cyrilzakka/clinical-trials huggingface dataset:
Testing the Gravitostat in Humans: the Impact of a Weighted Vest in Patients Post Bariatric Surgery on Fat-free Mass Retention and Weight Loss

The mechanisms regulating fat mass homeostasis are incompletely understood although recent animal and human trials would suggest that there is a leptin independent regulatory pathway which may play a role in weight control and maintenance. Although evidence would suggest that external loading in patients with obesity may promote body weight loss, this has not been explored in patients following bariatric surgery.

The aim of this study is to investigate the mechanisms regulating weight loss and the potential role of the 'gravitostat' in fat free mass retention in patients following bariatric surgery.

The aim of the study is to investigate the mechanisms that regulate weight loss, particularly following bariatric surgery. Previous animal studies have suggested that there is an underlying regulatory process controlled by 'the gravitostat' which is an evolutionary adaptation responsible for weight control and maintenance. Studies exploring this concept in rodent models have suggested that artificially increasing the animal's weight with the implantation of weighted capsules results in greater weight loss in mice with obesity but does not affect those of normal weight. We will use weighted vests in patients following surgery to replicate this increased mechanical loading to determine whether a similar process occurs in humans. This will improve our understanding of the underlying processes regulating weight in patients with obesity and following bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing bariatric surgery- Roux en Y gastric bypass or sleeve gastrectomy
* Age 18-60
* BMI \>30kg/m2
* Reporting regular physical exercise (\>3 days/week)
* Willingness to comply with the study protocol

Exclusion Criteria:

* Sedentary lifestyle
* Chronic pain that is constant and impairs the quality of life such as severe back, hip or knee pain
* Reduced mobility requiring the use of a mobility aid
* Undergoing revisional surgery
* Concerns from the investigator that the participant will be unable to fully comply with the study protocol
Multidisciplinary Team Approach: Working Together to Improve Glycemic Control in Hispanic Adults Diabetes

This study seeks to determine if a specialized multidisciplinary diabetes team (SMDT) approach that incorporates the use of the chronic care model can be an effective method for improving glycemic control in Hispanic adults with uncontrolled type 2 diabetes residing in the Rio Grande Valley. The study will expand the current model of care used and focus on the multidimensional aspects that consist of physical, nutritional, educational and psychological needs of this underserved Hispanic population residing in the Rio Grande Valley.


Eligibility Criteria:
Inclusion Criteria:

* Have physician-diagnosed type 2 diabetes
* Be self-identified as Hispanic or Latino
* An A1c value between 9-14% within the last three months
* English or Spanish speaking

Exclusion Criteria:

* Type 1 diabetes or gestational diabetes
* Cognitive impairment
* Prisoners or individuals under detention
* Unable to speak or understand English or Spanish
* Medical history of the end-stage renal disease or undergoing dialysis.
Effects of Liposomal Encapsulation on Calcium Powder Absorption and Metabolism

Compared with traditional calcium supplements, liposome calcium can increase the bioavailability of calcium and reduce the waste caused by gastric acid destruction of calcium. This allows calcium to be released slowly in the intestines, reducing the risk of indigestion or other side effects caused by excessive intake at one time. Liposomal calcium can be taken orally directly. It does not need to be dissolved in water before taking like other calcium supplements, making it more convenient to use. Based on the above advantages, liposomal calcium is a relatively safe and easy-to-absorb calcium supplement, suitable for long-term use, and can meet the body's demand for calcium. According to the recommendations of the World Health Organization, the daily calcium intake for adults should be 1000-1300 mg. In Taiwan, the seventh edition of the revised reference intake of dietary nutrients for Chinese people recommends that the daily intake for adults should be 1,000 mg. The calcium dose used in this study was 500 mg. The purpose was to explore whether the sustained-release characteristics of liposome coating technology can improve the absorption rate after consuming calcium powder and achieve better bioavailability. It is expected that microlipids made by lecithin can Lipid calcium powder increases its maintenance time in the blood, thereby increasing the supplementary effect of calcium, and is an alternative to calcium supplements.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20-60 years old, without heart, liver, kidney, endocrine or major organic diseases (patient report), and able to fully cooperate with the experiment.

Exclusion Criteria:

1. Patients with renal insufficiency and dialysis
2. Cancer patients
3. Underweight (BMI#17) or obese (BMI#27)
4. Those taking medications for chronic diseases
5. Blood pressure systolic blood pressure # 130 mmHg or diastolic blood pressure # 85 mmHg
6. Fasting blood glucose # 100 mg/dL
7. Fasting triglycerides # 150 mg/dL, total cholesterol # 200 mg/dL
8. Have a history of vitamin C allergy
9. People suffering from mental illness
10. Pregnant and breastfeeding women
11. Patients with hemosiderosis
12. Kidney stone patients
13. Supplements for those who take calcium for a long time
Weekly TP-HDFL in the Treatment of Advanced TCC

The purpose of this study is to evaluate the efficacy of Weekly TP-HDFL in advanced transitional cell carcinoma in terms of response rate and overall survival.

Transitional cell carcinoma(TCC)of urothelium,including bladder, ureter, and renal pelvis TCCs, was the most lethal urology malignancy in Taiwan. In 1995, approximately 1,300 new cases of TCC was diagnosed in Taiwan and more than 600 patients died of this disease. Advanced TCC is a moderately chemosensitive disease. A combination of methotrexate, vinblastine, and cisplatin with or without doxorubicin (M-VAC or CMV) has been widely used since 1980s. Despite the response rate was as high as 40-70%, the survival of these patients was only slightly increased from a median of 7 to 9 months for those who were treated with supportive care or cisplatin alone to a median of 12 months by cisplatin-based combination chemotherapy. One of the reasons for the poor treatment results is the inevitable treatment-related toxicities related to conventional systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Pathology proven TCC Recurrent or metastatic TCC Muscle-invasive TCC
2. Measurable disease
3. Age\>18
4. KPS\>60﹪
5. Creatinine clearance\>35ml/min,
6. AST/ALT \< or = 3.5times upper limits of normal reference values
7. Bilirubin\< or = 2.0 mg/dl
8. WBC \> or = 4,000/mm3, PLT \> or = 100,000/mm3
9. Written informed consent

Exclusion Criteria:

1. Previous systemic chemo is not allowed
2. TG \<70mg/dl
3. CNS metastasis
4. Life expectancy less than 3 months
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery

We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.

STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with the dietary standard of care at Boston Medical Center, in obese women subjects undergoing Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also be provided as part of the study's protocol.

Subjects will be selected from surgical candidates of the Nutrition and Weight Management Center who meet the study criteria. Subjects will be randomly assigned to one of the 2 groups (treatment and control). Subjects will be seen at the study site 2 weeks before surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5 visits). Data recorded during the study visits will be used to assess post-operative progress and will include: body composition, resting energy expenditure, muscle strength, quality of life questionnaires, hair loss, and blood markers for insulin resistance, nutritional state, organ function, lipid profile and inflammation. Safety indicators and compliance will also be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Obese and morbidly obese women (BMI 30 - 50)
* 25 years and older undergoing laparoscopic gastric bypass surgery
* Present with at least either metabolic syndrome or diabetes

Exclusion Criteria:

* Have smoked in the past 4 weeks
* Pregnant
* Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
* There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study
The PaTHS Descriptive Correlational Longitudinal Study

The primary objective of this study is to measure parent's post-traumatic stress before and after their infant's second palliative heart surgery for single ventricle congenital heart disease. The investigators will use the posttraumatic stress disorder checklist for the DSM-V (PCL-5) to measure levels 2-4 weeks before and after the infant's second heart surgery. The investigators aim to describe the levels at the two-time points, compare the scores, and identify demographic information that correlates with the scores.


Eligibility Criteria:
Inclusion Criteria:

* Parent who is 18 years or older of an infant with SVCHD
* Following with CHAMP through Children's Mercy Hospital. Any person personally identifying as a parent of the child, who lives in the same household as the infant, and who will provide primary care after discharge from the hospital is eligible to participate.

Exclusion Criteria:

* Parents of an SVCHD infant who is undergoing end-of-life care, determined by the primary care team.
Type 2 Diabetes Mellitus as Catalyst for Alzheimer's Disease

In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes and or the presence of its related genes favors the conversion of MCI to AD.

In recent years, it has been observed that the type 2 diabetic patients (DM-2) have an increased risk of developing dementia, both vascular and Alzheimer's disease (AD). The term mild cognitive impairment (MCI) describes a transition state between normal cognitive function and dementia. The annual rate of conversion to dementia in MCI patients is around 15% in the general population, ie regardless of the presence or absence of diabetes. At present it is not possible to identify which patients with MCI are most likely to progress to AD. On this basis, the main objective of this study is to evaluate whether the presence of diabetes favors the conversion of MCI to AD. We propose a case-control study comparing a group of 110 diabetic patients and a group of 110 non-diabetic patients with MCI matched by age, sex and cardiovascular risk factors. The main objective is the conversion to AD between the groups and if DM-2 is an independent risk factor. The secondary objective is to investigate whether genetic mechanisms related both to AD and DM-2 are associated with the increased risk of AD in diabetic patients. We will analyze 10 genes simultaneously associated with an increased risk of diabetes and / or its complications and AD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MCI using the NBACE neuropsychological tests battery.
* Age \>65 years.
* At least two years follow-up.
* 110 subjects with type 2 diabetes
* 110 subjects without diabetes
* written informed consent.

Exclusion Criteria:

* patients with cerebrovascular disease (previous stroke, intracerebral lesions, etc.), including significant vascular load according to scale Fazekas (escor˃2)
Pharmacokinetics of Oral Antiplatelet Agents After Distal Gastrectomy

This study is aimed to investigate the changes in pharmacokinetics and efficacy of antiplatelet agents before and after distal gastrectomy in gastric cancer patients taking oral antiplatelet agents for primary or secondary treatment for cardiovascular disease and to evaluate its impact on the occurrence of postoperative bleeding complications and thromboembolic events.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pathologically proven gastric cancer of clinical stage I according to the AJCC 8th edition.
* Patients who are scheduled to undergo distal gastrectomy (access: either minimally invasive surgery or open surgery)
* Patients taking aspirin and/or clopidogrel for primary or secondary prevention for cardiovascular disease or cerebrovascular disease before surgery.
* age 18 - 90 years
* A person who voluntarily agrees to participate in this study and signs the consent form.

Exclusion Criteria:

* Patients with coagulation disorder or abnormal findings in coagulation test (low platelet count, prolonged PT/aPTT)
* Patients taking other anticoagulants in combination
* Patients with imparied liver or renal function that may affect drug metabolism.

Impaired liver function: liver cirrhosis Impaired renal function: CKD grade 3 or higher

* Patients requiring adjuvant chemotherapy after surgery that may affect postoperative bone marrow function and hematopoietic function (those with gastric cancer of clinical stage II or more according to the AJCC 8th edition)
* Patients participating in other clinical trials within 6 months
* Vulnerable patients (pregnant women, those with cognitive impairment, etc)
CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies

This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
* Eastern Cooperative Oncology Group \[ECOG\] performance status 0-1

Exclusion Criteria:

* Significant active cardiac disease
* Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
* Inadequate bone marrow, renal, cardiac or liver function
Superficial Radiation Therapy (SRT) for the Treatment of Recurrent Keloid Scars

Keloid formation in response to skin trauma inflicts about 18 million individuals. A key impediment in successful treatment of keloids is that the predominant treatments, particularly surgical excision and shaving, tend to initiate the regrowth of the keloid at the excision site, and therefore, recurrence rates are high. There is much evidence to demonstrate that following surgical excision procedures with a course of radiation therapy can significantly reduce recurrence rates to as little as 10% or below. This prospective study is to evaluate this claim.

A keloid is an unsightly non-malignant tumor comprised of an abnormal proliferation of scar tissue that forms at the site of cutaneous injury (e.g. skin trauma such as cuts, abrasions and puncture wounds, burns or surgical incisions). It appears as a raised scar and does not regress and grows beyond the original margins of the scar. Keloids most commonly develop on the earlobes, neck, shoulders, chest, back, upper arms and cheeks. Keloids tends to grow slowly and continue to spread for weeks, months or even years. As a keloid grows, it may cause significant itching, pain, and tenderness upon touch, reduced mobility and emotional distress.

About 18 million people worldwide are genetically prone to form keloids in response to skin trauma, with equal gender distribution and greater susceptibility for darker-skinned individuals and those aged 10 to 30 years.

The greatest obstacle in treating keloids with many available surgical and non-surgical methods is that new keloids typically recur at the site of excision due to the treatment itself. For example, the recurrence rate using surgical excision alone is 45 to 100 percent.

Surgical excision followed by radiotherapy is a helpful treatment option for large and more difficult-to-treat keloids that cannot otherwise be treated by, or have failed, more conservative measures. It is thought that because keloid fibroblasts are sensitive to x-ray irradiation, it may prevent the recurrence of keloids by controlling fibroblast proliferation, arresting the cell cycle, and inducing premature cellular senescence. When surgical keloid excision is followed by Radiation Therapy, recurrence drops dramatically to 10% or below.

The SRT-100™ is a United States Food and Drug Administration (U.S. FDA) approved device for delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) to treat keloids caused by surgery or injury. This prospective study has been designed to focus on recurrence rates and associated treatment variables of the SRT-100™ for the treatment of recurrent keloid scars.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of keloid(s)
* Independently scheduled for treatment with SRT-100™, SRT-Vision™ or SRT-100+™ for one or more keloids
* Subject voluntary provides written consent to be in the study

Exclusion Criteria:

* Lesions of etiology other than keloids
* Any factor(s) that in the professional opinion of the investigator warrants the individual unsuitable for study participation
Effectiveness of Cotton vs. Waterproof Cast Padding

This study aims to: 1) investigate the effectiveness of waterproof spica cast using Delta-Dry® Pantaloon and cast padding (BSN medical, USA) versus standard gortex pantaloon with cotton cast padding in maintaining the femur fracture and developmental dysplasia of the hip reduction after application of hip spica; 2) evaluate the overall quality ratings of both cast paddings from the perspectives of the patient and the clinicians; and 3) determine the cost difference between the both cast paddings.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients (\<6 years old) diagnosed with developmental dysplasia of the hip or femur fracture who present to Texas Children's Hospital and plan to be treated with a spica cast.

Exclusion Criteria:

* Patients with thigh diameter more than 13.4 inches will be excluded because of the size limitation of the Delta-Dry Pantaloon
* Patients with femur fracture who present for treatment more than 2 weeks from the date of injury, comminuted fracture, non-displaced fracture, or with other surgical comorbidity
Neuro-navigated TMS for Chronic SCI Patients

Can neuro-navigated Transcranial Magnetic Stimulation be used as an additional outcome measure to EM-SCI assessments in a Spinal cord injury trial?

* Compare EM-SCI assessment with nTMS in ten chronic thoracic SCI patients
* Compare EM-SCI assessment with nTMS in ten chronic cervical SCI patients

This is an exciting time for translating experimental Advanced Therapies into treatments for spinal cord injury (SCI). There are currently no regenerative therapies available that target the underlying biology. Over the last 5 years the investigating team have developed a viable gene therapy approach for treating SCI in pre-clinical models. The investigators are on the cusp of translating this therapy to first-in-human studies and are leading a programme to establish a world-first regenerative gene therapy for traumatic SCI affecting upper limb mobility (since recovery of arm/hand function is one of the highest patient priorities). The team will develop an innovative trial design involving neurosurgical delivery of the gene therapy into the spinal cord, followed by specialist neurorehabilitation.

For a clinical trial to have the best chance of success, one of the key steps needed to be addressed include validation of new assessment methods for the clinical trial. Our aim is to determine whether neuro-navigated Transcranial Magnetic Stimulation (nTMS) can be used as an adjunct to standard assessments of function in SCI patients. Following two patient and public involvement events (patient focus group and feedback for project design with our rehabilitation partners), the investigating team will recruit chronic SCI subjects to carry out European Multicenter Study about SCI (EM-SCI) assessments. EM-SCI assessments are well established assessment tools for SCI patients and include the EM-SCI 'core' assessments (ISNCSCI, WISCI-III, Walk Test, SCIM 3) and EM-SCI 'additional' assessments (GRASSP, Pain score, neurophysiology). Following this investigators will compare and validate nTMS with EM-SCI assessments in stable chronic SCI patients with both cervical and thoracic injuries. nTMS with combined Tractography MRI of the cortico-spinal tract (the main motor pathway of the spinal cord) will allow functional characterisation and density measurements of this tract in SCI patients.

Eligibility Criteria:
Inclusion Criteria:

* Single traumatic event at least 6 months prior to recruitment
* ISNCSCI grade A, B, C or D
* Able to participate in EM-SCI and nTMS assessments and capable of informed consent

Exclusion Criteria:

* History of Malignancy
* History of other Neurological disease
* Pregnancy
* Other cord lesions or tethering
* Cord transaction or penetrating injury
Testing of Innocuousness of Benzalkonium Chloride on the Eye Concerning Possible Growth of Langerhans Cells

The study analysis the influence of benzalkonium chloride on the density of antigen presenting Langerhans cells. This is achieved in a double blind randomized study using in-vivo confocal microscopy to identify and quantify Langerhans cells of the human cornea in its central and peripheral part. This study design is based on observations with raised Langerhans cell density after the application of benzalkonium chloride containing eye drops in glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* healthy probands

Exclusion Criteria:

* eye diseases
* pregnancy and lactation period
* drug dependency
The Dynamic Fluctuation of Donor Microbiota Affects the Prognosis of Fecal Microbiota Transplantation for C. Difficile Infection

Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota. Recently, FMT has been widely used in the treatment of various gastrointestinal diseases, including but not limit in CDI. In this study, we focused on the demonstration of FMT action mechanism in CDI treatment.


Eligibility Criteria:
Inclusion Criteria:

1. aged over 18 years old;
2. positive stool test for Clostridium difficile 16S rDNA and/or glutamate dehydrogenase;
3. can tolerate nasojejunal tube and complete full course of FMT treatment;
4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion Criteria:

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;
2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment