cyrilzakka/clinical-trials huggingface dataset:
Donation of Post Mortem Tumor Tissues

DONUM is an observational prospective independent protocol for patients with advanced lung cancer, colorectal cancer or cancer of unknown primary, willing to donate their tumor tissue samples post mortem for biomedical research purposes. All patients who fulfill the inclusion criteria will be eligible for the study after giving their Informed consent. Informed Consent will be obtained in two steps. During the pre-information step patients will be acquainted with the existence of a post-mortem cancer tissue donation research program governed by the DONUM protocol. If the patients manifest interest to participate into the program (in writing) during the pre-information step, they will proceed to step 2 and undergo the final informed consent process.

Despite the recent technological advancement in genomic and proteomic, the molecular understanding of clonal evolution in solid tumor patients is hampered by intra tumor heterogeneity (ITH), while remaining essential to the effective treatment of patients. Recent evidence suggests that branched evolutionary tumor growth may contribute to ITH both within a primary tumor and between primary and metastatic tumors. To study the full extent and consequences of ITH, and grasp clonal evolution, the investigators need to have access not only to circulating biomarkers (circulating tumor DNA) but also, simultaneously and separately, to the primary tumor and all its derived metastases. However multiple biopsies in live patients are neither medically feasible, nor ethical acceptable. A lesser known tissue collection method is through rapid tissue donation (RTD), which is the procurement of 'fresh' tissue within 2 hrs following the death of a patient. RTD-based research provides an effective way to investigate advance tumors biology in a manner not possible by any other means. With an RTD approach, the full extent and consequences of tumor heterogeneity can be evaluated by deep sequencing and global analysis of genetic alterations at the protein level of simultaneous core biopsies from several areas of the primary tumor and metastases and correlation with clinical outcome. To investigators' knowledge, no such studies have been done in Italy and are currently being pursued only in selected USA and UK cancer centers.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with confirmed metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), CUP (cancer of unknown origin syndrome) with life expectancy less than or equal to 3/4 months;
* Age ≥18;
* Signed informed consent from patient to enter the study and to undergo post-mortem tissue sampling.

Exclusion Criteria:

* Medical, or psychological conditions that would preclude informed consent;
* History of high-risk infections (e.g. HIV-positive, hepatitis C, tuberculosis and Creutzfeldt-Jacob disease).
T2 Heart Mapping in AMI Population for the Prediction of Short Term Major Adverse Cardiovascular Events

A novel Cardiac MRI sequence, developed by Dr. Maria Altbach (Double Inversion radial fast Spin Echo T2 mapping), has been tested clinically. It demonstrated a high sensitivity to the heart muscle swelling ("edema") in different types of heart injury, including heart attacks.

The investigators propose to use T2-Map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients.

If successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

In the initial feasibility project, a novel Cardiac MRI sequence (Double Inversion radial fast Spin Echo T2 mapping)developed by Dr. Maria Altbach at the University of Arizona, has been tested clinically. It demonstrated a high sensitivity to the heart muscle swelling ("edema") in different types of heart injury, including heart attacks. The investigators have successfully tested the reproducibility of the new method in a series of healthy volunteers. The Phase I study revealed a robust clinical performance of the T2-Map sequence in multiple cardiac disorders.

Based on these promising results, presented on several international Cardiac Imaging meetings, the investigators propose to use T2-Map methodology in patients with acute heart attacks and to compare value of this method with other clinical and imaging parameters in predicting short-term (30 day) clinical outcomes of these patients.

If successful, the project will provide an effective risk-stratification tool to identify patients with heart attack as a result of atherosclerotic disease, who require more aggressive therapeutic approach and closer follow-up after initial hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* between 18 to 89 years old
* diagnosis of Acute MI
* clinically

Exclusion Criteria:

* contraindications for contrast enhanced CMR
* acute congestive heart failure
* ventricular or atrial arrhythmias
* ongoing chest pain/unstable angina
* ECG changes suggestive of acute/ongoing ischemia
* hypotension with systolic blood pressure \<100 mmHg
* severe hypertension despite therapy, with systolic BP\>180 mmHg,
* Patients without a telephone number and/or address for follow up
* Patients with severe claustrophobia.
* Vulnerable populations, such as minors, pregnant women, prisoners, or cognitively impaired patients
Effect of I31 Probiotic on Lactose Intolerance

This randomized study evaluates the usefulness of the I31 probiotic formula, against placebo, in the treatment of symptoms of lactose intolerance.

People with lactose intolerance are unable to fully digest the sugar (lactose) in milk. As a result, they may have diarrhea, abdominal pain, gas and bloating after eating or drinking dairy products. A deficiency of lactase - an enzyme produced in your small intestine - is usually responsible for lactose intolerance. Many people have low levels of lactase but are able to digest milk products without problems. In lactose intolerance, though, lactase deficiency leads to symptoms after eating dairy foods.

I31 is a probiotic formula composed of Pediococcus acidilactici strain CECT7483 and Lactobacillus plantarum strains CECT7484 and CECT7485, previously shown to improve intestinal sensitivity in patients with Irritable Bowel Syndrome (IBS). IBS is a functional intestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits, often accompanied by bloating. Given the overlap in symptoms between IBS and lactose intolerance, it is hypothesized that I31 formula could be beneficial for individuals with lactose intolerance.

Eligibility Criteria:
Inclusion Criteria:

* Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent.

Exclusion Criteria:

* More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if \>10ppm persisted, patient was excluded.
* BMI below 18 or above 40
* Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study
* Subjects with congenital lactase deficiency
* Pregnant or lactating women
* Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis
* History of gastrointestinal surgery in the 6 months prior to inclusion
* History of intestinal perforation
* History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion
* Substance abuse
* Untreated thyroid disorder
* Cancer
* Other severe diseases that in the doctor's opinion could interfere with the study
* Known allergy to any of the components in the treatments
a Randomized Multicenter Trial Comparing Vacuum Assisted Delivery With the New Device "iCUP" Versus the Reference Cup.

The hypothesis is that the new vacuum assisted delivery device iCup is more effective than the reference cup, in terms of maternal and newborn morbidities and functioning

Currently, instrumental extractions are used in about 10% to 15% of the 860 000 annual deliveries in France and the use of vacuum extractors increases from year to year. In addition to sterilizable vacuum extractors several different types of vacuum extractor have been developed, in particular the single use Kiwi cup or the so-called 'soft' cup extractors. However, studies evaluating these new cups have not shown their superiority in comparison to the conventional metallic vacuum extractor.

Accordingly, it is legitimate to assess the new vacuum extractor iCup, an innovative "mix" of metallic cup and 'soft' cups that should combine the advantages of both; and to compare the iCup vacuum extractor with the sterilizable metallic cup extractor, the most effective vacuum extractors available to date.

Eligibility Criteria:
Inclusion Criteria:

* maternal age between 18 and 45 years old
* singleton delivery after 37 weeks, in cephalic presentation,
* indication of vacuum extraction,
* affiliation to the french social security system or equivalent

Exclusion Criteria:

* no informed consent
* singleton delivery before 37 weeks, in non-cephalic presentation,
* patient deprived of freedom
Safety and Immunogenicity of CJ-50300

The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy Korean male and female subjects between 20 and 28 years of age at the time of screening visit.
2. Willing to participate and have signed the informed consent form
3. In good general health, without clinically skin diseases history, physical examination or laboratory test results
4. Hematocrit \>33% for women; \>38% for men
5. White cell count 3,300-12,000/mm3
6. Total lymphocyte count \> 800 cells/mm3

Exclusion Criteria:

1. Diseases or conditions that cause immunodeficiency (For examples; HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, therapy with alkylating agents, antimetabolites, radiation, or oral or parenteral corticosteroids).
2. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
3. history or present of eczema or atopic dermatitis
4. Allergy or sensitivity to any known components of vaccine or other medicines
5. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
6. Subjects with inflammatory ophthalmic disease requiring steroid therapy
7. Subjects who are planning for blood donations
8. Autoimmune disease such as lupus erythematosus
9. Subjects who work in medical institution
10. Household contacts with women who are pregnant or breast-feeding
11. Female Subjects who are pregnant or breast-feeding and have positive result by serum pregnancy test or urine pregnancy test, or do not using approved contraceptives such as sterilization, contraceptive ring injectable, combined oral contraceptive pills and barrier contraceptive, combined hormone-based therapy, contraceptive cream, contraceptive jelly, diaphragm or condoms
12. Subjects household member \<1 year old or work with children \<1 year old
13. Subjects with a known history of Cardiac disease or have three or more of the following risk factors: hyperpiesia, obesity, hyperlipidemia, glucosuria, sclerosis, cerebral arteriosclerosis
14. Receipt of immunoglobulin and steroid within 14 days of vaccination
15. Receipt of investigational research agents within 120 days of vaccination
16. HBsAg seropositive
17. HCV antibody seropositive
18. HIV seropositive
19. Subjects having fever (oral temperature \> 38℃) or severe nutrition disorder
20. Blood donation within 12 weeks in advance screening visit
21. Subject who are not suitable to participate in study according to invesigator's judgement
Depression Agency-Based Collaboration

Seniors who receive supportive services face a variety of psychosocial vulnerabilities that put them at risk for depression. One group with very high risk is older adults receiving aging services through Medicaid waiver programs. This 3-year research uses a randomized controlled clinical trial to assess the effectiveness of brief behavioral therapies (problem solving therapy \[PST\] and Brief Behavioral Therapy for Insomnia \[BBTI\]) to prevent depression in seniors receiving aging services.

The research will determine (i) if a course of problem solving therapy (PST) and Brief Behavioral Therapy for Insomnia (BBTI), with boosters, reduces incidence of major depressive episodes over 12 months relative to usual care, and (ii) the extent to which behavioral therapies achieve these effects through enhancement of protective factors, such as greater self-efficacy, better targeting of services to address needs, and greater control over home environments.

Periodic blood draws will be used to assess biosignatures of depression. Guiding our investigations of pharmacogenetics, inflammation, and proteomics are synergistic interactions among the serotonergic system, the HPA axis, systemic inflammation, growth factors such as brain derived neuro-trophic factor (BDNF), psychosocial stressors, and vascular co-morbidity. Genetic variation in vasopressin receptors, potentially involved in both cardiovascular risk and social attachment, is also associated with recurrence of depression. Similarly, genetic variation in inflammation may influence antidepressant response and medical co-morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Age =\> 60 years
* Modified Mini Mental State (3MS) Examination =\>80
* Receiving aging services or difficulty with 1+ ADL/IADL
* PHQ-9 score \> 0 and \<= 9 (and question 1 or 2 is \>0)

Exclusion Criteria:

* Major depressive episode or anxiety disorder within 12 mo
* Ever diagnosed with bipolar disorder or schizophrenia
* Drug or alcohol use disorder within the past 12 months
* Currently taking antidepressants
* Currently taking antianxiety med \>4x/week for past 4 weeks
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation

The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent prior to any study-specific procedures.
* NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (\<3 SBMs/week and experiencing \>1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (\<3 SBMs/week on average over the 2-week OIC confirmation period.
* PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
* FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if BM has not occurred within at least 72 hours of the last recorded BM.

Exclusion Criteria:

* Patients receiving Opioid regimen for treatment of pain related to cancer.
* History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues related to the gastrointestinal tract that could impose a risk to the patient.
* Pregnancy or lactation.
Culturally Relevant Exercise for Diabetes (CURE-D)

The Culturally Relevant Exercise for Diabetes (CURE-D) study will determine whether a culturally-sensitive dance intervention is an accepted and effective physical intervention for South Asian women with type 2 diabetes mellitus. The CURE-D study will determine if Bollywood dance exercise improves diabetes outcomes in South Asian women.


Eligibility Criteria:
Inclusion Criteria:

* Sex: Females
* Ethnicity: South Asian
* Hemoglobin A1c ≥ 6.0 mg/dL
* A PAMF patient for ≥ 24 months
* Able and willing to enroll and meet the requirements of the study.

Exclusion Criteria:

* BMI \> 35
* Insulin dependent
* Current atrial fibrillation
* Active treatment for cancer
* Diagnosis of a terminal illness and/or in hospice care
* Any serious medical condition which would prevent long-term participation or which would contraindicate physical activity
* Pregnant, lactating, or planning to become pregnant during the study period
* Inability to speak, read, or understand English
* No longer a PAMF patient or planning to transfer care outside of PAMF during the study period
* Investigator discretion for clinical safety or protocol adherence reasons.
Bevacizumab and Trastuzumab With Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer

The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
* Lesion bigger than 2cm.
* life expectancy \> 12 weeks.
* Normal Heart function (LVEF\>55%)
* Patient should give his/her signed, written informed consent.

Exclusion Criteria:

* Previous chemotherapy treatment.
* Previous treatment with HER2 or VEGF inhibitors.
* Pulmonary disease not controlled.
* Hypertension not controlled (systolic \> 150 mmHg and/or diastolic \> 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
* Antecedents of coagulopathy or clinically significant thrombosis.
* Major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study.
* Peripheral Neuropathy \> CTC 2 at inclusion.
* Altered renal function a. Creatinine \> 2.0 mg/dL or 177 mmol/L. b.Proteinuria \> 2+ with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h.
* Daily chronic treatment with corticosteroids
* Daily chronic treatment with aspirin (\> 325 mg/day) o clopidogrel (\> 75 mg/day)
* Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage.
* Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion.
* Active infection to be treated with iv antibiotics
* Serious injury not curing, peptic ulcer or bone fracture.
* Pregnant or active sexual patient not using contraceptive methods. or lactating woman
* Current or recent treatment with another IMP or participation in another clinical trial (30 days before inclusion)
* Another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
A Clinical Trail of Integrative Medicine Approaches for Post-Stroke Cognitive Impairment

The traditional Chinese medicine rehabilitation for the post-stroke cognitive impairment will be intervened, which can promote the recovery of post-stroke cognitive function patients, reduce the disability rate and improve the quality of life.

This study will collect inpatients from April 2019 to December 2024 who from the third affiliated hospital of Zhejiang university of traditional Chinese medicine, Jiaxing hospital of traditional Chinese medicine, Hangzhou hospital of traditional Chinese medicine.this study sets strict time window (stroke recovery, 30-180 days), use multi-center, large sample, randomized controlled study method and the objective recognition rehabilitation evaluation criteria and efficacy evaluation system to evaluate the clinical effect and analysis of health economics.

Eligibility Criteria:
Inclusion Criteria:

1. Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental activity of daily livings.
2. age above 18 years;
3. disease duration of 30-180 days;
4. written informed consent by the patient's legal guardian;
5. MoCA (Montreal Cognitive Assessment) score of 17-26. If patient was educated for ≤ 12 years, one score will be deducted;
6. HAMD(Hamilton Depression Scale) score \< 20;
7. indications for acupuncture and moxibustion techniques.

Exclusion Criteria:

1. Cognitive impairment caused by subarachnoid hemorrhage, transient ischemic attack, or other intracranial lesions., such as tumors, aneurysms, vascular malformations, cysticercosis, schistosomiasis, encephalitis, meningitis, hydrocephalus, or head trauma;
2. non-atherosclerotic thrombotic cerebral infarction (such as cardiac embolism, procoagulant state, endovascular shedding, or arteritis);
3. pregnant or lactating women;
4. severe chronic diseases of the heart, liver, kidneys, other viscera, or endocrine system or hematopoietic system;
5. severe dementia, serious language understanding disorders, or mental illness;
6. bleeding tendency;
7. lack of inclusion criteria or not suitable for clinical observation.
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.


Eligibility Criteria:
Main inclusion criteria:

* Patients with chronic obstructive pulmonary disease (COPD)
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-06

Main exclusion criteria:

* If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day
* Patients with long-term oxygen therapy
* Serious diseases