cyrilzakka/clinical-trials huggingface dataset:
New CVD Risk Factors for Lowered Cognitive Functioning

To explore the associations between cognitive functioning and three major cardiovascular disease risk factors: high blood pressure; high total plasma homocysteine (tHcy); and ApoE e4 genotype.

BACKGROUND:

Arterial hypertension and high blood pressure (HBP) are major risk factors for cardiovascular disease (CVD) and stroke; they are also risk factors for lowered cognitive functioning. Except for diabetes, there have been comparatively few studies of other common risk factors, particularly with regard to interrelationships among risk factors which may adversely affect cognitive ability.

DESIGN NARRATIVE:

The study examines associations between cognitive functioning and three cardiovascular risk factors: 1) high blood pressure; 2) high total plasma homocysteine (tHcy), and 3) ApoE e4 genotype. These associations are examined cross-sectionally as well as longitudinally, using data collected at a follow-up visit of members of a cohort that has been followed for the past 18-19 years. Longitudinal data are used to examine both current and change in cognitive functioning. Some analyses are prospective (e.g., high blood pressure and change in cognitive functioning), while others are cross-sectional (e.g., ApoE e4 and current cognitive functioning) or retrospective (e.g., tHcy and change in cognitive functioning). Structural equation models are used to examine cross-sectional data in elucidating a general theoretical model. Two-stage growth curve analyses and survival analyses are appropriate methods for analyzing the longitudinal data. The study includes a very comprehensive set of measures that have already been collected or will be collected during the follow-up visit. All potential confounders of the association between the three target predictor variables and the various domains of cognitive functioning appear to have been included in this design.

Eligibility Criteria:
No eligibility criteria
Setting up a COVID-19 Care Facility at a Prison in Pakistan

Presenting outline of the steps taken by our team to set up a Covid Care facility within the Prison setting. The facility was set up at Camp Jail (Lahore District Jail) located on Ferozpur Road, Lahore.

A prisoner brought to Camp Jail developed symptoms of and later tested positive for COVID-19. This lead to almost 527 contacts. An outbreak was expected. To manage the situation , a COVID-19 Care Facility was established within the prison. The study describes the steps taken by the team to set up this facility.

Eligibility Criteria:
Inclusion Criteria:

- All COVID-19 positive prisoners within the Camp Jail

Exclusion Criteria:

* Any patient being shifted to any other facility (except designated)
Neuromuscular Electrical Stimulation in Acute Ischemic Stroke

The purpose of the study is to examine the added effect of NeuroMuscular Electric Stimulation (NMES) in addition to exercise therapy in the acute phase of ischemic stroke.

This randomized controlled trial includes 50 patients allocated to either control or intervention.

The inclusion, test, training and re-test will be provided during the first 14 days after ictus, starting day 1 or 2 after ictus and a follow-up at day 90.

The exercise training with external NMES is done with the patient every weekday for 12 minutes.

Stroke is the third most cause of disability in adults over 65 years of age worldwide. In 2008, 30.7 million people had survived a stroke. Every year, there are about 14,000 new cases of stroke in Denmark and the number is expected to rise with about 40% by 2035, due to the increasing population of elderly. Stroke survivors have the worst odds of reporting severe disability and the greatest variety of individual domains of disability compared to a range of other diseases. Therefore, these patients have essential rehabilitation needs. Little is known about who will benefit from functional interventional rehabilitation and what kind of intervention is best.

The purpose of the study is to examine the added effect of NeuroMuscular Electric Stimulation (NMES) in addition to exercise therapy in the acute phase of ischemic stroke.

This RCT includes 50 patients allocated to either control or intervention. The inclusion, test, training and re-test will be provided during the first 14 days after ictus, starting day 1 after ictus and a follow-up at day 90.

The exercise training with external NMES is done with the patient every weekday for 12 minutes.

If NMES increases functionality in acute stroke patients it would mean a greater degree of independence for individual patients and thus have the potential to improve on a major problem for society.

By combining comorbidity, stroke severity, and other demographic data it might be possible to get a greater knowledge about who will benefit from the intervention and early rehabilitation and that will be the a step towards "personalized medicine" in stroke rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic apoplexy and paresis in lower extremity, verified with picture diagnosis (CT/MR) or clinically diagnosed.
* Leg palsy equalizes 2-4
* Modified Ranking Scale(mRS) =0-1
* Cognitive function adequate to participate

Exclusion Criteria:

* Patients with dementia and/or malign diseases
* Pregnancy
* Epilepsy
* Total loss of sensation
* Pacemaker
* Previous or current blood clot in the leg
* Untreated depression
* Untreated alcohol or drug abuse
* Untreated hypertension
* Heart disease which limits function
Key circRNA Identification of Postoperative Delirium in Elderly Patients Undergoing Cardiac Surgery

The observational study aims to discover differentially expressed circRNAs in the peripheral blood of patients with postoperative delirium, which aims to answer the main questions at:

Whether there are changes in circRNA expression in peripheral blood in elderly patients with delirium after cardiopulmonary bypass surgery? Whether the circRNA with altered expression plays an important role in the occurrence and development of POD? What are the functions and underlying mechanisms of circRNA with altered expression in POD? Voluntary patients will receive follow-up 1 day before and 7 days after surgery to assess their cognitive function, and peripheral blood will be collected 1 day before and 3 days after surgery. The study divided patients into POD group and non-POD group according to whether delirium occurred within 7 days after surgery.

Investigators combined qRT-PCR by performing circRNAs chip analysis to study differential expression of circRNAs in plasma samples of elderly patients with non-POD who underwent cardiac surgery under general anesthesia and cardiopulmonary bypass. Subsequently, miRNA binding sites and associated mRNAs are predicted by bioinformatics analysis. Moreover, we plan to construct predicted circN-MIRNA-MRNA co-expression networks to study the main functions and pathways of target genes, thereby attempting to provide a preliminary view of the potential role of a circRNA in POD. The study may provide an important perspective on the differential expression of circRNA in patients with POD, and may also provide insights into biomarkers and therapeutic targets of POD.

Eligibility Criteria:
Inclusion Criteria:

1. Be over 50 years old;
2. ASA Grade I-III;
3. Heart surgery is planned under general anesthesia.

Exclusion Criteria:

1. Patients with the second surgery;
2. The ejection fraction is less than 40%;
3. The score of the preoperative simple mental status examination (MMSE) is less than 24 points;
4. Patients with mental illness or central nervous system disease;
5. Patients who cannot or refuse to complete MMSE before surgery.
Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)

Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.

Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability \& validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Patient age between 40-65 with diagnosis of COPD
* Outpatient individual who are on follow up
* Healthy individual
* Those who can read and understand English and Urdu as well.

Exclusion Criteria:

* Patient with cognitive impairment or sensory disorder were exclude.
* Patient physical disability
* Refuse to perform test
Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in Korea

To evaluate the efficacy of a fixed dose of Azilect® (1 mg/day) vs placebo as assessed by the change from baseline in mean total daily OFF time during 18 weeks of treatment in levodopa-treated Parkinson's Disease (PD) patients with motor fluctuations in Korea.

Levodopa has been the mainstay therapy for PD for decades, and it is considered to be one of the most effective medications for relief of the symptoms of PD. However, within few months to few years the majority of levodopa-treated patients notice a decline in the duration of benefit of each dose and develop motor-complications. A major problem is the appearance of fluctuations in mobility, cycles of ON and OFF periods. The administration of Azilect®, a monoamine oxidase type B (MAO-B) inhibitor, can slow the elimination of the endogenous dopamine supplies or the dopamine produced from the exogenous levodopa therapy and may therefore improve ON-OFF fluctuations. Azilect® is approved for treatment of PD in Europe and the US.

The objective of this study is to evaluate the efficacy, tolerability, and safety of Azilect® compared to placebo in Korean PD patients with motor fluctuations on levodopa therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic PD
* Patients with motor fluctuations averaging at least 1 hour daily in the OFF state during the waking hours (not including morning akinesia)
* Patients with a Modified Hoehn and Yahr stage \<5 in the OFF state
* Patients taking optimised levodopa/DOPA decarboxylase inhibitor (DDI) therapy for at least 14 days prior to baseline
* Patients receiving at least 3 daily doses of levodopa, not including a bedtime dose, and not more than 8 daily doses of levodopa
* Patient who have demonstrated the ability to keep accurate 24-hour diaries prior to randomisation

Exclusion Criteria:

* Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation
* Patients taking any disallowed medication according to the Azilect® approved label
* Patients taking MAO inhibitors within 3 months prior to baseline visit
* Patients with a known serious adverse reaction to selegiline
* Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study
* Patients with a Mini Mental State Examination (MMSE) score \<=24
* Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion
TXA Nebulization for the Treatment of Hemoptysis

Hemoptysis is a common presentation in medical emergency. Prompt medical therapy, bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis. Priority is given for medical management to achieve hemostasis and prevent aspiration as well as treatment of underlying etiology, before undertaking any definitive bronchoscopic or endovascular intervention. While majority of the patients are managed successfully by prompt medical therapy, only the refractory cases and life-threatening hemoptysis need more definitive procedures like DSA guided bronchial artery embolization and bronchoscopic procedures like endobronchial biocompatible glue, endobronchial embolization using silicone spigots, endobronchial stents, laser photocoagulation. Tranexamic acid is an anti-fibrinolytic agent which prevent breakdown of fibrin clots, thus helping in clot stabilization and controlling bleeding. As a medical therapy Tranexamic Acid is used for bleeding control in hemoptysis as well as other surgical or traumatic bleeding. Previously conducted institutional study comparing IV infusion of TXA to placebo in patients with sub massive hemoptysis showed results favoring TXA over placebo in terms of decreasing frequency \& quantity of hemoptysis, duration of hospital stay and need for DSA/ broncoscopic/ surgical intervention and blood transfusion (1). While the oral and IV routes have been most commonly studied, use of novel approaches like aerosolized TXA and endobronchial instillation of TXA during bronchoscopy have showed positive results in achieving hemostasis in hemoptysis (2). A recently conducted RCT, to assess the effectiveness of TXA nebulization in sub-massive hemoptysis concluded that nebulized TXA is effective in reducing the frequency and quantity of hemoptysis. Nebulized TXA was also found to be safe as no severe ADR was noted during its use as per previous RCT as well as multiple case reports.

However, because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized TXA is limited in hemoptysis. In hemoptysis nebulized form of TXA is supposed to reach local site of bleeding (lung/ airway) promptly at a higher concentration leading to rapid control of hemoptysis. So, this study has been planned to evaluate further this novel approach of TXA nebulization for the management of hemoptysis. Similarly, data regarding adverse drug reaction related to TXA nebulization is also limited. This study will produce additional information regarding efficacy, safety and ADR related to TXA nebulization.


Eligibility Criteria:
Inclusion Criteria:

* All cases of active hemoptysis
* irrespective of gender
* age≥ 18 years

Exclusion Criteria:

* Massive hemoptysis
* Pregnancy
* Drug allergy to TXA4
* Renal failure
* Receiving Oral Contraceptive Pills.
* Already on blood thinner
* Not willing for consent.
Study of Acute Normovolemic Hemodilution (ANH) in People with Ovarian Cancer Who Are Having Cytoreductive Surgery

Participants will be scheduled for primary cytoreductive surgery as part of their standard care. Before surgery, participants will be assigned by chance to a study group. Depending on which group they are in, they will receive either acute normovolemic hemodilution/ANH during surgery or standard surgical management during surgery. The researchers think acute normovolemic hemodilution/ANH may decrease the need for allogenic blood transfusion/ABT in people having primary cytoreductive surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years)
* BLOODS score ≥2 as calculated by surgeon
* High preoperative suspicion (or diagnosis) of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV), as determined by CT or MRI of the abdomen/pelvis
* Planned for exploratory laparotomy and primary or interval cytoreductive surgery
* Preoperative hemoglobin concentration ≥10 mg/dl within 45 days of surgery
* Patients scheduled for cytoreductive surgery, with or without other planned procedures o Note: Patients scheduled for diagnostic laparoscopy should not be included

Exclusion Criteria:

* A history of active coronary artery disease

  o Patients with a history of coronary artery disease will be eligible if they have had a cardiac stress study showing no reversible ischemia and normal LV function within 45 days of surgery.
* A history of cerebrovascular disease
* A history of congestive heart failure
* A history of uncontrolled hypertension
* A history of restrictive or obstructive pulmonary disease
* A history of renal dysfunction (Cr \>1.6 mg/dl)
* Abnormal coagulation parameters (INR \>1.5 not on coumadin, or platelet count \<100,000 mcL)
* Presence of active infection
* Evidence of hepatic metabolic disorder (bilirubin \>2 mg/dl, ALT \>75 U/L in the absence of biliary tract obstruction)
* Preoperative autologous blood donation within last 30 days or plan to donate autologous blood prior to surgery
* Refusal to accept allogenic or autologous blood transfusion
Low Levels of Electromagnetic Fields to Treat Advanced Cancer

Following the discovery of tumor-specific frequencies in patients with advanced cancer, compassionate treatment with tumor-specific frequencies administered at levels that are significantly below the levels generated by cell phone will be offered to patients with limited therapeutic options.

We have previously shown that the intrabuccal administration of low and safe levels of electromagnetic fields, amplitude-modulated at a frequency of 42.7 Hz by means of a battery-powered portable device modifies the electroencephalographic activity of healthy subjects (1, 2) and is associated with subjective and objective relaxation effects (3). These results prompted us to study the effects of the 42.7 Hz frequency in patients suffering from insomnia. A randomized control trial did not reveal any difference between 42.7 Hz treatment and placebo (4) but sequential administration of four insomnia-specific frequencies, including 42.7 Hz, resulted in a significant decrease in sleep latency and a significant increase in total sleep time in patients suffering from chronic insomnia (5). Dosimetric studies have shown that the amount of electromagnetic fields delivered to the brain of patients with this approach is 100 to 1000 times lower than the amount of electromagnetic fields delivered by handheld cellular phones and do not result in any heating effect within the brain (4). The U.S. FDA has determined that such a device is not a significant risk device. Lastly, a long-term follow-up survey of 807 patients who have received this therapy revealed that the rate of adverse reactions were low and were not associated with increases in the incidence of malignancy or coronary heart disease (6).

Given the advantageous safety profile of athermal, non-ionizing radiofrequency electromagnetic fields and the emerging evidence that low levels of electromagnetic or electric fields may modify the growth of tumor cells (7-9), we decided to test the hypothesis that low levels of electromagnetic fields modulated at tumor-specific frequencies may alter the growth of human malignancies. We have developed a novel patient-based biofeedback method with the goal to identify cancer-specific frequencies and have examined patients with this approach. Following identification of such frequencies in a total of 163 patients, we will offer compassionate treatment to 28 patients with advanced cancer and limited palliative therapeutic options.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with advanced disease and limited therapeutic options

Exclusion Criteria:

* Any patient with curative treatment options
Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

The primary objective of the study is to estimate the annualized relapse rate (ARR) over a 12-month period in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) as their initial therapy (treatment-naïve), or switching from interferon (IFN) or glatiramer acetate (GA) (after suboptimal response defined as suboptimal efficacy, intolerance, or poor adherence to IFN or GA), as determined by the Prescribing Physician. The secondary objectives of this study in this study population are: To assess the impact of DMF over a 12 month period on patient reported outcomes (PROs) and health economic related outcomes; and to evaluate additional clinical outcomes at Month 12.


Eligibility Criteria:
Key Inclusion Criteria:

* Have access to the internet and are able to complete online assessments on a computer.
* Have relapsing-remitting MS and satisfy the approved therapeutic indication for DMF per the Canadian Product Monograph.
* Are either treatment-naïve or being treated for RRMS with IFN or GA but, per the Prescribing Physician, have a suboptimal response (e.g., suboptimal efficacy, intolerance, or poor adherence) to IFN or GA or have stopped treatment with IFN or GA for RRMS as a result of suboptimal response within 30-60 days of enrollment.

Key Exclusion Criteria:

* Have major comorbid conditions that would preclude their participation in the study as determined by the Prescribing Physician.
* Have a history of malignancy. (Patients with basal cell carcinoma that has been completely excised prior to study entry remain eligible.)
* Are receiving disease modifying therapies other than IFN or GA or have initiated treatment with a new disease modifying therapy since discontinuation of IFN or GA.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Tolerability of Modafinil for Methamphetamine Dependence

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* not currently enrolled in a treatment program
* subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
* subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
* women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study

Exclusion Criteria:

* current diagnosis of alcohol, opiate, or sedative physical dependence
* ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
* history of schizophrenia, or bipolar type I disorder
* present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
* medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
* Current suicidality or psychosis
* liver function tests (i.e., liver enzymes) greater than three times normal levels
* pregnancy or breastfeeding