cyrilzakka/clinical-trials huggingface dataset:
Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases

Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).

Previous studies have shown that NOD2 gene mutants were associated with the Crohn's disease (CD), colorectal cancer (CRC) and many other diseases, suggesting the critical role of NOD2 signaling in human physiology and pathogenethesis. However, whether decreased NOD2 ligands also contributed to these diseases is unknown. In this study, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ). For each of the patient, a sex- and age- matched control were chosen. Both the targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters were used to test NOD2 ligands in the fecal and plasma samples.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females at least 18-70 years old.
2. Patient able to give informed consent.
3. Patient with biopsy-proven CRC
4. Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.
5. patients with clinical diagnosed DM2
6. patients with ACVD:coronary angiography more than 50% stenosis in single or multiple vessels.
7. The age- and sex- matched health controls for each patient.

Exclusion Criteria:

1.Use antibiotics or probiotics within the last 2 weeks.
V3: Vancouver-Victoria Valacyclovir Trial for Early Psychosis

This is an 18 week (2 weeks run-in, 16 weeks double blind) trial, to determine if an antiviral drug, valacyclovir (Valtrex) is helpful in treating the symptoms of psychosis, a form of a mental disorder.

There is evidence that some of the symptoms of psychosis may be related to past infection with common viruses.

Researchers are looking to recruit a total of 100 subjects with evidence in the past, of exposure to at least 1 of 3 viruses. The viruses include herpes type 1 (HSV-1, which causes cold sores of the lip and has affected about 6/10 people in Vancouver), herpes type 2 (HSV-2 which causes genital sores, and has affected less than 1/10 people in Vancouver) and cytomegalovirus (CMV, which causes few symptoms but has affected 8/10 people in Vancouver). People who have been infected with these viruses in the past develop antibodies in the blood. The antibodies can be measured in blood, and are a test of whether or not there was infection in the past, and possibly affecting the symptoms of psychosis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects antipsychotic, mood stabilizing and antidepressant drug treatment must have been stable for at least 3 months, and there is no plan to change the drug treatment during the 4-month phase of the study.
* Subjects must be seropositive for HSV-1, HSV-2 and/or CMV.
* Subjects must achieve a level of understanding and expressive capacity sufficient to communicate adequately with the study coordinator and to participate in cognitive testing.
* Subjects must be able to provide written informed consent.

Exclusion Criteria:

* Females of childbearing age will agree not to become pregnant and will agree to use a medically acceptable method of birth control.
* Inability to participate in cognitive testing due to severe persistent psychosis or other condition.
* Mental handicap.
* Subjects with known hypersensitivity or allergy to valacyclovir or acyclovir.
* Patient taking nontopical antiviral medications with anti-herpes activity on a regular basis
A Study of a Novel Precision Medicine Approach for Obesity

This study is being done to assess the efficacy of a saliva- based biomarker to predict response to semaglutide for the treatment of obesity.

The purpose of this study is to test the effectiveness of semaglutide 2.4 mg SQ weekly in patients with obesity with a positive MyPhenome test for abnormal postprandial satiety compared to patients with obesity with a negative MyPhenome test for abnormal postprandial satiety.

Eligibility Criteria:
Inclusion Criteria:

- Obesity (BMI ≥30 kg/m2) without or with controlled chronic conditions (e.g., controlled hypertension).

Exclusion Criteria:

* Weight changes greater than 3% in the previous 3 months
* History of bariatric surgery including lap band and bariatric endoscopy
* Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) and Columbia Suicide Severity Rating Scale (C-SSRS). If such a dysfunction is identified by an anxiety or depression score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. Any suicidal ideation of type 4 or 5, any suicide attempt during the patient's lifetime, or any suicidal behavior in the last month.
* Current use of anti-obesity medications or GLP1R agonists for Type 2 Diabetes
* Any contraindication to FDA-approved GLP1R agonists
* A person who is pregnant or wanting to become pregnant
* Once the positive or negative cohort is filled at 2:1 ratio, some patients will be screen failed if their gene cohort is full.
* A family member who is enrolled in this study.
* Principal Investigator Discretion
A Study to Evaluate the Neovista Ophthalmic System for the Treatment of Subfoveal CNV in Patients With AMD That Have Failed Primary Anti-VEGF Therapy

The objective of this clinical study is to evaluate the safety and feasibility of focal delivery of radiation for the treatment of subfoveal choroidal neovascularization (CNV) in patients with age related macular degeneration that have failed Primary Anti-VEGF therapy.

Therapeutic advances in the arena of neovascular age-related macular degeneration (AMD) have provided multiple treatment options for the disease. Radiotherapy has been studied in multiple clinical trials in the past with many studies showing a therapeutic benefit. Treatment with radiotherapy and anti-VEGF compounds is a promising approach to treating AMD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the Investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of \< 12 total disc areas (21.24 mm2), and a GLD ≤5.4 mm
* Subjects must have received a minimum of three (3) prior injections (a minimum of 3 prior injections of the same compound) of anti-VEGF therapy (Lucentis® or Avastin®, subjects may have been treated previously with Macugen®, but must have been most recently treated with Lucentis® or Avastin® and met the criteria for failure below) with evidence of "failure" to respond to therapy
* Subjects must be age 50 or older

Exclusion Criteria:

* Subjects with prior or subfoveal CNV therapy with photodynamic therapy, intravitreal or subretinal steroids, or transpupillary thermotherapy (TTT) (Note: This includes subjects with no known history, but with photographic evidence of prior therapy)
* Subjects who underwent previous radiation therapy to the eye, head or neck
* Subjects who have been previously diagnosed with Type 1 or Type 2 diabetes mellitus. Subjects who do not have a documented diagnosis but have retinal findings consistent with Type 1 or Type 2 Diabetes Mellitus.
* Women of child-bearing potential (female subjects must be post menopausal or surgically sterilized)
Incidence of Diarrhea Using High and Low Osmolality Enteral Tube Feeding in Critically Ill Surgical Patients

The purpose and primary objective of this study is to determine if there is an association between enteral tube feed (TF) osmolality and diarrhea in critically ill patients. The investigators hypothesize that the administration of a TF formulation with high osmolality will cause more diarrhea than a TF formulation with a lower osmolality.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* admitted to SICU or CVICU requiring TF for enteral nutrition
* anticipated ICU stay and TF requirement \>72 hours

Exclusion Criteria:

* Contraindication to receiving one of the study TF formulations
* Inability to tolerate at least 75% of estimated requirement by day 3 of enteral TF administration
* Clostridium difficile infection or other cause of infectious diarrhea prior to study enrollment
* Presence of an ileostomy or colostomy
* History of inflammatory bowel disease, bowel resection, short gut syndrome, or chronic diarrhea
Breastfeeding Roadmap in Primiparous Women

The effect of the breastfeeding roadmap used in primiparas on breastfeeding self-efficacy perception and breastfeeding success will be evaluated.

The research was planned as a randomized controlled experimental study. Mothers who meet the inclusion criteria and agree to participate in the study will be assigned to the intervention and control groups according to the randomization list.

A total of 74 primiparous mothers who gave birth, 37 in the intervention group and 37 in the control group, will be included in the study.

In addition to the routine breastfeeding education given by the clinic's education nurse, the mothers in the intervention group will also receive a "Breastfeeding Roadmap" education poster developed by the researchers, which will be hung on the wall of their rooms. The researcher will introduce the Breastfeeding Roadmap to the mothers and provide information on breastfeeding. Routine hospital breastfeeding education will receive to mothers in the control group after childbirth.

Data Collection Pre-Test; Introductory Information Form, Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool at the 1st hour after birth. Pre-test data will collect by the researcher in the patient room within the first hour after birth (before Breastfeeding Roadmap breastfeeding education and hospital breastfeeding education were implemented) by face-to-face interview method.

Post-test; Breastfeeding Self-Efficacy Scale Short-Form, LATCH Breastfeeding Assessment Tool at least two hours before mothers are discharged from the hospital (the discharge period usually varies between 24 and 48 hours).

At the end of the study, the results of the mothers in the experimental and control groups will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study,
* Primiparous,
* Giving birth at 37 weeks of gestation or later,
* No condition preventing breastfeeding,
* No condition preventing breastfeeding in the baby,
* At least primary school graduate,
* Mothers aged 18 and over

Exclusion Criteria:

* Those who have given birth to multiple pregnancies,
* Those who received general anesthesia for Caesarean section,
* Those who have any chronic disease, diagnosed mental or psychiatric illness history,
* Those who have a history of preeclampsia, eclampsia and gestational diabetes,
* Those whose babies are in intensive care after birth
Safety and Efficacy Study of Vilazodone and Discovering Genetic Markers Associated With Response in Patients With Major Depressive Disorder

The purpose is to evaluate the safety and usefulness of the investigational drug, vilazodone in depression.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients 18-65 years of age, inclusive.
Cone Beam CT for Breast Imaging

The objective of this pilot study is to investigate Cone Beam Computed Tomography Imaging (CBCT), with the primary goal, the accumulation of a body of evidence to provide preliminary data for a future extensive clinical trials.


Eligibility Criteria:
Normal Group:

Inclusion Criteria:

* Are at least 40 years of age of any ethnicity
* Had a routine mammogram, read as BI-RADS® 0, 1, 2 or 3
* Will undergo study imaging no later than six months from date of routine mammogram.
* Is able to undergo informed consent.

Exclusion Criteria:

* Pregnancy
* Lactation
* Patients with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Patients who are unable to tolerate study constraints.
* Patients who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)

  * Treatment for enlarged thymus gland as an infant
  * Irradiation for benign breast conditions, including breast inflammation after giving birth
  * Treatment for Hodgkin's disease
* Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis

Diagnostic Group:

Inclusion Criteria:

* Women who are at least 40 years of age of any ethnicity
* Have a palpable abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE) or have a non-palpable abnormality detected by an imaging modality
* After diagnostic work-up are categorized as BI-RADS® 4 or 5.
* Are scheduled for biopsy either by large gauge needle biopsy or excisional biopsy.
* Will undergo study imaging prior to biopsy and within four weeks of diagnostic work-up.

Exclusion Criteria:

* Pregnancy
* Lactation
* Patients who have already undergone biopsy for the index lesion
* Patients who are unable or unwilling to undergo biopsy for the lesion of concern
* Patients with physical limitations that may prohibit the patient from resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker.
* Patients who are unable to tolerate study constraints.
* Patients who have received radiation treatments to the thorax or breast area for malignant and nonmalignant conditions, such as (but not limited to)

  * Treatment for enlarged thymus gland as an infant
  * Irradiation for benign breast conditions, including breast inflammation after giving birth
  * Treatment for Hodgkin's disease
* Patients who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
* Patients who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)

  * Tuberculosis
  * Severe scoliosis
Oral Immunotherapy for Desensitization in Children, Adolescents, and Young Adults With Hen Egg Allergy

To determine the efficacy and safety of AR201 in a characterized oral desensitization immunotherapy (CODIT™) regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive.

This is a phase 2, randomized, double-blind, placebo-controlled study of the efficacy and safety of AR201 in a CODIT regimen in hen egg-allergic subjects aged 4 to 26 years, inclusive. The study was conducted at 8 sites in the United States.

Eligibility Criteria:
Key Inclusion Criteria:

* Age 4 to 26 years, inclusive
* Written informed consent from subjects, as appropriate per local requirements, and parent/guardian
* Written assent from subjects who are minors, as appropriate per local requirements
* History of physician-diagnosed hen egg allergy
* Elevated egg specific IgE and/or mean wheal diameter on SPT to egg
* Experience dose-limiting symptoms at or before the 300 mg challenge dose of dried egg white protein on Screening DBPCFC
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* History of severe or life-threatening anaphylaxis within 60 days before screening
* History of non-IgE mediated hen egg allergy such as food protein-induced enterocolitis syndrome (FPIES)
* History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia or recurrent gastrointestinal symptoms of unknown etiology
* History of a mast cell disorder including systemic mastocytosis, urticaria pigmentosa, chronic idiopathic or chronic physical urticaria beyond simple dermatographism (e.g., cold urticaria, cholinergic urticaria), and hereditary or idiopathic angioedema
* History of chronic disease (except asthma, atopic dermatitis, or allergic rhinitis) which may require a change in immunosuppressive medication regimen or chronic corticosteroid use
* History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
* Developing dose-limiting symptoms to placebo challenge during the Screening DBPCFC
* Having the same place of residence as another subject in the study
* Any other condition that, in the opinion of the Investigator, precludes participation for reasons of safety
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
2. Measurable disease as per modified RECIST 1.1

   • A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
3. Subjects (male or female) ≥ 18 years of age
4. Female subjects with reproductive potential must have negative serum or urine pregnancy test
5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
3. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
4. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter
A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis

This study aims to determine if the CloudCath device can detect infections related to peritoneal dialysis (peritonitis) as fast or faster than the current standard methods used by patients and doctors to detect such infections.

This study will evaluate the safety and effectiveness of the CloudCath System to detect the onset of peritonitis as compared to standard of care.

Study Participants will connect the CloudCath System to their home peritoneal dialysis unit and the CloudCath System will analyze the effluent dialysis solution for changes associated with peritonitis. The notification capability of the CloudCath System will be deactivated for this study so that neither Study Participants nor Study Investigators will be aware of the device measurements.

Following enrollment, Study Participants will use the CloudCath System for 12 continuous months.

Eligibility Criteria:
Key Inclusion Criteria:

* currently using peritoneal dialysis
* provides informed consent
* willing to comply with the requirements of the study
* has cellular data coverage at home

Key Exclusion Criteria:

* active or history of cancer requiring chemotherapy within prior 6 months
* signs or symptoms of an active infection within 14 days prior to enrollment
* peritonitis diagnosis within 30 days prior to enrollment
* participating in another investigational device or drug study that may potentially affect study results
* other medical, social or psychological problems that, in the opinion of the investigator, exclude the study participant from the study
Methotrexate-Inadequate Response Autoinjector Device Sub Study

The purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (RA) subjects to compare the steady-state serum trough concentration (Cminss), Cmax and area under the curve (AUC) during the dosing interval (TAU) of subcutaneous (SC) Abatacept injection of 125 mg via the autoinjector and via the BD Hypak™ Physiolis prefilled syringe.

Study Classification:

* Safety: show if the drug is safe under conditions of proposed use
* Efficacy: measure of an intervention's influence on a disease or health condition
* Safety/Efficacy
* Pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localization in tissue, biotransformation, and excretion of the compound.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects who have been treated in the long term (LT) with open-label SC Abatacept for at least 3 months
* Must continue to meet inclusion criteria specified in main IM101-174 Study Protocol

Exclusion Criteria:

* Participation in previous device substudy (implemented by Amendment 10)
* Must continue to meet exclusion criteria specified in main IM101-174 Study Protocol
Inflammatory Markers in Pregnant Women Destined to Develop Preeclampsia

The purpose of this study is to assess the predictive role of serum inflammatory markers in pregnant women who subsequently develop preeclampsia.


Eligibility Criteria:
Inclusion Criteria:

* caucasian,
* nulliparous

Exclusion Criteria:

* preexisting cardiovascular diseases,
* diabetes,
* hypertension,
* inflammatory bowel diseases,
* serious organ diseases, and
* development of separate gestational diabetes and/or hypertension.
Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy

this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.In addition to evaluate the change in insulin resistance value after treating patients from HCV.

There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.

Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy.

The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Eligibility Criteria:
Inclusion Criteria:

* patients suffering from HCV
* male or female
* easy to treat naive patients

Exclusion Criteria:

* pregnant women
* seffering from HBV
* diffecult to treat
* other comorbodities as heart diseases or COPD