cyrilzakka/clinical-trials huggingface dataset:
Impact of Dietary Intervention on Weight Change in Subjects With Type 2 Diabetes

This trial is conducted in Europe, and North and South America. The aim of this trial is to investigate if a dietary intervention has an effect on weight when initiating insulin treatment in subjects with type 2 diabetes currently treated with oral antidiabetic drugs (OADs).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for at least 6 months prior trial start
* Insulin naive subjects
* HbA1c: 7.0-9.0 % (both inclusive)
* Body Mass Index (BMI): 25.0-45.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Use of Thiazolidinedione (TZDs) or Glucagon-like peptide-1 analogue (GLP- 1) receptor agonists within the last 3 months prior to trial enrollment
* Cardiovascular disease within the last 6 months
* Recurrent severe hypoglycaemia or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Uncontrolled treated/untreated severe hypertension, impaired liver function, impaired renal function, known proliferative retinopathy or maculopathy requiring treatment
* Cancer and medical history of cancer in the past 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer Survivorship in Hematologic Malignancies

General objective: to improve care for haematological cancer survivors. This study will (i) Estimate the incidence of cancer survivor syndrome (CSS) in adult Egyptian patients with haematological neoplasms (HN). (ii) Asses the risk factors of CSS in patients with HN. (iii) Study the effect of CSS on quality of life in patients with HN. (iv) To explore coping strategies of patients with HN having CSS

According to the American Cancer Society the term cancer survivor refersto people who have no signs of cancer after finishing treatment, people receiving extended treatment over a longer period of time to control the cancer or reduce risk of its return, and people with advanced cancer. Most hematologic malignancies (HM) are incurable and typically follow unpredictable remitting-relapsing pathways associated with varying need for treatment, which may be distressing for patients. Distress symptoms and psychological disorders secondary to cancer have also been shown to have significant negative consequences for both the patient and the family.

Maladaptive coping and abnormal illness behavior have been associated with psychiatric conditions, with negative effects on adherence to treatment, health behavior, and quality of life (Grassi et al 2017). Moreover, an increased length of stay in the hospital and/or an increased time in rehabilitation have been found to be more common among patients showing psychiatric symptoms, especially depression, than those with normal adjustment to illness (Cordova et al 2017). Unfortunately, cancer-related distress is commonly underrecognized and subsequently undertreated especially for patients with HM in developing countries. Search in literature revealed several screening methods for the psychological consequences of cancer such as Distress Thermometer , Symptom related checklist questionnaire, Quality of life questionnaire, Coping strategies questionnaire. Also, guidelines for the management of psychological distress have been developed by several scientific cancer associations.

Eligibility Criteria:
Inclusion Criteria:

* a. Inclusion criteria:

  1. Age will be more than or equal 18 years old regardless with six.
  2. Patients have been clinically diagnosed with haematological cancers.
  3. Being Native Egyptian patients.

Exclusion Criteria:

* History of psychiatric disorders. b) Having other concomitant haematological diseases or solid neoplasm or relapse or other chronic disorders
Assessment of the Effect of n-3(Omega 3) Fortified Egg in Healthy Subjects

Study Rationale:

As epidemiological research has shown negative effects of high egg consumption on increased all-cause mortality and diabetes and on diabetes outcomes, and egg modification may modulate their effects on diseases risks, it is important to test the effect of eggs with different composition on markers associated with dyslipidemia, dysglycemia and inflammation.

The aim of this study is to assess the effect of n-3PUFA (Omega 3) fortified egg compared to omega-6 Israeli regular egg on metabolic, inflammation and other physiologic parameters.

STUDY OBJECTIVES

First endpoint:

To assess the effect of high n-3 PUFA (Omega 3) egg, as compared to regular- high n-6 PUFA (Omega 6) Israeli egg, on glycemic levels after night fasting and post prandial of 2 egg breakfast test meal.

Secondary endpoint:

To compare the effect of high n-3 PUFA fortified egg versus high n-6 PUFA (Regular) egg on measures associated with CVD risks including: CRP, LDL oxidation, MDA, post prandial Flow mediated dilatation (FMD), liver enzymes, and blood lipids and lipoproteins, and further blood chemistry measures.

Third endpoint:

To assess the influence of n-3 Egg on erythrocytes fatty acid profile.

Study design: Prospective, Crossover, Compared Study Study population: 20 Healthy subjects

Study Methods:

Subjects will complete two study stages. In first stage study participants will get 3 weeks regimen including 2 Regular, Israeli (high n-6 Pufa) eggs/day.

In second stage after 3 weeks washout without eggs, study participants will get 3 weeks regimen with 2 high n-3Pufa eggs/day.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men volunteers (age 18-45 years)
2. BMI 23-28

Exclusion Criteria:

1. Use of lipid-modifying medications or nutritional supplements
2. Known malignancy
3. Allergy to eggs or other materials use in the experiment
4. Substance abuse (including alcohol
Healthy Nordic Foods to Prevent Cardiometabolic Risk in Obese Subjects

This project will examine whether long-term consumption of healthy Nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. The study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. The follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy Nordic diet group and a control diet group. During the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.


Eligibility Criteria:
Inclusion Criteria:

* age 25-67 years, BMI 30-40 kg/m2, waist circumference men \>102cm and women \> 88cm or sagittal abdominal diameter men \>22cm and women \>20cm, stable body weight

Exclusion Criteria:

* glucose \>7.0 mmol/l, B-Hb1aC \>48 mmol/L, triglycerides \>4 mmol/l, total cholesterol \>8 mmol/l, bloodpressure \>160/100 mmHg, chronic disease, gastro-intestinal disease, hyper-/hypothyroidism, alcohol abuse, cancer, gastric bypass operation, gluten allergy, lactose intolerance, pregnancy
The Safety and Efficacy of Multimodal Thermal Therapy in the Treatment of Early-stage Invasive Breast Cancer

Multimodal thermal therapy (MTT), as an initiative integration of cryotherapy and radiofrequency heating, has been applied to treat various solid tumors. However, the feasibility and safety for MTT in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study aimed to evaluate the efficacy and safety of MTT in the treatment of early-stage invasive breast cancer, and to explore the ablation-induced immune activating response.


Eligibility Criteria:
Inclusion Criteria:

1. Female，age 18-80 years.
2. Invasive carcinoma confirmed by core biopsy.
3. Newly diagnosed breast cancer patients, without neoadjuvant therapy.
4. Imaging findings showed an unifocal breast tumor with a maximum diameter of 2 cm, with no distant metastasis, no calcification, no skin or nipple adhesion, and no invasion of chest wall.
5. The functional level of major organs must meet the following requirements: blood routine: neutrophil (ANC)≥1.5×10\^9/L; platelet count (PLT) ≥ (PLT)≥90×10\^9/L; hemoglobin (Hb) ≥90g/L; coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN; activated partial thromboplastin time (APTT) ≤1.5×ULN.

Exclusion Criteria:

1. Tumor involving skin, ulceration, inflammatory breast cancer patients.
2. Tumor involving the superficial layer of the skin.
3. KPS score \< 70, or ECOG score \> 2
4. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents.
5. Heart, brain, lung, kidney and other vital organ failure.
6. Uncorrectable severe coagulopathy
7. Patient is pregnant or lactating
8. Poor glycemic control in diabetes
9. Patients with foreign body implantation around the tumor (such as breast augmentation injections or prostheses).
10. Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
11. Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
12. Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.
Antiviral Therapy in Infants With HBV Infection

This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and/or HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.


Eligibility Criteria:
Inclusion Criteria:

* a. Age ≤ 1 year;
* b. HBsAg and HBV DNA positive;
* c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).
* d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.

Exclusion Criteria:

* a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;
* b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;
* c. WBC \<9 × 10\^9/L, or PLT \<90 × 10\^9/L;
* d. Combination of other systemic serious diseases or hereditary diseases, etc;
* e. Other conditions deemed by the investigator to be unsuitable for participation in this study.
HuMax-CD20 i(Ofatumumab) n Follicular Lymphoma (FL) Patients Refractory to Rituximab

A Single-Arm, International, Multi-Center Trial of HuMax-CD20 (Ofatumumab), a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Follicular Lymphoma Who Are Refractory to Rituximab as Monotherapy or in Combination With Chemotherapy

Patients in the study will be randomized into two dose groups. Patients in each dose group will receive one infusion of 300 mg of HuMax-CD20 followed by 7 weekly infusions of either 500 or 1000 mg of HuMax-CD20. Disease status will be assessed every 3 months until month 24.

Eligibility Criteria:
Inclusion Criteria

* Patient with follicular lymphoma grade 1 - 2
* Refractory to rituximab given as monotherapy or in combination with any chemotherapy or to rituximab given as maintenance treatment following R-chemo, defined as:
* failure to achieve at least PR to rituximab given as monotherapy or in combination with any chemotherapy; or,
* disease progression while on rituximab (either given as monotherapy or in combination with any chemotherapy or during rituximab maintenance treatment following R-chemo); or,
* disease progression in responders within 6 months of the last dose of rituximab (either given as monotherapy or in combination with any chemotherapy or after rituximab maintenance treatment schedule following R-chemo)
* Tumor verified to be CD20+ positive from excisional lymph node biopsy
* CT scan in screening phase (based on local evaluation) showing:
* 2 or more clearly demarcated lesions with a largest diameter ≥ 1.5 cm, or
* 1 clearly demarcated lesion with a largest diameter ≥ 2,0 cm
* ECOG Performance Status of 0, 1, or 2
* Age ≥ 18 years
* Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study related activity is carried out

Exclusion Criteria

* Previous autologous stem cell transplantation within 6 months
* Previous allogeneic stem cell transplantation
* More than 1 previous radio immunotherapy regimen
* Received radio immunotherapy within 3 months
* Received any Anti-cancer treatment within 4 weeks
* Received monoclonal antibodies, other than rituximab within 3 months
* Patients previously treated with anti-CD20 monoclonal antibodies, other than rituximab
* Life expectancy less than 6 months
Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions

Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with nutritional interventions exert limited immunologic effects, but a deep understanding of how these interventions could ameliorate gut dysbiosis and influence health among HIV-infected individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio\<1 will be included and randomized to either repeated low-dose oral fecal microbiota transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio, inflammatory markers, T cell activation and markers of enterocyte barrier function through week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint will be studied by combination of untargeted mass spectrometry and two different and complementary separation techniques in bacterial and plasma samples.


Eligibility Criteria:
Inclusion Criteria:

* On stable antiretroviral therapy with plasma HIV RNA \<20 copies/mL during at least 48 weeks.
* CD4/CD8 ratio \<1

Exclusion Criteria:

* Pregnancy
* Gastrointestinal diseases, including cirrhosis
* Active infections, including HCV
* EBV and/or CMV negative patients (donors are not screened for EBV/CMV).
* Planned used of chemotherapy or antibiotics
* Allergy to sodium chloride or glycerol (the former components are capsule ingredients Generally Recognized As Safe (GRAS)
* Current or planned use of antimicrobial agents (including prophylactic treatments against P. jiroveci) other than ART.
* Neutropenia \<500 cells/uL or CD4 counts \<350 cells/uL
* Patients unable to give informed consent
* Patients unable to comply with the protocol requirements
* Predicted death within time period of follow-up
* Any other condition for which the treating physician thinks the treatment may pose a health risk
* Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS)
* History of aspiration
* History of gastroparesis
The Visceral Adiposity Measurement and Observation Study

The Visceral Adiposity Measurement and Observation Study

Visceral adiposity (VA) is a form of ectopic fat deposition that correlates with cardiometabolic risk in both the general population and among people with human immunodeficiency virus (HIV) (PWH).1 Excess VA (EVA) is prevalent among PWH,2,3 and prevalence rises with age and time on antiretroviral treatment.3 Effective plasma virologic suppression is not protective against EVA and associated comorbidities, possibly due to adverse metabolic effects of certain antiretroviral agents, the low-level expression of HIV gene products within the adipose tissue, and other factos.4

Although EVA has been reported to occur in nearly half of PWH on antiretroviral therapy (ART),2,3 it may go unrecognized or be mischaracterized as generalized obesity. Whereas obesity and EVA both increase waist circumference (WC), they differ in that overweight and obese individuals accumulate fat primarily in subcutaneous depots, whereas individuals with EVA accumulate fat within the abdominal cavity. Ectopic fat accumulation (EFA) also occurs at various other depots, namely around and within various internal organs (e.g., the heart, skeletal muscle, liver, and pancreas).1,5 For purposes of the VAMOS study, EFA is defined as the amount of pericardial fat, skeletal muscle fat, and liver fat the VAMOS study subjects have. VA for the VAMOS study is held separately as it is the primary endpoint.

Because it represents a potentially modifiable cardiovascular risk factor among PWH, simple, practical surrogate markers are needed to identify patients with probable EVA. Anthropometric measurements such as WC correlate with EVA in the general population1, but their predictive value is less well defined for subgroups of PWH.

Eligibility Criteria:
Inclusion Criteria:

1. Adult, ≥18 years
2. HIV+, on continuous ART for ≥12 months
3. ≥3 years since initiation of ART
4. 20.0 ≤ BMI ≤ 40.0 kg/m2

Exclusion Criteria:

1. Detectable HIV plasma viremia 12 months prior enrollment, defined by ≥1 measurement of HIV-1 ribonucleic acid (RNA) \> 1000/mL
2. Unable or unwilling to undergo any study procedures
3. Known hepatic cirrhosis
4. Active hepatitis C within past 12 months, defined by detectable hepatitis C RNA
5. Hepatitis B positive
6. Current pregnancy or breastfeeding
7. History of liver transplant
8. Self-reported weekly alcohol consumption meets National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for problematic drinking (binge or chronic daily intake)
9. Any active malignancy, excluding non-melanoma skin cancer
10. Patient has been treated with tesamorelin or human growth hormone within the last 12 months
11. Patient has used insulin in the previous year
12. Patient has undergone bariatric surgery in the year prior to enrollment or is currently undergoing a weight loss program
Hepatocellular Cancer (HCC) Screening in Zhongshan City

All participants in the selected communities will be tested for HBsAg by using serum samples. Among those who are positive for HBsAg, further clinical work-ups including AFP test and ultrasonography for liver exam will be performed. High risk group will be selected according to the definition. HCC diagnosis will be determined according to imaging and/or biopsy result. Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.

All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Sample selection

* Select communities of 70,000 to 120,000 populations in Zhongshan City as the investigators' fields.
* Divide them into screening group and control group according to the areas of administration

Participants recruitment

- Subjects voluntarily attend this screening study

Informed consent - Informed consent forms will be collected at the recruitment.

Questionnaires

- Face-to-face interviews are conducted by well-trained investigators

Serological tests

* Each blood samples will be tested for the surface antigen of the hepatitis B virus (HBsAg).
* Among those who are positive for HBsAg, further clinical work-ups including Alpha-Fetoprotein(AFP) test and ultrasonography for liver exam will be performed and high risk group will be selected according to the definition.
* HCC diagnosis will be determined according to imaging and/or biopsy result.
* The rest of the blood samples will be stored at the biobank of Zhongshan People's Hospital.

Follow up

* The cohort will follow up according to the screening protocol. Briefly, Repeated check-ups will be performed in 6-months among HBsAg positive group and 3-years among HBsAg negative group.
* All subjects in the control arm (control communities) will be followed by record linkage to Cancer Register and Population Register.

Eligibility Criteria:
Inclusion Criteria:

* Residences in Zhongshan City
* Have no medical records of hepatocellular cancer
* ECOG 0-2
* Provide written informed consent forms
* Have a good physical and psychological condition

Exclusion Criteria:

* Have severe cardiovascular or kidney disease
* Have medical records of hepatocellular cancer
Preparation for Medical and Surgical Procedures in Oncogeriatry.

Surgical management is one of the most frequently used interventions in the treatment of many cancers, but it can be associated with a high risk of postoperative complications.

The maintenance and optimization of functional abilities before, during and after treatment are major for elderly cancer patients, as it is now well established that there is a link between the level of functional capacity and the occurrence of these complications.

The scientific literature shows that the benefits of pre- and post-operative training programs, but these benefits only apply to a fraction of the patients adhering to the programs. The modalities of intervention (training load, follow-up, etc.) as well as patient involvement in these programs are major issues that need to be addressed to optimize their benefits.

Individualizing pre-habilitation, on the basis of the management of the training load, and therefore objective fatigue, would enable better patient adherence to the program, and optimize its benefits.

In this context, the PRIMECHO project aims to individualize pre-habilitation in order to improve functional of patients in the pre-habilitation or accelerated recovery after surgery phase. The aim is for the patient to be in optimum physical condition at the time of the intervention or treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 70 or over
* Cancer patient with planned surgery,
* Mini Mental State Examination score greater than or equal to 24 (performed in advance by the geriatrician),
* Patient affiliated to or benefiting from a social security insurance
* Signed free and informed consent.

Exclusion Criteria:

* Inability to walk or perform unsupervised exercises.
* Vulnerable people