cyrilzakka/clinical-trials huggingface dataset:
Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?

The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose

The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.

From this, we will evaluate GIP's role as blood sugar stabilizer.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR
* Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR
* Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND
* Normal hemoglobin
* Informed consent

Exclusion criteria:

* Unwillingness to participate or the wish to leave the present study
* HbA1c \> 9 %
* Liver disease (ALAT or ASAT \> 2 times normal value)
* Diabetic nephropathy (serum creatinin \> 130 microM and/or albuminury)
* Proliferative diabetic retinopathy (anamnetic)
* Atherosclerotic heart disease or heart failure (NYHA group III and IV)
* Anemia
* Treatment with medicine which cannot be paused for 12 hours
* Pregnancy and/or breast feeding
* Fasting plasma glucose \> 15 mM on the day of the experiment
PSA Antibody Levels in Samples From Patients With Prostate Cancer Treated on Protocol ECOG-E9802

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This clinical trial studies prostate-specific antigen (PSA) antibody levels in samples from patients treated for prostate cancer on trial ECOG-E9802.

OBJECTIVES:

Primary

* To evaluate changes in prostate-specific antigen (PSA) antibody levels over time among patients treated on ECOG-E9802.

Secondary

* To characterize the concordance of PSA antibody assessment between the ECOG Immunology Laboratory and the NCI Immunology Laboratory.

OUTLINE: Previously tested samples are evaluated for changes in PSA antibody levels over time (from baseline to follow-up at 12 and 24 weeks) at the ECOG Immunology Laboratory and the NCI Immunology Laboratory. Results are compared between the laboratories.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Samples collected on ECOG-E9802 (A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox/TRICOM with GM-CSF in Patients with PSA Progression after Local Therapy for Prostate Cancer)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer

Phase I trial to study the effectiveness of gene therapy plus chemotherapy in treating patients who have breast cancer. Inserting the p53 gene into a person's cancer cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. Combining chemotherapy with gene therapy may kill more tumor cells.

OBJECTIVES:

I. Determine the effect of adenovirus p53 (Ad-p53) on chemotherapy-induced apoptosis in lesions in patients with breast cancer.

II. Determine p53 protein expression following intralesional injections of Ad-p53 by immunohistochemistry and reverse transcriptase polymerase chain reaction in this patient population.

III. Determine the time course and magnitude of the development of a humoral antibody response to the adenoviral vector in this patient population.

IV. Determine the ability of transfected p53 to upregulate downstream signals important in G1 arrest by assaying for WAF1 mRNA and apoptosis in this patient population.

V. Determine the toxicities and side effects of intralesional injections of Ad-p53 given in combination with standard chemotherapy in patients with cutaneous and subcutaneous metastatic breast cancer amenable to injections and biopsies.

VI. Determine if there is an increase in apoptosis induced by Ad-53 compared to baseline in this patient population.

OUTLINE:

Patients undergo biopsy of one of their skin nodules prior to any treatment. Patients receive the Ad-p53 gene therapy in one nodule and injection of a second nodule with Dulbecco's phosphate buffered saline. The next day, patients begin chemotherapy, which may be given weekly and continues every 21-28 days for up to 6 courses. On day 3, patients return for biopsy of injected nodules. Biopsies are only performed during the first course. Patients may receive further injections of the Ad-p53 gene with subsequent courses of chemotherapy, for up to six courses.

Patients are followed monthly for 4 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed epithelial breast cancer
* At least 3 cutaneous or subcutaneous lesions required
* Measurable disease that includes, but is not limited to, cutaneous or subcutaneous metastases

PATIENT CHARACTERISTICS:

* Age: Over 18
* Performance status: ECOG 0-2
* Absolute granulocyte count at least 1,500/mm3
* Hemoglobin greater than 8 g/dL
* Platelet count greater than 100,000/mm3
* Bilirubin less than 2 mg/dL
* PT/PTT within normal range
* SGOT/SGPT less than 2 times upper limit of normal
* Creatinine less than 1.8 mg/dL
* Not pregnant
* Fertile patients must use effective contraception during and for 3 months after therapy

PRIOR CONCURRENT THERAPY:

* Concurrent cytotoxic chemotherapy allowed, if stable and responding
* At least 4 weeks since prior chemotherapy, if starting a new regimen
* At least 4 weeks since radiotherapy
* Prior adjuvant radiotherapy to the chest wall allowed
* At least 6 months since radiotherapy to lesions that are to be injected
* Recovered from prior therapy
COld Exposure With Controlled BReathing And Meditation in Patients With Multiple Sclerosis (COBRAMS)

The goal of this interventional study is to test the effect of the anti-inflammatory and neuroprotective effects of this supplementary training program that includes breathing exercises, cold exposure, and meditation in patients diagnosed with multiple sclerosis.

Researchers will compare the effect to control groups of MS patients without intervention.


Eligibility Criteria:
Inclusion Criteria:

* RRMS diagnosed according to the official 2020 McDonald's criteria,
* age 18-55 years,
* MS duration up to 10 years,
* EDSS 1.0-5.5,
* willingness to participate

Exclusion Criteria:

* relapse or corticosteroid treatment within 3 months prior to study enrollment
* severe/unstable comorbidity
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week. Liver disease will be determined by the presence of choline deficiency, cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level), and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).

The objective of this study is to investigate the presence/prevalence of liver disease in patients dependent on PN (≥4 days a week).

Eligible participants will provide blood samples at Visit 1 to determine choline deficiency, elevated serum ALP liver isoenzyme level and liver dysfunction, and complete one imaging study (MRI-PDFF) at Visit 1 to assess steatosis.

The purpose of this study is to understand and document critical epidemiological data related to choline deficiency and the incidence of liver disease in patients dependent on PN (≥ 4 days a week) and to better understand this patient population to help determine who might benefit from innovative treatments including IV Choline Chloride treatment.

Eligibility Criteria:
Inclusion Criteria:

* The participant and/or their parent/Legally Authorized Representative is willing and able to provide signed informed consent or assent as appropriate
* Male or female adults 18 to 80 years of age, or adolescents 12 to 17 years of age
* Patients dependent on parenteral nutrition (PN) that receive PN for an average ≥ 4 days a week for 10 weeks or longer prior to screening to meet nutritional, caloric, fluid, and/or electrolyte needs
* The Investigator expects no changes in the lipid, dextrose, amino acid, or vitamin regimen to be medically necessary during the participant's participation in the study
* Willingness of participant to maintain his/her current habitual oral diet and fluids regimen for the study duration

Exclusion Criteria:

* Participants taking steatogenic medications for ≥12 weeks in the past 12 months (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids, over the usual dose of estrogen for hormone replacement therapy, and valproate); those taking any medicine (e.g., metformin, thiazolidinediones, ursodeoxycholic acid, pentoxifylline, S-adenosyl-L-Methionine, and betaine) that could affect the measurement of IFALD within 12 weeks prior to study entry
* Participants taking potential hepatotoxic medications that in the judgement of the Investigator is causing hepatic abnormalities
* Participants with a cardiac pacemaker, intravascular stents, other metallic devices, and claustrophobia which are contraindicated to magnetic resonance imaging
* Participants who took choline supplements or choline-containing multivitamins within 14 days of screening
* History of major organ transplant (e.g., heart, kidney, liver, etc.)

For more information on eligibility criteria, please contact the sponsor.
Grouptraining for Overactive Bladder in Adults

Hypothesis:the effect of bladdertraining in groups for patients with OAB (overactive bladder syndrome) equals the effect of bladdertraining individually for patients with overactive bladder.

The effect of the training is measured in a 3 dimensional scope by the means of 3 primary outcome measures used in the statistical evaluation. Symptoms of OAB (either (1)urgencyepisodes or (2)urgencyincontinence) and (3)quality of life (VAS score).

Program consisting of 3 hourly sessions with bladdertraining and daily training with a pocket bladder schedule. patients are randomised either for groups or individual training with a continence nurse over a period of 2 months.

Eligibility Criteria:
Inclusion Criteria:

* women at the age of 18 and more
* patients with overactive bladder

Exclusion Criteria:

* dominance of stress incontinence
* not able to attend sessions
* do not to understand danish
* do not want training in groups or individual
* hormonebalanced (if postmenopausal with added hormonetreatment for at least 2 months)
* no treatment for OAB up till 1 month before study and during study
* no renal or neurological diseases, symptomatic cystitis or non regulated diabetes
* no pregnancy during study
* no normal gynecological examination
* no operation in pelvis up till 3 month before studystart
* no polyuria measured 2 times before studystart (\> 40 ml/ kg/ day)
* no upstart of treatment with medication during studystart which according to the investigator can create symptoms of OAB
* no participation in other CT
Y-90 SIRT for Unresectable HCC Larger Than 7cm

This is a phase II clinical study to evaluate the efficacy and safety of SIRT in patients with HCC greater than 7 cm. After enrollment, patients received yttrium-90 selective internal radiation therapy. The primary endpoint of the study is objective reponse rate (ORR) as assessed by mRECIST. Secondary endpoints were: objective response rate (ORR) as assessed by RECIST 1.1, disease control rate (DCR), progression-free survival (PFS), time to response (TTR), duration of response (DOR), overall survival (OS), and safety (incidence and severity of adverse events).


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed or clinically diagnosed HCC
* Unresectable HCC as assessed by a team of surgeons
* The largest tumor size \> 7 cm
* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment
* At least one measurable intrahepatic target lesion
* Appropriate for SIRT treatment after evaluation (including SPECT/CT evaluation after arterial perfusion with 99Tc-MAA)
* Child-Pugh score ≤ 7
* ECOG PS ≤ 1
* Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, haemoglobin ≥85 g/L, ALT and AST≤5×ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds
* life expectancy of at least 6 months

Exclusion Criteria:

* Macrovascular invasion or extrahepatic metastasis
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy
* Organ (heart and kidneys) dysfunction
* History of other malignancies
* Uncontrollable infection
* History of organ or cells transplantation
* History of HIV
* Pregnant or lactating patients
CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM\| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.

The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM\|G or V for the same indication.

Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.

Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to any study related procedure.
2. Male or female age ≥ 18 and ≤ 85 years.
3. Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation
4. Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation.
5. For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin.
6. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria:

1. Unable to give written informed consent.
2. Medically unfit for operative intervention.
3. Soft-tissue defects that prevent direct skin closure at revision surgery.
4. Females who are pregnant or lactating.
5. Females of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions may be included.
6. Known allergy to gentamicin or vancomycin (or related antibiotics).
7. Patients with previous nephro- or ototoxicity events due to aminoglycoside and/or vancomycin (or glycopeptides) use.
8. Presence of relevant contraindications as described in the EU CE mark Instructions for Use (IFU).
9. Myasthenia gravis.
10. Need of a fully cemented joint prosthesis.
11. Psychiatric or neurological disorders.
12. Active infection at the site of surgery as diagnosed by clinical and/or laboratory and/or imaging investigations.

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Community Walks: Clinical Trial

This research study will investigate the independent effects of an environmental intervention (E only), an individual-level eHealth phone program intervention (I only), or both (E+I) on changes in moderate intensity physical activity. A cluster randomized design will be implemented whereby all residents of one of 12 of Boston's public housing developments (PHDs) will be randomized to one of the four study groups (E only, I only, E+I, or control). The activities with this multilevel design include:

* Screening/enrollment/baseline assessment activities
* Environmental components to promote moderate intensity walking and other physical activity at the PHDs
* Changing the environment surrounding the development making it more amenable to walking through the creation of walking trails and walking maps; and advocating for changes to the built environment
* Healthy Living Advocates (HLA)-led walking groups within the community
* Individual level components to increase motivation and self-efficacy for physical activity
* eHealth program, an automated telephone-based physical activity program
* 12-month and 24-month follow up assessment activities

The investigators hypothesize that the participants living in the PHDs in any of the three intervention groups (E only, I only, and E+I combined) will increase minutes of moderate intensity physical activity more than participants in control group developments at 24-month follow up. It is further expected that delivery of an intervention package targeting environmental and social cues to become active, combined with an individual level intervention, will improve overall physical activity levels to recommended guidelines at the development level. The findings will inform future health promotion efforts among residents in public housing developments.


Eligibility Criteria:
Inclusion Criteria:

* Willing to wear device to track physical activity during assessment periods
* Able to speak English or Spanish
* Current resident of Boston Public Housing Development or housing property on Boston Housing Authority owned land
* No plans to move within the next 2 years
* Has access to a phone (of any kind)

Exclusion Criteria:

* Currently enrolled in a research study about physical activity that is incompatible with study participation
* Unable to provide informed consent in judgement of research assistant
Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer

This pilot clinical trial studies copper Cu 64-DOTA-B-Fab positron emission tomography (PET)/computed tomography (CT) in imaging patients with ovarian and breast cancer. Cancer antigen (CA)6 is an antigen (substance) found on the surface of several types of cancer cells such as cancer of the ovary and breast. Diagnostic procedures, such as copper Cu 64-DOTA-B-Fab PET/CT, may help identify CA6 positive tumors and allow doctors to plan better treatment.

PRIMARY OBJECTIVES:

I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).

SECONDARY OBJECTIVES:

I. To evaluate the safety of 64Cu-DOTA B-Fab single administration.

II. To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions.

III. To compare PET results with the immunohistochemistry (IHC) analysis of the excised tumor samples.

OUTLINE:

Patients receive copper Cu 64-DOTA-B-Fab intravenously (IV) followed by PET/CT 60 minutes post-injection and 24 hours post-injection

After completion of study, patients are followed up for 12 months.

Eligibility Criteria:
Inclusion Criteria:

Ovarian Cancer Participants

1. Patient is ≥ 18 years old at the time of the drug administration
2. Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian cancer but is not a surgical candidate
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patient is able to remain still for duration of each imaging procedure

Breast Cancer Participants

1. Patient is ≥ 18 years old at the time of the drug administration
2. Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patient is able to remain still for duration of each imaging procedure

Exclusion Criteria:

Ovarian Cancer Participants

1. Patient is pregnant or breast-feeding
2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Patients participating in other research imaging protocols will be excluded from this study.

Breast Cancer Participants

1. Patient is pregnant or breast-feeding
2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Patients participating in other research imaging protocols will be excluded from this study.
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 mL/min/1.73 m2 for participants

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
* History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
* Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Other protocol defined inclusion/exclusion criteria could apply