cyrilzakka/clinical-trials huggingface dataset:
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study

This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to:

* Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use
* Evaluate patient compliance to dual antiplatelet therapy (DAPT)


Eligibility Criteria:
Inclusion Criteria:

* The patient or patient's legally-authorized representative agrees to participate in this study by signing the Ethics Committee-approved informed consent form (ICF).
* Only XIENCE V stent(s) is/are implanted into the coronary vasculature during the index procedure.

Exclusion Criteria:

* The inability to obtain a signed ICF
Chemotherapy With Anlotinib in Advanced Cervical Cancer

STUDY HYPOTHESIS: The primary hypothesis is whether chemotherapy with Anlotinib improves overall survival in advanced cervical cancer.

TRIAL DESIGN: The study is a prospective, single-arm, observational clinical study. The study will be performed on an intent-to-treat population. All the enrolled patients received chemotherapy with Anlotinib.

PRIMARY ENDPOINT: Overall survival, defined as the observed length of life from entry into the study to death from any cause or the date of last contact.

Patients with advanced (metastatic, persistent, and recurrent) cervical cancer will be recruited from Zhongda Hospital. Only patients who treated with paclitaxel plus nedaplatin will be included in the analysis. All patients receive paclitaxel (135-175mg /m\^2) and nedaplatin (100 mg/m\^2) infusion on day 1, and then take Anlotinib 12mg/d orally on day 7-21, every 3 weeks. Once patients reached CR or PR, Anlotinib was continued on 12mg/d maintenance therapy until disease progression or unacceptable toxicity was noted.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced (metastatic, persistent, and recurrent) cervical cancer confirmed by imaging and unsuitable for surgery and radiotherapy .
* Eastern Cooperative Oncology Group (ECOG) Performance Score(PS) 0-1
* Estimated life expectancy \> 3 months
* Adequate bone marrow function: hemoglobin \> 90 g/L, absolute neutrophil count(ANC) \> 1.5 × 10\^9/L, platelet \> 80 × 10\^9/L);
* Adequate hepatic function: total bilirubin \< 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\<2.5×ULN or \<5×ULN for patients with liver metastases;
* Adequate renal function: serum creatinine \< 1.5 × ULN or creatinine clearance rate (CCR) \>60 mL/min;
* Adequate cardiac function: left ventricular ejection fraction (LVEF) \> 50%.

Exclusion Criteria:

* Preexisting thyroid disease, thyroid function cannot be maintained in the normal range after treatment;
* Have used other anti-VEGF or VEGFR-targeted drugs or received immunotherapy;
* A history of major surgical treatment within 4 weeks, radiotherapy within 3 weeks, and concurrent chemoradiotherapy within 6 weeks;
* Receiving hormone or immunosuppressive therapy for various reasons;
* Inability to swallow oral medication;
* Any malabsorption;
* Diseases diagnosed as severe or uncontrollable within 6 months prior to the first day of treatment.
* Participate in clinical trials of other antitumor drugs within 28 days prior to the start of study treatment;
* The patient has comorbidities that may endanger the patient's safety or affect the patient's ability to complete the study.
* According to the researcher's judgment, the patient has an accompanying disease that may jeopardize the patient's safety or affect the patient's ability to complete the study in the investigator's judgment.
Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)

The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.

Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.

Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS)
* showing a perfusion-diffusion mismatch on MRI of 20 %
* enrolment within a 3 h to 9 h time window after symptom onset.
* 18-85 years of age

Exclusion Criteria:

* Participation in any interventional trial in the previous 30 days.
* Women in the childbearing age.
* Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm.
* Conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well).
* MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early infarction on DWI assessed by evidence of involvement of \>1/3 of the middle cerebral artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology that would interfere with the MRI assessment of acute ischemic stroke.
Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis With Cotrimoxazole

First study to test the validity of the treatment of idiopathic pulmonary fibrosis, which causes inflammation and fibrosis (scarring) of the lung tissue, with cotrimoxazole.

Cotrimoxazole may improve the clinical course of the disease through eradication of Pneumocystis jiroveci colonization and other mechanisms as inhibiting the activation of alveolar macrophages and producing alterations in the surfactant system which favours the persistent activation of the inflammatory response and the development of pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that is clinically manifested by the appearance of effort dyspnea and impaired lung function.

The natural history of the disease is poorly understood and there is no clear consensus as to the most appropriate markers for predicting patient outcome.

This pilot controlled trial aims to test the efficacy and safety of cotrimoxazole in the treatment of IPF. This novel therapeutic strategy, with very encouraging preliminary data is based on its pathophysiological basis, primarily related to the elimination of Pneumocystis colonization. That elimination, could serve as a potent weapon for reducing morbidity and mortality and the cost associated with this devastating disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient, regardless of gender, aged 18 to 80 years.
* Well-established diagnostic criteria of the Idiopathic Pulmonary Fibrosis (IPF) as ATA/ERS/JRS/ALAT 2011.
* Ability to obtain a sample of sputum or oropharyngeal washing.
* Forced Vital Capacity (FVC) above 50% from the theoretical value expected.
* Patient compliance or legal guardian to participate in this study by signing the informed consent.

Exclusion Criteria:

* Allergy / hypersensitivity or known gastrointestinal intolerance to cotrimoxazole.
* Use of immunosuppressants or corticosteroids in the previous 90 days at baseline.
* Exacerbation of IPF and / or pneumonia in the 90 days prior to baseline.
* Presence of autoimmune diseases or asthma.
* Patients with other significant diseases other than IPF. It is considered significant disease any disease or condition that, in the investigator's opinion, may jeopardize the patient's health participating in the study or influence the results of the study or the patient's ability to participate in the study.
* Pregnant or lactating or of childbearing potential not using medically approved contraceptive methods at least three months before or during trial.
* Participation in another trial with an investigational drug within 30 days or six half-lives (the larger of the two) above the baseline.
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.
Mother-Infant Psychoanalysis Project of Stockholm

Mother-infant relationship disturbances broadly comprise three areas; maternal distress, infant functional problems, and relationship difficulties. Given the high frequency of such disturbances and the relative paucity of randomized treatment studies, substantial systematic investigation is needed. This project is a randomized controlled study comparing mother-infant psychoanalytic treatment with treatment as usual in cases where mothers and/or health visitors demanded expert help.

DESIGN

Eighty dyads with infants below 1½ years of age were interviewed and then randomly assigned to MIP or TAU. An end-point interview followed after ½ year, evaluating the intervention effects.

The MIP treatments were performed by IPA psychoanalysts at the Infant Reception Service of the Swedish Psychoanalytic Society. TAU implied contact with a nurse at a Child Health Centre, as part of regular Swedish health care of infants and mothers. Additional treatments within the TAU framework suggested at the initiative by the health visitor or the mother were registered at the end-point interview.

INSTRUMENTS

Mother-report questionnaires; the Ages and Stages Questionnaire:Social-Emotional (ASQ:SE; Squires et al., 2002), the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987), the General Severity Index of the Symptom Check List-90 (Derogatis, 1994)and the Swedish Parental Questionnaire (SPSQ; Östberg et al., 1997).

Time frame: All four instruments were measured at intake interviews and six months later.

Independently rated video-taped mother-infant interactions: the Emotional Availability Scale (EAS; Biringen, 1998).

Relationship assessment: the Parent-Infant Relationship Global Assessment Scale (PIR-GAS; ZERO-TO-THREE, 2005).

Eligibility Criteria:
Inclusion Criteria:

* The mother expressed significant concerns about one or more of the following domains: herself as a mother, her infant's well-being, or the mother-baby relationship (this was operationalized as a score \< 80 ("perturbed relation") on the PIR-GAS or, alternatively, \> 2.5 on the SPSQ).
* Infant of any gender, age below 18 months.
* Duration of worries exceeding two weeks.
* Domicile in Stockholm.
* Reasonable mastery of Swedish.

Exclusion Criteria:

* Maternal psychosis.
* Substance dependence according to DSM-IV, to an extent precluding collaboration.

No mothers met these criteria.
Comparison of BCG RIVM and Russian Strains for Treating Non-Muscle-Invasive Bladder Cancer (NMIBC)

The goal of this clinical trial is to compare the efficacy and safety of two Bacillus Calmette-Guérin (BCG) substrains (RIVM and Russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) in adult patients.

The main questions it aims to answer are:

* Is there a significant difference in recurrence-free survival (RFS) between the BCG RIVM and BCG Russian substrains?
* Is there a significant difference in progression-free survival (PFS) between the two substrains?
* Are there notable differences in the incidence of treatment-related adverse events between the strains? Researchers will compare patients treated with BCG RIVM to patients treated with BCG Russian to determine whether one substrain offers superior clinical outcomes in terms of recurrence, progression, and adverse events.

Participants will:

Undergo transurethral resection of bladder tumor (TURBT) prior to initiating therapy.

Be randomly assigned to receive either BCG RIVM or BCG Russian intravesical therapy.

Receive an induction course of six weekly instillations of the assigned BCG substrain.

Receive maintenance therapy at regular intervals (3, 6, 12, 18, 24, 30, and 36 months) based on risk classification.

Undergo regular follow-up with cystoscopy and urine cytology to assess recurrence, progression, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* histopathologically confirmed NMIBC (stages Ta, T1, or CIS),
* classification as intermediate, high, or very high risk (who either refused or were not suitable candidates for radical cystectomy),
* no prior BCG therapy,
* no evidence of upper urinary tract carcinoma or distant metastases and
* a minimum follow-up period of 12 months.

Exclusion Criteria:

* patients who did not receive adequate BCG therapy (defined as receiving fewer than 5 of the 6 induction doses or fewer than 2 of the 3 maintenance doses),
* patients with a follow-up period of less than 12 months and
* patients who received multiple BCG strains during the follow-up period.
Mediterranean Diet and Endothelial Function

To assess the effect of Mediterranean diet and some of its specific components (olive oil, non fried fish and nuts) on endothelial function in overweight and obese patients

Abdominal obesity is well known to increase the risk of cardiovascular disease (CVD), since it is commonly associated with hypertension, dyslipidemia, impaired fasting glucose, type 2 diabetes, metabolic syndrome, insulin resistance, systemic inflammation and endothelium dysfunction.

Abnormal endothelial function, expressed as lower vasodilatation through flow-mediated vasodilatation (FMD) of brachial artery in response to an increase in blood flow, is considered an index of subclinical atherosclerosis, and an early hallmark of cardiovascular disease, with a strong prognostic value for future cardiovascular events. Changes in diet, level of physical activity and behavior are well known key elements influence endothelial function. Recent studies seem to show that Mediterranean diet has beneficial role on cardiovascular risk. It could protect against the development of coronary heart disease also through a possible effect on body weight and obesity.

At the best of our knowledge, the effect of Mediterranean diet on endothelial function in obese subjects has not been definitely established. Therefore, the aim of this study was to evaluate the impact of Mediterranean diet on anthropometric parameters (body weight, BMI and waist circumference), lipid profile \[total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C)\], triglycerides (TG), fasting glucose and endothelium function, evaluated by FMD, in a group of obese and overweight subjects. In particular, subjects were invited to follow a standard Mediterranean diet for a short (3 months) or a longer (18 months) period. The specific role of some components of Mediterranean diet (olive oil or non fried fish or nuts) was also investigated.

Eligibility Criteria:
Inclusion Criteria:

BMI: \> 25.0 kg/m2 Age between 18-70 years

Exclusion Criteria:

BMI \< 25.0 kg/m2 Age \<18 or \>70 years low left ventricular ejection fraction (LVEF \< 50%) symptomatic cardiac disease in advanced stage or poorly controlled by medication cerebral disorders major liver and kidney diseases cancer excessive alcohol intake use of drugs addressed to lose weight.
Urinary Retention After Arthroplasty

Arthroplasty increases the risk of postoperative urinary retention. Treatment of postoperative urinary retention is indwelling or intermittent catheterization. The need for catheterization is most commonly determined with an ultrasound scanner. Catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. There is no evidence of an optimal way to monitor the onset of spontaneous urination.

The aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.

Adult patients undergoing knee arthroplasty will be recruited to this study. Participants will be randomized to the ultrasound monitoring group or the symptoms alone group. In the symptoms alone group, urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis or if spontaneous voiding has not started 10 hours after the spinal anesthesia. Symptoms that indicate catheterization are lower abdominal pain or need to void. In the ultrasound group, urinary retention is monitored according to current practice with an ultrasound scanner and the patient is catheterized if residual urine exceeds 800 ml or if the patient is symptomatic.

The primary outcome variable is the change in IPSS score from the baseline to 3 months after the procedure. The baseline score is evaluated preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* elective total knee arthroplasty

Exclusion Criteria:

* previous surgery for urologic cancer
* fracture as indication for surgery
* lack of co-operation
* untreated urinary retention
* nephrostoma
* general anesthesia
Dexamethasone Efficacy in HELLP I Syndrome

The purpose of this study is to determine the efficacy of dexamethasone for treatment of HELLP I (hemolysis, elevated liver enzymes and low platelet count) syndrome.

Treatment of HELLP syndrome usually is restricted to measures of support and treatment of complications. In 2005, in a subgroup analysis we showed that, among patients with HELLP 1, there were a shorter average time to platelet recovery and less duration of hospitalization in women who received dexamethasone therapy, however the importance of this finding is diminished because this was an unplanned analysis and the severity of the disease was not taken into account at randomization.

Eligibility Criteria:
Inclusion Criteria:

* Women who were at \>20 weeks of gestation or during the first 3 days of puerperium if hypertension developed during the pregnancy or the puerperium with:
* platelet count, \< or = 50,000/mm3; aspartate aminotransferase (AST), \> or = 70 U/L; lactate dehydrogenase (LDH), \> or = 600 U/L.
* Women who consent to be included informed consent by signature

Exclusion Criteria:

* diabetic ketoacidosis
* oral temperature \> 37.5 grade
* Contraindication for use steroids
A Comparison of Primary Care and Traditional Internal Medicine Residents

The goal of this study is to identify objective differences between primary care and traditional medicine residents in clinical performance, continuity of care and utilization of resources. Specifically, this retrospective study will analyze the database collected by CLIMACS, the computer system at Cornell Internal Medicine Associates (CIMA). This system is used for clinical and administrative purposes; it manages and tracks patient's information and demographics, appointment booking, clinical diagnosis, prescriptions and medications, laboratory and radiology test, and consults. In our study, we will analyze a subset of the CLIMACS database from previous years.

Three areas will be examined:

1. Clinical performance
2. Continuity of care
3. Utilization of resources

Clinical performance will be assessed using Health Plan Employer data and Information Set (HEDIS) performance standards. These standards were developed for the purposes of quality assessment, and in our study we will examine the following HEDIS standards:

1. Breast Cancer Screening- the proportion of women between the ages of 52 and 64 who have had a mammogram within a two year period.
2. Cervical Cancer Screening- the proportion of women between the ages of 21 and 64 who had a Pap test in the preceding 3 years.
3. Cholesterol Screening- the proportion of patients ages 20 to 39 and 40-59 who have had their cholesterol tested at least once in the past five years.
4. Asthma admission rate- the proportion of asthmatics admitted to the hospital for the care of asthma per year.
5. Diabetic Standards-

   1. Admission for cellulitis/ 1000 diabetics per year.
   2. Admission for diabetes/ 1000 diabetics per year.
   3. Inpatient days per 100 diabetics per year.
   4. Prevalence of ischemic heart disease.
   5. Prevalence of severe renal disease.
   6. Diabetics with \>2 hemoglobin A1C drawn per year.

Continuity of Care will be assessed by 3 different indicators:

1. The proportion of visits that are made to the designated primary care provider of the number of visits made.
2. The proportion of missed appointments of the total number of appointments.
3. The proportion of walk in visits of the total number of appointments.

Resource utilization will be assessed by examining the following:

1. Number of lab test per year per patient.
2. Number of specialty consults per year per patient.
3. Hospital admission rates per patient per year.
4. Cost to medications. Confidentiality will be maintained throughout the study. In clinical practice access to CLIMACS is limited to the medical providers and administrators by individuals access codes. Furthermore, our study will remove specific identifiers to maintain the anonymity of both the patients and residents.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are followed as outpatients by a Cornell affiliated internist at the Cornell Internal Medicine Associates (CIMA).
2. Patients at New York Hospital who may or may not go on to be followed as outpatients at CIMA.

Exclusion Criteria:

Patients who elect not to participate in the study.