cyrilzakka/clinical-trials huggingface dataset:
An Invasive Controlled Desaturation Study to Determine the Accuracy of the CART-I Pulse Oximeter

A pulse oximeter is used for continuous monitoring of peripheral oxygen saturation (SpO2) and plays an important role in the early detection of hypoxia, guiding the titration of supplemental oxygen, and reducing the need for blood gas analysis. Therefore, the SpO2 accuracy of a pulse oximeter should be validated for patient safety. The objective of this study is to evaluate whether the CART-I pulse oximeter with a ring-type wearable PPG sensor (Sky Labs Inc., Seoul, Korea) provides clinically reliable SpO2 readings over the range of 70-100% SaO2, during steady-state, non-motion conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 20-50 years2
* COHb \< 3 %
* MetHb \< 2 %
* ctHb \> 10 g/dl
* Non-smoker
* An individual deemed fit by the investigators to be included in the clinical trial

Exclusion Criteria:

* History of respiratory disease
* History of cardiovascular disease
* Smoker
* Pregnant
* History of fainting
* History of diabetes
* Obesity (defined as BMI \> 30 kg/m2)
* Allen's test positive (poor collateral blood supply of hand)
* An individual who is judged to be difficult for the collection of normal PPG signals because CART-I is loose when being worn on fingers other than the thumb and little finger
A Registered Cohort Study on Cerebellar Ataxia in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR)

Cerebellar ataxia is a form of ataxia originating in the cerebellum. Cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. To understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up Chinese patients with cerebellar ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cerebellar ataxia based on the diagnoses of tow neurologists
* Relatives of patients with cerebellar ataxia
* Unrelated healthy controls
* Participants or legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Participants are unable to comply with trial procedures and visit schedule
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens.

The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or standard induction treatment with cytarabine and daunorubicin("7 and 3" regimen).

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 and \<76 years at the time of diagnosis of AML
* Pathological confirmation of AML
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Able to adhere to the study visit schedule and other protocol requirements
* Laboratory values fulfilling the following:

Serum creatinine \< 2.0 mg/dL Serum total bilirubin \< 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase \< 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.

* Cardiac ejection fraction \> 50% by echocardiography or MUGA scan

Exclusion Criteria:

* Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors \>5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for \>2 years before randomization are eligible)
* Prior treatment for AML; only hydroxyurea is permitted (see below)
* Acute promyelocytic leukemia \[t(15;17)\] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
* Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
* Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
* Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
* Clinical evidence of active CNS leukemia
* Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
* Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
* Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
* Hypersensitivity to cytarabine, daunorubicin or liposomal products
* History of Wilson's disease or other copper-related disorder
Short Message System (SMS) Monitoring Intended for the Suicidal Patients

The study wants to prove that SMS monitoring reduced the number of suicide attempts in six months according to the beginning of its implementation in the group of the patients benefiting SMS compared with the group of patients benefiting from the usual care.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Surviving a suicide attempt
* Leaving directly the emergency department or hospitalized less than 7 days
* Being able to be joined by telephone mobile

Exclusion Criteria:

* under guardianship
* Patient who are not able to provide a consent
Pathological Results of Aggressive Hepatocellular Carcinomas Treated Using SIRT

The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization.

The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.


Eligibility Criteria:
Inclusion criteria:

- aggressive hepatocellular carcinomas with vascular invasion, large tumors or multifocal distribution

Exclusion criteria:

* Other treatment after SIRT (confounding effect)
* contraindications for surgery
Microbial Profile Among Patients Before and After Partial Maxillectomy

Patients after maxillecotmy develop gum disease and teeth decay often. these two diseases are caused by bacteria. In addition, these patients may have oral infections such as candida . The therapeutic approach now days to these diseases (dental decay and periodontal disease) can change following the results of the study.

the purpose of the study is to examine whether the connection between the oral cavity and anatomical structures exposed by maxillectomy procedure causes a change in the level of microbes examined. To the best of our knowledge, there are not yet studies examined the clinical and microbiological changes in the oral cavity before and after surgery.

This study will include 15 patients who are scheduled to undergo partial maxillectomy as part of a prescribed treatment program prior to their eligibility for the study. The patients will undergo the surgery at the Department of Otolaryngology or Oral and Maxillofacial Surgery and will be given an obturator during surgery by a physician from the Internal and Maxillofacial Rehabilitation Department of the School of Dentistry .

demographic data on the patient's age and gender, general medical history, smoking habits, oral and periodontal and clinical examination (presence of periodontal disease) and microbiological testing will be preformed.

Eligibility Criteria:
Inclusion Criteria:

1. signed Consent form
2. Patients who are supposed to undergo Maxilla removal without closing the defect using a tissue implant and will need to complete the missing area by an obturator.
3. Men and women aged 18 and over

Exclusion Criteria:

1. Allergy to substances from which the obturator is made.
2. Pregnant women
3. Taking antibiotic drugs that affect bacterial flora 4 weeks before taking the saliva sample.
4. Psychiatric problem
Diagnostic Reliability of OCT Biomarkers for iERM

Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. A recent multifactorial analysis outlined macular thickness and DRIL to be significant predictors for postsurgical visual acuity (Karasavviodou et al.). Nevertheless, reliability of diagnosing OCT biomarkes among patients with iERM was not yet assessed, to our knowledge. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* a) presence of an iERM,
* b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the ERM,
* c) pseudophakia at the final visit at 3 months after surgery, and
* d) written informed consent for study participation.

Exclusion Criteria:

* macular edema caused by conditions other than ERM were excluded from the study.
Investigating the Pharmacokinetic Drug Interactions Between HGP1201 and HGP0904

The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, age 19\~45 years
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
* Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study
* History of relevant drug allergies or clinically significant hypersensitivity reaction.
Peroperative Use of Positive End-expiratory Pressure Prevents Formation of Atelectasis as Studied by Computerised Tomography at End of Surgery

Atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. The use of Positive End Expiratory Pressure (PEEP) during general anaesthesia has in recent years been questioned.

The investigators hypothesize that the use of PEEP as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero PEEP.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, American Society of Anesthesiology (ASA) I-II.
* Patients scheduled for non-abdominal day case surgery under general anaesthesia.

Exclusion Criteria:

* ASA class III or higher.
* Body Mass Index (BMI) 30 or higher.
* Arterial oxygen saturation (SpO2) \<96% breathing air.
* Chronic Obstructive Pulmonary Disease (COPD).
* Ischaemic heart disease.
* Known or anticipated difficult airway.
* Active smokers and ex-smokers with a history of more than 6 pack years.
* Need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).
Depression Outpatient Cardiology Screening Study

This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.

Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). The American Heart Association recently recommended that all cardiac patients be screened for depression in order to improve identification and treatment of this risk factor.

Patients are screened for depression during an outpatient cardiology visit and those that screen positive will be contacted for enrollment into this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician (PCP), the cardiologist and the nurse case manager, or usual care (the patient is informed he/she screened positive for depression and is advised to contact their PCP and/or cardiologist). The PCP and/or cardiologist are free to evaluate, treat and refer that patient to mental health services as they deem necessary.

Patients in both groups will be monitored for depression severity and duration at 3, 6 and 12 months after enrollment. The course of their depression since enrollment or last follow-up includes remissions, new onsets, relapses, recurrences, and treatment will be determined.

Eligibility Criteria:
Inclusion Criteria:

* recent history of Acute Coronary Syndrome or other cardiac event or documented heart disease
* score of 10 or higher on the Patient Health Questionnaire

Exclusion Criteria:

* suicidal ideation or behavior
* cognitive impairment or inability to read or speak English
* schizophrenia, bipolar disorder
* active substance abuse or alcoholism
* severe valvular disease, severe congestive heart failure, malignancy
* physical limitations that would interfere with participation in the study
* medical contraindications to the use of available antidepressants
* participation in a competing research protocol
* physician or patient refusal
Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff.

The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

* age \<18 years
* absence of informed consent
* pregnancy
* documented treatment-limitation orders in the patient's chart
The Analgesic Efficacy of Oxycodone Hydrochloride Versus Fentanyl After Total Hip Arthroplasty:

Oxycodone showed similar or superior analgesic effects than fentanyl and was proposed as an alternative for fentanyl for pain control in the postoperative period. However, it was mainly directed to control visceral pain, due to the mediation of analgesic effects by the kappa receptors. However, few studies compared the oxycodone to fentanyl for postoperative pain relief in patients undergoing total hip arthroplasty (replacement). Therefore, we established this randomized study to compare the efficacy of oxycodone and fentanyl for relief of postoperative pain after total hip arthroplasty (replacement).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 28-62 years old,
* Both genders, American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for elective total hip surgery.

Exclusion Criteria:

* Patients with history of any kind of drug allergy.
* drug abuse.
* psychological or other emotional problems,
* renal and hepatic chronic disease.
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)

The objective of this trial is to study the management of PPE in participants with metastatic ovarian or breast cancer treated with Caelyx, and determine the frequency of use of pharmacological treatment (preventive or therapeutic) for PPE and compliance of educational recommendations for PPE.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older.
* Participants with metastatic breast or ovarian cancer who are receiving treatment with pegylated liposomal doxorubicin.
* Participants who have given their written consent.

Exclusion Criteria:

* Participants who are currently participating in a clinical trial.
A Randomised Study of Docosahexaenoic Acid (DHA) in Metastatic Breast Cancer

The aim of this study is to increase, by DHA-induced chemosensitization, the activity of anticancer chemotherapy in patients with a metastatic advanced breast cancer, by a nutritional approach with marin-derived PolyUnsaturated Fatty Acids (PUFA).

Local relapses and metastases make breast cancer a deadly disease. A major goal remains the improvement of treatment efficacy, meaning increasing toxicity to tumor tissue, without additional toxicity to non-tumor tissues.

The literature indicates that DHA sensitizes breast malignant tumors, but not non-tumor tissues, to chemotherapy and to radiotherapy through a variety of mechanisms. DHA enrichment of tissues can be achieved through a dietary supplementation of DHA-containing oils, such as fish oil, both in experimental animal models or in humans. Therefore, this represents an original nutritional approach to increase the activity of anticancer treatments through an enhanced specificity toward tumor tissues.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic breast cancer requiring first-line taxanes or anthracyclines based chemotherapy
* HER2 negative, HR positive
* Life expectancy \> 3 months
* ECOG Performance Status \< or = 2 within 15 days before randomization
* Measurable and/or evaluable disease according to RECIST criteria 1.1
* Age \> or = 18 years and \< or = 80 years
* Body Mass Index (BMI)\>17 for patients \< 70 years and BMI\>21 for patients \> 70 years, within 15 days before randomization
* Hepatic parameters : total bilirubin strictly normal, AST and ALT \< or = 3xULN (5 if liver metastases) within 15 days before randomization
* Signed written informed consent

Exclusion Criteria:

* Triple negative breast cancer or HER2 over expression
* Symptomatic central nervous system metastases
* Previous chemotherapy for metastatic breast cancer
* Obesity with BMI \> 35 within 15 days before randomization
* Presence of another invasive cancer
* Uncontrolled Cardiac disease or uncontrolled hypertension
* Milk protein intolerance
* Known food allergy to fish
* Women of childbearing potential not using adequate contraceptive measures, pregnant or breast feeding.
FreeFlow Percutaneous Atrial Septal Shunt for IPAH

The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are:

* Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension?
* Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy.

Participants will:

* underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation.
* will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* 18≤ age ≤70 years old, female or male;
* 10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
* The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure \> 45 mmHg);
* WHO grade III or IV;
* NT-proBNP≥650 ng/L;
* The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up.

Exclusion Criteria:

* Local or systemic sepsis or other acute infection;
* Severe coagulopathy;
* Allergy to nickel and/or titanium and/or nickel/titanium-based materials;
* Patients with contraindications to antiplatelet, coagulant or thrombotic therapy;
* Intolerance to contrast media;
* Have participated in other drug or device clinical trials during the same period;
* Glomerular filtration rate (GFR) \< 50 mL/min;
* Patients with severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal);
* The patient had malignant arrhythmia;
* The patient did not receive standardized drug therapy (triple sequential therapy) according to the Chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months;
* Women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding;
* Severe restrictive or obstructive lung disease;
* Implanted atrial septal defect (ASD)/ patent foramen ovale (PFO) closure device;
* Left ventricular ejection fraction (LVEF) \<50%;
* SpO2 \< 90% without oxygen inhalation (pulse measurement);
* The anatomical structure of the heart is abnormal, and the shunt cannot be implanted on the atrial septum;
* Other circumstances in which the patient was deemed by the investigator to be ineligible for inclusion in the trial.