cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock

Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.

1. The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.
2. If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.
3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.

Eligibility Criteria:
Inclusion Criteria:

1. 19 years old or older
2. ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.

   ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.
3. Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
4. Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

Exclusion Criteria:

1. Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
2. Shock with cardiac arrest outside the hospital
3. People with allergic reactions to anticoagulants such as heparin.
4. Those who refused active treatment.
Treadmill and Music Cueing for Gait Training in Mild to Moderate Parkinson's Disease

Sensory and motor cueing have been demonstrated as useful ambulation training techniques for Parkinson's disease (PD). This study is aimed to evaluate the effectiveness of treadmill training program with music cueing for mild to moderate PD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Male PD patients aged 60-80 years with Hoehn and Yahr stage 2-3 diagnosed by attending neurologist
2. Good cognitive function with Thai Mental State Examination \>23
3. Stable medication without freezing
4. No prior exercise program within the last 2 months
5. No contraindication for exercise

Exclusion Criteria:

1. Medication change during the study program
2. Inability to walk on treadmill (in treadmill groups)
3. Cannot complete 80% of the prescribed program
Retrospective Review of FDG PET MRI Management of Patients With Muscle Invasive Bladder Cancer

Background:

Bladder cancer is a common cancer in the U.S. Survival rates for metastatic bladder cancer have not gotten better for 15 years. Diagnosing and assessing the disease is important for treating it. The best way to tell what stage a cancer is in is computed tomography. This is also called CT. But it does not always give the best images of the bladder. Adding a test called positron emission tomography (PET) can help. Magnetic resonance imaging (MRI) is even better than CT for detecting bladder cancer. But it is not widely used.

Some people with bladder cancer have already had MRI/PET and CT. Researchers want to study their records. They want to compare the different ways of assessing the disease.

Objective:

To evaluate the use of MRI/PET for diagnosing and treating metastatic bladder cancer.

Eligibility:

People 18 years and older who were in studies between 2013 and 2016

Design:

Researchers will study existing records. There will be no active participants.

The records will have no data that could identify the participants. Data will be stored on secure computers.

No study participants will be contacted without approval from a review board.

This protocol is a chart review of the diagnostic imaging and management of patients with metastatic bladder cancer who have undergone PET MRI. The study will involve only review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled on a number of different protocols between 2013 and 2016.

Eligibility Criteria:
* INCLUSION CRITERIA:

Patients with metastatic bladder cancer seen between 2013 and 2016 at the NIH Clinical Center.

EXCLUSION CRITERIA:

Patients who opted out of storage of specimens/data for future use on prior studies will be excluded from this study.
A Study of Survivorship Service Capacities Among Health Care Agencies in New York City

To describe the range of services available to cancer survivors in the NYC area.

To determine organizations' need for assistance to enhance services for survivors.

To describe the range of services available to cancer survivors in the NYC area.

To determine organizations' need for assistance to enhance services for survivors.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in the study, an agency must:

  1. Be a current provider of either:

     * General health services (GHS), such as primary care, health education and wellness, mental health services, home health care, palliative care, or cancer screening and diagnosis;
     * Cancer-specific medical treatments (CMT), such as cancer surgery, radiation, chemotherapy, hormonal therapy; experimental therapies; cancer pain and symptom management; rehabilitation services; post-treatment monitoring and surveillance; or prophylactic treatments, such as chemoprevention; or
     * Any type of specialized 'post-cancer' or 'after-cancer' medical care or support services (SMC) (i.e., psychotherapeutic, relationship and family, psycho-educational,wellness and quality of life)
  2. Be located within the five boroughs of New York City
  3. Have been serving cancer patients for 12 months or longer, and
  4. Be willing and able to identify an English-speaking representative, 21 years of age or older as its designated key informant.

Exclusion Criteria:

* We will limit this study to provider agencies such as hospitals, diagnostic centers, clinics, health and human service agencies, and grassroots community organizations and public service settings that offer programs for cancer survivors. Independent practitioners or private practice settings will not be surveyed. Our survey questions are intended for major health services organizations and are not appropriate for private practices settings.

We will use our screening questionnaire to determine where or not a given agency should be included or excluded from the study AGENCY SCREENER.
Investigating National Solutions for Personalised Iodine-131 Radiation Exposure

This is a single-arm non-interventional prospective observational study to perform quantitative I-131 imaging and patient-specific dosimetry for patients undergoing radioiodine treatment.

The hypothesis underlying this study is that treatment outcome in molecular radiotherapy is dependent on the absorbed doses delivered rather than on the radioactivity administered. For up to 50 patients, post treatment dosimetry will be performed to establish the range of absorbed doses and associated uncertainties delivered to thyroid remnants, residual disease, and healthy organs from an ablative administration of I-131 radioiodine.

Imaging systems in participating centres will be characterised (system volume sensitivity, partial-volume effect and dead-time) and set up for quantitative imaging to allow for collation of data. Patients will be assigned to one of two dosimetry gamma camera scanning schedules. For scanning schedule 1 (Standard of Care) a single standard-of-care scan (SPECT/CT) will be acquired according to local protocol with regards to time post-radioiodine administration. A minimum of 20 patients will be assigned to scanning schedule 2 (Standard of Care + Additional Imaging), for which a standard-of-care scan and two to four additional SPECT scans will be acquired between 6 - 168 hours post-administration.

SPECT imaging datasets will be reconstructed with attenuation and scatter corrections to allow quantitative dosimetry calculations. Time integrated activity will be derived from analysis of the quantitative SPECT data and combined with relevant dose factors to obtain absorbed dose estimates for each target tissue. The subset of patients with additional imaging will be used to establish the pharmacokinetic properties of radioiodine in each tissue type (biological retention half-life) to enable determination of time integrated activity in patients with a single standard-of-care scan.

A minimum of 3 whole-body retention measurements will be performed per day during the patient's stay in hospital, approximately every 2-6 hours, according to local standard of care procedures. At each external measurement time point the quantified level of radioactivity in the whole body will be recorded.

Patients will be followed-up at their standard-of-care clinic visits to assess the success of treatment as well as for short to mid-term toxicity. Results from standard of care biochemical, radiological and haematological assessments (TSH, thyroglobulin, anti-thyroglobulin antibodies, ultrasound, serum creatinine, haemoglobin, white cell count, neutrophil count and platelet count) will be recorded to assess response to treatment. Statistical analysis of the relationship between the absorbed doses and outcome data will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Histologically proven DTC (pT1b - pT3, any N, any M)
* Total thyroidectomy performed
* WHO PS 0-2 (autonomous, self-caring)

Exclusion Criteria:

* External radiotherapy in the last 6 weeks
* Systematic chemotherapy in the last 6 weeks
* Pregnancy or breast feeding
Patient International Normalised Ratio (INR) Self-Testing Program

The aims of the study are to prove correlation between laboratory and patient self-testing (PST) measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

This is the first French, prospective, randomised, single centre study, comparing patient self-testing (PST) of international normalised ratio (INR), with conventional laboratory monitoring. Aims of the study are to prove correlation between laboratory and PST measurements, estimation of INR variability within a target therapeutic zone and frequency of hemorrhagic and/or thromboembolic events after mechanical heart valve replacement.

Patients (206) were postoperatively, randomly, consecutively included (2004 - 2008): 103 patients in each group, with a one year follow-up. Two INR control devices were selected: Coaguchek® (Roche) and INRATIO® (Hemosense).

Eligibility Criteria:
Inclusion Criteria:

* adults
* patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization
* oral anticoagulant treatment
* patients with social security cover
* written informed consent signed by both patient and investigator
* able to be followed up during 12 months

Exclusion Criteria:

* refusal of participation in the study
* Participation in another clinical study
* Patient is pregnant or nursing
* Life expectancy less than three months
* Contra-indication of to an A.V.K treatment
* Difficult comprehension of the French language
* Patients unable to master the self-monitoring procedures
* Individuals under judicial control or enquiry
* Patients on dialysis Patients with incomplete understanding of instructions
* Blind patients and those unable to read
Xian-Hua-Cha for Relieving Hyperlipidemia With Obesity

In the past decades, lipid and body fat disorders become a serious global healthcare issue, especially among the obese population. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to explore the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among obese patient. For this purpose, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are analyzed in the end of this study.

Recently, there are more and more studies show the natural herbal products can improve obesity and related metabolic disorders through changing the body composition and even body weight, but most of the studies are still at the phase of animal studies.

In the ancient Chinese medical book Danxi's mastery of medicine mentioned "Overweight people often have phlegm." From the past observational study, obesity is related phlegm, and the recent concept shows that obesity is a chronic inflammation disease. Therefore, we combined phlegm removal herbal medicine and Chinese medicine for clearing heat and detoxifying together for obese patients with lipid disorders in clinical practice. The aim of this study is to include 100 selected patients with BMI higher than 27 and hyperlipidemia, and a crossover design is used to analyze the efficacy of "Xian-Hua-Cha (XHC)" on relieving hyperlipidemia among the obese population. For this reason, the changes of patients' body weight, body fat and the metabolic parameter including blood sugar, cholesterol, triglyceride are collected for analysis. Besides, we also record adverse effects from taking XHC to assess the safety of XHC.

Eligibility Criteria:
Inclusion Criteria:

1. BMI ≧ 27kg/m2
2. Total cholesterol \> 200 mg/dL or LDL \> 130 mg/dL or triglyceride \> 150 mg/dL
3. Age ≧ 20 years and \< 75 years
4. No recognition difficulties
5. Willing to sign inform consent and comply to protocol

Exclusion Criteria:

1. Pregnant or breast-feeding women
2. Endocrine disorders (uncontrolled hypo/hyperthyroidism, adrenal gland disorder)
3. Diagnosis of neurologic or psychiatric diseases
4. Liver or renal dysfunction (AST/ALT higher than 3 times of upper normal limits; eGFR \< 60 mL/min/1.73 m2)
5. Acute stress condition (severe infection, receive major surgery in the recent 1 month)
6. Vision, or hearing impairment
7. With other clinical trial medication
8. With medication for obesity or hyperlipidemia in the recent 1 month
9. Heavy smoker, alcoholism or substance abuse
10. Severe organ dysfunction: malignancies, autoimmune diseases
Observational Study of Ocular Inflammation in Patients Undergoing a Pars Plana Vitrectomy

This study will evaluate the degree of post-operative ocular inflammation in patients who are undergoing a pars plana vitrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Require pars plana vitrectomy in at least 1 eye
* Best corrected visual acuity in the study eye between 20/400 and 20/40

Exclusion Criteria:

* Use of any NSAIDs (topical or systemic) within 14 days
* Use of topical or systemic steroids within 30 days
* Active eye infection in either eye
* Any eye surgery within 6 months
* Prior pars plana vitrectomy, YAG capsulotomy or uveitis
"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period

The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.


Eligibility Criteria:
Inclusion Criteria:

* highly symptomatic patients refractory to at least two antiarrhythmic drugs
* patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.

Exclusion Criteria:

* congestive heart failure
* ejection fraction \<35%
* left atrial diameter \>60 mm
* previous ablation procedure
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context

The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.


Eligibility Criteria:
Inclusion Criteria:

* Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion
* Non-opposition of the patient
* Patient willing to comply with all procedures of the study and its duration

Exclusion Criteria

* Cancellation of orthognathic surgery
* Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire
The Effect of a Blue Light Filtering IOL

To compare the effect on blood retinal barrier disruption 3 and 12 months after implantation of either a blue light filtering intraocular lens(blue-filtering IOL) or an ultraviolet light filtering intraocular lens(UV-filtering IOL).

The following parameters were measured for evaluation of blood retinal barrier disruption.

* the incidence of macular leakage by fluorescence angiography (FA)
* the mean fluorescein concentration in the vitreous by fluorophotometry (VFP)
* the thickness of the macula by optical coherence tomography (OCT)

Results

* the incidence fo macular leakage decreased significantly from 24%(3 months) to 5% (12 months) in the blue-filtering IOL group (P\<0.05), and was significantly lower compared with the UV-filtering IOL group at 12 months.
* the VFP significantly decreased in both group from 3 to 12 months.
* the OCT decreased from 175 (3 months) to 166 um (12 months) in the blue- filtering IOL group.

Eligibility Criteria:
Inclusion Criteria:

* cataract patients
* All eligible for intraocular lens implantation

Exclusion Criteria:

* Patients had undergone an intraocular operation
* Patients had hypertensive retinopathy
* Patients had diabetic retinopathy
* Patients had ange-related macular degeneration
* no observable fundus
* The cataract operation was more than 30 minutes in duration
Optimizing Infection Prophylaxis Prior to Shoulder Surgery

The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application. The main question it aims to answer is:

Does changing the pressure applied during the ChloraPrep application impact the amount of C. acnes bacteria on the skin after one hour? Researchers will compare ChloraPrep applied at a pressure similar to a gentle wipe to ChloraPrep applied at a pressure similar to a massage to see if wash the amount of C. acnes on the skin after one hour is different.

Participants will have one shoulder washed with ChloraPrep using pressure meant to impact the dermal layer, similar to a gentle wipe, and the other shoulder washed with ChloraPrep using pressure meant to impact the subdermal layer, similar to a massage. Participants will have swabs taken of their skin before the ChloraPrep application and again one hour after application to look for the amount of C. acnes on the skin.


Eligibility Criteria:
Inclusion Criteria:

* English speaking

Exclusion Criteria:

* Self report very sensitive skin
* Allergic to chlorhexidine
* Used antibiotics in the last three months
* Used acne treatment in the last three months
* Wounds on your shoulders
mTBI Identification and Monitoring Through Retinal Scanning

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-45 years
2. Presents to the facility within 2 weeks of head trauma
3. Able to provide informed consent

   * If minor, then able to provide parental consent and minor consent
4. Able to participate in the examination, including the ability to follow simple instructions
5. Fluency in English or Spanish

Exclusion Criteria:

1. Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment
2. Under the influence of alcohol or drugs
3. Previous eye surgery
4. Visual acuity known to be 20/200 or less in either eye
5. Known strabismus, amblyopia (lazy eye), or double vision
6. Known eye movement disorder, including nystagmus
7. Known optic nerve disease, including papilledema or optic neuropathy
8. Known retinal disease, including macular degeneration or retinal degeneration
9. Known cataract
10. History of neurosurgery
11. History of stroke/brain hemorrhage, brain tumor, or epilepsy
12. Any head trauma requiring medical attention from a physician within the last 6 months
13. Diagnosed dementia or cognitive impairment requiring assistance for daily living
14. Other condition(s) under the care of a neurologist
15. Psychiatric hospitalization in the last 90 days
16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
17. Any minor brain injury regardless of loss of consciousness
Effect of Omega-3 Fatty Acids on Insulin Sensitivity in Chinese Gestational Diabetic Patients

This study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil (n=25) and flaxseed oil(n=25), in Chinese gestational diabetic patients. Corn oil(n=25), rich in omega-6 fatty acids, will be selected as a controlled oil. The intervention will start from the third trimester of these pregnant women and finish at the 4wk after the birth of their children. The investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in these patients.


Eligibility Criteria:
Inclusion Criteria:

* 1)gestational diabetes 2) female, \<40 years old 3)willing to participant in the trial

Exclusion Criteria:

* 1）type 1 diabetes or type 2 diabetes before pregnancy 2）Deny to sign the informed consent 3）Family history of hypertriglyceridemia or fasting triglyceride\>4.56 mmol/L 4）Have severe liver disease, kidney disease or cancer 5)Participating in the other clinical trial within 30 days 6)Other diseases or conditions, for which the doctor of the patients do not agree his or her participating
Phase 2 Hyper-CVAD/Rituximab for Untreated Mantle Cell Lymphoma

rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years

Eligibility Criteria:
Inclusion Criteria:

* Untreated mantle cell lymphoma

Exclusion Criteria:

* Pregnant or breast feeding