cyrilzakka/clinical-trials huggingface dataset:
Viome Nutritional Programs to Improve Clinical Outcomes for Gastrointestinal Conditions

US residents who have gastrointestinal issues sign the informed consent form and are screened and enrolled for this study. Participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. This study is direct to participant and will NOT utilize clinical sites.

Participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, VIOME's condition-based supplements (VCS) arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo, Viome-designed condition-based supplements and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with gastrointestinal wellness. The trial will last approximately 4 months for each participant.

Eligibility Criteria:
Inclusion Criteria

* Resident of the United States
* Females and males ages 25-75 (inclusive)
* Able to speak and read English
* No unexplained weight loss, fevers, anemia, or blood in stool
* Willing and able to follow the trial instructions, as described in the recruitment letter
* Signed and dated informed consent prior to any trial-specific procedures.
* Diagnosis of IBS according to ROME IV criteria AND IBS-SSS score of 125-450 (inclusive)

Exclusion criteria

* Unwilling to change current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* Women who are pregnant (current or planned in the next 4 months), or breastfeeding
* \< 90 days postpartum
* Active infection
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Significant diet or lifestyle changes in the previous 1 month
* IBD diagnosis
* Use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial
* Cancer therapy within the previous 1 year
* Major surgery in the last 6 months or planned in the next 4 months
* Prescribed any drug(s) that may interact with the supplement formulations
* Have any medical condition or allergy that may interact with, or prevents the healthy consumption of the supplements
* Allergies to any study-specific supplement ingredients
* Currently on a specific diet:

FODMAP KETO PALEO

- Gastrointestinal disease including: Esophagitis Celiac disease GI malignancy or obstruction Peptic ulcer Duodenal or gastric ulcer disease

* GI surgery except:

Appendectomy and benign polypectomy
Characteristics of Patients With Amyloidosis & Heart Failure Being Evaluated for a Heart Transplant

The purpose of this study is to describe the characteristics of patients with amyloidosis and severe heart failure being evaluated for cardiac and stem cell transplantation.

Systemic amyloidosis is a progressive disease leading to organ failure and death. Treatment has improved survival with stem-cell transplantation. Unfortunately, patients with amyloidosis and severe heart failure are not eligible for stem-cell transplantation.

The average rate of survival for patients with amyloidosis who receive a heart transplant is decreased.

Previous trials have raised the possibility that survival may be increased in patients with amyloidosis, if chemotherapy and stem-cell transplantation is performed after a heart transplant.

We plan to review data of patients with amyloidosis and heart failure who were being evaluated for a heart transplant.

Eligibility Criteria:
Inclusion Criteria:

* Patients with amyloidosis
* NYHA class III or IV heart failure
* Patients undergoing heart transplant evaluation
* Patients less than 18 years of age

Exclusion Criteria:

* Patients who have unstable pulse and blood pressure
Therapeutic Effects of Traditional Chinese Medicine, Shen-Mai San in Cancer Patient Undergoing Chemotherapy or Radiotherapy

Using Shen-Mai-San for cancer patients undergoing chemotherapy or radiotherapy could help these people improve the quality of life.

Shen-Mai-San could improve fatigue, general weakness, neutropenia for patients under going chemotherapy or radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative patients with histologically confirmed cancer within 3 years and undergoing chemotherapy or radiotherapy
* age above 18 years old
* signed informed consent
* ability to read Chinese, ability for oral intake.

Exclusion Criteria:

* being pregnancy
* on breast feeding
* completed chemotherapy or radiotherapy
* brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four
* delusion or hallucination
* acute infection
* received medications for other clinical trials.
Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics

Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, investigators propose to examine the impact of dysbiosis on the endogenous innate inflammation known to exist within families affected by T1D and if probiotic supplementation may beneficially modulate this inflammatory state.

Participants will be asked to take the probiotic VSL#3 daily for six weeks. Stool and blood samples will be analyzed before and after the six week course of probiotics.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 5-17 years of age
2. Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes
3. Treatment naïve of any immunomodulatory agent
4. Naïve of any probiotic supplement within the past 12 months

Exclusion Criteria:

1. Presence of severe/active disease that interferes with dietary intake
2. Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives
3. Diagnosis of celiac disease and/or following a gluten-free diet
4. Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
5. Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
6. Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
7. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
8. Female participants of child-bearing age must not be pregnant
Effect of Cupping Therapy on Nitric Oxide Level in Patients With Cervical Spondylosis

this study will be conducted to investigate the effect of cupping therapy on the nitric oxide level in patients with cervical spondylosis

Cupping therapy is one of the oldest alternative medical procedures, along with acupuncture, with more than 3500 years of history to treat pain and various disorders. Cupping induces various biological responses that could be evoked by suction of the skin, About 5 to 10 minutes of cupping causes extravascular blood within the subcutaneous tissue and creates bruise-like marks. Therefore, cupping induces mild damage to a painful part of the body and accelerates healing by evoking the natural healing process. While this hypothesis is acceptable for some people, it might not be enough to change the minds of skeptics since cupping itself has no curative effects. Suppose the healing process after cupping can be accelerated by merging cupping with scientifically proven techniques. In that case, this new form of therapy might help to persuade skeptics of the efficacy of cupping. Integrative medicine, including acupuncture, dry needling, and cupping, is being used increasingly in the United States. evidence regarding their efficacy in the management of musculoskeletal conditions is heterogeneous and subject to several limitations. despite these limitations, acupuncture consistently is more effective than no treatment and is relatively safe. for chronic back pain, it is recommended as a first-line noninvasive therapy. for neck pain, acupuncture provides benefits when it is combined with other treatments. dry needling is similar to acupuncture and frequently is regarded as a form of acupuncture. sixty patients with cervical spondylosis will receive cupping therapy for three months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with (cervical spondylosis) from both sexes.
* Age range (24-60) in chronic stages.
* BMI from20-25 kg/m2.

Exclusion Criteria:

* Renal and hepatic patients.
* Anemia, hepatic disease, and dermatological diseases.
* Morbid obese patients if their BMI exceeds the 25 kg/m2 will be also excluded.
* the patients are taking any medications known to affect the pain level
* The patients have a systemic illness, dermatological problems, skin allergy, local ischemic problems
End-expiratory Occlusion Test and Prediction of Preload Dependence

Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. Patients were considered responders to fluid loading after an increase in sub-aortic VTI of more than 10% following a volume expansion. SPSS was used for statistic study. A p \< 0.05 was considered significant. The investigators performed univariate and then multivariate analysis.

The patients included were in the supine position in a prone position at 30°. They had continuous monitoring by: electrocardioscopy; pulse oximetry and invasive blood pressure. Diuresis was monitored hourly.

A venous access to the superior vena cava territory (central venous catheter) was set up.

The patients were sedated with a Ramsay score \> 4 and ventilated in controlled assisted mode.

The sub-aortic TVI (in cm) was measured in an apical 5-chamber section by pulsed Doppler using a 1-5 MHz ultrasound probe (M-Turbo sonosite). Three sets of measurements of hemodynamic parameters and sub-aortic VTI were performed: before and at the end of 15 seconds end-expiratory occlusion and after 250 mL saline administration over 10 minutes. At each point, the investigators noted the hemodynamic, ultrasound and biological parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patients under mechanical ventilation and sedation in the intensive care units
* patients for whom the decision of 250 mL saline administration was taken for : hypotension (systolic pression under 90 mmHg or diatolic pression under 40 mmHg or tachycardia more than 90 pulse per minute or oliguria or the increase in cathecholamin needs.

Exclusion Criteria:

* Pulmonary Edema
* arrythmia
* dialysis
* Prone position
Use of Thalidomide in Patients With Arachnoiditis

This pilot study will evaluate whether thalidomide decreases pain in patients with arachnoiditis.

Arachnoiditis, a neuropathic disease caused by inflamation of the arachnoid membrane that surrounds and protects the spinal nerves,can result in a debilitating state that is characterized by numbing and tingling, stinging and burning in the lower back or legs, and possible muscle cramps, twitching and spasms. Current treatments are not always effective in treating the pain associated with arachnoiditis. Recent research has indicated that a group of chemicals called cytokines that are produced by various cells in the body may be responsible for generating the pain response. Medications that effect the release of cytokines or block the action of cytokines may reduce the pain response. Various anti-cytokine medications are now being used to treat painful disease states such as rheumotoid arthritis and Crohn's Disease. In this study the anti-cytokine medication, Thalidomide, is being evaluated for it's effect in treating pain associated with arachnoiditis.

Eligibility Criteria:
Inclusion Criteria:

* Radiographically confirmed Arachnoiditis
* Involvement of the lower limb(s)

Exclusion Criteria:

* Subjects with baseline peripheral neuropathy to include diabetic neuropathy and other metabolic or toxic neuropathies.
Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition

The purpose of this study is to elucidate mechanisms whereby oxidative stress induced by acute reflux esophagitis: 1) activates p38 to regulate proteins that control the G1/S cell cycle checkpoint, and 2) activates HIFs (hypoxia inducible factors) to cause autocrine VEGF (vascular endothelial growth factor) signaling that triggers the EMT (epithelial-mesenchymal-transition) program in Barrett's esophagus.

Gastroesophageal reflux disease (GERD) and its complication, Barrett's esophagus (BE), are risk factors for esophageal adenocarcinoma. In BE, GERD causes inflammation with oxidative DNA damage and genomic instability that contributes to carcinogenesis. In BE, one response to oxidative stress is p38 pathway activation, which might protect against cancer development by initiating G1 arrest and enabling repair of DNA damage. Inflammation and oxidative stress also might induce epithelial-mesenchymal transition (EMT), the process in which epithelial cells acquire mesenchymal characteristics including the ability to migrate. This study will elucidate mechanisms whereby the oxidative stress of acute reflux esophagitis in BE activates p38 to regulate proteins controlling the G1/S cell cycle checkpoint, and activates HIFs to cause autocrine vascular endothelial growth factor (VEGF) signaling that triggers the EMT program.

Eligibility Criteria:
Inclusion Criteria:

* U.S. Veteran
* Barrett's Esophagus

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy or breastfeeding
* Esophageal varices
* Warfarin use
* Coagulopathy that precludes safe biopsy of the esophagus
* Comorbidity that precludes safe participation in the study
Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor

The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.

Epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. Many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. Some papers revealed the increasing in the rate of cesarean delivery. The main reason is assume to be a failure to progress labor after epidural analgesia. However, the recent report from Cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. Various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication.

The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.

Eligibility Criteria:
Inclusion Criteria:

* Age\>,= 18 years
* Accept epidural analgesia for labor
* ASA classification I-II

Exclusion Criteria:

* Unable to communicate Thai
Obesity, Iron Regulation and Colorectal Cancer Risk

Obesity is an independent risk factor for colorectal cancer (CRC) although the underlying mechanisms have not been elucidated. Dietary nutrients play a key role in both the prevention and promotion of CRC. While iron is an essential nutrient, excess iron is associated with carcinogenesis. Unlike the systemic compartment, the intestinal lumen lacks an efficient system to regulate iron. In conditions when dietary iron malabsorption and intestinal inflammation co-exist, greater luminal iron is associated with increased intestinal inflammation and a shift in the gut microbiota to more pro-inflammatory strains. However, treatments designed to reduce luminal, including diet restriction and chelation, are associated with lower intestinal inflammation and the colonization of protective gut microbes. Obesity is associated with inflammation-induced, hepcidin-mediated, iron metabolism dysfunction characterized by iron deficiency and dietary iron malabsorption. Obesity is also linked to intestinal inflammation. Currently, there is a fundamental gap in understanding how altered iron metabolism impacts CRC risk in obesity.

The investigator's objective is to conduct a crossover controlled feeding trial of: 1) a "Typical American" diet with "high" heme/non-heme iron", 2) a "Typical American" diet with "low" iron, and 3) a Mediterranean diet with "high" non heme iron and examine effects on colonic and systemic inflammation and the gut microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as Hispanic, African American, or Caucasian.
* Meet body mass index (BMI \> = 30.0 kg/m2) and C-reactive protein (CRP) criteria (\> 2.0 mg/dl)
* Post-menopausal (no menstruation in the past 12 months)
* Weight stable (\< 3% weight change in the past 3 months)
* Non-smoker
* No major medical problems
* Have a working phone
* No known allergies, intolerance, medical, secular or religious dietary restrictions

Exclusion Criteria:

* Chronic constipation (less than three stools per week for several months)
* History or intestinal cancer, inflammatory bowel disease, celiac disease, or malabsorptive bariatric surgery
* Previous intestinal surgery
* H pylori infection or taking H2 blockers (e.g., Zantac, Pepcid) /antacids (e.g., Rolaids) more than 3 times per week
* Significant blood loss or blood donation in past 3 months
* Active gastrointestinal bleed
* Any surgery in the past 3 months
* Hemochromatosis
* Sickle cell disease
* Hereditary polyposis
* Rheumatoid arthritis
* Type I or Type II diabetes
* Smoker
* Antibiotic use in the past 2 months
* Excessive alcohol consumption \[\> 2 standard alcoholic drinks (12 ounces of beer, 5 ounces of wine, 1 shot of hard liquor) per day\]
* Aspirin use \>81 mg/day OR \>325 mg/every other day
* Regularly taking probiotics, fiber supplements, Orlistat (over the counter brand name: Alli), or steroids (inhaled or oral)
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone

This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.

This is a monocentric, prospective observational study.

This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.

The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.

All patients will undergo imaging assessments as follows:

* At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
* Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.

Additional patient assessments to be performed include:

* questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities.
* clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS.

The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI.

Neither treating clinicians nor patients will be blinded at any point.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of castration-resistant prostate cancer,
* Single or multiple bone metastases,
* Life expectancy of over 6 months,
* No current active malignancy other than prostate cancer,
* Provision of written informed consent.

Exclusion Criteria:

* Absolute contraindication to WB-MRI, CT or BS,
* Radical treatment of sole site of metastatic disease (e.g. Cyberknife to solitary metastatic lesion),
* Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions are to be discussed with the patient as part of the informed consent process.
The Quantitative Study of the Habenula Based on Multi-channel Cascaded Neural Network and the Establishment of the Prediction Model of the Curative Effect in Patients With Depression

Depression is the second leading cause of disease burden in our country. It has serious effects on the physical and mental health of human beings, and about 30% of patients with depression are unresponsive or respond poorly to antidepressant treatment. Clinical practice is in a tough position of wanting objective measures of assessing depression. The applicant and her team have devoted many years to the basic and clinical research on habenular nucleus (Hb) accumulating a significant amount of experience from animal experiments and patients' magnetic resonance (MR) studies. These studies have demonstrated that the habenular nucleus is the key target area that is responsible for the pathophysiological changes in depression as well as its treatment. Small volumes and unsatisfactory contrast have been knotty problems in the MR imaging of Hb. In addition, time-consuming manual segmentation and lack of quantitative standards in conventional studies has impeded the advancement of Hb research. Fortunately, the development of high-resolution multi-parametric quantitative MR imaging and the extensive use of artificial intelligence (AI) technology in medical imaging can just provide powerful support for the imaging, segmentation and quantification of Hb. This project proposes to use high resolution MR anatomy of Hb combined with multimodal fusion to 1) construct a model for automatic 3D segmentation of Hb MR images based on the densely connected multichannel dilated convolutional neural networks; 2) sift out the quantitative imaging signatures related to the antidepressants' efficacy using the radiomics methodology, and in combination with clinical information, construct an individualized prediction model for treatment efficacy.

Overall, this study focuses on the translation of basic research to clinical application in the hope of providing quantifiable objective imaging markers in clinical practice, facilitating clinical decision-making and bringing about individualized precise diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Premiere depressed patients

Exclusion Criteria:

* Drug therapy modality change、Incomplete MR image data