cyrilzakka/clinical-trials huggingface dataset:
Management of OAB in Female Patients .

The objective of this study is to compare the effectiveness of mirabegron, solifenacin, tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a double-blinded prospective randomized placebo-controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Women from 18 to 65 years of age with LUTs due to OAB

Exclusion Criteria:

* Severe cardiovascular disorders. \\

  * Severe neurogenic dysfunction.
  * Drug administration which interfere with bladder function .
  * Abnormal bleeding profile.
  * A verified urinary tract infection as determined by urinalysis and/or urine culture during screening
An Observational Study of Fecal Calprotectin as Clinical Tool in Monitoring Moderate-to-severe Crohn's Disease on Adalimumab Induction Therapy: a KoRean Experience (FAIR)

The objective of this observational study was to assess changes in fecal calprotectin levels and its suitability as a monitoring tool in participants with moderate-to-severe Crohn's Disease who were treated with adalimumab.


Eligibility Criteria:
Inclusion Criteria:

1. Crohn's Disease participants were defined as:

1. Active luminal, moderate-to-severe Crohn's Disease with Crohn's disease activity index (CDAI) greater than 220, who started Adalimumab treatment in a normal clinical practice setting.
2. Fecal Calprotectin greater than or equal to 150 microgram/g.
3. Ileocolonic or colonic disease, with or without involvement of proximal gastrointestinal areas.

Exclusion Criteria:

1. Disease restricted to proximal (small bowel, gastroduodenal) gastrointestinal tract.
2. Participants who had undergone colectomy other than ileocecal resection.
3. Pregnancy or breast feeding.
4. Contraindication to any anti-tumor necrosis factors (TNF) agent.
5. Any drug dependency.
A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients

This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at risk / malnourished, defined by an MST score ≥ 2 the first 24 hours post hospital admission
* Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal
* Patient is able to consume foods and beverages orally
* Patients with life expectancy ≥ 30 days
* Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF)

Exclusion Criteria:

* Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements
* Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures
* Subject is known to be allergic or intolerant to any ingredient found in the study products
* Subject is pregnant
* Subject is intubated, receiving tube feeding or parenteral nutrition
The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma

In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had been studied that are also correlated to sputum eosinophils in similar patients group. According to well controlled asthma, althoug hin clinical practice guidelines recommend that the stepping down therapy should be considered to those patients due to the risks or costs of daily treatment, there is previous study has been shown that the airway hyperresponsiveness and sputum eosinophilia are predictors of loss of control during dose reduction. And, these tests are not readily available in primary care. However, there is limit number of clinical study to study the correlation of biologic markers among the patients with well controlled level before the stepping down management.

This is a single prospective trial. Enrollment will continue until 50 patients with well controlled asthma have been entered into this trial and have completed blood tests and spirometry. In this trial, the following parameters are to be evaluated:

Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF, MMEF 25-75%, % reversibility

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of asthma (according to the guidelines)
* Age \>15 years
* Patients with treating with step 3 base on GINA by only low dose ICS/LABA without oral bronchodilator with being in well controlled asthma based on ACT (\> = 23) and ACQ-7 (\<0.75) for at least 12 weeks
* Ability to provide informed consent and do spirometry following ATS guideline

Exclusion Criteria:

* Pulmonary infection or exacerbation within the last 12 weeks before enrolment
* Patients with preceding taken systemic steroid 12 week before enrolment
* Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
* A history of smoking \>= 10 pack-year
Obesity Among Young Adult Males Born With Cesarean Section.

Previous research has suggested that cesarean section may be associated with an increased risk of developing obesity in childhood, adolescence and adulthood. Yet, previous studies have been small or unable to differentiate between elective and non-elective cesarean section. Therefore, using a population-based cohort the purpose is to examine the associations between vaginal delivery, elective and non-elective cesarean section on the risk of developing obesity in young adulthood among Swedish young singleton males. Using the Swedish medical birth registry, the recorded mode of delivery and indication of delivery which will be matched to those males who perform military conscription, where their body mass index is recorded. The investigators hypothesize that there will be an elevated risk of obesity in those born with non-elective cesarean section, as a function of confounding, while those born with elective cesarean section will not have a higher risk of obesity than those born with vaginal delivery.


Eligibility Criteria:
Inclusion Criteria:

* Singleton birth.
* Retrievable from medical birth registry.

Exclusion Criteria:

* No available information on mode of delivery.
* Not conscripted.
* Extreme values at conscription.
Study of Intravenously Administered SNS-032 in Patients With Advanced B-lymphoid Malignancies

The purpose of this study is to assess the safety and tolerability of escalating doses of SNS-032, given in 3 weekly administrations per cycle and to identify a recommended Phase 2 dose.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body) and identifying potential biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically confirmed chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), or multiple myeloma (MM).
* Evidence of relapsed disease
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1

Exclusion Criteria:

* Prior treatment with SNS-032 injection (previously known as BMS-387032)
* Pregnant or breastfeeding
* Unwilling to use an approved, effective means of contraception according to the study site's standards
* Use of therapeutic anticoagulation agents
* Prior allogeneic bone marrow transplantation
* Prior chemotherapy, monoclonal antibodies, investigational agents, or radiation therapy within 21 days before the first dose; nitrosoureas and mitomycin are not permitted for at least 42 days before the first dose.
* Prior pelvic radiation therapy or radiation to \> 25% of bone marrow reserve
* Any other medical, psychological, or social condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if the patient meets all study criteria.
A Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

A safety and tolerability study in healthy subjects including examination of how the body takes up, distributes, and gets rid of ACT-1014-6470


Eligibility Criteria:
Inclusion Criteria:

General criteria

* Signed informed consent prior to any study-mandated procedure.
* Healthy male subjects (both study parts) and female subjects of nonchildbearing potential (Part B) aged between 18 and 55 years (inclusive) at Screening.
* Healthy on the basis of medical history, physical examination, cardiovascular assessments, and clinical laboratory tests.
* Male subjects with a partner that might become pregnant must either be vasectomized or agree to practice adequate contraception from admission to the study site until 3 months after dosing, or the partner must consistently and correctly use (from Screening, during the entire study, and for at least 3 months after last study treatment intake) a highly effective method of contraception.

Criteria for Part B only:

• Women of non-childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day-1.

Exclusion Criteria:

* Previous exposure to the study medication.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment.
* Relevant bacterial, viral, fungal, or protozoal infection that manifested within the last 6 weeks prior to Screening and/or ongoing relevant bacterial, viral, fungal, or protozoal infection, as judged by the investigator, and/or evidence of immune dysfunction based on laboratory tests at Screening.
* Any signs or symptoms of active, ongoing infection judged to be clinically relevant by the investigator (special attention should be given to clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, or fatigue).
Safety and Efficiency of γδ T Cell Against Breast Cancer

In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks.

Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Eligibility Criteria:
Inclusion Criteria:

Age: 18-75 Karnofsky performance status \>50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease Insulin dependent diabetes Thyroid disease
Camrelizumab and Apatinib for Neoadjuvant Therapy in Thyroid Cancer

To determine the efficacy and safety of anti-PD-1 antibody Camrelizumab combined with Apatinib for neoadjuvant therapy in locally advanced thyroid cancer.


Eligibility Criteria:
Inclusion Criteria:

* The patient volunteered to participate in the study and signed an informed consent form;
* Pathologically diagnosed locally advanced thyroid cancer, including papillary thyroid cancer, medullary cancer, follicular cancer, poorly differentiated cancer, etc., require surgical resection with or without distant metastasis;
* Preoperative assessment of locally advanced thyroid cancer (unable to achieve R0/1 resection or T4 disease);
* Have at least one measurable lesion (RECIST 1.1);
* Age\>=14 years, Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Patient agree to receive surgery/ core needle biopsy before and after neoadjuvant treatment.
* The main organ functions meet the criteria before treatment.

Exclusion Criteria:

* Patients who have previously been treated with immune checkpoint inhibitors (including but not limited to nivolizumab, pembrolizumab, teriplizumab, sintilizumab, etc.);
* Received external radiation therapy or iodine-131 therapy within the past 28 days; or planned systemic anti-tumor therapy during this study;
* Pathologically confirmed non-thyroid epithelial cell-derived malignant tumors (including lymphoma, metastatic cancer, sarcoma, etc.);
* With other uncontrolled / under treatment malignancies;
* Those who have multiple factors (such as inability to swallow) that affect oral medication;
* Patients with any severe and / or uncontrolled illness,
* Patients whose imaging showed that the tumor had invaded the important blood vessels or the researchers judged that the tumor was likely to invade important blood vessels during the subsequent study period and caused fatal bleeding;
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of patients or affect patients to complete the research.
Early Versus Late Adjunctive Vasopressin in Septic Shock

The goal of the CASPER-Pilot study is to develop clinical decision support (CDS) technology within Epic to randomize patients with septic shock to early versus standard of care vasopressin initiation. The primary aim of this study will be to test the hypothesis that CDS technology can be utilized to create two distinct cohorts of patients reflecting different times of vasopressin initiation based on norepinephrine dose requirements. Secondarily, this study will evaluate the proportion of patients whose norepinephrine dose at the time of vasopressin initiation is within the specified range for the intervention arm they were randomized to. Other outcomes of evaluation will include adherence to the developed CDS technology and comparison of clinical outcomes between the two treatment arms.

Sepsis is a highly prevalent and morbid disease estimated to account for up to 20% of annual deaths globally. If not rapidly identified and intervened upon, patients with sepsis may progress to septic shock, which is associated with mortality rates up to 50%. Patients with septic shock have persistent hypotension requiring vasoactive agents to augment blood pressure despite fluid resuscitation. Norepinephrine is recommended first-line by the Surviving Sepsis Campaign (SSC) guidelines for patients with septic shock. If mean arterial pressure (MAP) remains inadequate on norepinephrine, vasopressin is suggested as the second-line adjunctive agent. Over 30% of patients with septic shock in the United States (US) receive adjunctive vasopressin, with use rising over time. Despite increased use over time, ideal patient selection and initiation timing for adjunctive vasopressin in the course of a patient's shock are not well elucidated. The 2021 iteration of the SSC guidelines note that initiating vasopressin when the patient requires between 0.25 and 0.5 mcg/kg/min of norepinephrine "seems sensible". Yet, many questions remain regarding the timing of vasopressin initiation. The goal of this proposal is to evaluate the timing of vasopressin initiation in patients with septic shock based on the norepinephrine requirements at the time of vasopressin initiation. This pilot study will attempt to develop CDS technology in which to answer this clinical question.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 Years
* Diagnosis of Septic Shock
* Admitted to Cleveland Clinic Main Campus Medical ICU
* Receiving continuous infusion of norepinephrine at a dose \> 5 mcg/min at time of enrollment

Exclusion Criteria:

* Administration of any other vasoactive agent other than norepinephrine at time of enrollment
* Initiation of vasopressin by provider outside of the context of study when NE \< 10 mcg/min (before BPA firing)
Neuroaxial Prophylaxis for CABG

Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.

Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery bypass grafting

Exclusion Criteria:

* Absolute contraindications for the use of thoracic epidural analgesia
Thousand Asian American Study

The "Thousand Asian American Study" or "TAAS" aims to test 2,000 foreign-born and children of foreign born Asian Americans residing in Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV.

The "Thousand Asian American Study" or "TAAS" aims to better understand the factors associated with testing for hepatitis B viral (HBV) testing among foreign-born Asian and African adult residents of Sacramento county, characteristics of those infected with HBV, and the efficacy of follow-up and linkage to care for those infected with HBV, and develop a research platform for future studies. Thus, what the investigators want to do is 1) test 2000 foreign-born Sacramento county residents for HBV and (2) counsel at least 90% of those whose screening results are positive for HBV. The investigators want to better characterize factors associated with HBV testing and factors that may differentiate those determined to be free of infection, infected with HBV, and those with resulting primary liver cancer.

Eligibility Criteria:
Inclusion Criteria:

* All foreign-born Asians and any foreign-born adults born in CDC-defined high to intermediate endemic areas residing in Sacramento County, California.

Exclusion Criteria:

* Individuals who have been previously serologically tested for Hepatitis B (self-reported).
ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading

An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise