cyrilzakka/clinical-trials huggingface dataset:
Viome Precision Nutritional Programs to Improve Clinical Outcomes for Mental Health Disorders

US residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. Participants complete a survey upon enrollment and are randomized into one of two study 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 two study arms including: the placebo arm or the VIOME Precision Nutrition Program (VPNP) arm.

Placebo and Viome's Precision Nutrition Program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. 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.
* PHQ9 score of 5-24 (inclusive)

Exclusion Criteria:

* Unwilling to change their current diet
* Prior use of Viome products or services
* Antibiotic use in the previous 4 weeks
* Pregnancy (current or planned in the next 4 months)
* \< 90 days postpartum
* Breast feeding
* Active infection
* Unable or unwilling to use Viome's App on an iPhone or Android smartphone
* Significant diet or lifestyle change in the previous 1 month
* IBD diagnosis -Major psychiatric/DSM-4 disease diagnosis (e.g. Schizophrenia, Bipolar disorder, Post- traumatic Stress Disorder, Obsessive Compulsive disorder)
* 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
* Allergies to any supplement ingredients listed in the screening survey
* Currently on a specific diet: FODMAP, KETO, PALEO
* Answered yes to the question, "In the past few weeks, have you wished you were dead or had thoughts about killing yourself?"
* Gastrointestinal disease including:

  * GI surgery except:

    * Appendectomy and benign polypectomy
* Esophagitis
* Celiac disease
* GI malignancy or obstruction
* Peptic Ulcer Disease
* Duodenal or gastric ulcer disease
hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure

The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.

Eligibility Criteria:
Inclusion:

* Primary islet allotransplant
* surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team
* Age 18 or older
* must give written informed consent
The Investigation of the Mechanism of Cachexia Occurrence for Patients With Gastrointestinal Cancer

The study is going to recruit patients with gastrointestinal cancer, collect clinical data and peripheral blood sample and possible fat samples. The expression of SIRT-6 in peripheral blood will be tested and connect with different status of cachexia of the patients. A mathematical model of the relationship between cachexia classification and SIRT-6 expression is going to constructed as anticipated.

At the start of cancer develop, not all patients with gastrointestinal cancer manifest cachexia, it may be associated with SIRT-6 expression. This study will collect and test the peripheral blood sample of patients, use it as an important indicator of the degree of cachexia, and provide references for clinical drug intervention, prognosis and dietary intervention for cachexia patients. If possible, fat sample of the patients will be collected during surgery, and the adipose progenitor cells will be cultured to find the key target proteins by detecting differences in protein expression, changes in protein modification levels, and protein interactions.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 90 years old, unlimited gender;
2. Patients who are diagnosed with gastrointestinal cancer for the first time and are planning to undergo further treatment;
3. Volunteer to participate and sign the informed consent form.

Exclusion Criteria:

1. Women who are pregnant or lactate;
2. Patients with severe metabolic diseases; combined with cardiac function, liver and kidney dysfunction, acute myocardial infarction and acute stroke in the past 3 months , COPD acute onset respiratory failure and other serious medical diseases and patients who need hormone therapy
Prospective Evaluation of Hypofractionated Stereotactic RT Using CyberKnife for Patients With Prostate Cancer

The main purpose of study is to evaluate hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients with low and intermediate risk of progression prostate cancer.

Evaluation of the usefulness expression of selected proteins (PTEN, SMAD4, Cyclin D1, SPP1) as prognostic and predictive factors.

Eligibility Criteria:
Inclusion Criteria:

* men from 40 to 75 years of age with a confirmed adenocarcinoma prostate, prostate biopsy will be performed \<180 days prior to the randomization date,
* completed assessment of tumor differentiation according to Gleason grading allows to perform stratification;
* general Performance Status according to the Eastern Cooperative Oncology Group (ECOG) classification ( 0 -1),
* belonging to the group of low and intermedium risk of progression; (cT1-cT2c, Gleason 7, PSA to 19.9 ng / ml), cT specified by AJCC 7 Edition (appendix 2),
* PSA marked at least 10 days after or before the biopsy, and for patients taking phytosterol 30 days after discontinuation,
* no distant metastases,
* signing informed consent,
* morphological and biochemical blood parameters within the normal limits.

Exclusion Criteria:

* the presence of active cancer, except skin cancer preceding period 5 years prior to randomization,
* surgical treatment (radical prostatectomy) or RT in the pelvic area,
* co-morbidities that may significantly affect the expectancy life of the patients
* do not meet the criteria for inclusion.
Diet Quality, Pecans, and Cardiometabolic Health

A three-period, randomized, crossover controlled feeding trial will be conducted to examine the effect of including 2 oz./day of pecans, as a snack, in a diet representative of average American intake, compared to a diet representative of average American intake devoid of nuts, and a healthy dietary pattern including 2 oz./day of pecans on markers of peripheral vascular health, lipids and lipoproteins, blood pressure, and glycemic control.

Participants will be randomized to each diet for 4-weeks with a minimum 2-week break between the diet periods. All caloric foods and beverages will be provided. Outcome assessments will be done at baseline and the end of each diet period.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥25 and ≤40 kg/m2
* ≥ 1 criterion for metabolic syndrome (i.e. waist circumference ≥ 94 cm men or ≥80 cm women; triglycerides ≥150 mg/dL; HDL ≤ 40 mg/dL men or ≤50 mg/dL women; systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; fasting plasma glucose ≥100 mg/dL) at screening.
* non-smoking

Exclusion Criteria:

* Current tobacco use or use within the previous 6 months
* Diagnosed diabetes or fasting glucose levels \> 126 mg/dL at screening
* Systolic blood pressure \>160 mm Hg or diastolic blood pressure \> 100 mm Hg at screening.
* Use of anti-hypertensive, lipid lowering, glucose lowering drugs, steroids, or antibiotics in the previous month
* History of a cardiovascular event (heart attack, revascularization, stroke), or heart failure, liver, kidney, autoimmune diseases or inflammatory conditions such as gastrointestinal disorders or rheumatoid arthritis
* Use of supplements and botanicals known to affect study outcomes (e.g. psyllium, fish oil, soy lecithin, and phytoestrogens) and not willing to cease for the duration of the study
* Pregnancy, lactation or planning to become pregnant
* Consumption of \>14 alcoholic drinks/week
* Intolerance/allergy/sensitivity to foods included in the study menus
Endoscopic Band Ligation for Treating Reflux Disease

GERD is a chronic disease the require different treatment modalities; non have proven long term efficacy with concerns about their safety. The use of band ligation in endoscopy appears safe, repeatable with short learning curve. Placing multiple bands at the Z-line can create a fibrous ring in the distal esophagus acting as a barrier against reflux of gastric content.

The aim of the study is the complete resolution of reflux symptoms without the use of any drug.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic GERD

Exclusion Criteria:

* Any previous surgery for GERD
Radiation Stent Versus Self-expanding Metallic Stents (SEMS) for Palliative Treatment of Malignant Biliary Stricture

Malignant biliary obstruction is a common clinical condition caused by various malignancies. Currently,biliary stent implantation guided either by fluoroscopy or endoscopy has become the most important methods for relieving malignant biliary obstruction. However, the benefit for the survival of the patients with palliation of the stent treatment is limited because no therapeutic effects on process of the tumor itself by a stent implantation. Encouraged by the success of 125I esophageal stent in esophageal carcinoma, a novel biliary stent loaded with 125I radioactive seeds has been developed in our institute. After ex vivo and in vivo evaluations for the delivery system, the investigators prospectively compare the responses to treatment with this radiation biliary stent, versus the conventional biliary SEMS in patient with malignant biliary obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or older
* Biliary obstruction by any malignant process with histologically or cytologically confirmed by biopsy or previous surgical procedures
* Clinical symptoms of biliary obstruction
* Unresectable or refused to be surgically treated biliary obstruction by any malignant process
* Willing and able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Suspected benign bile duct stricture
* Strictures that can not be dilated enough to pass the delivery system
* Perforation of any duct within the biliary tree
* Presence metallic biliary stent or bile duct surgery
* Patients for whom PTC procedures are contraindicated
* Patients with active hepatitis or intrahepatic metastases that extensively involves both lobes of the liver
* Noncooperation or no authorization and signature
Polypectomy in Patients Taking Dual Antiplatelet Agents

Current guidelines recommend discontinuation of antiplatelets (i.e clopidogrel) for 7 days in patients taking DAT (dual antiplatelet therapy) before colonoscopy and polypectomy. The purpose of this study was to examine if a) discontinuation of these drugs reduces bleeding risks during polypectomy and if b) discontinuation of these drugs increases the occurence of thromboembolic events.

Patients taking dual antiplatelets (DAT) and who visited for colonoscopy were eligible for enrollment in this study. On enrollment, patients were randomized to two groups. One group continued DAT and the other group discontinued antiplatelets (i.e. clopidogrel, ticagrelor, prasugrel) for 7 days before colonoscopy. If polyps (≤1 cm) were observed during colonoscopy, they were removed by cold snare polypectomy. The primary aim was to compared the delayed bleeding rates of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* patients over the age of 20 years undergoing routine colonoscopy
* patients who are taking DAT (dual antiplatelet therapy)

Exclusion Criteria:

* patients not abiding to the study protocol
* history of inflammatory bowel disease
* severe comorbidities
* American Society of Anesthesiology class III or more
* pregnancy
Colors, Can They Reduce the Dental Anxiety

The investigator's aim in this study was to evaluate the preoperative anxiety and pain felt during the operation due to exposure to green, red, and blue light. For this purpose, the participants will wear colored glasses before the operation. The investigator will evaluate the patient's anxiety change and the pain she/he feels during the procedure.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 and ASA 2 patient population
* not having had a third molar surgery before
* volunteer to participate in the study

Exclusion Criteria:

* dental phobia
* patients who will be treated under general anesthesia
* refusing the measurements
* not filling out the VAS
* encountering complications during surgery
* operations lasting more than 45 minutes
"Investigation of the Relationship Between New Coronary Virus Disease (COVID-19) and Anxiety and Depressive Symptoms in Pregnant Women"

In our study; Anxiety and depression levels, socio-demographic characteristics of the pregnant women who were admitted to our hospital between 25.04.2020-25.07.2020 and treated with the diagnosis of covid 19, and the change in anxiety and depression levelsWİTH Beck Depression and Anxiety Score after the disease regressed are planned.

(Beck depression scale contains 10 questions and a total of 1 to 100 points is obtained. High score indicates that depression and anxiety are high.) 0-16 points = mild depressive symptoms

17-29 points = moderate depressive symptoms

30-63 points = severe depressive symptoms

The sociodemographic data form prepared by the researchers will be filled out by interviewing the patients who are willing to participate in the study. In addition, Beck Depression Scale, Beck Anxiety Scale, State and Trait Anxiety Scale will be given by the participants themselves. When the patients come to their first control after discharge, the scales specified will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* covid -19 pcr positive pregnant women
* no psychiatric diagnosis no use of psychiatric medicine

Exclusion Criteria:

Non-pregnant patients, A psychiatric diagnosis use of psychiatric medicine
Deep rTMS (H-coil) for Neuropathic Pain or Fibromyalgia

This study will investigate the efficacy and safety of "deep" rTMS on neuropathic pain or fibromyalgia. It will be randomized and sham controlled and will last 3 months. Patients will be randomized to receive acctive rTMS or sham rTMS and will receive repeated rTMS sessions (5 daily sessions then one session per week then every 2 to 3 weeks for up to 10 weeks).

This double blind sham controlled parallel group bicenter study will assess the efficacy and safety of repeated sessions of deep rTMS using H coil in patients with neuropathic pain or fibromyalgia. Primary outcome will be % of pain relief at week 13.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pain ≥ 6 months, at least 4/10 on a 0-10 NRS, present every day or nearly every day
* Neuropathic pain (confirmed with Douleur Neuropathique en 4 questions and international criteria from NeuPSIG) or fibromyalgia (revised ACR criteria)
* Stable concomitant medications for pain for at least one month
* Able to fill out questionnaires and understand and speak French

Exclusion Criteria:

* Contraindications to rTMS
* Prior treatment with rTMS
* Progressive severe condition (eg cancer)
* Psychosis
* Psychoactive drug abuse
Reanalysis of CVD Risk Factors Via Likelihood Methods

To reanalyze data on risk factors for cardiovascular disease (CVD) including total cholesterol and high density lipoprotein (HDL) cholesterol for the subjects in the first, second, and third exams of the NHLBI Twin Study.

BACKGROUND:

The results of these longitudinal analyses yielded new insights on genetic effects affecting CVD risk factors during the aging process.

DESIGN NARRATIVE:

The analyses utilized maximum likelihood estimators of genetic variance which were asymptotically more efficient than the method-of-moments estimators used in previous analyses. The models used incorporated terms to partition the variance in a trait from twin data into either i) additive genetic variance and unshared environmental variance (the AE model), ii) additive genetic variance, dominance genetic variance, and unshared environmental variance (the ADE model), or iii) additive genetic variance, shared environmental variance, and unshared environmental variance (the ACE model). The AE, ADE, and ACE models were fitted separately to data from each of the three exams to obtain a cross-sectional analysis. The investigators also extended these models for use with longitudinal data by incorporating terms to represent the covariance of variance components from different exams.

Two important additional objectives of this study were i) to introduce resistant estimation techniques in twin modeling, which trimmed the effect of outlier data points smoothly, and ii) to carefully study the performance of maximum likelihood and method-of-moments estimators when assumptions of the twin model were violated. The results of these parts of the study should yield a more complete understanding of the relative merits and limitations of twin modeling procedures.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Fingers Hook Technique to Facilitate Nasotracheal Intubation

to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation

It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet. However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea. Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.

Eligibility Criteria:
Criteria:

Inclusion Criteria:

1. patients with American Society of Anesthesiologists physical status I-III
2. aged 20-65 years
3. Requiring general anesthesia undergoing oxo-maxillofacial surgery
4. unlimited mouth open
5. unlimited neck motion

Exclusion Criteria:

1. mouth open \< 3 cm
2. Ankylosing arthritis patients.
3. BMI≧35 kg/m2
Media Effects Study on Health-Related Content

A media lab study will be conducted to determine the mechanism by which podcasting may exert an effect. This study will examine both physiological (heart rate, skin conductance, etc.) and psychosocial (knowledge, perceived control, elaboration, etc.) measures in participants listening to a podcast on health versus reading health content on the Web. We hypothesize that podcasting will create a greater physiological response than the Web. There will also be more elaboration in the podcasting group. Podcasting will produce greater feelings of control. Changes in knowledge will be greater in the Web group.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Be willing to be randomized to either the podcast or Web condition
* Able to attend the intervention session

Exclusion Criteria:

* Not living in the Chapel Hill area
Smart Device-based Cardiac Rehabilitation After Myocardial Intervention

The aim of this study is to evaluate the influence of cardiac rehabilitation based on smart band use and telemonitoring on functional capacity change and risk factors control among patients hospitalized for acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent with the study
2. Men and women \>18 years of age
3. Patients ≥1 and ≤6 months after type I myocardial infarction
4. Physical inactivity before MI defined as the absence of moderate to vigorous exercise for at least 30 minutes 5 or more days a week

Exclusion Criteria:

1. Heart failure NYHA IIIB-IV
2. Planned coronary revascularization
3. Planned major surgery within the next 12 months
4. Inability to walk for any reason
5. Comorbidities that would preclude adherence to the rehabilitation program (e.g. arthrosis, active malignancy, major depression or other significant psychiatric disorder, cognitive impairment) - at the discretion of the physician
6. Life expectancy less than 12 months
7. Pregnancy
8. Inability to operate the smart-watch