cyrilzakka/clinical-trials huggingface dataset:
Heart Failure and Sleep Disordered Breathing

The purpose of this study is to analyze and summarize the characteristics of arrhythmia and heart rate variability of Chinese patients with three different types of heart failure combined with sleep disordered breathing based on the clinical data, to provide new diagnosis and treatment ideas for domestic patients, and then to improve the prognosis of patients betterly.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years.
2. The diagnosis of heart failure conforms to the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure .
3. Echocardiography, dynamic electrocardiogram and polysomnography monitoring should be improved during the period of hospitalization.
4. Patients with sleep apnea have not received standard treatment.

Exclusion Criteria:

1. Patients undergoing cardiac surgery in the past 6 weeks.
2. Patients with acute decompensated heart failure or heart failure requiring oxygen therapy.
3. All patients with sleep apnea who receive standard treatment.
4. Patients who use pacemakers or implantable cardioverter defibrillators.
5. The patient did not complete the echocardiography, dynamic electrocardiogram, and polysomnography monitoring during hospitalization.
DPP4 Inhibitor and Coronary Atherosclerosis in Patients Receiving Insulin Therapy

The study aim is to evaluate whether DPP4-inhibitor could reduce coronary atherosclerosis assessed by CT scan in patients receiving insulin for diabetes mellitus. In this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary CT scans will be compared in patients with and without receiving DPP4-inhibitor.

This is a retrospective study using medical records in two hospitals affiliated to the Catholic University of Korea. Patients with diabetes mellitus who received insulin are retrospectively enrolled. Among those, only patients who underwent coronary CT scan for more than two times will be included. Included patients will be classified into DPP4-inhibitor group and no DPP4-inhibitor group according to the prescribed medication. The changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Receiving chronic insulin therapy (prescription of insulin pen)
* Who underwent more than 2 times of coronary CT scan

Exclusion Criteria:

* Age \<18
Effects of Remifentanil Infusion on Emergence Delirium After Dental Surgery in Children

In this study, the investigators tried to show the effect of remifentanil on emergence delirium caused by sevoflurane used in general anesthesia.We planned a retrospective study. We formed two groups of 80 participants. One group included patients who were received remifentanil infusion during general anesthesia.The other group included patients who were received only sevoflurane inhalation anesthesia.

The patients included in the study were evaluated for emergence delirium in the postoperative period be evaluating the past recorded informations.


Eligibility Criteria:
Inclusion Criteria American Society of Anesthesiologists score 1-2

-

Exclusion Criteria:

* neurological disease, psychiatric illness
Investigation of a Novel Gene Expression Test (ASGES or Corus CAD) for Diagnosis of Obstructive Coronary Artery Disease

The objective of this study is to collect data on the commercial use of Corus CAD (Age/Sex/Gene Expression score - ASGES) blood test to evaluate the clinical referral patterns of Primary Care Physicians after receipt of their patients' Corus Score, and to better understand patient management patterns for clinicians ordering the test.

This is a prospective, multicenter observational registry collecting and analyzing commercial utilization data of the Corus CAD assay ("Test") also known as Age/Sex/Gene Expression score (ASGES) . The study will prospectively enroll approximately 670 evaluable subjects from qualified sites and evaluate the rate of referral versus Corus CAD (ASGES) score as continuous variables.

Objective of the study is to assess whether the score provided by the Corus CAD (Age/Sex/Gene Expression score - ASGES) test has an effect on the Primary Care Physician's patient management and referral patterns once received:

1. No further cardiac testing or treatment
2. Medical therapy for angina or non-cardiac chest pain
3. Referral to a cardiologist for stress testing with or without imaging, CT angiography, or invasive cardiac catheterization.

Since it takes approximately two days for the physician to receive the result of the Corus CAD (Age/Sex/Gene Expression score - ASGES) , initial diagnostic testing will reflect local standard of care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptoms suggestive of CAD, including typical or atypical angina or angina equivalent
2. The patient has signed the appropriate Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

1. History of myocardial infarction
2. Current MI or acute coronary syndrome
3. Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
4. Any previous coronary Revascularization
5. Any individuals with:

   * Diabetes
   * Suspected unstable angina
   * Systemic infections
   * Systemic inflammatory conditions
6. Any individuals currently taking:

   * Steroids
   * Immunosuppressive agents
   * Chemotherapeutic agents
7. Recipient of any organ transplant
Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections

To assess and compare the efficacy and safety of ciprofloxacin extended-release (CIPRO XR) tablet 1000 mg PO once-daily (OD) versus ciprofloxacin immediate-release (CIPRO IR) tablet 500 mg PO twice-daily (BID) for 7-14 days in patients with complicated and/or nosocomial urinary tract infections (cUTI).


Eligibility Criteria:
Inclusion Criteria:

The primary diagnosis in this clinical trial was cUTI in men or non-pregnant women over 18 years of age. Other main inclusion criteria:

* One or more clinical symptoms and signs of a lower UTI: fever (\> 38°C, orally), chills, frequency of micturition, dysuria, urge sensation.
* One or more of the following underlying conditions suggestive of cUTI:
* Indwelling urinary catheter.
* 100 mL of residual urine after voiding.
* Neurogenic bladder.
* Obstructive uropathy due to lithiasis, tumor or fibrosis.
* Acute urinary retention in men.

Exclusion Criteria:

Diagnosis of pyelonephritis supported by clinical signs/symptoms of fever (\>38°C orally), chills and flank pain (all 3 signs/symptoms must be present).

* Have a history of allergy to quinolones
* Are unable to take oral medication
* Have an intractable infection requiring \> 14 days of therapy
* Have a requirement for concomitant administration of sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminum or calcium
* Have prostatitis or epididymitis
* Have had a renal transplant
* Have ileal loop or vesica- urethral reflux
* Have significant liver or kidney impairment
* Have a history of tendinopathy associated with fluoroquinolones
* Are pregnant, nursing
* Have a history of convulsions or CNS disorders
FX Shoulder Solutions Retrospective / Prospective Clinical Study

Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.

To evaluate patient outcomes following shoulder replacement with FX Shoulder Solutions medical devices To demonstrate effectiveness, safety and survivorship of FX Shoulder Solutions medical devices To provide data and analysis to FX Shoulder Solutions to meet regulatory requirements.

To provide data and analysis for presentations, abstracts, publications and other public release of results.

Clinical data in the Investigator's clinic notes and patient files regarding demographics, baseline medical and shoulder status, surgical procedure and implant components, and any completed postoperative clinical data will be collected retrospectively as data for the Study following signed patient consent and enrollment into the study.

Each patient will be evaluated prospectively, and clinical data collected at the first baseline clinical evaluation using the protocol specified evaluations following study enrollment with successive postoperative evaluations in accordance with the postoperative intervals.

Eligibility Criteria:
Inclusion Criteria:

* Received an FX Shoulder Solutions replacement medical device in accordance with the Indications for Use based upon surgeons' determination and standard of care for the selected device system beginning January 1, 2018, through June 30, 2023.

Exclusion Criteria:

* Patient who does not meet the inclusion criteria above
A Brief Intervention Programme for TID

The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. The questionnaires will be mixed in a way that two adjacent questionnaires are always different. The intervention leaflets will contain information for tobacco industry denormalisation. The control leaflets will contain information for tobacco control policy in Hong Kong. The study aims to test the effect of a leaflet-based intervention on primary school students' attitudes towards tobacco industry.


Eligibility Criteria:
Inclusion Criteria:

* Parents and children should all understand Chinese

Exclusion Criteria:

-
Ophthalmologic Examinations After Infusion of ZK200775

ZK 200775 is an antagonist at the α-Amino-3-hydroxy-5-methyl-4-isoxazolepropionate (AMPA) receptor and had earned attention a possible neuroprotective agent in cerebral ischemia. Probands receiving the agent within a stroke therapy related Phase I trial reported on an alteration of visual perception. In this trial, the effects of ZK 200775 on the visual system will be analyzed in detail.

In a randomised, placebo-controlled, double-blind study eyes and vision will be examined before and after the intravenous administration of ZK 200775. The following methods will be applied: clinical examination, visual acuity, ophthalmoscopy, colour vision, rod absolute threshold, central visual field, pattern-reversal visual evoked potentials (pVEP), ON-OFF and full-field electroretinogram (ERG).


Eligibility Criteria:
Inclusion Criteria:

* The participant must be a voluntary proband
* Age between 55 and 65 years
* Body weight must not exceed the following value: Body height in cm minus 100 = body weight \[kg\] +/- 20%
* Male sex
* Written informed consent
* Physical examination: Probands must show normal findings without clinical relevance, mental and physical health is required;

Exclusion Criteria:

* Clinical history:

  * Substantial pre-existing medical condition
  * Known allergy to the employed effective components or galenic components
* Medicaments and drugs

  * Intake of systemically or locally acting drugs which conflict with the aim of the trial or that can influence the results (antipsychotic drugs, antidepressants, barbiturates and benzodiazepines)
  * A clinical history that hints to substance or alcohol abuse
  * Nicotine abuse of more than 10 cigarettes a day
  * Consumption of alcoholic beverages on the day prior to the examinations
  * Extreme physical stress (sports or work) within 8 days prior to the examinations
  * Blood donation within 2 months prior to the examinations
  * Relevant vaccination or stay abroad
  * Special or onesided alimentation (strict vegetarianism, low-caloric diet)
  * Simultaneous participation in another clinical trial
* Vital signs (after 3 minutes of rest)

  * Blood pressure with systolic values \> 160 mmHg and / or diastolic values \> 95 mmHg
  * Heart frequency: Values beyond 50-100 beats per minute
* Electrocardiogram

  * abnormal 12-channel ECG
* Laboratory findings

  * Hepatitis antigen (HBsAG), hepatitis C-antibodies or positive HIV-test
* Clinical pharmacology

  * positive drug test
  * clinically relevant abnormalities of the examined parameters
* Opinion of the investigator: when due to scientific or personal reasons or matters of compliance or safety a patient should not take part in the trial
* Opacification of optic media, retinal disease, optic nerve disease, amblyopia or color vision defects
* Status post intraocular surgery (exception: cataract surgery with implantation of a posterior chamber lens), laser coagulation
* Myopia \> -5 diopters, hyperopia \> +5 diopters
* Narrow angle glaucoma
Prevalence of Acromegaly in a Diagnostic Consultation for Sleep Apnea Syndrome

Prevalence of sleep apnea syndrome in patients with acromegaly is about 70%. It seems that comorbidities of arterial hypertension or type 2 diabetes are more severe in patients with acromegaly and sleep apnea syndrome. Besides sleep apnea syndrome associated to acromegaly gives rise to few symptoms, that explains it is under diagnosed. The mechanisms of the association are based on maxillofacial modifications linked to acromegaly, a thickening of soft tissues with deposits of glyco-aminoglycanes but probably also because of the associated obesity, of the potential existence of a goiter and a muscular dystrophy of the dilatative muscles of the pharynx.

At present, no study clearly documented prevalence of acromegaly in a diagnostic consultation for sleep apnea syndrome.

60 investigators will participate to this study. They will be chosen among those participating to the sleep observatory of the federation of pneumology (www.osfp.fr).

All participating pneumologists would have to fill in the questionnaire (co-morbidities, concomitant treatments, biological analysis) directly online and also clinical signs and symptoms of acromegaly. A blood test for the insulin-like growth factor (IGF-1) dosage will be systematically prescribed to the patient. Pneumologists will have to include all consecutive patients presenting with sleep apnea syndrome suspicion.

According to first IGF-1 results, patients may have to do a second blood test in a referenced laboratory to confirm the dosage.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \< 40 kg/m2
* Patient consulting for sleep breathing disorder
* Informed consent signed
* patient covered by french health insurance

Exclusion Criteria:

* Other sleep disorder already diagnosed
* Pregnant women
* Patients participating in an other study
Comparison of Twice- and Four-times-daily Amoxicillin Administration in 2-week Tegoprazan-based H. Pylori Eradication

Gastric acid depressant play a major role in an H. pylori eradication therapy by (1) increasing the intragastric pH, which improves antibiotic stability and bioavailability; (2) increasing the intragastric pH to 6 or more, which prompts H. pylori to replicate and thus become more sensitive to antibiotics that are effective only against replicating bacteria, such as amoxicillin; (3) increasing the concentration of antibiotics in the stomach. Of antimicrobial agents against H. pylori, amoxicillin is a penicillin derivative that inhibits the synthesis of the bacterial cell wall. Therefore, amoxicillin's bactericidal effect requires the bacteria to be replicating. Amoxicillin is excreted by the kidneys, the plasma half-life is approximately 1 hour, and the bactericidal effect is time dependent. Theoretically, amoxicillin should be given 3 or 4 times daily to maximize the time above minimal inhibitory concentration (MIC) However, in most H. pylori eradication therapies, amoxicillin is given twice daily, where the estimated time above MIC attained by twice daily dosing is insufficient for amoxicillin. Because most strains of H. pylori are sensitive to amoxicillin, 3 or 4 times daily administration may be appropriate to increase the H. pylori eradication success. Nevertheless, data regarding the amoxicillin dosing interval for successful H. pylori eradication are lacking.

The investigators aim to compare the H. pylori eradication rates between twice- and four-times-daily amoxicillin administration in 2-week tegoprazan-based triple therapy. Secondary outcomes are treatment compliance and drug-related adverse event rates.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding
A Comparison Laparoscopic With Open Gastric Cancer Surgery for Locally Advanced Gastric Cancer

Nowadays, the proportion of patients with locally advanced gastric cancer is estimated up to 90 percent of all gastric cancer cases in Russian Federation. Surgical procedure with D2 Lymphadenectomy is the main option for treatment. Conventional open approach is still the current standard for advanced gastric cancer. Laparoscopic procedures for gastric cancer as minimally invasive surgery has gained popularity for the treatment of early gastric cancer in East Asia. Several studies indicated that laparoscopic procedures both total and subtotal gastrectomy with D2 lymphadenectomy is a technically feasible and safe procedure by experienced surgeons in high-volume specialized hospitals. However, lack of solid evidence on the oncologic efficacy.

Starting clinical trials for evaluate safety of oncology laparoscopic subtotal gastrectomy for locally advanced gastric cancer. Aim of this trial is show safety, feasibility and oncologic efficacy of Laparoscopic radical surgical procedures both total and subtotal gastrectomy for treatment gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG 0-1
* ASA I-III
* Histologically proven cancer of the stomach cT 2-4a(clinical stage tumor), N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
* Preoperative examination with no distant metastasis, no significantly enlarged lymph nodes around abdominal main artery, and tumor not a direct violation of the pancreas, spleen and other surrounding organs
* The gastric tumors are located in the stomach, are macroscopically resectable by subtotal or total gastrectomy with D2 lymph node dissection.
* Written informed consent

Exclusion Criteria:

* Clinically apparent distant metastasis
* Free cancer cells
* Bulky lymph node metastasis is detected by abdominal CT
* Previous treatment with radiation therapy for any tumors.
* Previous surgery for the present disease
* Pregnancy
* Psychiatric disease
Clinical Application of Circulating Tumor DNA (ctDNA) in Patients With Late-stage Breast Cancer

This is a retrospective, observational, multi-center clinical study of circulating tumor DNA (ctDNA) application in late-stage breast cancers.

This study aims to evaluate the feasibility of plasma ctDNA mutation spectrum and clonal spectrum in late-stage metastatic breast cancer patients. Meanwhile, this study tries to establish a model of ctDNA subtyping system to evaluate the molecular load of tumor, to evaluate the curative effect comprehensively and to detect the disease progression in advance. In addition, the investigators plan to explore the clonal evolution of ctDNA in patients with progressive disease (PD), and to monitor the changes of tumor heterogeneity from the molecular level, so as to provide reference for the analysis of drug sensitivity.

Eligibility Criteria:
Inclusion Criteria:

* Recent progression of TNBC after multiple lines of chemotherapy or of HR+ or HER2+ MBC after multiple lines of endocrine or targeted therapy;
* No available recommendation for the next treatment regimen;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
* An updated, available pathological HR/HER2 status for metastasis;
* According to RECIST 1.1 standard, there should be at least one measurable target lesion;
* The expected survival time is \> 3 months;
* Those aged 18-70 years old;
* Liver and kidney function and blood routine test meet the following conditions: Neutrophil \> 2.0g/l, Hb \> 9g / L, PLT \> 100g / L; ALT and AST \< 2.5ULN; TBIL \< 1.5ULN; Cr \< 1.0ULN
* Signing informed consent;
* Those willing to accept polygenic testing.

Exclusion Criteria:

* Patients with multiple primary tumors;
* Those who are unable to obtain blood samples;
* Those with a history of immunodeficiency or organ transplantation;
* Those with abnormal cardiac function or previous history of myocardial infarction or serious arrhythmia;
* The researchers think it is not suitable to participate in this experiment.
Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment

This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.

This is a phase I-II, randomised, controlled, open-label clinical trial, currently ongoing in eleven Spanish hospitals, to evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered human anterior corneal substitute in adults with severe trophic corneal ulcers refractory to conventional treatment, or with sequelae of previous ulcers. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 45 days, receiving the bioengineered corneal graft. In the second phase of the trial (currently ongoing), subjects are block randomised (2:1) to receive either the corneal graft (n=10), or amniotic membrane (n=5), as the control treatment. Adverse events, implant status, infection signs and induced neovascularization are evaluated as determinants of safety and feasibility of the bioengineered graft (main outcomes). Study endpoints are measured along a follow-up period of 24 months, including 27 post-implant assessment visits according to a decreasing frequency. Intention to treat, and per protocol, and safety analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged≥18, with no upper age limit.
* Patients that give their informed consent for study participation.
* Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, or patients having undergone previous stage 3 Mackie corneal ulcers,33 currently suffering sequelae such as stromal fibrosis or corneal thinning, having no effective therapeutic alternative.
* Stromal involvement, not reaching the Descemet membrane. Central or peripheral localization.
* Minimum duration of the disease causing the corneal ulcer: 6 weeks.
* No active ocular infection.
* Patients with normal laboratory parameters as defined by: Leukocytes≥3000 cells/µL; Neutrophils≥1500 cells/µL; Platelets≥100 billion/L; AST/ALT≤1.5 ULN; Creatinine≤1.5 mg/dL.

Exclusion Criteria:

* Absence of stromal involvement.
* Good response to standard medical treatments for corneal disease in less than 3 to 5 weeks.
* Bullous keratopathy or other endothelial decompensations.
* Active ocular infection.
* Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up.
* Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol.
* Medical history of active neoplasia within the past 5 years. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies.