cyrilzakka/clinical-trials huggingface dataset:
Isomaltulose VS Sucrose - Postprandial Effect on Incretin Profile and Second Meal Effect

This study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as an determinant for the second meal effect.

In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separate days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.

Isomaltulose is a natural occurring disaccharide with a similar structure to sucrose. It is composed of glucose and fructose, but is linked by an α-1,6-glycosidic bond instead of α-1,2. Due to its binding, isomaltulose is slowly hydrolysed, which results in a rather weak postprandial glycemic-insulinemic response, accompanied by a minimal GIP secretion and a stimulated secretion of GLP-1. In addition, several studies have shown that the intake of foods with a low glycemic index, such as isomaltulose, tend to improve the metabolic reaction to a subsequent meal. As the exact mechanism of this "second meal effect" is still unknown, the investigators hypothesize that the modified release and action of GIP and GLP-1 are key players in regard to the described effects.Therefore, isomaltulose could be a suitable tool for reducing the risk of developing diabetes, obesity and CVD as well as improve blood glucose control in people with diabetes.

In summary, this study evaluates the different postprandial effect of isomaltulose and sucrose on the incretin profile and as a determinant for the second meal effect.

In this nutritional intervention study, healthy participants and T2DM patients ingest 2 standardized meals for breakfast and lunch in combination with either sucrose or palatinose on 2 separated days. In addition, blood samples are taken to analyze markers of the carbohydrate metabolism, incretins and specific inflammation markers.

Eligibility Criteria:
Inclusion Criteria:

* for T2DM patients: insulin-independent
* for healthy subjects: at least 1 component of the metabolic syndrom:

  * Body mass index (BMI) ≥ 30 kg/m²
  * Waist-hip ratio (WHR) ≥ 85 for women and ≥ 90 for men
  * hypertension
  * dyslipidemia
  * glucose / insulin intolerance

Exclusion Criteria:

* medications: intake of medications which influence glucose metabolism
* alcohol / drug abuse
* physical diseases: endocrinological, malign, serious cardiovascular diseases
* acute / chronic communicable disease
* psychic diseases
Fractional CO2 Laser Therapy for Survivors of Breast Malignancies

This pilot clinical trial studies how well fraction carbon dioxide (CO2) laser therapy works in treating vaginal atrophy in patients with breast cancer. Fraction CO2 laser therapy uses intense beams of light to cut, burn, or destroy tissue and may remodel vaginal tissue and direct controlled thermal damage of vaginal mucosa.

PRIMARY OBJECTIVES:

I. To demonstrate the feasibility of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy by determining treatment completion rates and tolerability of treatment.

II. To demonstrate the efficacy of fractionated CO2 laser treatments in patients with breast cancer with vaginal atrophy as determined by improvement from baseline to post treatment in the score of the Vaginal Assessment Scale (VAS).

SECONDARY OBJECTIVES:

I. Sexual behavior/function as measured by the Sexual Experiences Scare, Global sexual satisfaction scale, Female Sexual Function Index (FSFI), and the Female Sexual Distress Scare (FSDS).

II. Other symptoms of urogenital atrophy using the Urogenital Distress Inventory (UDI).

III. Overall patient assessment of symptoms by Patient Global Impression of Improvement scale (PGI-I).

OUTLINE:

Patients undergo fractional CO2 laser therapy every 4-6 weeks for 3 treatments.

After completion of study treatment, patients are followed up at 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with non-metastatic breast cancer with any hormone receptor and Her 2 neu status who have completed surgery, chemotherapy, and radiation and are currently on endocrine therapy, single agent Herceptin, or observation
* Symptoms of urogenital atrophy including dyspareunia or vaginal dryness

Exclusion Criteria:

* Patients with metastatic breast cancer
* Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
* Active genital infection at the time of enrollment (if present initially, can be treated and then patient can be re-evaluated for eligibility)
* Pelvic organ prolapse greater than stage II
* Prior reconstructive pelvic surgery involving mesh
* Hormone replacement therapy, vaginal estrogen therapy, DHEA, or biosynthetics within 6 weeks prior to enrollment
Evaluation of Icotinib in Metastatic Triple-negative Breast Cancer After Second-line Therapy

Evaluating the safety and efficacy of Icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

This is a phase II, multi-center study. Sixty-seven patients are planned to be enrolled. All patients will receive Icotinib 125 mg BID administered for 8 weeks. Patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. Follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* ECOG 0 or 1
* Primary or metastatic tumor onfirmed as triple negative
* Measurable disease per RECIST version 1.1
* normal organ function, including bone marrow function, renal function, liver function, and cardiac function
* Two or more prior chemotherapy
* signed and dated an informed consent form
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Pregnant or breast feeding
* ECOG score ≧2
* Uncontrolled medical problems
* Hepatic, renal, or bone marrow dysfunction as detailed above
* Concurrent malignancy or history of other malignancy within the last five years except as noted above
* Patients were unable or unwilling to comply with program requirements
Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites

SBRT (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. At present, SBRT has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis.

However, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of SBRT in different sites are different, and the prescription dose is also different.

This study intends to make a detailed division of the chest region and explore the safety and efficacy of SBRT in different areas. It is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure.

48-60Gy / 4-10f (EQD2 = 62.5Gy \~ 99.7Gy) was given according to the location of the tumor. Main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis was malignant tumor.
* The location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm.
* There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment.
* KPS\>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy.

Exclusion Criteria:

* Poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment.
* The general condition is poor, and the expected survival time is less than 3 months.
* Psychiatric patients or poor compliance, unable to cooperate to complete treatment.
* For other reasons, the researcher believes that it is not suitable to participate in this trial.
Efficacy of Pigmented Rice on Reducing Cardiometabolic Risk Factors Among Filipino Adults

The primary purpose of this clinical trial is to investigate whether the consumption of pigmented rice (black rice) in the diet improves cardiovascular health, specifically body weight, lipids, and glucose levels. It also aims to know whether people enjoyed eating pigmented rice and if they would continue eating it.

The goal of this clinical trial is to test if pigmented rice consumption can lower the cardiometabolic risk factors of adults. The main question\[s\] it aims to answer are:

* Will pigmented rice significantly reduce lipid levels compared to white rice after six weeks?
* Will pigmented rice significantly reduce glucose levels compared to white rice after six weeks? Will pigmented rice significantly reduce weight and waist-hip ratio levels compared to white rice after six weeks? What are the participants' experiences in consuming pigmented rice?

Participants will consume black-pigmented rice for six weeks while maintaining their usual physical activity. Researchers will compare the white rice group and the black rice group to see if lowers cardiometabolic risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20-59 years.
* Body mass index between 18.5 -35 kg/m2
* Elevated cholesterol (total cholesterol \>200 mg/dL or LDL cholesterol 130-190 mg/dL), and/or impaired fasting glucose (100-125mg/dL)
* Eat rice as a staple food at least twice per day

Exclusion Criteria:

* Are pregnant or lactating
* Regularly consume pigmented rice (two meals per day in the past 4 weeks)
* Have cardiovascular disease (hypertension, stroke, ischemic heart disease, myocardial infarction, or congestive heart failure) or diabetes mellitus
* Take cholesterol or glucose-lowering medications
* Have elevated blood pressure (\>130/80 mmHg)
* Have an illness that may influence lipid metabolism or metabolic rate (liver cirrhosis, pancreatitis, chronic kidney disease, hyperthyroidism, hypothyroidism)
* Take supplements that may influence lipids and glucose levels (including polyphenols)
* Are on a strict diet regimen (calorie-restricted or excluding food groups, examples: (Examples: Ketogenic diet, Intermittent fasting, No Rice diet)
* Have an active lifestyle (Ex. Goes to the gym daily, regularly (≥3 times a week) and perform vigorous activities such as lifting weights, swimming, cycling fast or uphill, or running, or athlete)
Serum CA9 Level as Biological Marker of the Treatment Response in Metastatic Renal Cell Cancer

One third of patients with kidney cancer are diagnosed in the metastatic stage, and among patients with a localized form, about 30 to 40% will develop metastases after surgery.

Medical treatment of metastatic renal cancer include immunotherapy with interferon α and/or IL-2, or targeted therapies such as anti-angiogenic (anti-vascular endothelial growth factor (VEGF), anti-tyrosine kinase inhibitors and m-TOR). These treatments sometimes associated (or IL2 + INF or INF AntiVEGF) do allow for objective response in 15 to 30% of cases (net benefit of targeted therapies), but are carriers of potentially significant side effects and are very expensive. The treatment response is considered on imaging exams repetitive, costly and inconsistently reliable. A serum marker of tumor development would be particularly welcome.

CA9 is an oncogene also know as CA IX, carbonic anhydrase 9 or MN/CA9. The gene encoding an oncoprotein called indifferently membrane antigen MN, MN/CA9 isoenzyme, carbonic anhydrase IX CA9, G250/MN/CA9 or protein G250. It was demonstrated that the level of expression of CA9 in tumor tissue can be used as a predictive marker of response to immunotherapy.

In previous studies, the investigators tried to use CA9 to improve the differential diagnosis of kidney tumors using tumor biopsy or fine needle aspiration. More recently, the investigators have developed the ELISA and quantitative reat time polymerase chain reaction (RT-PCR) to study the CA9 protein and CA9 mRNA in the serum of patients with non-metastatic kidney cancer. The investigators have thus shown that CA9 was overexpressed prior to surgery and that this expression disappeared after tumor ablation.

We propose a pilot study of CA9 serum in patients with adenocarcinoma metastatic cell treated by conventional immunotherapy and / or targeted therapy. This pilot study aims to test the CA9 serum marker of response to medical treatment

Eligibility Criteria:
Inclusion Criteria:

* Conventional renal cell cancer with a pathological diagnosis
* Metastatic disease
* Consent form signed
* social security regimen affiliated

Exclusion Criteria:

* Other cancer treated
Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults

This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.


Eligibility Criteria:
Inclusion Criteria:

* All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and 32.
* Individuals must be able to give informed consent.
* Subjects willing and able to:

  * consume prebiotics or placebo preparations for a period of 4 weeks.
  * Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.
  * provide stool and blood (via venipuncture) samples.
* Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.

Exclusion Criteria:

* Less than 18 years of age or older than 55 years of age
* Pregnant or breastfeeding
Efficacy of Blue Light Treatment in Patients With Nonseasonal Major Depressive Disorder

To compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults.

The current study aims to compare the efficacy of blue light, bright light and dim light in the treatment of with nonseasonal major depression disorder(MDD) in adults. 162 patients with nonseasonal MDD will be randomized into three groups (i.e. blue light, bright light or dim light). The treatment will be performed five times a week for the first two weeks. And for the next 2 weeks, the treatment for patients will be undertook three times a week. There will be 16 times in total. The investigators will assess nonseasonal MDD'symptom severity in the baseline, 1 week,2 week, 4 week,6 week and 8 week. Through the study, 17-item Hamilton Depression Rating Scale (HAMD17),14-item Hamilton Anxiety Rating Scale (HAMA14),Quick Inventory of Depressive Symptoms, Self-Rated version (QIDS-SR)，Pittsburgh sleep quality index (PSQI) , Clinical Global Impression scale(CGI), Quality of Life, Enjoyment and Satisfaction Questionnaire (Q-LES-Q),Morningness-Eveningness Questionnaire (MEQ),Repeatable Battery for the Assessment of Neuropsychological Status(RBANS),subjective fatigue symptom scale and semantic differential scale will be obtained. The patients will also get individual's data of heart rate and blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* meet criteria for major depressive episodes as determined by MINI
* HAMD17≥17
* received antidepressive medication at stable dosages for at least 14 days

Exclusion Criteria:

* Any axis I psychiatric disorder comorbidity
* who have received formal psychological therapy, MECT or rTMS in 3 months
* any current significant medical condition especially eye diseases
* serious suicide risk
* pregnant or breastfeeding women
* depression with seasonal pattern
* treatment-resistant depression
* epilepsy in the past
Study on Inferior Vena Cava Thrombosis

This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or without thrombosis in other veins.

The purpose of this study is to assess risk factors, safety and effectiveness of treatment options, and outcomes of patients with IVC thrombosis.

Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT). Optimal treatment strategies and clinical outcomes are not well established.

This multicenter, international, observational study will assess the effectiveness and safety of current treatment options in patients with IVC thrombosis, and describe the long-term outcomes of patients with IVC thrombosis.

Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT will be included. Information will be collected on baseline characteristics, risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins), treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and duration of treatment, recanalization assessment (if available), recurrence of VTE during follow up, bleeding according to International Society on Thrombosis and Haemostasis criteria, development post-thrombotic syndrome (PTS) according to Villalta score and mortality during follow up. Patients should be followed up for 24 months from diagnosis. The number of visits is left to the discretion of the treating physician, but information on clinical outcomes at two intermediate time points is requested.

Eligibility Criteria:
Inclusion criteria:

1. Consecutive adult patients (\> 18 years) with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT (involving the femoral, common femoral, or iliac veins) will be eligible for the study.
2. Diagnosis should be obtained by either doppler ultrasonography, CT angiography or MRI angiography.
3. Patients who had objective diagnosis of IVC thrombosis within 6 months prior to the starting of the registry will also be eligible, providing they are prospectively followed up by the participating centers and all requested information is available.

Exclusion criteria:

Patients enrolled in interventional studies.
Open Label Study of a Single Dose of a New Extended Long Acting Formulation of Octreotide Pamoate in Healthy Volunteers

This study will assess the pharmacokinetic profile, safety and tolerability of an octreotide extended long-acting formulation after a single dose in humans. It will investigate the profile of a single dose of drug in a healthy volunteer subject in order to understand the timing and extent of fluctuations in octreotide concentrations in the blood with this formulation, the relationship of drug concentration with dose, and how long the drug remains in the body system.


Eligibility Criteria:
Inclusion criteria:

* Male or female from 18-60 years of age, cholecystectomized at least 4 months prior to the start of the study.
* In a good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening
* Body mass index within 19-29 kg/m2
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria:

* Any clinically significant abnormal laboratory values at screening, or evidence of clinically significant abnormal findings at the physical exam at screening, or significant illness within 2 weeks prior to dosing
* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or untreated)
* History of clinically significant drug allergy, history of atopic allergy, history or clinical evidence of pancreatic injury or pancreatitis, clinical evidence of liver disease or liver injury , history or presence of impaired renal function, or history of urinary obstruction or difficulty urinating
* History of immunocompromise, including a positive HIV
* Known positive hepatitis B or C surface antigen (HBsAg) or Hepatitis C test result (anti-HCV)
* History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays at screening
* Female subjects who are pregnant or lactating, or are of childbearing potential and without a medically acceptable and highly effective method for birth control.
* Demonstrating intolerance to octreotide at baseline
* Any subject who has a known history of diabetes mellitus in parents or grandparents.

Other protocol-defined inclusion/exclusion criteria may apply