cyrilzakka/clinical-trials huggingface dataset:
Islet Transplantation Through an Indwelling Catheter in the Umbilical Vein

Islet transplantation is one of the effective and promising options for type 1 diabetes mellitus treatment1-4. The liver is the primary target location for infusion and portal vein catheterization is generally used. Percutaneous transjugular, percutaneous transhepatic, laparoscopically transmesenteric and laparoscopically transumbilical approaches were often utilized to access the portal. Current islet infusion approach via portal vein of liver has various defects. Percutaneous trans-hepatic puncture is risk of possible severe hemorrhage and portal thrombosis. The laparoscopic entry techniques require longer surgical duration and have an increased rate of catheterization failure. Moreover, the catheters were not allowed to indwell for subsequent infusions.

In the current study, the investigators aim to performed open surgery, catheterized the umbilical vein and infused islets into the portal vein. The catheter was indwelled for one month after surgery. Therapeutic effects, surgical parameters and complications were observed to evaluate feasibility and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age 18 to 60 years of age.
* Ability to provide written informed consent.
* Clinical history compatible with type 1 diabetes (T1DM) as defined by the WHO guidelines(2007) on the Diagnosis and classification of Diabetes Mellitus.
* manifest signs and symptoms that are severe enough to be incapacitating.
* Basal C-peptide\<0.5ng/mL
* patients with poor diabetes control (HbA1c \>7% but \<12%)
* progressive diabetic complications.

Exclusion Criteria:

* age \<18 years or \>60 years
* diabetic history \<5 years
* BMI\>27
* body weight \>80kg
* exogenous insulin requirement \>1 unit/kg/day
* severe anemia (male \<8g/dl, female \<7g/dl)
* low white blood cell count (\<3000/dl)
* liver dysfunction
* Symptomatic peptic ulcer disease
* Any malignancy
* Active infection including hepatitis B, hepatitis C, HIV, or TB
* panel reactive antibody \>20%
* Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Video-assisted Informed Consent for Cataract Surgery

The investigators will investigate whether video-assisted informed consent is superior to routine discussion for cataract patients about risks, benefits and alternatives to receiving phacoemulsification cataract extract and intraocular lens implantation, and will determine whether video-assisted informed consent can reduce the work load of physicians.

Patients with age-related cataract who scheduled for elective phacoemulsification cataract extract and intraocular lens implantation surgery and their physicians who on charge of these patients will be enrolled in the study. Patients will be randomized to the video assistance group watched a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians. The control group will receive traditional verbal information and discussion from their physicians. A questionnaire for patients will be administered to assess the comprehension and satisfaction with the informed consent process before surgery.

Eligibility Criteria:
Inclusion Criteria:

Patients with age-related cataract scheduled for elective phacoemulsification and intraocular lens implantation for the first time in Department of Ophthalmology, Affiliated Hospital of Guangdong Medical College will be recruited in this study. Recruited patients shall own normal intelligence and understanding capability and their best corrected visual acuity more than 0.1 in either eye.

Exclusion Criteria:

Patients who have undergone previously cataract surgery or whose best corrected visual acuity is lower than 0.1 in either eye or patients who complicated with complex other eye diseases such as uveitis and retinal detachment or patients whose language is not cantonese or mandarin will be excluded from this study.
Virtual Exercises in Patients With Parkinson's Disease.

Introduction: Although the motor changes are well determined in Parkinson's disease (PD), few studies describe the effects the virtual exercises on the clinical and functional outcomes in this disease.

Objectives: To analyze the effectiveness of virtual exercises on functional exercise capacity, fatigue and quality of life in patients with PD.

Methods: 20 subjects, 60 years old will be included, who will be randomized into 2 groups: group of virtual exercises associated with conventional exercises (n = 10) and control group with conventional exercise group (n = 10).

The following variables are evaluated: functional exercise through walking test in 6 minutes, fatigue by the Fatigue Severity Scale and Quality of Life through Quality of Life Questionnaire-PDQ-39.


Eligibility Criteria:
Inclusion Criteria:

* will be selected for the study
* subjects with a clinical diagnosis of Parkinson's disease
* 0-III H\&Y
* 40 to 80 years
* both sexes
* with preserved cognitive stage (Mini Mental\> 24).

Exclusion Criteria:

* will be excluded subjects who have some acute pain or associated diseases
* such as severe or unstable heart disease
* visual disturbances
* using some march auxiliary device, which compromise the 6MWT and exercise protocol
Effect of Prewarming on Microcirculatory Response

Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.

Microcirculatory parameters can be obtained from vascular occlusion test. Among those parameters, recovery slope during vascular occlusion test is known to reflect recruitment of microvasculature in response to hypoxic or ischemic insult. In this study, we will compare the recovery slope during vascular occlusion test between prewarming treatment group and control group.

Eligibility Criteria:
Inclusion Criteria:

* off-pump coronary artery bypass surgery

Exclusion Criteria:

* refuse to enroll
* cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
* preoperative left ventricular ejection fraction \< 35%
* preoperative continuous infusion of vasopressor or inotropes
* pregnancy
Bipolar Proteomic Assay Validation Study

The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.

This is a hypothesis-driven confirmatory study to validate the diagnostic signature (model) for distinguishing BDI from MDD that also aims to optimize the models to discriminate BDII from MDD and BDI. A binary classification model, using linear discriminant analysis and based on 13 a priori-defined proteomic markers will aim to distinguish BDI from MDD. An alternative binary classification model based on multiple logistic regression and using 10 a priori -defined proteomic markers will aim for the same result. To improve the predictive performance of the signatures, items from self-report mood rating scales and treatment-emergent changes in proteomic markers will be analyzed. In addition, the study will examine if baseline or early treatment-emergent changes in proteomic markers predict treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with BDI, BDII, or MDD, confirmed with the Structured Clinical Interview for DSM-5 (SCID).
* Currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features,
* MADRS score ≥ 20 (consistent with at least moderately-severe depression)
* YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms)

Exclusion Criteria:

* At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS
* Current depression has psychotic features, diagnosed with the SCID
* Meeting criteria for severe alcohol, cannabis, or THC use disorders, as defined by DSM-5 and confirmed by the SCID, in the past 3 months, or meeting criteria for other substance use disorders of any severity (eg. cocaine use disorder). For substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. Caffeine and nicotine use disorders of any severity will not be exclusionary.
* Diagnosis of borderline personality disorder, diagnosed with the Zanarini Rating Scale for Borderline Personality Disorder.
* Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness \> 30 min, HIV)
* Severe chronic pain, at the discretion of the investigator
* Receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis
* Any acute unstable medical illness (at the discretion of the site investigator)
* In MDD patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting DSM-5 time criteria for hypomania; 2) a family history of BDI or BDII in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania.
Muscle Strength, Muscle Endurance, Lower Extremity Function, Aerobic Capacity, Pressure Pain Threshold and Edema in Women with Lipedema

Lipedema is a chronic progressive disease that causes disproportionate, painful extremities with abnormal fat distribution. Lipedema is known to cause physical and psychosocial disorders in individuals, but there are very limited studies on this subject. The aim of this study is to evaluate muscle strength, muscle endurance, lower extremity function, aerobic capacity, pressure pain threshold and edema parameters in individuals diagnosed with lipedema and to compare them with individuals without lipedema. Volunteer women aged 18 years and older with lipedema (study group) and without lipedema (control group) will be included in the study. After recording the demographic information of the patients, lower extremity muscle strength will be assessed with the K-force handheld dynamometer, lower extremity muscle endurance with the 30 Second Sit-to-Stand Test, lower extremity function with the Lower Extremity Functional Scale, aerobic capacity with the 6-Minute Walking Test, pressure pain threshold with the Baseline algometer, and edema with the moisturemeter. Data from the study and control groups will be recorded in the SPSS program and compared using the appropriate statistical method.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18 diagnosed with lipedema

Exclusion Criteria:

* Having cardiovascular, orthopedic and/or neurological problems that may affect physical capacity

  * Having diseases such as heart failure, kidney failure that may cause general or localized edema
Home Based Exercise Program for Elderly Cancer Patients

Implementation of a home based exercise program to reduce functional decline, cancer related fatigue (CRF) and improve quality of life in the elderly gynecologic oncology patient

Problem:

Can prevention of CRF and loss of function improve QOL in the elderly gynecologic oncology patient undergoing chemotherapy?

Support:

Fatigue and its impact on QOL is a major concern with the elderly patient receiving chemotherapy. When compared to younger adults QOL is more important than gain in survival for elderly patients. (Eyigor, et al., 2010).

The National Comprehensive Cancer Network recommends exercise as the most effective intervention for cancer related fatigue.

Methods:

This is a single institution randomized controlled study to evaluate a home based exercise program in elderly gynecologic oncology patients undergoing chemotherapy. Subjects will be randomized to the intervention group or to the control group receiving usual care.

Intervention group will receive a home exercise program 3 days weekly consisting of 30mins of strength and aerobic activity, utilizing a follow along exercise DVD and patient log to assist with compliance.

The two groups will be compared by 1) objective PT assessment with the Berg Balance and 6 minute walk test (before or after) Cycle 1 and 6, 2) subjective nursing assessment with the NHANES (National Health and Nutrition Examination Survey) and FACIT- F (Functional Assessment of Chronic Illness Therapy: Fatigue) prior to Cycle 1 (baseline),4 (midpoint), and following cycle 6 (completion).

Conclusion:

PT directed home exercise program may improve CRF, functional decline, and QOL in elderly gynecologic oncology patients undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Endometrial, Ovarian, Cervix, Vaginal Cancer Initiating Chemotherapy
* Age greater than or equal to 65yrs
* ECOG (Eastern Cooperative Oncology Group) performance status less than 3
* No current physical therapy intervention
* English speaking

Exclusion Criteria:

* Non-gynecologic malignancy
* Recurrent cancer
* Receiving radiation alone
* Gait or balance disturbance
CERAMENT™|G - Bone Healing and Re-infection Prophylaxis

The surgical management of long bone infections is often challenging. Adequate surgical debridement decreases the bacterial load, removes dead tissues, and gives a chance for the host immune system and antibiotics to arrest infection. Adequate debridement may leave a large bony defect. An appropriate management of the dead space is essential to arrest the disease, and for maintenance of the bone's integrity. The current strategy includes the use of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous graft harvested from the hip of the patient.

CERAMENT™\| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent colonization of gentamicin-sensible microorganisms in order to protect bone healing.

The aim of this study is to investigate the device absorption and bone in-growth of CERAMENT™\| G in a surgically revised bone infection. In addition, bone healing and infection non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a treatment success of \>90 % and that a similar bone healing will be obtained as with a standard two-stage surgical procedure. In addition, the investigators believe that the use of CERAMENT™\| G will be of advantage for the patient as bone healing will be achieved with a one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage procedure, thus decreasing potential surgery-related complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a long bone infection in femur, tibia, humerus or radius
* Candidate for one stage procedure
* Patients above the age of 18
* Written informed consent obtained before any study-related activities
* Patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program

Exclusion Criteria:

* Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
* Hypersensitivity to aminoglycoside antibiotics
* Myasthenia gravis
* Severe renal impairment
* Pre existing calcium metabolism disorder.
* Women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential)
* History of hypersensitivity to the investigational device or any of its ingredients
Non-Response to Exercise

The purpose of this prospective intervention study is to find biomarkers and underlying pathomechanisms for non-response of improvement in glucose metabolism to exercise.

An additional goal is to identify non-responders at an early stage, where prevention strategies (pharmacologically or by specific training) will be successful.

At baseline and end of study, an intensive metabolic phenotyping including cerebral insulin sensitivity as well as tissue biopsies are performed in overweight untrained healthy participants at high risk for type 2 diabetes. During the study, an individual exercise training at 80% VO2max is performed for 9 weeks. Before and after the training intervention, acute tissue biopsies after a standardized bout of exercise are obtained.

Eligibility Criteria:
Inclusion Criteria:

* at least one of the following risk factors for type 2 diabetes:

  * overweight (BMI\>27 kg/m2)
  * impaired fasting glucose and/ or glucose tolerance
  * former gestational diabetes
  * family history for type 2 diabetes (first-degree relative)
* sedentary participant (\< 2 exercise bouts/week)

Exclusion Criteria:

* any kind of metal in or on the body
* thermosensory or heightened sensitivity to heating
* heightened sensitivity to loud noise or diseases of the ear
* claustrophobia
* Diabetes mellitus
* current pregnancy or breastfeeding
* cardiovascular diseases
* surgery, \< 3 months ago
* participation in other clinical trials
* acute illness/infection, \< 4 weeks ago
* severe mental illness
* hemoglobin, women \< 11g/dl, men \< 13g/dl
* potentially incompliant subjects and/or inability to absolve the exercise training
* glucose influencing drugs
* continuous analgetic drugs
* use of anticoagulants
Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine in Healthy Infants

To assess the efficacy, immune response and safety of the oral live attenuated HRV vaccine (Rotarix) in healthy infants approximately 2 months of age and previously uninfected with human rotavirus


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants 6 and 12 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parents or guardians of the subject.
* Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
* Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
* Any clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
* Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
* Household contact with an immunosuppressed individual or pregnant woman.
* Abnormal stool pattern.
* Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
* Previous confirmed occurrence of rotavirus gastroenteritis.
Application and Generalization of Flutter Mucus Clearance Device

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices.

Respiratory diseases are still increasing in elder population. Sputum detaining is a common contributing factor to acute exacerbation. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but need more clinical randomized control trial evidence.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary department: available to perform the device, in-hospital patients

  * Male and female
  * Age: 45 - 85 years
  * Chronic bronchitis, COPD
* Thoracic surgery department and surgical department (upper abdomen):

  * Patients with endotracheal intubation of general anesthesia
  * Age: 40-75 years

Exclusion Criteria:

* Not available to perform the procedure
* Untreated pneumothorax
* Diffusion interstitial lung disease
* Acute coronary syndrome
* Third stage hypertension
* Advanced cancer
* Severe heart, liver, renal , blood system and endocrine system dysfunction
* Noninvasive mechanical ventilation more than 6 hrs per day
* Patients with invasive ventilation and cannot weaning and extubation within 48 hours
* Active hemoptysis
Integrating Systematic Data of Geriatric Medicine to Explore the Solution for Health Aging

This project aims to build up the comprehensive database of geriatric medicine for local Taiwanese.

This project is the pilot for the basis of establishing the schema of database and efficient procedures including subject recruitment, specimen collection, management, and measurement of samples obtained from multiple sources. We will focus on deciphering the correlation of sleep quality and the integrity of brain structure by integrating the holistic health data, socio-demographic characteristics, MRI, wearable technique, and laboratory technology including clinical lab, genotyping, metabolomics, gut microbiome, to unravel the clinical feature of which the age will effect on the frequency of sleep disturbance. This project will not only systematically study the aging effect on the sleep quality and brain structure integrity, but pave the way for exploring a variety of aging-related indications.

Eligibility Criteria:
Inclusion Criteria:

* Participants of annual health checkup conducted by either Taipei city or Chang Gung Health and Culture Village.
* aged ≧ 60 years old.
* have medical record in Chang Gung Memorial Hospital.
* resided in the Taiwan area over 180 days in past one year.

Exclusion Criteria:

* Participants with the medical history of severe organ disorders, severe autoimmune disease, or cancer under treatment.
* Contraindications or previously failure for receiving brain computerized tomography or magnetic resonance imaging scan.
* Participants who had receive outpatient clinic follow-ups with diseases that may affect the cognitive evaluation or presentation.
* Depression with ongoing diagnosis and treatment, suicide idea or suicide behavior in the past 6 months.
* Difficulty in communication or disabilities
Albumin Use in Burn Patients

This is a study of why and how physicians use albumin during the first 72 hours after a burn injury.

While albumin has been a part of burn resuscitation for many years, its use remains varied and controversial. The purpose of this study is to describe the current practices of albumin administration during the first 72 hours after a burn injury. Participating sites will collect data on patients with at least a 20% Total Body Surface Area (TBSA) burn. Information will be recorded on type and extent of burn injury, basic demographic data, co-morbidities, outcomes and, for the first 72 hours post injury, if albumin was used and why, amount of resuscitation fluids and urine output, and use of vasopressors and diuretics.

Each participating site will retrospectively review 20 charts of consecutive admissions with at least a 20% TBSA burn. In addition, each site will collect data prospectively on 20 more patients with 20% TBSA burns. Prospective data is requested in order to capture as close as possible to "real time" the reasons physicians choose to give albumin. No Protected Health Information (PHI) will be recorded.

Data will be analyzed for patterns of albumin use and reasons for albumin administration.

Eligibility Criteria:
Inclusion Criteria:

* Burn Injury, with and without inhalation injury

Exclusion Criteria:

* \<20% Total Body Surface Area Burned
* Comfort care only for the burn injury