cyrilzakka/clinical-trials huggingface dataset:
A Ketogenic Diet as a Complementary Treatment on Patients With High-grade Gliomas and Brain Metastases

The survival interval of patients with gliomas ranges between 12 to 15 months. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. Ketosis can be an effective therapy to extend the survival of patients with gliomas.

Gliomas are invasive and aggressive tumors, which derive from glial or stem cells, and after neoplastic transformation, acquire glial cell characteristics. Treatment of high-grade gliomas includes measures to relieve symptoms and eliminate or control the tumor. Surgery, radiation, and chemotherapy are the most common options. Recent findings revealed that dietary interventions to reduce glucose and glycolytic pathways could have a therapeutic effect. CKD is a restrictive therapeutic diet consisting of a 4:1 ratio of fat-to-CHO and protein. Fat provides up to 90% of the caloric intake, while overall CHO intake is less than 50 g/day. CKD reducing blood glucose levels and increasing ketone body levels stimulates biochemical changes to achieve systemic ketosis. Though, evidence for CKD in clinical practice is still limited. This study focuses on the classic ketogenic diet (CKD), adjusted for each patient's energy needs by dieticians to achieve ketosis. The primary outcome is to assess the efficacy of CKD to extend the survival of patients with high-grade gliomas and brain metastases. Historical controls will be used to compare the outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80
* Karnofsky Performance Score of 50 or more.
* Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy.
* Normal function of liver and kidneys
* Ability to sign informed consent form

Exclusion Criteria:

* Diabetes mellitus
* Life expectancy \>3 months
* Inability to adhere to diet
* Inability to give informed consent form
* Cholecystectomy last 1 year (before the study entry)
* Diagnosis of genetic disorder of fat metabolism
The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.

Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of CD4+T Cells in the case of hepatitis and the function enhancement of CD4+T Cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD4+T cells function, or recovery of CD4+T Cells function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage CD4+T cells function, and the loss of HBsAg and HBeAg led to recovery of CD4+T cells function.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

Exclusion Criteria:

* Active consumption of alcohol and/or drugs
* Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
* History of autoimmune hepatitis
* Psychiatric disease
* Evidence of neoplastic diseases of the liver
Safety of Metformin in Pregnancy

This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Exposed group: exposed to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).
* Reference group: at no time during pregnancy were exposed to metformin, insulin or any other hypoglycaemic agent.

Exclusion Criteria:

* exposed to any of the following known major teratogen or major fetotoxicant: acitretin, isotretinoin, mycophenolate, thalidomide, valproic acid, angiotensin-II receptor blockers (only when used in 2nd or 3rd trimester), ACE inhibitors (only when used in 2nd or 3rd trimester), or (b) following treatment indications coded: malignancies (MedDRA code: malignant or unspecified tumors (SMQ 20000091), ICD-10: C00-D09)) or malignancy related conditions (MedDRA: SMQ 20000092), ICD-10: C00-D09).
* lost to follow-up
Switch to Atazanavir and Brachial Artery Reactivity (SABAR) Study

The purpose of this study is to evaluate the change in brachial artery reactivity in HIV-infected subjects with elevated lipid levels who are switched to an atazanavir containing antiretroviral regimen

HIV-infected subjects on a stable protease inhibitor (PI) containing antiretroviral regimen with plasma HIV RNA \<500 copies/mL, who have LDL cholesterol levels \>130 mg/dL or fasting triglycerides levels \>200 mg/dL, will be randomized (1:1) to continue their current antiretroviral regimen or to switch the PI to atazanavir (ATV). Brachial artery reactivity will be measured before (at entry) and 12 and 24 weeks after subjects are randomized.

ARM A: Switch current PI to atazanavir 400 mg once daily plus current \> 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.

Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (\<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily.

ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus \> 2 NRTIs) for 24 weeks

Brachial artery reactivity in response to two vasoactive stimuli (increased forearm blood flow and nitroglycerin) will be assessed by measuring brachial artery diameter.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* HIV-1 RNA \< 500 copies/ml
* Fasting LDL cholesterol \>130 mg/dl OR fasting triglycerides \>200 mg/dl
* CD4 count \>100 cells/mm
* Stable antiretroviral regimen for at least 12 weeks prior to study entry that includes a protease inhibitor (PI) with or without ritonavir boosting

Exclusion Criteria:

* History of heart disease, uncontrolled hypertension, peripheral vascular disease
* Current non-nucleoside reverse transcriptase inhibitor (NNRTI) in the PI-containing regimen within 4 weeks
* Prior or current use of atazanavir
* Initiation of treatment with lipid-lowering drugs within 4 weeks prior to study entry
The Experiences of Women with Spinal Cord Injury Regarding Fertility, Contraception and Pregnancy

The aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

Although some studies exist in the literature on contraception and pregnancy in women with spinal cord injury, the data still remain insufficient.

The aim of this study was to investigate the experiences of women with spinal cord injury regarding fertility, contraception and pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-55
* Post-spinal cord injury period \> 1 year

Exclusion Criteria:

* Having cognitive impairment
Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery

The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Dumping Syndrome

Exclusion Criteria:

* Patients with diabetes mellitus type 1 and 2
* Patients with impaired balance of fluids and electrolytes
* Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.
Unveiling the Digital Phenotype of PA Behavior

Observational data from healthy adults aged 65+ will be collected through cross-sectional and longitudinal methods to analyze physical activity patterns, identifying digital phenotypes. Measurements include self-reports, clinical assessments, and EMA, with statistical analysis using multivariate regression and time series analysis, and a neural network if needed to find digital phenotypes related to physical activity in older adults.

Observational data will be collected in healthy older adults aged 65 or above combining both cross-sectional and longitudinal data collection methods to analyze patterns of PA behavior and identify prognostic factors affecting PA outcomes in order to identify digital phenotypes related to PA.

The measurements are based on the Behavioral Change Wheel and include self-reporting assessments, clinical assessments for cross-sectional data collection and ecological momentary assessment (EMA) as well as time series data collection for longitudinal data. The statistical analysis will involve multivariate regression analysis and time series analysis, with a Bonferroni correction to account for multiple comparisons. A machine learning algorithm is used due to the complexity of the data. If no suitable model is found, a neural network will be used to determine digital phenotypes related to PA behavior in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Participants are 65 years of older
* Participants are competent to give informed consent
* Participants are able to actively participate in the study
* Participants are community-dwelling (living independent at home or in a service apartment)
* Without a severe illness
* Dutch language proficiency as native speaker

Exclusion Criteria:

* Current neurological disorder such as Parkinson's disease, multiple sclerosis, cerebrovascular accident, ...
* Current cardiovascular disorder such as stroke, acute myocardial infarct, coronary artery bypass grafting, percutaneous coronary intervention less than 5 years ago
* Current respiratory disorder, such as chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, asthma, ...
* Current severe metabolic disorder, such as diabetes type 1 and 2, severe osteoporosis, ...
* Current severe cognitive disorders, such as Alzheimer's disease, vascular dementia, Lewy Body dementia, frontotemporal dementia,
DCVAC/OvCa After Standard-of-care Chemotherapy in Women With Relapse of Platinum-sensitive Epithelial Ovarian Cancer

The purpose of this trial is to investigate if maintenance DCVAC/OvCa after second-line chemotherapy of carboplatin/gemcitabine or carboplatin/paclitaxel improves efficacy outcomes in women with FIGO stage III and IV epithelial ovarian carcinoma who experienced relapse more than 6 months after complete remission of first line platinum-based chemotherapy (platinum sensitive ovarian cancer)

All patients who fulfill all eligibility criteria will undergo a leukapheresis procedure. All eligible/enrolled patients will receive standard-of-care therapy with carboplatin/gemcitabine or carboplatin/paclitaxel starting 2 to 7 days after leukapheresis.

After 6 cycles of chemotherapy, patients will start maintenance treatment with DCVAC/OvCa.

Treatment will continue irrespective of tumor progression until completion, refusal, intolerance of treatment or death.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed FIGO stage III or IV epithelial ovarian, primary peritoneal or fallopian tube carcinoma (serous,endometrioid, or mucinous) who had complete remission after first-line platinum-based chemotherapy
* Radiologically confirmed relapse after \>6 months of remission ( platinum-sensitive cancer)
* Laboratory parameters per protocol

Exclusion Criteria:

* FIGO I, II epithelial ovarian cancer
* FIGO III, IV clear cells epithelial ovarian cancer
* Non-epithelial ovarian cancer
* Borderline tumors ( tumors of low malignant potential)
* Prior or current systemic anti-cancer therapy for ovarian cancer (chemotherapy, monoclonal antibody therapy, tyrosine kinase inhibitory therapy, vascular endothelial growth factor or hormonal therapy) except first-line Pt based chemotherapy ( with or without bevacizumab)
* fertile women of child-bearing potential not willing to use a highly effective method of contraception or a combination of methods
* Pregnant of lactating women
* Pre-defined co-morbidities
* Known hypersensitivity to any constituent of DCVAC/OVCa or the selected chemotherapy compounds
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.


Eligibility Criteria:
Inclusion Criteria:

* US military veteran currently receiving healthcare through the Veterans Health Administration
* Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
* Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
* Any current or past clinical evidence of Child-Pugh B or C classification
* Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery

The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery and has the potential of reducing both irradical resections and morbidity. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR
* Patients provide written 'informed consent'

Exclusion Criteria:

* No exclusion criteria
Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.


Eligibility Criteria:
Inclusion Criteria:

* Blood glucose criteria must be met
* On a stable dose of insulin as defined by the protocol
* Body mass inde (BMI) in the range 22-45

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy or lactation
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular complications
* Laboratory value abnormalities as defined by the protocol
* Other protocol defined exclusion criteria may apply
The DETECT HCV Screening Trial

The investigators propose to compare the effectiveness of nontargeted rapid opt-out hepatitis C (HCV) screening versus targeted rapid opt-out HCV screening using recommended risk characteristics in multiple urban emergency departments (EDs) across the United States (Aim 1 - "Screening Trial").

The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing electronic health records (EHRs) for each ED. Patients will therefore be offered HCV testing based on the result of the screening arm to which they are assigned, and in the case of the targeted arm, the results of the risk assessment evaluation performed by the intake nurse. All randomization will be completely integrated into electronic medical screening systems and workflow at each site. Integration of randomization into the electronic systems will allow for real-time concealed random allocation. Nurses who perform screening and all other ED staff (e.g. physicians, technicians) will understand the conceptual goals of the project but will be blinded to study hypotheses, and patients will be completely blinded to the purpose of the study.

This study will be performed at multiple sites, including the EDs at Denver Health Medical Center (DHMC) (Denver, Colorado), Johns Hopkins Hospital (JHH) (Baltimore, Maryland), and the University of Mississippi Medical Center (UMMC) (Jackson, Mississippi).

Eligibility Criteria:
Inclusion Criteria:

* Present to EDs during study enrollment period
* Clinically stable per screening nurse or physician assessment
* Able to provide consent for medical care

Exclusion Criteria:

* Younger than 18 years of age
* Are unable to consent for care (i.e., altered mentation, critical illness, or injury)
* Have already participated in the trial
* Self-Identify as already living with HCV
Safety And Tolerability Of Lixisenatide In Monotherapy In Patients With Type 2 Diabetes

Primary Objective:

To assess the overall safety of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks in patients with type 2 diabetes in Japan

Secondary Objective:

To assess the effects of lixisenatide once daily treatment in monotherapy over 24 and 52 weeks on:

* HbA1c (Glycated hemoglobin A1c) reduction;
* Fasting plasma glucose;
* Body weight.

* Group 1: 60 weeks ± 11 days
* Group 2: 32 weeks ± 7 days

Eligibility Criteria:
Inclusion criteria:

* Patients with type 2 diabetes mellitus diagnosed for at least 2 months.
* Not treated with anti-diabetic drug or treated with a stable dose of 1 oral anti-diabetic drug (OAD) for at least 3 months prior to screening visit. Previous OAD (if any) have to be stopped at Visit 1.1 to be washed out during the run-in period at least for 6 weeks;
* Signed written informed consent.

Exclusion criteria:

* At screening
* age \<20 years;
* HbA1c \<7% or \>9.5% (for patients on OAD \<6.5% or \>8.5%);
* fasting plasma glucose \>250 mg/dL (\>13.9 mmol/L);
* Use of more than one OAD within 3 months prior to screening;
* Use of Thiazolidinedione (TZD) within 6 months prior to screening;
* Use of insulin within 3 months prior to screening; Note: Short time use (≤10 days) of insulin due to acute illness or surgery (eg, infectious disease) is allowed.
* Any previous treatment with lixisenatide (eg, participation in a previous study with lixisenatide) or any other GLP-1 receptor agonist;
* Type 1 diabetes mellitus
* Women of childbearing potential with no effective contraceptive method;
* Pregnancy or lactation;
* Laboratory findings at the time of screening:

oAmylase and/or lipase \>3 times the upper limit of the normal laboratory range (ULN);

* ALT \>3 ULN;
* Calcitonin ≥20 pg/mL (5.9 pmol/L);
* Positive serum pregnancy test in women of childbearing potential;
* History of acute or chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease;
* Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes);
* Allergic reaction to metacresol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.