cyrilzakka/clinical-trials huggingface dataset:
Investigation of Asprosin a Novel Adipokine in Periodontitis

Asprosin, a recently discovered glucogenic adipokine, is mainly synthesized by white adipose tissue and released during fasting. Appetite, glucose metabolism, insulin resistance, cell apoptosis, etc. asprosin is associated with diseases such as diabetes, obesity, polycystic ovary syndrome, and cardiovascular diseases. Periodontal tissue may act as a source of endocrine-like inflammatory mediators (such as TNF-α, IL-6 and IL-1) that are important in periodontal inflammation and can affect glucose and lipid metabolism. Production of TNF-α and IL-6 in adipose tissues strengthens the relationship between obesity, T2DM and periodontitis.we postulated that asprosin may be candidate for explaining the triangular relationship among obesity, T2DM, and periodontal disease.

Periodontal disease is a chronic, multifactorial, and infectious disease caused by bacteria. It is characterized by the formation of an inflammatory response in the supporting bone and connective tissue against microbial dental plaque, and the nature of the resulting inflammatory response determines the course of periodontal disease. Type 2 Diabetes Mellitus (T2DM), obesity, and periodontal disease are closely related, presenting a triad association. Obesity is the crucial cause of T2DM and periodontitis is the sixth complication of diabetes. Asprosin circulates in the blood at nanomolar levels and is taken to the liver, where it activates the G protein-cAMP-PKA pathway, causing rapid glucose release into the circulation. Insulin-resistant humans and mice have been reported to have pathologically elevated plasma asprosin levels. It will be investigated whether asprosin, which we know to be effective on glucose metabolism, is affected by the periodontal condition.

Eligibility Criteria:
Inclusion Criteria: -

* All individuals were generally healthy,
* non-smoking

Exclusion Criteria:

* Pregnant or breastfeeding women
* None had undergone periodontal therapy and/or antibiotic therapy in the past 6 months.
* None has a contagious disease such as HIV or AIDS
Exercise and Overnight Motor Sequence Task

The objective of this randomized controlled trial (RCT) is to compare the changes of the sleep-related memory functions in patients with psychosis after they have completed the 12-week high-intensity exercise intervention, the 12-week low-intensity exercise intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one patients with psychosis, patients who received either the high-intensity exercise or low-intensity exercise as intervention shown a significant improvement to their impaired sleep-related memory function, while those who received non-exercise intervention has no such improvement. Moreover, high-intensity exercise may have a more prominent effect compare to low-intensity exercise.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 55
* Based on the SCID diagnosed to have schizophrenia and related psychotic disorders
* Ability to understand the nature of the study and to give written informed consent

Exclusion Criteria:

* Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
* Comorbid substance dependence
* Unstable psychotic symptoms
* A history of brain trauma or organic brain disease
* Known history of intellectual disability or special school attendance
* Answered one or more "yes" in the PAR-Q and without doctors approval for exercise
Clinical Evaluation on the Use of the X-pander Device

The purpose of this study is to clinically evaluate the use of the x-pander device.

Clinical evaluation on the use of the x-pander device during THA-surgery

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for hip osteoarthrosis

Exclusion Criteria:

* Previous surgery of the actual hip
Safety and Efficacy Study

The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with study requirements
* Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 26 days post-natal age at enrollment visit
* Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
* Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures
Sleep and Breathing in the General Population - Chemical Stimuli

Central sleep apnea (CSA) is a common condition and its treatment remains elusive. The focus of this proposal is to identify the role of the physiologic path involving cortical arousals in CSA by decreasing arousal frequency using the pharmacological agent zolpidem. The goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of CSA and propensity to develop CSA. This study will shed light on the mechanisms underlying CSA that involve cortical arousals and will guide future therapeutic interventions for CSA.

The literature suggests that zolpidem may be effective in the treatment of central sleep apnea (CSA). However, evidence regarding the efficacy of zolpidem and the underlying mechanisms involved in its effect on CSA are not well-studied. Furthermore, respiratory-related arousals are hypothesized to contribute CSA symptoms and severity. The aim of the study is to determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. The investigators hypothesize that administration of the nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related arousals, lower the central apnea-hypopnea index, and widen the CO2 reserve during sleep in patients with CSA compared to no treatment. Participants will complete a night study on a low dose of zolpidem and another night study without zolpidem in a crossover manner. The order of night studies is randomized. The results will help unveil the role of arousals in CSA and the acute effect of zolpidem on CSA severity and the propensity to CSA.

Eligibility Criteria:
Inclusion Criteria:

* Men and women Veterans with central sleep apnea, defined as Apnea Hypopnea Index (AHI)\>15/hour with CAHI\>5/hour, will be included in the experiments.

Exclusion Criteria:

* less than 18 years old
* pregnant or breastfeeding female
* have severe respiratory disease that require to be on oxygen
* recent health event that may affect the ability to participate in the study,
* Body Mass Index (BMI) is \>40 kg/m2
* significant insomnia
* mental instability
* recent health event that may affect sleep
* if at any time the principal investigator (PI) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study
Functional Neuroimage in Assessment of Post-stroke Aphasia

The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.

2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.

Eligibility Criteria:
Inclusion Criteria:

* Aphasic stroke in chronic stage (over 3 months)

Exclusion Criteria:

* No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Intervention Study on Digital Health Management

The aim of this study is to construct a digital precision intervention system for cardiometabolism disorders based on the characteristics of the Chinese population, focusing on the core components of metabolic syndrome such as hypertension, hyperglycemia, and obesity. Through dynamic monitoring of wearable devices, the individualized risk factors (including genetic predisposition, lifestyle, and psychological factors) of metabolic disorders were systematically analyzed, and dynamic intervention strategies were formulated accordingly. The closed-loop management of "monitor-feedback-optimization" based on the digital platform will provide patients with one-stop metabolic risk assessment and panoramic health management plan, realizing a paradigm shift from "generalized intervention" to "precise regulation". By reducing the abnormal fluctuations of key metabolic indicators such as blood pressure, blood glucose, and blood lipids, the risk of cardiovascular events will eventually be reduced, the long-term quality of life of patients will be improved, and a practical path of "digital therapy" can be promoted for the prevention and control of chronic diseases in China


Eligibility Criteria:
Inclusion Criteria:1. Age 18-65 years old; 2. Meet one of the following three conditions:

1. Diastolic hypertension (systolic blood pressure \< 140 MMHG and diastolic blood pressure ≥90mmHg)
2. Glycosylated hemoglobin (6.0-6.5)
3. Obesity (BMI≥28kg/m²)
4. Mild hyperlipemia: total cholesterol (TC) ≥5.2 mmol/L and \< 6.2 mmol/L, or low-density lipoprotein cholesterol (LDL-C) ≥3.4 mmol/L and \< 4.1 mmol/L 3. Antihypertensive or lipid-lowering medications have not been started 4. Use a smartphone and volunteer

Exclusion Criteria:

1. Complicated with chronic liver and kidney disease, coronary heart disease, heart failure and severe valvular disease
2. Previous cardiovascular and cerebrovascular events
3. Diastolic blood pressure ≥99mmHg
4. Glycated hemoglobin ≥6.5
5. Other life expectancy such as cancer is less than 5 years
6. Participate in other clinical trials
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study

The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.


Eligibility Criteria:
Inclusion Criteria:

* Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead
* Patient has signed and dated the study-specific Patient Informed Consent form
* Subject is at least 18 years of age

Exclusion Criteria:

* Patient has a previous LV lead implanted not requiring repositioning
* Pregnant woman
* Patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma

The clinical trial is designed to evaluate the safety of inhaled Technosphere/Insulin compared with non-inhaled anti-diabetic therapies in subjects with type 1 or type 2 diabetes mellitus and concurrent asthma.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of Step 1 to 3 asthma as per the NAEPP guidelines
* Clinical diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
* Current stable anti-diabetic regimen (insulin alone or in combination with oral anti-hyperglycemic agents)
* Subjects must exhibit \<30% variability in PEF measurements during the 2 week run in period.
* Subjects must not meet any criteria for exacerbations of asthma during the 2 week run in period
* Body mass index (BMI) \< 40kg/m2
* HbA1c \>6.0% to \<11.5%

Exclusion Criteria:

* Severe complications of diabetes in the opinion of the investigator
* Seizure disorder
* Significant cardiovascular dysfunction and/or history within 3 months of screening
* Hypertension with systolic blood pressure of !80 mm Hg and/or diastolic blood pressure \>110 mm HG at screening despite pharmacologic therapy.
* Clinical nephrotic syndrome or renal dysfunction or disease
* Total daily insulin requirement of \>1.4 U/kg body weight
* Clinical diagnosis of Step 4 asthma
* Use of \>6 puffs/day of fast acting bronchodilator
* Currently using an insulin delivery pump
* Use of Pramlintide acetate or any incretins must be discontinued 8 weeks prior to screening
* Two or more severe hypoglycemic episodes within the past 6 months.
* Any hospitalization or emergency room visit due to poor diabetic control with 6 months of screening.
* Current use of systemic steroids
* Subjects who currently smoke tobacco or who have smoked within the past 6 months
* Urine cotinine test of \> 100ng/ml
* Current drug or alcohol abuse
* Clinically significant abnormalities on screening laboratory evaluation
* Cancer within the past 5 years or any history of lung neoplasms
* History of active and/or cirrhotic hepatic disease and/or abnormal liver enzymes.
* Active infection or history of severe infection with 30 days of screening.
* Anemia
* History of anaphylaxis and/or angioneurotic edema
* Diagnosis of chronic obstructive pulmonary disease (COPE)
* Previous exposure to any inhaled insulin product
A Study to Assess the Safety and Efficacy of Vatiquinone in Participants With Friedreich Ataxia

The primary objective of this study is to assess the long-term safety of vatiquinone in participants with Friedreich ataxia (FA) previously exposed to vatiquinone.

This long-term, open-label study will serve as a continued access study for participants with FA who have previously participated in a vatiquinone study. The purpose of this study is to assess continued safety and efficacy of vatiquinone dosing in previously treated participants. This study addresses the medical need for participants to continue vatiquinone with a planned study duration of 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Participants with FA who completed and directly rolled over from a previous vatiquinone clinical study.
* Males and females of childbearing potential must be willing to use an effective method of contraception (for example, implants, injectables, transdermal patches, combined oral contraceptives, barrier methods, and intrauterine devices) from the time consent is signed until 30 days after the last dose of study drug or Early Termination Visit.

Exclusion Criteria:

* Current participation in any other interventional study
* Pregnancy or breastfeeding
Power Training in Older Multiple Sclerosis Patients

The study seeks to investigate whether 24 weeks of power training has neuroprotective effects in older PwMS. Additional purposes are to examine the effects of 24 weeks power training on physical function, cognitive function and neuromuscular function. Further, it is investigated whether the potential effects of power training are maintained after 24 weeks of follow-up.

Over the past 3-4 decades, the lifespan among people with multiple sclerosis (MS) has increased substantially. Today more than one-third of all people with MS are 60 years or older. With advanced age, people with MS are more likely to have impairments in cognitive and physical function.

Positive adaptations within the nervous system (\~neuroplasticity) have been shown to occur in people with MS following periods of resistance training (RT). This resembles the observations in young and old healthy individuals. Moreover, a specific type of RT termed power training appears to be particularly beneficial, as it emphasizes an explosive concentric phase of muscle contraction. This taxes the nervous system to a very high extent. As a result, power training has been shown to improve several aspects that rely on the nervous system in older individuals without MS. These aspects include cognition, neuromuscular function, and physical function.

The investigators speculate that older people with MS would also benefit. However, no studies have looked into the effects of power training in older people with MS.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 60 years of age.
* Clinically diagnosed with MS according to the McDonald criteria (48).
* Having an EDSS ≤ 6.5.
* able to transport themselves to the testing at Aarhus University and Aarhus University Hospital.
* able to transport themselves to training, if randomized to the PRP group.

Exclusion Criteria:

* having comorbidities (cardiovascular, respiratory, orthopedic, or other neurological diseases than MS) affecting PRP participation or MRI scans.
* having a pacemaker.
* having metallic implant(s) that prevents MRI scans.
* having untreated osteoporosis; t-score below -2.5 and a history of low energy facture or t-score below -3.0.
* participating in more than two sessions per week of structured PRE and have done so for the past 3 months.
* Are cognitively impaired at a level expected to prevent the participant from understanding training and testing instructions.
Efficacy of Two Intermittent Subglottic Secretion

The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease

Ventilator-associated pneumonia (VAP) is a common and serious complication of mechanical ventilation. Many studies have shown that the accumulation of subglottic secretions above the endotracheal cuff plays an important role in the pathogenesis of VAP. Subglottic secretion drainage (SSD) has been shown to be associated with a lower incidence of VAP in previous meta-analyses. Most studies in past reported that in the group of patients in whom endotracheal tube (ETT) was used and subglottic secretion drainage was applied compared to the group without subglottic secretion drainage.Very few studies compared two different methods of SSD,such as subglottic secretion lavage combined with aspiration or pure aspiration.The tubes need frequent cleaning as they often get blocked, especially the draining duct. This may be the reason why they are not commonly applied. However,subglottic secretion lavage combined with aspiration can reduce the incidence of tube blockage.So The purpose of this study is to determine the efficacy of intermittent subglottic secretion lavage combined with aspiration preventing ventilator associated pneumonia in patients with severe neurological disease.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 80 years requiring mechanical ventilation for more than 72 hours with placement of an ETT( equipped with a dorsal suction catheter for subglottic secretion drainage)

Exclusion Criteria:

* Exclusion criteria were patients endotracheal intubation was performed before admission, history of HIV, immunosuppression, leukopenia, patient refusal,and
Varenicline In-Patient Study

This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

The sample will be hospitalized patients smoking at least 10 cigarettes/day prior to hospitalization. Intention to quit smoking will not be required for study participation. Using a double-blinded, placebo-controlled, randomized design, participants will receive varenicline (0.5 mg BID as tolerated) or placebo during their hospitalization (Part 1) and will continue their study medication (placebo or active drug) for 4 weeks post-hospitalization (Part 2). Abstinence status will be examined at 4 weeks post-hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Exclusion Criteria:

- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance \<30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.
Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia

To study the efficacy of adding Transcutaneous Electrical Nerve Stimulation (TENS) to selected physical therapy exercise program on pain in patients with pudendal neuralgia.

Fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this study.

Methods: patients were assigned randomly into two groups equal in number; study and control groups with 26 patients in each. All patients were receiving the same physical therapy exercise program, in addition to the same prescribed analgesic medication. Patients in the study group received additional TENS therapy and those in the control group received sham TENS. Treatment was provided three sessions per week for twelve successive weeks. The participants underwent baseline and post treatment assessment for pain level as measured by three methods; Serum Cortisol Level (SCL), Daily Etodolac intake dose (DEID), and Numerical Pain Rating Scale (NPRS).


Eligibility Criteria:
Inclusion Criteria:

* Nonsmoking male patients
* Diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia
* Ages ranged between 30 to 50 years
* Did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training.

Exclusion Criteria:

* Those who had history of skin malignancy
* Diabetes
* Sensory disorders
* Circulatory insufficiency
* Acute infection of the treatment area
* Renal failure
* Myocardial infarction
* Communication problems, or those with pace maker