cyrilzakka/clinical-trials huggingface dataset:
Comparison of Artificial Intelligent Clinic and Normal Clinic

In this study, the investigators provide participants≤14 years old the artificial intelligent clinic or normal clinic in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.

Children ≤14 years old from ophthalmic clinic without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to two groups: participants in group A went to the artificial intelligent clinic and get the initial diagnosis, while in Group B, the participants went to the normal clinic. Investigators provide the final definite diagnosis from experts for two groups. Investigators compared the accuracy of the diagnosis, time consuming and the satisfaction level between two groups, aiming at comparison of artificial intelligent clinic and normal clinic for diagnosing congenital cataract.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients from collaborating eye clinics Written informed consents provided

Exclusion Criteria:

* Definitive diagnosis of cataract or other ocular abnormalities Previous eye surgery Can not cooperate with the slip lamp examination Unwilling to participate in this trail
Effective High Aerobic Intensity Endurance Training Regimes in Chronic Obstructive Pulmonary Disease (COPD) Patients

4 times 4 minutes interval training with and without hyperoxia is more effective than low intensity endurance training.


Eligibility Criteria:
Inclusion Criteria:

* COPD

Exclusion Criteria:

* Heart disease
* Walking or cycling inabilities
* Other diseases
Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937

This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of \[14C\]-BLU-5937.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males

Exclusion Criteria:

* History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator
Effect of Perioperative Lung Protective Strategies on the Occurrence of Postoperative Pulmonary Complications in Patients Undergoing Lumbar Spinal Surgery in the Prone Position

Postoperative pulmonary complications are main cause of overall perioperative morbidity and mortality in the patients following general anesthesia. A protective ventilation strategy refers to the use of low VT (in the range of 4-8 ml/kg of the predicted body weight) with positive end-expiratory pressure (PEEP), with or without recruitment maneuver. Protective ventilation has been considered the optimal practice in patients suffering from the acute respiratory distress syndrome (ARDS). However, few human studies have assessed how to ventilate healthy lungs in patients undergoing general anesthesia, especially in prone position. Prior studies reported that in the patients undergoing major abdominal surgery in supine position, intraoperative lung protective ventilator settings had the potential to protect against pulmonary complications. Therefore, the investigators planned this study to better specify the effect of intraoperative protective ventilation in surgical patients in the prone position.


Eligibility Criteria:
Inclusion Criteria:

* the patient undergoing elective lumbar spine surgery of two hours or more in the prone position
* the age: 19 yrs and older
* the patients had a preoperative risk index for pulmonary complications of more than 2.

Exclusion Criteria:

* Patients with altered mental status or increased intracranial pressure
* Body mass index more than 35 kg/m2
* Patients with persistent hemodynamic instability or intractable shock
* Severe cardiac disease defined as New York Heart Association class III or IV or acute coronary syndrome or persistent ventricular tachyarrhythmias
* Recent history of invasive ventilation (within two weeks)
* Recent history of pneumonia, ALI/ARDS or sepsis (within two weeks)
* History of pulmonary resection, emphysema or chronic obstructive pulmonary disease (COPD)
* Repeated systemic corticosteroid therapy for acute exacerbations of COPD or asthma
* Recent immunosuppressive medication defined as need of chemotherapy or radiation therapy (within two months)
* History of neuromuscular disease
* Emergency operation
* Patient refusal
* Pregnancy
The Change of Coagulation Markers in Children With β-thalassemia Disease After Stem Cell Transplantation

Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc) surface and consequent increased platelet activation and thrombin generation. In addition, a reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated. However, coagulable state in patients with β-thalassemia following stem cell transplantation (SCT) has not been characterized.

Hypercoagulable state is well recognized in patients with β-thalassemia. Evidences of hypercoagulability include abnormal expression of phosphatidylserine on red blood cell (rbc) surface and consequent increased platelet activation and thrombin generation. In addition, a reduction of anticoagulants i.e. proteins C and S and antithrombin (AT) was demonstrated. However, coagulable state in patients with β-thalassemia following stem cell transplantation (SCT) has not been characterized.Therefore, the objective is to compare coagulation markers and anticoagulants among β-thalassemics with and without SCT and normal control (NC).The subjects will be classified into 3 groups; β-thalassemia post SCT (Thal-SCT), β-thalassemia treated with regular transfusion (Thal-RT) and NC. Blood samples will be tested for annexin V (an index of abnormal expression of phosphatidylserine on rbc surface), markers of activation of coagulation system (thrombin antithrombin complex (TAT), prothrombin fragment (F1+2), and D-dimer) and anticoagulants (proteins C and S and AT).

Eligibility Criteria:
Inclusion Criteria:

Group 1: beta thalassemia major or beta thalassemia / Hb E who receive regular transfusion therapy (Thal- RT). The baseline Hct was more than 24% for at least 6 months.

Group 2: beta thalassemia major or beta thalassemia / Hb E post SCT (Thal-SCT) who were discontinued immunosuppressive drugs.

Group 3: Normal children (NC) who had normal Hb/Hct and MCV for age

Exclusion Criteria:

Children with beta thalassemia major or beta thalassemia / Hb E who have co-diseases such as immune hemolytic anemia, infection, or inflammatory diseases
Osteoporotic Vertebral Fractures and Exercise

Physiotherapy has an important place in the treatment of osteoporotic vertebral fractures. Therapeutic exercise is often recommended for patients with vertebral fractures to reduce pain and restore functional movement. There is not enough evidence in the literature to determine the effects of long-term exercise on osteoporotic fractures and their side effects.

Therefore, the aim of this study is to evaluate the effectiveness of 12-week exercise training in patients with osteoporotic vertebral fractures.

Osteoporotic vertebral fractures are associated with increased morbidity (eg, pain, poor quality of life) and mortality. Therapeutic exercise is a conservative non-pharmacological treatment that is often recommended for patients with vertebral fractures to reduce pain and restore functional movement.

There are preliminary studies showing that exercise may have an important role in improving quality of life and reducing the risk of re-fracture in these individuals. There are several reports of pain relief after short-term (6-10 weeks) exercise programs in people with spinal fractures, suggesting that there is uncertainty in the effects reported after longer-term (12-24 weeks) exercise. Data are scarce and there are only four studies examining this question, and one is a multi-component physical therapy intervention that includes exercise. Not all studies have examined individuals with severe pain at baseline. The quality assessment of the evidence for the effects of exercise on pain is very low.

There is insufficient evidence in the literature to determine the effects of exercise on osteoporotic fractures and their side effects.

Therefore, the aim of the study is to evaluate the effectiveness of 12-week resistance and balance exercises in patients with osteoporotic vertebral fractures.The group of patients who will exercise will be compared with individuals who do not receive any treatment or exercise.

It is aimed to reveal the effects of exercise on pain, physical performance, quality of life, depression, loss of function, kinesiophobia and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory,
* 55 years and over,
* A minimum pain score of 3 in the Short Form Mc-Gill, which we will use for pain assessment.
* Able to use mobile phone by himself or with the support of his family,
* Having at least one vertebral fracture at least 6 months ago as a result of X-ray,
* It was defined as having osteoporosis (Lumbar spine DEXA T score \<-2.5).

Exclusion Criteria:

* Metabolic disease that will prevent participation in exercise,
* Pain at a level that prevents participation in exercise (a score above 7 in Short Form Mc Gill)
* Severe cardiovascular or pulmonary diseases (such as Uncontrolled Hypertension, resting heart rate 100 beats/min),
* Psychiatric diseases
* Determined as a recent fracture history
Bioavailability and Bioequivalence of Ezetimibe Tablets in Healthy Subjects

This study was conducted to assess the bioequivalence of the ezetimibe tablet to Ezetrol ® in healthy Chinese volunteers and estimate the pharmacokinetic proﬁles of ezetimibe tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age
* The body mass index is in the range of 18.0-26.0 kg/m2 (including the critical value).
* The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* Serum total cholesterol was between 2.9 and 5.0mmol/L (not including critical value).

Exclusion Criteria:

* any medical history of cardiovascular, digestive, respiratory, nervous or ematological diseases
* hepatic/renal impairment
* abnormal vital signs
* drug or alcohol abuse
* smoking ≥5 cigarettes per day ,
* donation(≥300ml) o
* enrollment in other clinical trials during the 3 months prior to screening
* allergic to ezetimibe or its excipients
* any use of other prescription drugs or vitamins or caffeine/xanthine-rich beverages 48h prior to taking medication
* lactating or pregnant women
Study of Pemetrexed + Carboplatin + Bevacizumab + Enzastaurin Versus Pemetrexed + Carboplatin + Bevacizumab + Placebo in Participants With Non-Small Cell Lung Cancer Who Have Not Been Previously Treated With Chemotherapy

The purpose of this study is to determine if Pemetrexed plus Carboplatin plus Bevacizumab plus Enzastaurin, followed by maintenance Bevacizumab plus Enzastaurin can extend survival time without disease progression in the first-line treatment of participants with advanced stage non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* participants or their legal representative must have signed an informed consent document for clinical research
* have laboratory confirmed diagnosis of advanced, nonsquamous cell non-small cell lung cancer (NSCLC) (Stage IIIB or IV disease) which is not curable
* have not received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for advanced NSCLC, prior radiation therapy is allowed to less than 25% of the bone marrow
* have measurable disease
* have adequate organ function and estimated life expectancy of 12 weeks

Exclusion Criteria:

* have known central nervous system (CNS) disease; major surgery within 28 days; minor surgery within 7 days; serious concomitant systemic disorder; serious cardiac condition; have a serious, nonhealing wound, ulcer, or bone fracture
* have received treatment within the last 30 days with any drug that has not received regulatory approval for any indication at the time of study entry
* have previously received treatment with enzastaurin, pemetrexed, or bevacizumab
* are pregnant or breast-feeding
* are unable to swallow tablets
Vytorin Treating Uncontrolled Lipids (VyTUL) Study (0653A-122)

To compare the effectiveness of ezetimibe/simvastatin 10/40 daily to atorvastatin 80 daily in reducing the concentration of ldl-c at endpoint after 6 weeks of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
* Existing coronary heart disease and cholesterol \> 4.0 mmol/l

Exclusion Criteria:

* Uncontrolled diabetes
* Elevated liver function tests
* Elevated creatine kinase (ck)
* Triglycerides (tg) \> 4.5 mmol/l
* Drug or alcohol dependency within 6 months prior to visit 1
* Woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
* Woman of childbearing potential not using an acceptable method of birth control
* Women who are pregnant or breast feeding
Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome

This study has a double-blind, Randomized Placebo-Controlled Period and an Open-Label Period. The primary objective of the Randomized Placebo-Controlled Period is to demonstrate the efficacy of mavorixafor in participants with WHIM syndrome as assessed by increasing levels of circulating neutrophils compared with placebo, and relative to a clinically meaningful threshold. The primary objective of the Open-Label Period is to evaluate the safety and tolerability of mavorixafor in participants with WHIM syndrome. Participants are allowed to continue treatment in the Open-Label Period, if regionally applicable, until mavorixafor becomes commercially available, or until the study is terminated by the Sponsor.


Eligibility Criteria:
Inclusion Criteria for the Randomized Placebo-Controlled Period :

* Have signed the current approved informed consent form. Participants under 18 years of age (in the Netherlands and other applicable regions, participants under 16 years of age) will sign an approved informed assent form and must also have a signed parental/legal guardian consent.
* Have a genotype-confirmed mutation of chemokine (C-X-C motif) receptor 4 (CXCR4) consistent with WHIM phenotype.
* Agree to use a highly effective form of contraception.
* Be willing and able to comply with the protocol.
* Have confirmed ANC ≤400 cells/µL during screening, obtained while participant has no clinical evidence of infection.

Inclusion Criteria for the Open-Label Period:

* Completed the Randomized Period; or
* Granted Early Release from the Randomized Period.

Exclusion Criteria:

* Has known systemic hypersensitivity to the mavorixafor drug substance, its inactive ingredients, or the placebo.
* Is pregnant or breastfeeding.
* Has any medical or personal condition, which in the opinion of the Investigator may potentially compromise the safety or compliance of the participant or may preclude the participant's successful completion of the clinical study.
Sevoflurane, Propofol and Desflurane on POD/POCD

The investigators will perform clinical studies to test the hypothesis that participants who have total hip/knee replacement under sevoflurane, propofol or desflurane anesthesia will have different effects on the incidence and severity of POD/POCD, and POD/POCD is associated with retinal nerve fiber layer (RNFL) thickness, as well as Serum level of vitamin B12, folic acid, homocysteine and human myeloid differentiation protein-2 (MD-2s). The investigators plan to perform the studies in 300 participants at Shanghai 10th People's Hospital.

Postoperative delirium (POD) and postoperative cognitive disorder (POCD) are the most common complications of geriatric surgical patients, which could cause long-term social dysfunction, high mortality and increased medical cost. Currently, there is no efficient biomarker for POD/POCD, and it also remains largely unknown whether different anesthesia might lead to different incidence and severity of POD/POCD. The investigator's previous studies showed that thickness of retinal nerve fiber layer thickness (RNFL-T) measured by optical coherence tomography (OCT) was associated with POD/POCD; change of RNFL thickness (RNFL-C) in certain period correlated with cognitive deterioration. Thus, the investigators consider that RNFL might be a potential biomarker of POD/POCD. In the proposed large-scale longitudinal studies, the investigators will clinically validate RNF-LT as pre-operative POD/POCD biomarker, and RNFL-C as post-operative biomarker of POD/POCD. Finally, the investigators will compare the effects of surgery (total hip/knee replacement) under general anesthesia with sevoflurane, propofol and desflurane on the incidence and severity of POD/POCD in patients. Results from the proposed studies will likely establish RNFL as a potential POD/POCD biomarker, promote the clinical utilization of OCT-RNFL in early screening and outcome prediction of POD/POCD, and finally optimize anesthesia care of geriatric surgical patients to avoid or reduce POD/POCD incidence. These findings will lead to better postoperative outcomes of geriatric patients.

Eligibility Criteria:
Inclusion Criteria:

* 60 years old or older
* Chinese Mandarin as the native language
* scheduled to undergo hip/knee surgery under general anesthesia
* American Society of Anesthesiologists (ASA) class I-Ⅲ

Exclusion Criteria:

* Prior diagnoses of neurological diseases according to ICD-10
* History of severe psychiatric disorders according to DSM-IV
* Visual or auditory defects
* Participating in the investigation of another study
Single and Multiple Ascending Dose, First-in- Human Study in Healthy Subjects

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy subjects and Part B is a multiple ascending dose (MAD) study in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 19 - 55 years old
* Willing and able to give informed consent and comply with the study
* Medically healthy with no clinically significant medical history
* Body mass index (BMI) 18 to 32 kg/m2 and weighs at least 50 kg
* Women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method
* Males must use acceptable contraception
* Additional inclusion criteria apply

Exclusion Criteria:

* Positive for hepatitis A, B or C, HIV or tuberculosis
* Clinically significant abnormalities of laboratory evaluations
* Have abnormal ECG or vital sign measurements
* Any acute illness at time of screening
* Have a current bacterial, parasitic, fungal or viral infection
* Uses or have used tobacco or nicotine-containing products within 6 months prior to screening
* Additional inclusion criteria apply
Inhaled Sedation Using the Anesthetic-conserving Device ( ANACONDA) in Prehospital Emergency Medecine.

Achieving the optimal sedation level for patient management is not always possible using our standard intravenous medications in Pre-hospital Emergency medicine. Inhaled sedation is possible with the Anesthetic-conserving device with a standard respirator.

The pharmacodynamics and pharmacokinetics of halogenated agents allow deep sedation quickly after absorption.

The feasibility of inhaled sedation has never been studied in hospital.

Retrospecive clinical monocentric study with sedated ventilated patients with isoflurane with the AnaConda® system out of hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patient sedated by isoflurane with Anesthetic-conserving device in pre-hospital
* Major patient
* not opposed to participating

Exclusion Criteria:

* Adults Under legal protection
* patient refusal to participate in study
Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening

RATIONALE: Lifestyle factors, such as physical activity, diet, and obesity, and hormone function may affect breast density. Screening tests, such as mammography, may help doctors find tumor cells early and plan better treatment for breast cancer.

PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening.

OBJECTIVES:

* Correlate physical activity, diet, and obesity, as measured by body mass index and waist circumference, with percent breast density and the absolute estimate of total dense breast area in healthy Hispanic women undergoing screening mammography.
* Correlate fasting serum insulin growth factor (IGF)-1 and the molar ratio of IGF-1 to IGF binding protein-3 with breast density in participants undergoing screening mammography.
* Correlate insulin concentration and insulin resistance with breast density in participants undergoing screening mammography.

OUTLINE: This is a multicenter study.

Participants undergo blood collection and physical examination. Participants also complete breast cancer risk factor, food frequency, and physical activity questionnaires and receive breast health and physical activity education. Participants then undergo a digital screening mammogram. Participants are notified of mammogram results.

PROJECTED ACCRUAL: A total of 114 participants will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy Hispanic women
* Registered patient at the Erie Family Health Centers' West Town or Humboldt Park clinics
* No screening mammography within the past 12 months
* No abnormality on clinical breast exam
* No history of breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 40 and over

Sex

* Female

Menopausal status

* Not specified

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Perioperative Treatment Outcomes of Early NSCLC

This is an observational study evaluating the clinical characteristics, treatment patterns, and clinical outcomes of perioperative NSCLC patients receiving different treatment strategies. According to the inclusion and exclusion criteria, perioperative NSCLC patients admitted to the study center from January 1, 2020, to one year after the study initiation will be retrospectively screened and collected.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-III NSCLC patients confirmed by histological or cytological examination based on the 8th edition of the AJCC staging system.
* Patients who have undergone radical lung cancer surgery.
* Patients who have received neoadjuvant treatment before radical lung cancer surgery, including chemotherapy, targeted therapy, or immunotherapy both alone or combined.

Exclusion Criteria:

* Patients with other previous malignancies, except those who achieved complete remission at least two years before radical lung cancer surgery and did not require additional treatment.
* Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, neoadjuvant treatment, pathological response, imaging response after neoadjuvant.
* Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.
* Prior surgery, radiotherapy or systemic therapy for NSCLC, including radiofrequency ablation, etc.