cyrilzakka/clinical-trials huggingface dataset:
Clinical Validation of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System

This is a open-label, randomized, paired design, multicenter study of the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (R6000) for evaluating cardiovascular autonomic neuropathy. R6000 is novel intellectual diagnostic device for cardiovascular autonomic reflex tests and heart rate variability analysis. A total of 85 subjects will be enrolled in trial Ⅰ and 150 subjects will be enrolled in trial Ⅱ. In trial Ⅰ, subjects will be randomized to two groups, one of which will receive test by the tested device first and the other one will be tested by conventional blood pressure kit. The primary objective of this clinical trial is to evaluate the effectiveness of the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System. The secondary objective is to evaluate the safety of the cardiovascular autonomic testing system and stability.

Trial I Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (R6000). Control: Conventional blood pressure kit. Goal: To assess the consistency between the tested device and the conventional method in measuring blood pressure.

Trial IIa Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (R6000). Control: Ambulatory holter station. Goal: To assess the consistency between the tested device and the conventional devices in measuring heart rate variability (HRV).

Trial IIb Tested device: Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (R6000). Control: Manual method with digital ECG machine, stethoscope and sphygmomanometer. Goal: To assess the consistency between the tested device and the manual method in determining cardiovascular autonomic neuropathy (CAN).

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 18 or over, regardless of gender
* Voluntary membership to participate in the study and signing the Informed Consent Form.

Exclusion Criteria:

* For part I:

  • Unable to cooperate with the examination.
* For part II:

  * Ophthalmic examination within the past 1 month showed proliferative retinopathy, retinal detachment, fundus hemorrhage or presence of known history of illness described above;
  * Known history of glaucoma or ophthalmic examination within the past 1 month suggests glaucoma;
  * Poor control of hypertension (sedentary systolic blood pressure ≥ 160mmHg or diastolic blood pressure ≥100mmHg);
  * Known history of arrhythmia (except occasional premature beats), history of acute coronary syndrome within three months before signing the informed consent form;
  * In a state of stress such as infection and surgery; Be in the acute or unstable phase of any disease;
  * Pregnant women;
  * Unable to cooperate with the examination.
UK Validation of the Automated "AcceXible" Speech Analysis Software

Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

The present study has the objective of validating a digital method for detection and follow-up of patients with mild cognitive impairment (MCI) or dementia in a memory clinic setting.


Eligibility Criteria:
Inclusion Criteria for patients:

* Adult patients 55+ years of age with suspected MCI or diagnosis of dementia referred into secondary care memory clinic by their General Practitioner.
* Have English as first language (able to speak and understand verbal messages).
* Patients must have agreed to participate in the study and have voluntarily signed the informed consent.

Inclusion Criteria for healthy volunteers:

* Healthy older adults (55+ years of age), without a diagnosis neurological, or psychiatric disorders or any clinical evidence of cognitive decline.
* Have English as first language (able to speak and understand verbal messages).
* Controls must have agreed to participate in the study and have voluntarily signed the informed consent.

Exclusion Criteria for patients:

* To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
* To have significant vision problems that would affect the ability to perceive visual stimuli.
* To have significant hearing problems that would affect the ability to understand verbal cues.
* To be unable to give informed consent to participate in the study.

Exclusion Criteria for healthy volunteers:

* Objective evidence of significant cognitive decline in any one domain.
* Score of \<88 on ACE-III cognitive testing.
Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls

Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. These can result in a cycle of poverty for young women and their families. Despite this being a very pressing problem there is little evidence on what types of interventions can help break the vicious cycle of poor mental health and poverty.

This research program aims to evaluate, through the use of a cluster-Randomized Control Trial (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and unconditional cash transfers on adolescent girls' mental health and social functioning. Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create a better understanding of whether adolescent mental health improves through this cost-effective approach, and whether improved mental health impacts other outcomes of interest.


Eligibility Criteria:
Inclusion Criteria:

* 13-19 year old female who scores 10 or above on PHQ-8

Exclusion Criteria:

* male
* Score below 10 on PHQ-8
Reducing Emotional Distress, Enhancing Function and Improving Network Engagement in Adolescent and Young Adult Oncology

We propose to examine the effects of mindfulness based stress reduction (MBSR) on outcomes of health related quality of life, disease symptoms, and biological correlates of stress in a sample of young adults with cancer. The proposed work will serve as an essential foundation for launching a program of clinical stress reduction research with this traditionally underserved population and has the potential to lead to the discovery of specific, modifiable psychosocial, behavioral, and biological mechanisms from which to address the problem of health disparities with this group.

Primary Objective Examine the feasibility and acceptability of MBSR with YACs. We hypothesize that MBSR will be feasible and acceptable with this population, which will be assessed through examination of response rate and study attrition variables.

Secondary Objectives

1. Evaluate the effects of MBSR on outcomes of health related quality of life and disease symptoms among YACs.
2. Explore the impact of different forms of eHealth maintenance support following the MBSR intervention (instructor-delivered, peer-delivered, no message) to help uphold intervention effects over time.
3. Compare intervention and control groups on changes in biologic measures of stress (blood pressure, pulse, salivary cortisol, CRP and IL-6 biomarkers) over a 32-week period.

Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of any cancer between ages 18-39
* Must have signed and dated informed consent form, which includes agreeing to study procedures
* Must be currently between 18-39 years of age
* Must be able to read, write, speak and understand English
* Must be able to perform basic activities of daily living
* Must be cognitively intact and free of serious psychiatric illness
* Must have the ability to use a touchscreen keypad on a tablet device
* Must be willing to commit to either the MBSR course or waitlist control condition
* Must be willing to commit to eHealth intervention maintenance conditions
* Must be willing to complete all assessments

Exclusion Criteria:

* Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
* History of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians
* Regular user of mindfulness-based stress reduction or a similar mind-body therapy (e.g., yoga, meditation), which is defined as ≥ 3 times a week for the past 2 weeks
Investigating Central Mechanisms of Overactive Bladder in Adults With Parkinson's Disease

This study investigates the central mechanisms of Overactive Bladder (OAB) in Patients with Parkinson's Disease (PD).

The plan is to enroll 10 adults with Parkinson's disease and Overactive bladder (PD + OAB) and 10 adults with Parkinson's disease only (PD). Both groups will undergo fMRI (functional MRI).

Overactive bladder (OAB) is a physical problem that causes strong urges to urinate, frequent urination, and sometimes urinary incontinence (accidental loss of urine control) commonly in patients with Parkinson' disease (PD) severely impacting their quality of life.

Unfortunately OAB in adults with PD is difficult to treat. This is largely because the mechanisms underlying OAB in adults with PD are not known. Recent functional MRI (fMRI) studies suggest that certain areas of the brain have an important role in OAB. Blood oxygenation level dependent (BOLD) fMRI is an imaging technique in which neural activity of a region of the brain can be measured by fluctuation in the BOLD signal. It is hoped that the findings of this study will allow the development of new treatments for adults with Parkinson's disease and overactive bladder.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD by United Kingdom (UK) brain bank criteria.
* PD patients with and without OAB as per bladder questionnaire.
* No change in PD medications after screening, with no dose changes during the study, except that pro re nata (PRN) doses of carbidopa/levodopa will be allowed to address periodic worsening of parkinsonian symptoms.
* Patient willing and able to complete study questionnaires.
* Use of other medication that could influence bladder function, will be permitted as long as the dose is stable during the study.
* Patient expects to have valid health insurance for the duration of the study period.

Exclusion Criteria:

* Women who are breast-feeding, pregnant or have the potential to become pregnant during the course of the study (fertile and unwilling/unable to use effective contraceptive measures).
* Cognitive deficits that in the opinion of the investigator would interfere with the subject's ability to give informed consent or perform study testing.
* Evidence of Urinary Tract Infection (UTI) at screening.
* Bladder pain or history of chronic inflammation such as interstitial cystitis, recurrent UTIs, bladder stones, bladder obstruction, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs.
* Adults who have an interstim device in place.
* Claustrophobia, occupational risk for ferrous metal in the eye, or having an implantable medical device or foreign body precluding fMRI (e.g. cardiac pacemaker, metallic fragment, orthopedic hardware).
* Intravesical botulinum toxin treatment within the previous six months of screening.
* Use of indwelling catheter or self-catheterization.
* Any other serious and/or unstable medical condition
Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.

Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed, written informed consent
* 18 yeas of age and older
* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
* Meet specific Visit 2, Day 0 (Baseline)criteria at baseline

Exclusion Criteria:

* Females who are pregnant, nursing or planning a pregnancy
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
Sacrocolpopexy and Lateral Suspension Operations

Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is sacrocolpopexy and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had previously undergone hysterectomy for benign causes
* Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
* And for this, patients scheduled for operation

Exclusion Criteria:

* Patients with chronic diseases or medications that interfere with the operation
* Patients with oncology operated for malignant cause
* Non-localized patients with vaginal cuff prolapse
Primary Care CKD Registry

This study examines whether a safety-net primary care CKD registry directed at the entire primary care team can enhance the delivery of guideline concordant CKD care, including BP control, ACEi/ARB use and albuminuria quantification.


Eligibility Criteria:
Inclusion Criteria:

All PCPs who worked in practice teams and provided longitudinal primary care to patients were eligible to participate in this study. Practice teams that consisted of several physicians (+/- trainees), one nurse, nurse practitioners, medical assistants and behaviorists, were randomized 1:1 to one of two arms with a random number generator: access to an electronic CKD registry or a usual care registry for 12 months.

Exclusion Criteria:

PCPs who solely provided specialty care, for example HIV services or urgent care, were excluded.
Efficacy of KCl Plus 0.9%NaCl Compare With KCl Plus 0.45%NaCl

evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia

Hypokalemia is frequently encountered in hospitalized patients. Intravenous (IV) potassium repletion with saline is preferred used for initial therapy. However, administration of normal saline (0.9%NaCl) usually provokes sodium and potassium diuresis, thus, it might delay reversal of the hypokalemia.

Object of this study : to evaluate efficacy and safety of IV administration of potassium chloride (KCl) plus 0.9%NaCl compare with KCl plus half-strength normal saline solution (0.45%NaCl) in correcting hypokalemia.

Eligibility Criteria:
Inclusion Criteria:

* Serum K+ 2.5-3.49 mmol/L
* No life threatening condition from hypokalemia

Exclusion Criteria:

* Pregnancy
* Volume overload, heart failure
* Hypotension
* Acute kidney injury
* Dysnatremia
* K+ shift
* Salt wasting nephropathy
RAAS and Arterial Stiffness in SCI

The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls.

The study is examining differences in central arterial stiffness, orthostatic changes in blood pressure, norepinephrine, and plasma renin in individuals with spinal cord injury compared with age-matched uninjured controls. Arterial stiffness and blood pressure will be collected in the laying down position. A blood sample of norepinephrine and plasma renin will also be collected. The participant will tilt to 30, 45 and 60 degrees for 10 minutes at each angel. Blood pressure and heart rate will be monitored at each angle. Another blood sample of renin and norepinephrine will be collected at the end of 10 minutes at 60 degrees.

Eligibility Criteria:
Inclusion Criteria:

* SCI participants:
* injured between C1-T1 and T6-T12
* wheelchair dependent
* AIS classification A, B or C
* Injured occurred more than 1 year ago

Exclusion Criteria:

* currently have an illness or infection
* current smoker of at least 1 year
* controlled or uncontrolled hypertension or diabetes mellitus
* Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease)
* cardiovascular disease (coronary heart disease, congestive heart failure, peripheral artery disease)
Drug Interaction Statin

This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.

Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Signed Written Informed Consent form
* Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
* Men and women, ages 18 to 55 yrs, inclusive

Exclusion Criteria:

* Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure
* Current or history of symptomatic hypotension
* Current or history of liver diseases, including cirrhosis and liver failure
* Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis
* Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator
* History of significant head injury in the last 2 years
The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.

The purpose of this study is to test whether Rifampin affects blood levels of istradefylline in humans. Rifampin could possibly decrease istradefylline levels.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking male and post-menopausal female subjects
* Body Mass Index: 18.0-35.0 kg/m2, inclusive
* Subjects must not be taking drugs that are moderate to potent inhibitors of CYP3A4 or CYP1A2.
* Subjects without clinically significant medical history in the judgment of the investigator
* Subjects without clinically significant laboratory or ECG abnormalities

Exclusion Criteria:

* Females that are pregnant or lactating
* Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study;
* Known history of treatment for drug or alcohol addiction within the previous 12 months;
* Subjects with an average alcohol intake of more than 2 units per day or 14 units per week up to 48 hours prior to the istradefylline dose on Day 1. One unit of alcohol is ½ pint of beer (285 mL) or 1 glass of spirits (25 mL) or 1 glass of wine (125 mL);
* Donated or lost \> 500 mL of blood within 3 months prior to istradefylline dose on Day 1 of Period 1;
* Positive test results for human immunodeficiency virus (HIV) or Hepatitis B surface antigen, or Hepatitis C;
* Positive test results for drugs of abuse at screening;
* Unable, or unwilling to tolerate multiple venipunctures;
* Difficulty fasting or eating the standard meals that will be provided;
* Use of tobacco or nicotine-containing products within 90 days of the study start to the Follow-up visit
A Phase Ib Study of Fruquintinib in 3rd Line mCRC

Fruquintinib is a novel oral small molecule compound discovered and developed by Hutchison MediPharma that selectively inhibits vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3 and has demonstrated potent inhibitory effects on multiple human tumor xenografts.Based on first-in-human study, both 4mg QD and 5mg 3wks on/1wk off are safety and efficacy, this phase Ib study is to evaluable the safety, tolerability and efficacy of these 2 regimens with mCRC failed 2nd therapy or more and to determine the recommended dose and regimen in phase II/III study.

This is a phase Ib, randomize, interventional, open-label, multicenter study to provide fruquintinib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist.

The primary endpoint of this study will be safety.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and ≤ 70 years of age , with ≥ 40Kg
* Histological or cytological confirmed colorectal cancer
* ECOG performance status of 0-1
* Standard regimen failed or no standard regimen available
* Adequate hepatic, renal, heart, and hematologic functions
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Signed and dated informed consent.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

Exclusion Criteria:

* Pregnant or lactating women
* Any factors that influence the usage of oral administration
* Evidence of CNS metastasis
* Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure
* Abuse of alcohol or drugs
* Less than 4 weeks from the last clinical trial
* Previous treatment with VEGFR inhibition
* Disability of serious uncontrolled intercurrence infection
* Proteinuria ≥ 2+ (1.0g/24hr)
* Uncontrolled hemorrhage in GI
* Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.
* Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG
* Bone fracture or wounds that was not cured for a long time
* Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy