythmia if AICD is not present.
* History of ventricular aneurysm.
* Concurrent surgery such as CABG with valve surgery.
* Minimally Invasive bypass surgery
* Life expectancy \<6 months due to concomitant illnesses
* Treatment with immunosuppressant drugs (including Prednisone \> 5 mg per day)
* Patients undergoing urgent by pass surgical procedure
* Patients with HGB A1C \> 8.5%
Hypothermia and the Effect of Ambient Temperature

Neonatal hypothermia is associated with increased risk of mortality as well as multiple morbidities. The investigators objective is to determine if an increase in ambient operative room temperature decreases the rate of hypothermia. Operating room temperature will be randomized to the current institutional standard (67°F) or a temperature of 73°F on a weekly basis for a period of six months.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women and their neonates undergoing cesarean delivery by the Parkland Hospital Obstetrics Service on the Labor and Delivery "West" Unit (operating rooms 1, 2, 3, and 5) during the study period.

Exclusion Criteria:

* Subjects will be excluded from the study if cesarean delivery is planned but a precipitous vaginal delivery occurs, intrauterine fetal demise has been diagnosed prior to start of surgery, the neonate is noted to have a major congenital anomaly, resuscitative efforts are not performed ("comfort care only" provided), or a neonatal temperature is not available.
Treatment of HYpertension: Morning Versus Evening

Rationale:

The nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular disease (CVD) risk than either daytime office, awake or 24hour mean blood pressure. In general, when nocturnal blood pressure does not decline CVD risk is higher, usually referred to as "dippers" versus "non-dippers". Evening administration of treatment might lower nocturnal blood pressure more effectively than morning administration, which is most commonly advised.

The main hypothesis of this study is that evening administration of antihypertensive medication might resume the dipping pattern in non-dippers and as a consequence might reduce CVD risk more than morning administration.

Primary objective (in short):

-to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can resume a dipping blood pressure pattern in non-dippers

Study design: A double-blind placebo-controlled cross-over study Each person will use for one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening, and one period of six weeks the other way around


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension
* Stable blood pressure on treatment with Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor Blocker (ARB) and hydrochlorothiazide
* Age between 18 and 85 years
* WHO performance status 0-1
* Available for a time period of 15 weeks
* Written informed consent
* Dippers: Nocturnal blood pressure fall of 10-20% of daytime values.20
* Non-dippers: -Nocturnal blood pressure fall of \<10% of daytime values

Exclusion Criteria:

* secondary cause of hypertension
* use of ARB because of intolerability (e.g. dry cough) of ACEI
* nocturnal blood pressure fall of \>20% or rise
* renal insufficiency (GFR\<60 ml/min)
* shift work
* pregnancy or wish to get pregnant
* use of other antihypertensive medication than ACEI, ARB, hydrochlorothiazide or a calcium channel blocker
* use of sleeping medication
Hypoxia Blood Validation in Multiple Pulse Oximeters

The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.

This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.

The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals between the age of 18-50 years.

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications.
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.


Eligibility Criteria:
Inclusion Criteria:

* English or Spanish speaking
* American Society of Anesthesiologists (ASA) physical status 1-3
* Planned laparoscopic or robotic hysterectomy

Exclusion Criteria:

* History of chronic pain requiring preoperative opioids, Known alcoholism disorder
* Congenital coagulopathy,
* Localized soft tissue infection,
* Use of anticoagulants,
* Dementia, inability or refusal to provide consent for the surgery
* Morbid obesity (BMI \> 50), due to expected technical difficulty to achieve the block
Helicobacter Pylori Eradication and Follow-up

This randomized controlled clinical trial will estimate the eradication efficacy of different therapy for Helicobacter pylori treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.

Exclusion Criteria:

* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.
Comparison of Dexamethasone Doses on Persistent Postmastectomy Pain

This study evaluates the effect of dexamethasone on persistent surgical pain after mastectomy operations. Half of the participants will receive 0.1 mg/kg dexamethasone and the other half will receive 0.2 mg/kg dexamethasone.

Breast cancer is the most frequent malignancy of middle age women (%32) and causes 19% of cancer-related deaths. Acute pain can contribute to the development of persistent surgical pain. Persistent postsurgical pain has been demonstrated to be clinically relevant in 10% to 50% of patients undergoing various common operations, including breast cancer surgery. The pathogenic mechanisms are multiple, including nerve damage related to surgical technique resulting in risk of intercostobrachial neuralgia, neuroma pain, or phantom breast pain. Multimodal analgesic strategies are important.Glucocorticoid steroids can also provide beneficial effects when administered in appropriate doses as part of a multimodal analgesic regimen in the perioperative setting. A recent study demonstrated that preoperative application of dexamethasone reduced postoperative nausea and vomiting and pain in patients after thyroidectomy.. It is possible that the already established reduction in prostaglandin synthesis mediated by dexamethasone contributes to the analgesia. And also there are a lot of mechanisms more.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old, female patients
* Written informed consent.

Exclusion Criteria:

* American Society of Anesthesiologists Physical Status ˂3
* Any contraindication to dexamethasone
* Emergency or urgent procedure
* Obesity body mass index ≥27 kg m2
* Motion sickness and vertigo patients
* Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
* Significant hepatic (Alanine aminotransferase or Aspartate aminotrans \> 2 times normal)
* Renal (serum creatinine \> 2 mg/dl) impairment
Cerebral Oxygenation and Autoregulation in Preterm Infants

Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.

This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.


Eligibility Criteria:
Inclusion Criteria:

* inborn
* birth weight \<= 1250 grams
* indwelling arterial catheter in place
* age \<24 hours old

Exclusion Criteria:

* lethal chromosomal abnormality
* major congenital anomaly
* skin integrity insufficient to allow placement of NIRS sensors
* decision to not provide full intensive care
Tamoxifen Treatment in Patients With Motor Neuron Disease

The aim of this study is to survey the effect of Tamoxifen in motor neuron disease (MND) patients, amyotrophic lateral sclerosis (ALS) with regular riluzole usage. TDP-43 is related to ALS. Increased the ubiquitinated or phosphorylated TDP-43 can cause animal model of ALS, and TDP43 can be degraded either by proteasome or autophagy pathway system. Autophagy pathway can be activated by mTOR inhibition, resulting in ameliorating TDP-43 accumulation and rescue in motor function in animal model. Tamoxifen had shown ability of enhance both proteasome and autophagy pathway, therefore the investigators assume that Tamoxifen probably can ameliorate TDP-43 accumulation and inclusion body formation in ALS.

The investigators will assess the ALSFR-s in ALS patients at start, 1, 3, 6 and 12 months and correlate the score to the neurological outcome of the patients with and without tamoxifen treatment at dose of 40mg daily for one year.

The study will be able to prove the investigators hypothesis: Tamoxifen, a protease and autophagy enhancer, has synergic effect with riluzole in ALS patients to slowing the progression of neurological dysfunction, and respiratory insufficiency.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosed and confirmed ALS patients, with regular follow up and oral form riluzole at National Taiwan University or Shuang- Ho Hospital for more than 6 months.
2. Age ≧20 years old

Exclusion Criteria:

1. Patients who had already ventilator dependent, not regular followed up for more than 6 months or against medical advice, refuse to follow up at neurology department will be excluded in this study.
2. Patients with now or previous usage of Tamoxifen
3. Patients with any contraindications of Tamoxifen usage
4. Patients with other internal medicine illiness
Prospective Database for Colonic or Rectal Resection Surgery Patients

Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).

Colorectal cancer is the second leading cause of cancer death in France. It accounts for nearly 12% of all cancer deaths, especially among those 65 and over. However, mortality has declined steadily since 1980.

Access to screening for colorectal cancer and resection of precancerous lesions partly explains this decline. All sexes combined, it is estimated that about one in five colorectal cancer is diagnosed at a limited local stage. The treatment is then less heavy and gives better results.

With the development of Enhanced Recovery After Surgery (ERAS) protocols and their extension to rectal excision, it becomes imperative to be able to collect operative data from these patients on a perennial basis for the purpose of evaluating our results. Finally, the evaluations resulting from this database could have prognostic value and ultimately allow us to adapt the surgical management of the patient according to the results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated for colonic and / or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,
2. Patients over 18 years old,
3. Affiliation to a social security scheme, or beneficiary of such a scheme.
A Study to Observe the Safety, Tolerability, and Efficacy of Remodulin

This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The objective in this study is to observe the efficacy and safety of treprostinil in subjects with pulmonary arterial hypertension.

This is a multi-center, single-arm, prospective study to enroll patients diagnosed as pulmonary arterial hypertension. The expected study period will be 2 years. PAH patients, who met NHI criteria, to receive treprostinil subcutaneously/ intravenously, will be invited to join this study for observation. The dosage and administration schedule of study medication will be judged by investigators. If the eligibility criteria have been met and the subject have signed the informed consent, the subjects will be enrolled into this study. There will be 10 visits: Visit 1 (Screening visit, Week -2 \~ -1), Visit 2 (Week 1, initial of use treprostinil), Visit 3 to 9 (Week 13 to 85), Visit 10 (Week 97). The Day 1 in Week 1 should be the start day of treprostinil treatment. Subjects will be returned to the clinics every 3 months (i.e. 12 weeks) after Visit 2. The NT-proBNP level, WHO functional class, 6-minute walk distance, echocardiography, pulse oximetry, modified Borg Dyspnea Scale, SF-36 questionnaire, and dosage regimens of treprostinil (including dose adjustment) will be collected. For time to clinical worsening and death, it will be followed up during study period. All intercurrent events within 24 months will be recorded. Safety information, including vital signs, and physical exams will be checked. Adverse events of special interest (AESIs) will be reviewed every visit by using a predesignated AESI checklist.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic idiopathic or heritable PAH classified as WHO functional class III and IV symptoms.
* PAH patient, who met NHI criteria, will be scheduled to receive subcutaneous/intravenous treprostinil treatment.
* Ability to adhere to the study visit schedule and understand and comply with all protocol requirements.
* Will provide completed and signed written informed consents

Exclusion Criteria:

* Active treatment with injectable prostanoids different from subcutaneous/intravenous treprostinil
Effect Of Laparoscopic Sleeve Gastrectomy on Vitamin D, Parathormone and Calcium Levels

Obesity is likely to be the disease of the 21th century. The growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. Developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. The national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades.

the study aimed to assess the effect of Vit D supplementation on preventing altered levels of calcium, Vit D, and parathormone after laparoscopic sleeve gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* male or female
* from 18 to 60 ages
* BMI: 40 kg/m2 or \> 35 kg/m2
* comorbidities e.g., hypertension and DM
* conservative management for obesity failed in at least 2 years

Exclusion Criteria:

* BMI \> 60
* history of bariatric surgery
* symptomatic reflux oesophagitis
* stomach cancer
* active peptic ulcer disease
* alcohol or drug abuse
* major psychological disturbance
* major eating troubles
* risky anesthesia
* risky surgery.
Preventing the Return of Depression in Elderly Patients

The purpose of this study is to compare the effectiveness of two doses of nortriptyline in elderly patients whose depression returned after stopping treatment. Nortriptyline is an antidepressant.

This study enrolls patients who were treated for depression in an earlier research study and whose depression has returned since stopping treatment. Patients are treated for 4 months to bring the depression under control. Patients are then assigned randomly (like tossing a coin) to receive either the full dose of nortriptyline or half the usual dose of nortriptyline. Patients continue taking nortriptyline for 2 years or until a major depression returns. Throughout the study, patients are monitored for symptoms of depression and other side effects.

To determine whether elderly (60-80 years old) depressed patients who cannot sustain a remission without medication must be maintained at full acute-treatment dose. To compare the efficacy of full-dose vs half-dose nortriptyline (NT) in preventing recurrences of major depression in the elderly. To determine whether those patients who experience a recurrence while in a maintenance placebo condition (Study I) require 100 percent of their acute-treatment dose of NT to prevent subsequent recurrences or can be successfully maintained on 50 percent of their acute-treatment dose (Study II).

Investigators expect a pool of 60 patients from Study I to become eligible for Study II (the full-dose/half-dose maintenance trial). After treatment of the recurrence and following 16 weeks of stabilization therapy, patients are randomized to 1 of 2 maintenance therapy cells: full-dose NT or half-dose NT. Maintenance lasts 2 years or until recurrence of major depression. The following are assessed: differences in recurrence rates and time to recurrence under full-dose vs half-dose conditions; differences in symptomatic ratings of depression, suicidal ideation, social adjustment, and side effects; and differences in compliance rates as determined by variability in level-to-dose (L/D) ratios. Exploratory data analyses are used to generate a hypothetical profile of elderly patients who can remain well on half-dose maintenance nortriptyline.

For information on related studies, please follow these links:

http://clinicaltrials.gov/show/NCT00178100

http://clinicaltrials.gov/show/NCT00177671

Eligibility Criteria:
Inclusion Criteria:

-

Patients must have:

Recurrence of major depression while in a maintenance placebo condition in the currently funded maintenance therapy protocol (Study I).