cyrilzakka/clinical-trials huggingface dataset:
Adiponectin and Insulin Resistance in Diabetic Nephropathy

Plasma adiponectin concentration is inversely associated with renal function. There is little literature on adiponectin levels and regulation by antihypertensive medication with an angiotensin II-receptor blocker (ARB), especially in subjects with type 2 diabetes in different stage of chronic kidney disease (CKD).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic nephropathy
* CKD at stage 1\~4

Exclusion Criteria:

* Type 1 diabetes or nondiabetic renal disease
* An elevated plasma K level.
Investigation of Predictors of Typing Performance in Office Employees With Neck Pain

Determining the predictors that are effective on work performance and preventive approaches to be developed for these predictors must be individual and adaptable to every environment, time, and equipment. In this context, the purpose of the present study was to show the relations between neck disability, Upper Trapezius (UT) muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces.

The present study was conducted to show the relations between neck disability, UT muscle activation, posture, and demographic characteristics with typing task performance in office employees who have neck pain by using their equipment in their workplaces. We hypothesized that UT muscle activation, working posture, and age might be the main predictors of typing performance in office employees with neck pain. For this purpose, full-time office employees who use computers for at least 3 hours a day and have neck pain were invited to the study. Volunteers without any health concern, upper-body injury, and surgery provided informed, written consent to participate in the study.

The participants were given a 10-minute typing task in their working environments, during which right and left UT muscle activation was recorded with Surface Electromyography (sEMG). Work posture was evaluated with Rapid Upper Limb Assessment (RULA) and Forward Head Posture (FHP) was evaluated with Cervical Range of Motion (CROM) Device. Hierarchical Regression Analysis was conducted to examine the predictors of typing performance.

Eligibility Criteria:
Inclusion Criteria:

* Full-time and regular employees in the last 1 year,
* Office employees use computers at desk for at least 3 hours per day
* According to RULA, working in a posture that is above the acceptable level,
* No trauma history
* Non-specific neck pain but no chronic conditions of the cervical spine and upper extremity

Exclusion Criteria:

* Volunteer office employees with neck pain who did not meet the inclusion criteria and those who could not complete the study because of pain, discomfort, etc. were excluded from the study (Dropouts; n=3 because of pain and discomfort, n=1 because of incomplete evaluations not completed on their own will)
Comparison of Sensory Cuing Modalities for Freezing of Gait

The investigators intend to compare the effects on the resolution of visual and auditory sensory cues on the resolution of freezing of gait in patients with idiopathic Parkinson's disease.

As Parkinson's disease progresses, the patients develop 'Freezing of gait', which make it difficult to initiate gait, turn at the corner, and enter a narrow space. This is considered to be a very important symptom, as it is related to the performance of daily activities, independence of life, and serious injuries caused by falls while walking in Parkinson's disease patients.

It has been found that the use of external sensory stimulation (visual, auditory) can reduce the symptoms of Freezing of Gait, and is used as rehabilitation treatment and instant symptomatic resolution. However, the relative effectiveness of sensory stimulation is not studied yet.

Accordingly, the investigators intend to compare the effects of visual and auditory sensory cues on the resolution of freezing of gait in patients with idiopathic Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with idiopathic Parkinson's disease with freezing of gait according to the United Kingdom (UK) Brain Bank.
2. Scored more than 15 points of Korean version of mini-mental status exam (K-MMSE).
3. Independent gait for at least a minute without walking assistance device.

Exclusion Criteria:

1. History of concomitant brain disease other than idiopathic Parkinson's disease.
2. Other neurologically deteriorated states, such as neuromuscular disease, which can cause gait disturbance.
3. Other psychiatric disorders.
Monopolar Dielectric Diathermy and Therapeutic Exercise on Chronic Neck Pain and Therapeutic Exercise on Pain, Functionality, Movement Phobia on Pain, Functionality, Movement Phobia and Quality of Life of Patients of Patients With Chronic Neck Pain. Randomized Clinical Trial

The aim of this study is to compare the effects of applying monopolar dielectric radiofrequency diathermy plus therapeutic neck yoga with performing only therapeutic neck yoga in patients with non-specific chronic neck pain.

Chronic non-specific neck pain (CNNP) is a widespread public health problem in the modern world. CNNP is considered persistent neck pain or severe neck discomfort for more than 3 months, which is caused by poor posture and mechanical and degenerative changes, excluding pain due to neck cancer, infections, hernias or other neck disorders or pathologies. In the general population, 71% of adults have neck pain at some time in their lives, and its annual prevalence in the general and working population varies between 30% and 50%. In addition, CNNP is an important cause of work absenteeism and disability.

The research of effective techniques and therapies in the approach of this ailment is a current need within the field of physiotherapy and would mean a reduction of the direct and indirect costs in the health systems generated by patients diagnosed with non-specific chronic neck pain. One of the therapies that is achieving positive results in the symptomatology of different musculoskeletal pathologies such as fibromyalgia syndrome , multiple sclerosis or femoropatellar pain syndrome, is the technique of applying monopolar electric diathermy by radiofrequency emission (MDR), using the Physicalm® device which produces an increase in local temperature due to the action of electromagnetic waves that stimulate tissue metabolism and reduce pain.

Due to all the structural and functional alterations that occur in CNNP, within clinical practice guidelines exercise is one of the most important components in rehabilitation programs for patients with neck pain. Recently, supervised therapeutic exercise has been included as a common intervention in clinical practice worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 30 and 65 years of age.
* Diagnosed by a specialist physician of chronic cervical pain of non-specific origin.
* Acceptance and signature of informed consent for voluntary participation in the research study.
* Not to be undergoing any type of physical therapy or pharmacological treatment.
* Acceptance to attend the treatment sessions of the present research study.

Exclusion Criteria:

* Being under rehabilitation or pharmacological treatment of lumbar pathology.
* Alterations of sensitivity or coagulation.
* Thermal sensitivity problems.
* Present osteosynthesis material at lumbar level.
* Present cardiac, epilepsy or tumor complications.
* Non-acceptance of the informed consent or non-attendance to all the sessions that make up the treatment.
Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)

This project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and increase physical activity among low-income persons. The intervention is called Smoking Treatment and Exercise Program for Underserved Populations (STEP UP).

This pilot project proposes to evaluate the feasibility, acceptability, and efficacy of a mobile intervention to target smoking-cessation and physical activity among low-income persons. The intervention, named Smoking Treatment and Exercise Program for Underserved Populations (STEP UP), combines a smartphone-based contingency-management application (app), which provides monetary reinforcement for smoking abstinence and physical activity, 5 weeks of telephone-based cognitive-behavioral therapy (CBT) to prevent relapse, nicotine replacement pharmacotherapy, and text-messaging to support physical-activity goals. Participants are given a smartphone, a compact carbon-monoxide (CO) monitor, with which recency of smoking can by determined, and a Garmin Vivosmart wristband step-tracker. Twice a day at semi-random intervals, participants are prompted by the app to submit a video of themselves blowing into the CO monitor. Monetary reinforcement is then immediately provided contingent upon a below-threshold CO reading. The app also continuously syncs with the Garmin step-tracker, providing supportive messaging and bonus incentives-namely doubled reinforcement for smoking abstinence among participants who meet personalized daily step goals. The expected outcome of the project is to provide information to evaluate the efficacy of an innovative approach in preparation for a subsequent larger clinical trial that builds upon the capabilities of mHealth technology to reduce the prevalence of smoking among low income smokers.

Eligibility Criteria:
Inclusion Criteria:

* current household income less than twice the federal poverty guidelines (Finer \& Henshaw, 2006; for instance, someone from a family of 4 must have a household income less than $48,500 to be eligible)
* currently smoke \>10 cigarettes a day
* smoking for at least the past year
* can speak and write fluent conversational English
* are 18-70 years of age
* are willing to make an attempt to quit smoking and increase physical activity

Exclusion Criteria:

* inability to walk
* expected to have unstable medication regimen during the study
* currently receiving non-study behavioral treatment for smoking
* myocardial infarction in the past 6 months
* contraindication to nicotine replacement therapy (NRT) or bupropion with no medical clearance
* exclusive use of other forms of nicotine such as cigars, pipes, e-cigarettes, or chewing tobacco
* current pregnancy
* current imprisonment or psychiatric hospitalization
Oxytocin Administration and Emotion Recognition Abilities in Adults Reporting Adverse Childhood Experiences

This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.

Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.

In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.

Eligibility Criteria:
Inclusion Criteria:

• presence of moderate to severe experiences of childhood adversity (early adversity group)

Exclusion Criteria:

* Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
* Pregnancy
Observation Only Study Involving Participants Enrolled in the CHAT Trial

The aim of the CHAT study ("An open-label, randomized Phase II study of Herceptin (trastuzumab), Taxotere® (docetaxel) and Xeloda (capecitabine) in combination, versus Herceptin (trastuzumab) plus Taxotere® (docetaxel), in patients with advanced and/or metastatic breast cancers that overexpress HER2") was to test the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.

Overall Response Rate was the primary endpoint of the CHAT study. This study failed to meet its primary objective of showing a difference between the treatment groups, with equivalent high response rates for the Trastuzumab plus Docetaxel and Trastuzumab, Docetaxel plus capecitabine arms.

Secondary endpoints in the CHAT study were Progression-Free-Survival, Time-to-Progression, Overall Survival, duration of response and safety profile. Whilst analysis of the existing data is consistent with improvement with the triplet therapy, interpretation is compromised by the relatively short median follow-up of 24 months. In hindsight the statistical design was flawed by selection of a sub optimal primary endpoint and consequently data was collected and analysed early in relation to time-dependent endpoints. Beyond CHAT will permit capture of mature data for time-related endpoints. Time-to-Progression and Overall Survival are the co-primary endpoints for the Beyond CHAT protocol. The impact of treatment following the first progression, on survival, will be explored.

Time-to-Progression will be defined from the time interval between the date of randomisation and the occurrence of progressive disease under therapy according to RECIST criteria.

Overall Survival will be defined as the time from date of randomisation to date of death

The objective of this study is to gain mature data on the long-term efficacy of the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.

The study also aims to gain information on the additional treatments and sequencing used in patients that have progressed following the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer.

Overall Survival data on patients who have progressed following the combination of Trastuzumab and Docetaxel with or without capecitabine as first-line therapy for HER2 positive locally advanced or metastatic breast cancer will also be analysed and reported.

Eligibility Criteria:
Inclusion Criteria:

* CHAT trial participants whose data was used in the final data analysis for the CHAT study

Exclusion Criteria:

* Any patients who have withdrawn consent to the CHAT study
Optimizing Cardiac Resynchronization

Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions:

1. in the patient's native rhythm simulated by changing the pacing system to atrial pacing only;
2. in conventional dual chamber pacing (DDD mode); and
3. during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.


Eligibility Criteria:
Inclusion Criteria:

* All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
* The study is only open to patients as enumerated above, and also patients who have good imaging windows.
A Tasisulam and Midazolam Drug Interaction Study in Cancer Patients

The purpose of this study is to evaluate whether tasisulam acts as an inducer of CYP3A using midazolam as a sensitive and specific probe substrate of CYP3A.

The study will also assess the safety and tolerability of tasisulam and midazolam given in combination and document any antitumor activity with tasisulam.


Eligibility Criteria:
Inclusion Criteria:

* Have histologically or cytologically confirmed solid malignancy or lymphoma that is advanced and/or metastatic disease which has not responded to standard therapy or for which no standard therapy exists.
* Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 30 days (45 days for mitomycin-C or nitrosoureas) prior to study enrollment and recovered from the acute effects of therapy. Limited field radiotherapy is permitted (in consultation with the investigator)
* Have an estimated life expectancy, in the judgment of the investigator, of greater than or equal to 12 weeks

Exclusion Criteria:

* Have received treatment within 30 days of the initial dose of study drug with an experimental agent for non-cancer indications that has not received regulatory approval for any indication
* Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not required). Patients with active brain metastasis are excluded
* Have current acute or chronic leukemia
* Patients who have clinically significant chronic obstructive pulmonary disease (COPD) or other respiratory diseases that may be at risk during periods of conscious sedation under midazolam
* Patients with a known history of obstructive sleep apnea, difficult intubation, or syndromes associated with airway abnormalities.
NLR and Emergency Surgery

In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial injury. Since preoperative inflammation is a predictor of morbidity and mortality in patients undergoing non-cardiac surgery, a retrospective analysis of the inflammatory status of patients undergoing surgery at the center is proposed.

A retrospective analysis of patients operated on at the Clinical Hospital of the University of Chile is proposed. The search will be conducted in the electronic medical records of all patients operated on between January and December 2021, with no exclusion criteria for this analysis. Demographic data, complications, length of hospital stay, and specific characteristics such as the need for mechanical ventilation, time spent in intermediate care units, and ICU as well as total hospitalization time will be recorded. For the purpose of this study, the preoperative complete blood count of the patients will be analyzed to search for hematological variables that reflect the state of preoperative systemic inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Availability of complete blood count in electronic medical records of all patients operated on between January and December 2021

Exclusion Criteria:

* None
Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* suspected obstructive sleep apnea syndrome
* aged 18 or above
* must be able to speak, read and understand Chinese or English
* possess the ability to respond to questions and follow instructions.

Exclusion Criteria:

* already treated sleep apnea,
* a limited life expectancy due to illness unrelated to sleep apnea
* human immunodeficiency virus (HIV),
* advanced renal disease,
* uncontrolled malignancies
* documented alcohol or drug abuse up to 1 year prior to inclusion in the study.
Effect of Evogliptin on Bone Metabolism in Human

This study is designed to measure the effect of evogliptin on bone metabolism in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal healthy women (at least 5 years)
* BMI 18\~30 kg/m2

Exclusion Criteria:

* Presence or history of hypersensitivity or allergic reactions to any drug
* Clinically relevant abnormal medical history or present disease
* Presence or history of drug abuse
* Participation in other clinical trial within 2 months before dose.
* Bood donation during 2 months or apheresis during 1 month before the study.
* Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication or vitamin substances within 1 week before dose.
* Use of any drug which can affect bone metabolism such as sex hormones or their receptor related medicine, calcitonin or parathyroid hormone related medicine, systemic corticosteroid, bisphosphate, or etc.
* Smoking of more than 10 cigarettes/days within 3 months before first dose.
* Use of alcohol over 21 units/weeks
* Subject judged not eligible for study participation by investigator.
Randomized Crossover Study of Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants

The purpose of this study is to test the hypothesis that neurally adjusted ventilatory assist (NAVA) will allow to lower the ventilator pressure at equivalent fractions of inspiratory oxygen (FiO2) and partial pressure of CO2 of capillary blood in preterm infants in comparison with currently used standard ventilation (synchronized intermittent mandatory ventilation with pressure-support ventilation, SIMV+PSV).

The investigators will apply crossover comparison in preterm infants who received a ventilatory support. In patient whose frequency of mandatory support is under 25, the two ventilatory modes (SIMV+PSV and NAVA) are delivered by the same ventilator (Servo-I; Maquet Critical Care AB, Solna, Sweden) and will set to maintain similar blood gas analysis results.

Determination of the type of ventilatory mode used is performed using a cluster randomization. The randomized order of ventilatory mode will be used during total 9 hours; one mode for 4 hours and another mode for 5 hours. To rule out carry-over effects, a 1-hour interval for washout was guaranteed between modes. Recordings will be obtained over a total 8 hours.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants mechanically ventilated
* ventilatory set frequency is under 25
* with informed consent of their parents

Exclusion Criteria:

* major congenital anomalies
* patients without self respiratory effort
* use of sedative or anesthetic drugs
* grade III or IV intraventricular hemorrhage
* phrenic nerve palsy or insufficiency