cyrilzakka/clinical-trials huggingface dataset:
Quality of Life and Depression in Dialysis Patients

The aim of this study is to evaluate quality of life (QOL) and depression in peritoneal dialysis patients compare to hemodialysis patients and assess hydration effect on QOL and depression over time.

In dialysis patients, low QOL and depression affects clinical outcomes such as morbidity and mortality.

Therefore at the point of treating dialysis patients, It is important to provide not only physical health but also psychosocial health.

QOL could be decided by physical health (i.e. sign and symptom, laboratory results, death) and psychological health (i.e. fatigue, pain, consciousness of health and satisfaction).

And also generally it is well known that physical and psychological functions in dialysis patients are decreased.

And especially depression is common disease in dialysis patients. It is also well known that about from 25 to 50 percent of dialysis patients have depression which could result in low QOL moreover hospitalization, complication, and mortality.

But there is no QOL and depression study with hydration status. Therefore the investigators would like to explore it.

The objective of the study is to evaluate quality of life (QOL) and depression in dialysis patients and assess the hydration effect on QOL and depression over time

Eligibility Criteria:
Inclusion Criteria:

* Dialysis patients, age from 18 years to 75 years
* Incident continuous ambulatory peritoneal dialysis(CAPD) or automated peritoneal dialysis(APD) patients who don't have any experience of dialysis treatment before this study
* Prevalent peritoneal dialysis(PD) patients who are getting peritoneal dialysis treatment more than 6 months
* Prevalent hemodialysis (HD) patients who are getting haemodialysis treatment more than 6 months
* The subjects who are eligible for 1 year follow up
* Written informed consent before any trial related activities
* Eligible patients to complete questionnaire

Exclusion Criteria:

* Prognosis for survival less than 3 months
* Kidney transplantation less than 15 months
* Ineligible patients for questionnaire
* Any malignancies and ascites
* Any condition which could interfere with the patient's ability to comply with the study protocol
* Ineligible to measure BCM

  1. pacemaker, defibrillator
  2. pregnancy or lactation period
  3. amputation
  4. artificial joint
Technology-assisted Rehabilitation After Acute Stroke

The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.

The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or more
* first stroke

Exclusion Criteria:

* unstable cardiopulmonary condition
* severe cognitive disorder
* aphasia
Randomized Sizing and Hemodynamic Study Mitroflow vs. Magna

The purpose of this study is to compare sizing,implant techniques, and hemodynamics between the Mitroflow Pericardial Aortic Valve and the Edwards Magna Heart Valve.

Comparisons of valve types are often made according to labeled valve sizes. There is growing evidence that in the majority of cases the actual sizer and valve dimensions vary from the labeled diameters, which may not be related to any hemodynamically meaningful dimension. The disagreement between the true valve dimensions and the labeled valve size may render comparisons based on labeled size meaningless

Eligibility Criteria:
Inclusion Criteria:

* Patients who are indicated for implant with a bioprosthetic valve in the aortic position according to the current practice for valve selection at the center.

Exclusion Criteria:

* Less than 18 years of age
* Emergency Surgery
* Pre-existing valve prothesis in the aortic position
* Aortic root replacements or enlargements
* Active endocarditis
Computer-based Training of Face Recollection to Improve Face Recognition in Developmental Prosopagnosia

This study will examine the effectiveness of a cognitive training intervention targeting face recollection, repetition lag training, at improving face recognition in Developmental Prosopagnosia.


Eligibility Criteria:
Inclusion Criteria:

Developmental prosopagnosic participants will be included if they are...

* aged 18-90,
* have lifelong histories of face recognition difficulties that impact their everyday life (i.e., not associated with some event such as a stroke, seizure, etc)
* score significantly below the mean on the famous faces test and Cambridge Face Memory Test

Exclusion Criteria:

Participants will be excluded from the study if they...

* have a history of a significant neurological disorder including hydrocephalus, stroke, moderate to severe traumatic brain injury (TBI), severe neuromuscular diseases, or severe hypoxia due to cardiac arrest.
* have impairments that interfere with cognitive performance, such as uncorrected hearing or vision, lack of English proficiency, musculoskeletal or other issues
* have psychiatric disorders, such as schizophrenia, major depressive disorder, bipolar disorder, chronic intractable obsessive-compulsive disorder, or agoraphobia.
* We will exclude individuals who are currently dependent on alcohol or other substances, as this may negatively impact cognitive performance.
* We will exclude participants who currently are, or within the last 6 months, participating in a behavioral or pharmacological intervention.
* Patients with a history of mild TBI or simple concussion will not be excluded as long as it was \> 6 months ago and as long as they have not had repeated concussions (\>5)
* We will include individuals with a diagnosis of ADHD as long as their medication has been consistent for the past 6 months.
Effectiveness of Divalproex Sodium (Depakote) in Treating Children With Temper Outbursts and Severe Mood Swings

The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) versus placebo in treating children with temper outbursts and severe mood disorders.

Depakote has been used to treat seizures in children for more than 20 years. The purpose of this study is to determine the effectiveness of divalproex sodium (Depakote) in treating children with temper outbursts and severe mood disorders.

This study will last 12 weeks. Participants will be randomly assigned to receive either 250 mg Depakote or placebo. The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo; participants will remain on this dose through Week 5. At Week 6, participants will cross-over and receive the other treatment (either depakote or placebo), which they will take through Week 12. Study visits will occur weekly and will include a physical exam, blood and urine tests, and self-reports of adverse events. In addition, caregivers will complete reports about mood swings throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Explosive Mood Disorder (EMD)
* Explosive temper as evidenced by four or more outbursts of rage, property destruction, or fighting per month
* Mood liability as evidenced by multiple, daily, distinct shifts from normal to irritable mood with withdrawn or boisterous behavior, occurring without a clear precipitant
* History of an EMD for one year without treatment
* EMD symptoms resulting in impairment in two or more of the following areas: school, the law, family, substance use, peers, or work
* EMD symptoms do not occur only during substance toxicity or withdrawal
* EMD symptoms are not confined to a single setting or context
* Parent and child willing to consent to study
* Inadequate response to an adequate trial (8 weeks) of psychotherapy and/or family therapy

Exclusion Criteria:

* Meets criteria for pervasive developmental disorder or childhood schizophrenia
* Seizure or other neurologic disturbance
* Pregnant
* Moderate to severe mental retardation
* Physical exam or laboratory results with significant abnormalities
* Positive Hepatitis screen test
* Liver dysfunction
* Active suicidal or homicidal ideation
* History of suicide attempts
* History of barbiturate use
* Unequivocal manic or hypomanic episode
* Meets criteria for attention deficit hyperactivity disorder (ADHD) and has not failed a trial of psychostimulants for ADHD
* Meets criteria for major depression in prepuberty
* If female, unwilling to use an effective method of contraception for the duration of the study
* Mitochondrial disease or family history of mitochondrial disease
Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

Background. Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown. Weaning of propylene glycol/glycerol could allows a quick clearance of propylene glycol/glycerol from the body, with subsequent recovery of cardiorespiratory function.

Specific aim of the research. This research proposal tests the following hypothesis regarding the reversibility of propylene glycol/glycerol and nicotine intake:

* Propylene glycol/glycerol cessation restores cardiorespiratory function.
* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine proteomics profile, which are partially reversed after cessation.
* Chronic propylene glycol/glycerol and propylene glycol/glycerol/nicotine intake induces specific serum and urine metabolomics profile, which are partially reversed after cessation.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be regular propylene glycol/glycerol/nicotine intake users since at least 1 year
* Subject must be former smokers

Exclusion Criteria:

* Chronic or acute illness
* Substance abuse
* Chronic medication intake
Pilot Study of RR-HNK in OCD

The purpose of this study is to understand how RR-HNK works in the brain to bring about a reduction in OCD symptoms.

This protocol examines the safety and efficacy of 2 dosage levels of intravenous RR-HNK administration in individuals with OCD.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-65
* Meet the criteria for OCD diagnosis
* Failed at least 1 prior trial of standard first-line OCD treatment (e.g. SRI/CBT) or or had refused these treatments for individual reasons
* Agree to the following lifestyle modifications: comply with requirements for fasting prior to --the infusion session, not enroll in any other interventional clinical trials during the duration of the study, and commit to medication study procedures.
* Able to provide informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to ketamine
* Any current or past medical/psychiatric condition that makes participation unsafe in the opinion of the investigator or study physician
* Pregnant or nursing, or able to become pregnant and are not practicing an effective means of birth control
* Lifetime history of deep brain stimulation
Taxotere, Cisplatin, and CPT-11 in Advanced Solid Tumor Malignancies

The purpose of this study is to find the highest dose of the combination of taxotere, cisplatin and CPT-11, that can be given without causing severe side effects. We also want to test the safety of this drug combination and see what effects (good and bad) it has on patients with advanced cancer for which there is no known curable treatment.

* This is a Phase I clinical trial. We are unsure of the safest and most effective dose of the drugs and therefore are planning on treating 3-6 patients with a given dose before increasing to higher dose levels.
* Each patient will receive approximately two cycles of therapy. On day one and day eight, they will receive taxotere, cisplatin and CPT-11 intravenously. The cycle will begin again on day 22.
* The following tests and procedures will be performed: CAT scan prior to beginning therapy, after every 2 cycles of therapy, and at the end of the study; physical exam before each course of therapy; vital signs before and with each dose of therapy; routine blood tests before starting therapy and weekly during treatment; chest x-ray and echocardiogram before starting therapy and; toxicity assessment each week of therapy.
* Patients will remain on the study as long as their cancer responds to treatment and they do not have unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, incurable solid tumor malignancy
* 18 years of age or older
* ECOG performance status of \< or = to 2
* Life expectancy of greater than 12 weeks
* WBC \> 3,000/mm3
* ANC \> 1,500/mm3
* Platelet count \> 100,000/mm3
* Total bilirubin within normal limits
* SGOT \< 2.5 x ULN
* Alkaline phosphatase \< 4 x ULN

Exclusion Criteria:

* Prior chemotherapy for the treatment of metastatic or recurrent cancer
* Prior radiotherapy to greater than or equal to 15% of bone marrow
* Prior pelvic radiation therapy
* Prior nitrosoureas or mitomycin C
* Myocardial infarction in the past 6 months
* Major surgery in past 2 weeks
* Uncontrolled serious medical or psychiatric illness
* Uncontrolled diarrhea
* Peripheral neuropathy \> grade 1
* Pregnant or lactating women
* Clinically apparent central nervous system metastases or carcinomatous meningitis
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)

The main objective of this study is to test the safety and effectiveness of DS-8201a for participants with HER2-expressing advanced colorectal cancer.

At study start, only Cohort A is active.

If, and when, Cohort B and C become active depends on the assessment of benefit and risk observed in the program.

The sponsor will inform the investigators if, and when, Cohort B and C are active.

Eligibility Criteria:
Inclusion Criteria:

* Has pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma (until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer)
* Has received at least 2 prior regimens of standard treatment
* Has measurable disease assessed by the investigator based on RECIST version 1.1.
* Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

Exclusion Criteria:

* Has a medical history of myocardial infarction within 6 months, symptomatic congestive heart failure
* Has a medical history of clinically significant lung disease
* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department

The purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.


Eligibility Criteria:
Inclusion Criteria:

* Children with a SUD score of 30 or higher indicated by the caregiver

Exclusion Criteria:

* Active infection: abscesses, fever, respiratory issues, vomiting
* Patients presenting for burn care, dog bite, ESI triage category 1 or 2, or transferred from outside facilities
* Sterile procedures
* Oncology patients / patients with known neutropenia in past medical history
* Parent/caregiver or patient fear of dogs
* Parent/caregiver or patient allergy to dogs
* Dog bite injury
* Already underwent procedure during their visit
Automated Guidance Tool for Medical Encounters Addressing Therapeutic Lifestyle Changes (AuGMEnT).

ABSTRACT Although most primary healthcare practitioners recognize the important relationship among nutrition, physical activity and health, few incorporate either dietary or physical activity counseling into routine practice. AUGMENT will employ interactive technology to support effective patient life-style counseling during routine office visits. AUGMENT technology will automate the administration, collection, and analysis of dietary and physical activity questionnaires, and it will guide counseling and present intervention resources and strategies tailored to the patient's unique needs. Using tablet computers, wireless LANs, and inexpensive Internet communications, AUGMENT will have advantages over existing tools: 1.) Lower usage costs (minimal office personal required), 2.) Ability to customize the system, and 3.) Real-time, comprehensive assessment.

The AUGMENT system efficiently and relentlessly gathers important healthcare information (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and micronutrient intake; and energy output). This means patients are less likely to have their preventive needs overlooked by a busy practitioner. The assessment includes questions to determine the amount of effort the patient will commit to improved health. This will enable the physician to effectively guide the patient via targeted recommendations, obtainable goals, and a course of action that is both preventive and prescriptive; and to monitor progress. Patients who receive objective assessments of their healthcare practices and recommendations based on their own unique health history will be more likely to accept and act on the recommendations.

The specific aims of the study are to: 1) Incorporate key elements of a previously developed prototype tool into a dietary and physical activity risk assessment system, 2) Create a provider training tool to build proficiency in using AUGMENT for counseling to reduce disease risk.

3) Validate the AUGMENT dietary and physical activity assessments using dietary recalls and accelerometer data, 4) Complete a process evaluation of the AUGMENT program by using it in interventions managed by six physicians with at least 240 patients, and 5) Survey participating providers and patients to assess acceptability of AUGMENT within a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* adult patients at Staywell Community Health Center, Waterbury CT

Exclusion Criteria:

* terminally ill
* pregnant women
* children
* decisionally impaired / dementia
Evoked Potential Recording During DBS Surgery

Deep brain stimulation (DBS) has been approved for treatment of dystonia by the FDA under a humanitarian device exemption (HDE) status. DBS has been shown to be very effective in the treatment of a variety of diseases such as Parkinson's disease and essential tremor. It has been widely used for the treatment of primary and secondary dystonia as well. Surgery involves the placement of the DBS electrode in one or two of the deep nuclei constituting the basal ganglia. A subcutaneous thoracic or abdominal implantable pulse generator is placed and connected to the intracranial electrode. Pulsatile stimulation of the deep brain nuclei has been shown to result in significant improvement in many patients, including restoration of the ability to walk or make voluntary arm movements. A major difficulty with DBS is the accurate placement of the electrode. Adult patients are usually awakened during surgery and micro electrode recordings are used to determine the optimal electrode effectiveness and monitor for side effects. This requires the patient to be awake and cooperate, while on the operating table. When DBS is performed in children, such testing is often not possible because the children are scared or not cooperative when awakened during surgery, the procedure is most often done for Dystonia, which does not respond immediately, and dystonia may cause involuntary movements that could be dangerous in the operating room while the child's brain is exposed. As part of the routine clinical evaluation of target location in the operating room or Neuromodulation Unit, stimulation is performed using the deep brain or depth electrodes, typically at frequencies between 60hz and 185hz. For this research study, stimulation will occur at much lower frequencies, between 9hz and 20hz in order to be able to measure how electrical activity from the deep electrodes spreads to other electrodes or the scalp. As part of the research, peripheral nerves will also be stimulated at the wrist and knee at frequencies of 20hz to 150hz in order to measure the transmission of peripheral nerve stimulation to these areas of the brain. The investigators hope these additional studies will allow discovery for mechanisms that lead to movement disorders including dystonia, and that knowledge of these mechanisms will allow the investigators to develop new, safer, and more effective treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

* - Subjects 5 years of age and/or older (including adults, ages 18+)
* Has chronic, intractable (drug refractory), generalized dystonia
* DBS surgery must be clinically indicated

Exclusion Criteria:

* Contraindication to neurosurgery and or a potentially reversible cause of dystonia that does not include surgery.