cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease

The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.

This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.

This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.

As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19 years and older
* Individuals with multivessel coronary artery disiease(MVCAD), including those with recurrent lesions at the procedure site, such as neo-atherosclerotic lesions.
* Participants who have undergone percutanoeus coronary intervention (PCI) with genoss stnets
* Participants who have agreed to the trial protocol and clinical follow-up plan, have voluntarily decided to participate in this clinical trial, and have provided written consent in the informed consent form for trial participation. (Note: Foreign participants must be fluent in Korean and capable of understanding Korean documents, including the informed consent form, to be included.

Exclusion Criteria:

* Trial participants with known hypersensitivity or contraindications to the following drugs or substances: Heparin, Aspirin, Clopidogrel, Cilostazol, Contrast agents (Note: Even participants with hypersensitivity to contrast agents may be eligible for enrollment if their sensitivity can be controlled by steroids and antihistamines; however, those with known anaphylaxis are excluded).
* Cases where balloon expansion is unsuccessful during balloon angioplasty at the stenotic site.
* Participants with an expected residual lifespan of less than one year.
* Those who are planning to become pregnant, pregnant, or breastfeeding.
* Participants who presented with cardiogenic shock during hospitalization and are predicted to have a low likelihood of survival based on medical judgment.
* Individuals deemed unsuitable for this clinical trial or those for whom participation may increase risks related to trial involvement, as determined by the investigator.
* Foreign participants who cannot fluently speak Korean and have difficulty understanding Korean documents.
Incretin Effect on the Immunological Phenotype

Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

Assessment of immunological effects of Saxagliptin and Liraglutide on immune cells of the peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

-healthy subjects or patients with type 1 diabetes

Exclusion Criteria:

* pregnancy
* treatment with GLP-1-Analoga (Liraglutide, Exenatide)
* treatment with DPP4-inhibitor (Sitagliptin, Vildagliptin, Saxagliptin)
* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Possible Efficacy and Safety of Mebendazole in Patients With Ulcerative Colitis Treated With Mesalamine

To evaluate the possible efficacy and safety of mebendazole in patients with ulcerative colitis treated with mesalamine

A randomized, controlled, and parallel study will comprise 46 patients with UC. Patients will be recruited from GastroEnterology Department, Mansoura University Hospital.

The participants will be randomly assigned into two groups as follow:

Group 1: control group (Mesalamine group, n =23) who will receive 1 g mesalamine three times daily for 6 months.

Group 2: (mebendazole group, n = 23) which will receive the standard treatment for UC plus mebendazole 500 mg twice daily for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old Both male and female will be included Mild and moderate UC patients diagnosed and confirmed by endoscope Patient treated with 5-aminosalislic acid (mesalamine)

Exclusion Criteria:

* - Patients with severe UC
* Significant liver and kidney function abnormalities
* Diabetic patients
* Patients with Colorectal cancer patients
* Patients taking rectal or systemic steroids
* Patients on immunosuppressants or biological therapies
* Addiction to alcohol and / or drugs
* Known allergy to the studied medications
* History of complete or partial colectomy.
* Patients with congestive heart failure, other heart disease (arrhythmia, ischemic heart disease including angina and myocardial infarction).
* Patients with other inflammatory diseases and active infection.
* Patients with stressful condition (COPD, morbid obesity).
* Patients with liver disease.
* Patients with thrombocytopenia and neutropenia.
* Patients with any type of seizures (case report for mebendazole induced convulsion).
* Patients with renal disease (case report for mebendazole induced nephrotoxicity).
* Patients with coagulation disorders.
* Patients on metronidazole (to avoid Stevens-Johnson syndrome).
* Patients with hypersensitivity to mebendazole, albendazole or benzimidazole
* Patients using antioxidants.
* Pregnant and lactating females.
* Patients receiving, metronidazole, warfarin, low dose of aspirin, clopidogril, enzyme inducers (phenytoin, carbamazepine) and inhibitors (valoproate) to avoid potential pharmacodynamics and pharmacokinetic interactions.
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors

The purpose of this study is to determine if it is feasible for women to take both Flibanserin and tamoxifen for the duration of the study. This study is also trying to find out if Flibanserin improves or has any effect on hyposexual desire disorder/HSDD in women who are taking tamoxifen for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women age 21 and older
* Able to swallow tablets
* History of stage 0-III breast cancer that is estrogen and/or progesterone receptor positive
* History of breast cancer with no current evidence of disease and have completed primary treatment with any combination of surgery, radiation and/or chemotherapy at least 3 months ago and is currently on Tamoxifen, an AI, or ovarian suppression.
* Has been taking tamoxifen, an AI, ,or ovarian suppression for at least 3 months.
* Has LFTS within 2 times the upper limit of normal proven by a Comprehensive Metabolic Panel (CMP) performed within 6 months of protocol enrollment and while the patient was on Tamoxifen, an AI, or ovarian suppression
* Patients meet criteria for the diagnosis of HSDD as defined by the DSM-IV and ISSWSH Consensus paper. The criteria states that there must be a decrease in sexual desire and this must be a change for at least 3 months from what it was previously. Personal distress resulting from this change must occur. Initial screening will take place with The Decreased Sexual Desire Screener, a 5-question screening tool developed and validated to aid clinicians in making the diagnosis of HSDD. A "yes" response to the first 4 questions on the screener is consistent with HSDD.
* Patients must agree to follow the guidelines for alcohol consumption during the 24 weeks of treatment on study
* English speaking
* Able to participate in the informed consent process

Exclusion Criteria:

* Active secondary cancer requiring cytotoxic chemotherapy
* History or current diagnosis of metastatic breast cancer.
* Unwillingness to follow alcohol guidelines while taking flibanserin
* Hepatic dysfunction (more than 2 times the upper limit of normal for alt, ast, t.bili or alk phos) proven by Comprehensive Metabolic Panel (CMP) performed within 6 months of protocol enrollment and while the patient was on Tamoxifen or an AI
* Patients on strong CYP3A4 inhibitors including ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan
* Patients on moderate CYP3A4 inhibitors including Amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, grapefruit juice
* Non-English speaking
* Unable to participate in the informed consent process
A Study to Assess Drug-Drug Interaction Between ASP1941 and Miglitol

This study is to assess the pharmacokinetic interaction between ASP1941 and Miglitol in healthy volunteers.

This will be a randomized, open-label, 3-way crossover design study to assess the drug-drug interaction between a single oral dose of ASP1941 and a single oral dose of Miglitol in healthy adult male volunteers. Each subject will receive "ASP1941 alone", "Miglitol alone" and "ASP1941 + Miglitol".

Eligibility Criteria:
Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
* Body weight ; ≥50.0 kg, \<80.0 kg
* Body Mass Index ; ≥17.6, \<26.4
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Previous treatment with ASP1941
Voxelotor Sickle Cell Exercise Study

This study is a pilot, open-label, single-arm study to evaluate the effect of the sickle cell medication voxelotor on exercise capacity, as measured by cardiopulmonary exercise testing (CPET) in patients 12 years of age and older with sickle cell anemia (SCA).

This study will assess exercise capacity by cardiopulmonary exercise testing (CPET) before and after 8 weeks of voxelotor therapy.

Patients with genetically severe forms of sickle cell disease, including Hgb SS, Hgb S beta 0 thalassemia, Hgb SC Harlem, etc., age 12 or older, with stable Hgb and Hgb F will be recruited. Enrolled subjects will have study labs drawn, undergo baseline CPET in the exercise lab, then take voxelotor 1500mg daily for 2 months, followed by repeat study labs and a second CPET. Each subject's CPET results before and after voxelotor will be compared, and the study labs before and after voxelotor will be compared. Each subject will be compared to him/herself.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, age \> 12 years
4. In good general health as evidenced by medical history and diagnosed with a genetically severe form of sickle cell anemia (Hgb SS, Hgb S beta 0 thalassemia, Hgb SCHarlem, and others)
5. Patients who are on Hydroxyurea need to be on a stable dose for at least 3 months without anticipated change in dosing until the study is completed.
6. Ability to take oral medication and willingness to adhere to daily voxelotor and 2 CPETs at scheduled intervals.
7. For females of reproductive potential who are sexually active: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 30 days after the end of study.
8. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

1. Patients on chronic transfusions or who received a transfusion within last 8 weeks
2. Patients who had hospitalization for vaso-occlusive crisis or acute chest syndrome within 30 days prior to informed consent/assent.
3. Patients who have screening alanine aminotransferase (ALT) \> 4X upper limit of normal
4. Patients who suffer from physical inactivity attributable to clinically significant musculoskeletal, cardiovascular, or respiratory comorbidities
5. Patients already taking commercially available voxelotor
6. Prior hypersensitivity to voxelotor or excipients.
7. Pregnant patients
Role of Active Deresuscitation After Resuscitation-2

RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.

The optimal approach to fluid balance in critically ill patients is uncertain. A recent systematic review found low quality evidence in favour of a conservative fluid or deresuscitative approach (active removal of accumulated fluid using diuretics and/or renal replacement therapy) compared with a liberal strategy or usual care. The RADAR-2 pilot randomised trial will compare conservative fluid and deresuscitation with usual care in patients who are mechanically ventilated in an intensive care unit. The main hypothesis is that in critically ill patients, a post-resuscitation fluid strategy comprising conservative fluid administration and active deresuscitation reduces net fluid balance, is safe and improves clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Invasive mechanical ventilation
2. Treating ICU doctor expects patient to require treatment in an ICU beyond the next calendar day
3. Between 24 and 48 hours from ICU admission at the time of randomisation

Exclusion Criteria:

1. Age \< 16 years
2. Body weight \<40kg (measured or estimated)
3. Diabetic ketoacidosis or Hyperosmolar hyperglycaemic state
4. Non-traumatic subarachnoid haemorrhage
5. Acute cardiac failure or cardiogenic shock
6. End-stage renal failure (on dialysis)
7. Known to be pregnant
8. Suspected or proven active diabetes insipidus (DDAVP within 24 hours)
9. Not expected to survive for 72 hours
10. Active 'Do not attempt resuscitation' order
11. Refusal of consent
12. Inability of personal consultee to understand written or verbal information and for whom no interpreter is available
13. Known allergy to one or more of the study drugs
14. Inability to measure fluid balance
Barriers to Physical Activity in Familial Mediterranean Fever

This project is a 2209-A TÜBİTAK project. It has been developed to identify the barriers to physical activity among patients diagnosed with Familial Mediterranean Fever (FMF).

The project aims to determine the problems encountered by FMF patients when engaging in physical activity and the reasons behind these issues, using various assessment methods to identify the reasons for avoiding physical activity.

This project is a 2209-A TÜBİTAK project. It has been developed to identify the barriers to physical activity among patients diagnosed with Familial Mediterranean Fever (FMF) referred to the Department of Internal Medicine, Rheumatology Division, at Istanbul University-Cerrahpaşa, Cerrahpaşa Medical Faculty, as well as the Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation.

The project aims to determine the problems encountered by FMF patients when engaging in physical activity and the reasons behind these issues, using various assessment methods to identify the reasons for avoiding physical activity. Patients diagnosed with FMF will be evaluated based on pain (McGill Melzack Pain Questionnaire), quality of life (FMF Quality of Life Measure), fatigue status (Fatigue Severity Scale), kinesiophobia (Tampa Scale for Kinesiophobia), grip strength (Digital Hydraulic Hand Dynamometer), and aerobic capacity (Spirometer).

Assessments will be conducted twice a week for three months, with each session lasting 30 minutes, utilizing the Digital Hydraulic Hand Dynamometer and Spirometer under the supervision of researchers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Familial Mediterranean Fever (FMF)
* Ability to respond to the questionnaires
* Capability to engage in physical activity

Exclusion Criteria:

* Any form of disability (visual, auditory, mental, physical)
* Illiteracy in Turkish
* Presence of comorbidities that may hinder assessment
Transformation Potential of E2 Exposed Breast Cancer Susceptibility Gene Mutation Heterozygous Epithelial Breast Cells

Susceptibility to breast cancer is related to the combination of genetic, hormonal and multiple other environmental risk factors, such as mutations in the BRCA gene and excess exposure to exogenous estrogen, respectively. BRCA is a nuclear protein that maintains genome stability, by acting as a key player in the DNA repair complex. Recently, evidence has emerged that BRCA mutation heterozygosis itself enhances aborted DNA repair and can contribute to breast cancer initiation after exposure to irradiation. In our preliminary results on short-term lymphocyte cultures, we found additional evidence that healthy heterozygous BRCA1 and BRCA2 mutation carriers have a different response to DNA damage than do non-carriers.

The main aim of our ongoing project is to identify the transcriptional modulation and transformation potential of normal BRCA1 and BRCA2 mutation heterozygous epithelial breast cells following irradiation and to examine how it is affected by exposure to estrogen. Our hypotheses will be investigated by RNA-seq and microRNA-seq in order to identify a unique molecular expression profile of the estrogen exposed cells following ionizing irradiation.

Understanding the role of BRCA heterozygosity in cell response to exposure to estrogen and to irradiation may facilitate the development of more appropriate diagnostic and therapeutic strategies for these individuals.

To study the different cell lineages, we plan to isolate and propagate luminal progenitors from a normal human breast tissue. To this end, 10 human breast tissue samples will be obtained from risk-reducing mastectomy in healthy premenopausal women with BRCA1 mutations. Tissues from 10 premenopausal women undergoing esthetic breast surgery with no family history of breast or ovarian cancers will serve as a control group. In order to isolate primary epithelial cells, human mammary tissue will be minced and enzymatically digested overnight in collagenase and hyaluronidase to yield suspension of epithelial organoids. These organoids will be collected and further digested with trypsin, dispase and deoxyribonuclease 1 (DNAse), will be filtered to generate a single cell suspension, resuspended in Hank's + 2% fetal bovine serum (FBS) and 0.1 mg/mL DNAse, and also incubated with a blocking antibody for 15 minutes on ice.

Cells will be treated with estrogen (E2) (10 nM) for 48 h and then will be irradiated for inducing double-strand break. Cells will be irradiated with 8 Gray (Gy) using a Co60 source.

To accomplish our study, estrogen exposed and unexposed BRCA mutation heterozygous epithelial breast cells will be irradiated and 1 h later RNA will be extracted from the cells using Tri-reagent (Sigma). The RNA will be converted to a library of cDNA (complementary DNA) fragments and will be sent for deep sequencing in the illumina Hi-Seq platform.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* premenopausal
* women
* BRCA1 mutations
* BRCA2 mutations

Exclusion Criteria:

* women with breast or ovarian cancer
Sief_Twist Sign a Novel View in Fetal Echocardiography

To describe Sief_twist sign as a novel sign in fetal echocardiography as a new ,easy , time effective view in fetal heart examination .


Eligibility Criteria:
Inclusion Criteria:

1. Singleton fetus .
2. gestational age 14-37 weeks.
3. no maternal medical disorder .
4. no morbed obisity.

Exclusion Criteria:

1. evidence of fetal infection.
2. chorioamnionitis.
3. fetal anomalies.
4. abnormal fetal karyotype
5. patient withdrawal from the study and/or unavailability for follow-up.
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented HER2-positive locally advanced or metastatic breast cancer
* Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments
* Prior trastuzumab in any line of therapy (Phase Ib patients only)
* No prior T-DM1 or pertuzumab therapy
* Measurable or evaluable disease
* Cardiac ejection fraction \>=50% by either echocardiogram or multigated acquisition scan
* Life expectancy \>= 90 days as assessed by the investigator

Exclusion Criteria:

* Fewer than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal or radiotherapy for the treatment of breast cancer, with the following exceptions: hormone-replacement therapy or oral contraceptives are allowed; palliative radiation therapy involving \<=25% of marrow-bearing bone is allowed if completed within \>= 14 days prior to first study treatment
* History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued
* Peripheral neuropathy of Grade \>= 2 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase Ib patients)
* Peripheral neuropathy of Grade \>/=1 per NCI CTCAE, Version 3.0, at the time of, or within 3 weeks prior to, the first study therapy (Phase IIa patients)
* History of exposure to the following cumulative doses of anthracyclines: Doxorubicin \> 500 mg/m\^2; Liposomal doxorubicin \> 900 mg/m\^2; Epirubicin \> 720 mg/m\^2
* History of clinically significant cardiac dysfunction
* Brain metastases that are untreated, or progressive, or have required any type of therapy (including radiation, surgery, or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.
* History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, basal cell carcinoma, or synchronous or subsequent HER2-positive breast cancer or other malignancy with a similar expected curative outcome