cyrilzakka/clinical-trials huggingface dataset:
Effects of Lignan-rich Diet on Cardiometabolic Risk Factors

Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular disease and certain cancers. Studies have shown that diets with high whole-grain content could decrease the risk of these lifestyle related diseases and in Sweden the national dietary guidelines recommends whole-grain based instead of refined cereal products. It is, however, not clear whether whole-grain from wheat and rye share similar protective effects since there are large differences in amount and quality of dietary fibre and associated bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet with low- or high lignan content on different cardiometabolic risk factors with the primary endpoint being blood glucose levels after 2h oral glucose tolerance test in men with metabolic syndrome or sign thereof.

The study will be conducted in a randomized, cross-over design (8 wk intervention periods). The lignan-rich diet will be based on whole-grain rye products whereas the control diet will be based on whole-grain wheat products with some added wheat bran. Both diets will provide similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre quality will be different). Although rye has high lignan content, the aim is to further increase the lignan intake half-way through the whole grain rye intervention period. This will allow us to distinguish the effect of lignans from the effect of whole grain rye as well as evaluating potential differences in effects on cardiometabolic risk factors between whole grain wheat and whole grain rye intake after 4-week consumption. The study design will also allow us to investigate the effects of a putative interaction between microbiome x lignan rich diet and its implication of metabolic risk factors.

Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8 weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks of the second intervention period.

At each examination day participants will arrive to the test laboratory for blood samples and an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120 minutes. Furthermore, participants will be instructed to complete one 3-day weighted food record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 25 kg/m2
* waist circumference \> 102 cm
* at least one of the following: blood pressure \>130/85 mmHg, serum triglycerides ≥1.69 mmol/L; HDL cholesterol \<1.04 mmol/L; or serum glucose ≥6.1 mmol/L

Exclusion Criteria:

* smokers
* antibiotic use past 6 months
* cancer diagnose (past 5 years) or other chronic disease diagnosis
* excessive alcohol consumption (\>21 units/week)
To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.

This study will compare two commonly used soft tissue grafting techniques (connective tissue graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral ridge augmentation procedure.

Following ridge augmentation procedure, most of the times there is a need for soft tissue augmentation to change the quality of the tissue around future implant's site. To our knowledge, the influence of soft tissue augmentation at the time of ridge augmentation procedure has not been tested defects.

Research data and daily clinical observations reveal that implants with lack of surrounding keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more prone to persistent gingival inflammation, faster disease progression and compromised plaque control. Ridge augmentation procedure can alter the quality of tissue in the sites where it will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation procedure.

Specific aims for this project include the evaluation of:

1. To evaluate the quality of soft tissue regenerated with the use of the two available soft tissue grafts via histological analysis.
2. To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR) procedures.
3. To quantify the soft tissue augmentation achieved by the two available soft tissue grafts by direct clinical measurements after the healing

Eligibility Criteria:
Inclusion Criteria:

1. Be a registered University of Alabama at Birmingham (UAB) dental school patient
2. English Speaking
3. Healthy enough to undergo the proposed therapy
4. Demonstrated willingness to comply with study directions and time-line
5. Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan.
6. Able to read and understand the informed consent form
7. Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth.

Exclusion Criteria:

1. No English Speaking
2. Smokers/ tobacco users (\>10 cigarettes a day)
3. Less than 18 years old
4. Know hypersensitivity to titanium
5. Patients with significant medical conditions or habbits expected to interfere with bony healing.
6. Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse)
7. Bone dehiscence of \>4mm following tooth extraction or Vertical loss of bone at edentulous ridge
Visual Recognition of Allergens by Allergic Patients and/or Their Parents

Food allergies are constantly increasing. Peanut and nut allergies are a major cause of allergic reactions. Diagnosed patients are also at risk, because 27% of the patients that had an allergic reaction have another one in the following year with the same food, despite a real improvement in industrial products labeling.

The investigators have observed in the allergy Unit that patients (and/or their family) following an elimination diet, sometimes since several years, use very strict elimination strategies. Those strategies sometimes lead to incapacities to recognize the allergens. Yet, a good identification of the allergen is the key to a successful elimination and the non-identification a known risk factor.

Ferdman shown in 2006 that 27% of the patients didn't recognize the allergen there were allergic to. However, this is a US study, and geographical specificities have an impact on food consumption and culture. Food allergology needs to take those two elements into account. For example, in France, a single food can have two names. It is the case of peanut, which can be called "arachide", or more frequently "cacahuète".

The goal of the study is to observe patient aptitudes to recognize peanut (and the association between the two names) and other nuts available in France and define by the European law, using a plate with various food samples in seed or in shell.

Thus, patients in care at the allergy Unit of Saint Vincent Hospital of Lille (France) and their families were surveyed with a standardized procedure at the beginning of their therapeutic education and their capacity to recognize various nuts, to identify peanut ("cacahuète" or "arachide") and to associate the two words "cacahuète" and "arachide" was assessed. It is a standard procedure in therapeutic education, and the responses have been systematically entered in the medical record.

The main objective of this study is to describe peanut or nut allergic patient capacity (adult, children and/or the family) to visually identify the foods there are allergic to.

The secondary objective of this study is to describe the capacity of patient that describe themselves as allergic to "arachide" to associate this word to the word "cacahuète".


Eligibility Criteria:
Inclusion Criteria:

* Peanut or nut allergy
* Following an elimination diet since at least 3 months
* Results obtained at the beginning of a therapeutic education started from 2013 to 2015

Exclusion Criteria:

* Patients opposed to enter the study
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients

Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.


Eligibility Criteria:
Inclusion Criteria:

- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.

Exclusion Criteria:

* The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
* Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
* Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.
Macrophages, Portal Hypertension, and Liver Function During AbbVie Treatment of Chronic Hepatitis C

Investigation of the effects of the new Abbvie direct acting anti-viral (DAA) treatment of chronic viral hepatitis C infection on the macrophage specific activation marker soluble CD163, portal hypertension determined by the hepatic venous pressure gradient (HVPG), and metabolic liver function determined by the galactose elimination capacity (GEC) test and the functional hepatic nitrogen clearance (FHNC).


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C genotype 1 or 4 patients initiating the new AbbVie treatment (paritaprevir, ritonavir, ombitasvir og dasabuvir sammen med ribavirin)
* Child-Pugh A liver cirrhosis

Exclusion Criteria:

* Severe liver dysfunction - Child-Pugh klasse B-C
* Life expectancy less than 6 months
* planned liver transplantation or TIPS procedure within 6 months
* non-compliance to treatment or study procedures
* allergy to the DAA drugs used (paritaprevir, ritonavir, ombitasvir, dasabuvir, and ribavirin)
* pregnancy or expected pregnancy during the study (anti-conception has to be used)
* breast feeding
* portal vein thrombosis
* liver cancer or other malignancies
* alcohol consumption
Physical Therapy for Liver Cirrhosis

Patients with liver cirrhosis have severe physical deconditioning. Aim: To compare between the effect of neuromuscular electric stimulation(NMES) and exercises (EX)on treatment of patients with liver cirrhosis.

70 patients have been chosen from department of internal medicine, Cairo university hospitals, Egypt. 5 patients refused to participate .65 patients divided randomly into 2 groups. All the procedures were explained to patients.2 patients refused to sign informed consent and excluded from the study. 31 patients in group1 and 32 patients in group2. 1patients dropped in group1 and excluded from the study and two patients didn't continued the programmed treatment in group 2 and their data removed.

Thirty patients in each group signed an informed consent and complete the treatment program.

Eligibility Criteria:
Inclusion Criteria:

* Positive for anti-HCV.
* Not under antiviral therapy at entry.
* Positive for chronic hepatitis or compensated cirrhosis.
* Negative for hepatitis B surface (HBs) antigen.
* Free of co-infection with HIV.
* Not pregnant.
* Systolic blood pressure of less than 180 mmHg or diastolic blood pressure of less than 110 mmHg.
* (viii)No ischemic heart disease or severe arrhythmia

Exclusion Criteria:

* Significant cardiac disease (ejection fraction \<60% or history of coronary artery disease).
* Chronic renal failure on dialysis.
* Hemoglobin \<11.0 g/L.
* Human immunodeficiency virus infection.
* Hepatocellular carcinoma.
* Active non-hepatocellular carcinoma related malignancy.
* Myopathy.
* Any physical impairment or orthopedic abnormality preventing EX, or post-liver transplantation
Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

The aim of the study is to determine the influence of supplementation of probiotic Lactobacillus Plantarum 299V vs. placebo of probiotic during antidepressant monotherapy with SSRI (Selective Serotonin Reuptake Inhibitor) in patients with major depression.

For period of 8 weeks patient will receive probiotic Lactobacillus Plantarum 299V or its placebo as a supplementation of regular depression treatment with SSRI (Escitalopram or Sertraline). Psychometric and biochemical parameters will be monitored and evaluated. At day one, after 3 weeks (day 21) and after 8 weeks (day 56) of the study psychometric parameters will be measured such as Hamilton Depression Rating Scale, PSS-10 Scale, SCL-90 scale. At day one and after 8 weeks (day 56) of the study cognitive functions will be measured using: CVLT- California Verbal Learning Test, RFFT Ruff Figural Fluency Test, Stroop Test, Connecting Points Test (A and B), Attention and Perceptivity Test. At day one and after 8 weeks (day 56) of the study biochemical parameters will be measured such as: morning cortisol, pro and anti-inflammatory cytokines, tryptophan and its kynurenic pathway metabolites concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Unipolar depression, with at least one depressive episode, present episode since at least 2 weeks, with Hamilton Depression Scale scoring 18 and higher with BMI =18,9 - 29,9 kg/m2

Exclusion Criteria:

* Inflammatory diseases eg. rheumatoid diseases, inflammatory bowel diseases, autoimmunological diseases
* Metabolic diseases e.g. diabetes type I,II, obesity (Body Mass Index)\>30 kg/m2
* Previously diagnosed other psychiatric diseases other than depression, psychoactive substances abuse, organic brain dysfunctions
* Smokers
* Patients after surgeries in last 3 months
* Oncological patients
* Patients during pregnancy or lactation
* Drugs which might influence measured parameters (e.g. lithium, antibiotics, glucocorticosteroids, antipsychotic drugs)
* Changes in routine blood biochemical parameters: morphology, electrolytes, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), creatinine, urea, C-reactive protein (CRP), thyroid-stimulating hormone (TSH).
Isolated During COVID-19: Effects of COVID-19's Social Restrictions on Loneliness and Psychosocial Symptomatology

This study seeks to gather data and insight on epidemiologic trends of loneliness and other behaviors in the wake of the CDC recommended "social distancing" during the COVID-19 pandemic. The objective of this study is to use a cross-sectional survey to assess the impact of COVID-19's associated recommendations (social distancing, self-isolation, and self-quarantine) on loneliness and psychosocial symptomatology (depression, anxiety, substance abuse) on young adults (18-35 years old).


Eligibility Criteria:
Inclusion Criteria

* 18-35 years old
* Currently living in the United States

Exclusion Criteria

* Those under 18 years, or older than 35 years
* Adults unable to consent
* Non-English-speaking adults
Renal Retention of Microbubbles

Flank pain has been reported with ultrasound (US) contrast agents. The purpose of this study is to determine whether there is retention of ultrasound contrast agents in the renal microcirculation, which has been described in mice.

In this study patients undergoing clinically indicated contrast echocardiography will have renal ultrasound performed 10 minutes after completion of contrast infusion to determine the presence and location of renal retention of lipid microbubbles.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing clinically indicated contrast echo
* adequate renal ultrasound images

Exclusion Criteria:

* chronic inflammatory disease
* known kidney disease
* immunomodulatory therapy
Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection

The aim of this study is to investigate the relationships between interleukin 28B genetic variants and the response to treatment of chronic hepatitis C in Chinese children.

Hepatitis C affects thousands of children throughout the world. Most children acquire the virus through vertical transmission, although parenteral routes of acquisition are also common. Affected children are usually asymptomatic and histological findings are mild with a low risk of progression, about 5% develop significant liver disease in childhood.

The use of combination treatment with interferon-alpha and ribavirin were recommended in the treatment of chronic hepatitis C in children, SVR in children with genotype 1 ranged from 44% to 59%. SVR in children with genotype 2 and 3 was more than 90%. But both interferon and ribavirin have significant side effects which affect compliance, such as: repeated flu like symptoms, leukopenia and anemia, moderate weight loss, behavioural problems, thyroid dysfunction and transient deceleration of the growth rate. In addition, approximately 50% of children infected with genotype 1 do not respond to therapy.

Recent work has highlighted that single nucleotide polymorphisms (SNPs) around the IL28B gene have been identified as strong predictors of spontaneous and treatment-induced HCV clearance in adults, especially Rs 12979860 and Rs 8099917. A recent article in Hepatology also reported that interleukin (IL)-28B C/C genotype in the child was associated with spontaneous clearance of hepatitis C virus (HCV) genotype 1 infection. All this reports show that Genetic Variation in Interleukin-28B Locus is associated with the procession of CHC.

The aim of this study was to study the association between genetic variation in IL-28B and the development of CHC in Chinese children, such as: HCV viral load, serum alanine aminotransferase, histological change and the response to the treatment with interferon-alpha and ribavirin.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1-18 years
* Patients with chronic HCV infection

Exclusion Criteria:

* HCV infected patients previously treated with antiviral drugs
* Co-infected Patients with HIV or Hepatitis B virus (HBsAg positive)
* hepatocellular carcinoma or other malignancies
* anticipated with difficulty of follow-up observation
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Indication of Cesarean Deliveries
* Elective or Emergency with Incision in Lower Segment in Women with
* Gestational Age more than 37 Weeks.

Exclusion Criteria:

* Anemia
* Multiple Pregnancy
* Polyhydraminus
* Prolonged Labor
* Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
* Hypertension
* Cardiovascular Disease
* Coagulopathy Disease
CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome

This is a pilot and feasibility study of transplant eligible, higher risk myelodysplastic syndrome (MDS) patients to determine the safety and tolerability of a lower -dose and higher-dose CPX-351 regimen, with secondary objectives including complete remission (CR) rates and proportion of patients proceeding to transplant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myelodysplastic syndrome (MDS) with an IPSS-R score of Intermediate, High or Very High (see Appendix A) AND ≥ 5% myeloblasts in the bone marrow.
* Age 18-70 years.
* ECOG performance status ≤ 2 (see Appendix B)

Adequate renal and hepatic function as defined below:

\*Total bilirubin ≤ 2.0 x IULN\*

* AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
* Serum creatinine ≤ 2.0 mg/dL
* Note: If, in the opinition of the treatment physician, the bilirubin is elevated secondary to hemolysis or Gilbert's disease, the patient may be eligible after discussion with the Washington University PI.

  * Left ventricular cardiac ejection fraction ≥ 50% by echocardiography or MUGA.
  * Deemed by the treating physician to be a suitable candidate for cytotoxic induction therapy and an alloHCT candidate at the time of enrollment.
  * Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and continuing until 30 days after the last study treatment.
  * Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria:

* Prior treatment for MDS with disease-modifying therapy (conventional or investigational) (i.e. hypomethylator therapy, lenalidomide, or prior AML-like induction therapy intended for the therapy of MDS). Use of prior growth factor and ESA support is permitted.
* Currently receiving any other investigational agents.
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to CPX-351 or other agents used in the study.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* History of Wilson's disease or other copper-metabolism disorder.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
* Known active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients who are seropositive for HCV but have a negative viral load are also eligible provided that the patient has completed a course of therapy for HCV.
Impact of Rheumatoid Arthritis on the Course of Type 2 Diabetes During a Longitudinal Follow-up of 5 Years

The purpose of this study is to determine whether patients with rheumatoid arthritis and type 2 diabetes experience a more severe disease course compared to control patients with osteoarthritis and type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

Patients

* Adults (\>18 years)
* Rheumatoid arthritis fulfilling American College of Rheumatology (ACR )1987 or European League Against Rheumatism (ACR/EULAR) 2010 classification criteria
* Type 2 diabetes (HbA1c ≥6.5% OR fasting glycemia≥7 mmol/l OR glycemia 120 min after 75 mg glucose ingestion ≥ 11.1 mmol/l OR symptoms of hyperglycemia with glycemia ≥11.1 mmol/l)
* Affiliated to social security system

Controls

* Adults (\>18 years) matched for age, sex and BMI with patients with rheumatoid arthritis
* Osteoarthritis (knee, hip, spine and hand)
* Type 2 diabetes with disease duration matched with patients with rheumatoid arthritis
* Affiliated to social security system

Exclusion Criteria:

* Patient not able to understand study implication and rules
* Patient opposed to participate to the study
* Transient diabetes
* Gestational diabetes
* Secondary diabetes