cyrilzakka/clinical-trials huggingface dataset:
Evolving Routine Standards in Intracoronary Physiology

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Fractional flow reserve (FFR) has been validated as a reliable surrogate for inducible ischemia, supporting its use during invasive procedures for functional assessment of coronary lesions. Landmark randomized trials have demonstrated that deferral of nonsignificant lesions based on FFR is not only safe, but also that FFR-guided revascularization is associated with a better clinical outcome up to 2 years, when compared with standard angiography.

In spite of the overwhelming evidence of its potential clinical and economic benefits and strong guideline recommendation, the adoption of FFR in the real-world is perceived to vary significantly. Reasons for this disparity are several, but most operators still do rely the most on angiographic eye-balling to decide on the functional significance of coronary lesions and the need for revascularization.

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Eligibility Criteria:
Inclusion Criteria:

FRACTIONAL FLOW RESERVE PERFORMED GROUP

* age \>18 years
* written consent
* assessment with FFR of at least one coronary lesion

FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP

* age \>18 years
* written consent
* absence of assessment with FFR of at least one coronary lesion

  + at least one of the following criteria
  1. stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)
  2. stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)
  3. acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis)

     Exclusion Criteria:
* written consent denied
Study to Assess the Safety of Nivolumab in the Treatment of Metastatic Melanoma, Lung Cancer, Renal Cancer, Squamous Cell Carcinoma of the Head and Neck, and Chronic Hodgkin Lymphoma in Adults in Mexico

This is a post-marketing study of patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adult patients \> 18 years of age who have a confirmed diagnosis of advanced or metastatic melanoma and is indicated for the treatment of advanced (unresectable or metastatic) melanoma; metastatic NSCLC; metastatic RCC; recurrent or metastatic SCCHN; or cHL in Mexico
2. Male and female adult patients \> 18 years of age who completed the following lines of therapy: first-line platinum treatment for metastatic SqNSCLC or non-SqNSCLC; 1 first-line treatment for metastatic RCC; first-line platinum therapy for SCCHN; or bretuximab vedontin for the treatment of cHL
3. Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
4. Patients have received at least 1 dose of nivolumab

Exclusion Criteria:

1. The exclusion criteria are at the discretion of the physician. The physician should use his or her clinical judgement and international recommendations when determining eligibility. The patient will be excluded if he or she does not want to start or continue treatment.
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research

This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with hypercholesterolemia.


Eligibility Criteria:
Inclusion Criteria:

1. Any male or female aged between 18 and 80 on the date of signing the informed consent;
2. Diagnosed as hypercholesterolemia ;
3. Fasting triglyceride was less than 5.6 mmol/L during screening:
4. Understand the study procedures and methods, volunteer to participate in the study, and sign the informed consent.

Exclusion Criteria:

1. A history of the following diseases or treatments during the screening period:

   1. Known allergies to PCSK9 inhibitors or test drugs, or severe allergic reactions to other antibody drugs in the past;
   2. Participated in clinical studies of other drug interventions within the last 1 month (except for patients who failed in screening), or those who are within 5 half-lives of the drug before screening (whichever is longer);
2. Any of the laboratory test indicators meets the following criteria:

   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was more than 3 times the upper limit of normal value (ULN), and total bilirubin was more than 2 times ULN during the screening period or at random;
   2. The creatine kinase (CK) was more than 3 times of ULN during the screening period or at random;
3. Have used the following drugs:

   1. PCSK9 inhibitors had been used in the previous 6 months;
   2. Continuous systemic corticosteroid therapy with doses exceeding or equivalent to 10mg of prednisone (oral or intravenous) within the previous 3 months was screened.
4. Other circumstances:

   1. Women of reproductive age who are fertile but did not use contraception within 4 weeks before the screening period;Women who are pregnant or breastfeeding;Not agreed during the trial or at 24 weeks after the last dose
   2. Subjects who are considered by the investigator to have any unsuitable factors for participating in the study or who have poor compliance.
Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.

These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.

Surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p\<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 8 years of age at the time of inclusion.
* Patients being followed for fetal ovarian cyst.
* Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.
* Patients covered by a social security scheme.

Exclusion Criteria:

* Patients less than 8 years of age at the time of inclusion
* Ovarian cysts outside the neonatal period
* Refusal to participate.
* Opposition to disclosure of neonatal data.
* Pregnant or nursing patient.
Bisphenol Role in the Pathogenesis of PCOS

Polycystic ovary syndrome (PCOS) is the most common and the most heterogeneous endocrine disorder in premenopausal women. Its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria .

Apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with PCOS usually present with menstrual irregularities and fertility problems ..

Bisphenol A is formed from acetone and phenol, it is used in production of epoxy resin, polyster resins and polyvarbonate resins. Epoxy resins are used in plastics, adhesives, and structural composites .

Humans are at the end of the food chain, thus they are exposed to the highest doses of these compounds. EDs have been detected in human adipose tissue and biological fluids such as: serum, urine, milk and amniotic fluid .

Additionally, it has been proven that BPA can also directly stimulate androgen synthesis in the ovarian theca-interstitial cells. A correlation between increased serum testosterone levels observed in women with PCOS with serum BPA concentrations has also been found .

Eligibility Criteria:
Inclusion Criteria:

* Age group: 18-40
* Females
* Diagnosed a case of polycystic ovary syndrome

Exclusion Criteria:

* • Female patients with other acute or chronic illness

  * Cardiovascular disease
  * Neoplasms
  * Current smoking, diabetes mellitus,
  * Renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm Hg).
Randomised Controlled Trial of Method of Levels Cognitive Therapy

The purpose of this study is to determine whether Method of Levels Cognitive Therapy is an effective intervention for treating clients with a range of presenting problems in primary care by comparing it with a waiting list control condition.


Eligibility Criteria:
Inclusion Criteria:

* Anyone presenting to primary care services with mild to moderate mental health problems with capacity to provide informed consent and does not meet exclusion criteria.

Exclusion Criteria:

* Has been accepted into secondary care services.
* Aged under 16 years.
* Have an organic basis for their mental health problems. That is, mental health problems that are primarily caused by an identifiable brain malfunction such as thyroid problems or brain injury.
* Unable to provide informed consent.
* Is not able to speak, read, write or understand written and verbal English.
* Individuals who will be unable to understand and/or answer therapist questions due to learning disabilities, brain injury or similar neurological difficulties.
* Cannot attend sessions at the appropriate clinic.
Renal Artery Contrast-Free Trial

This study will compare the results of a clinically ordered abdominal CT angiography to a research non-contrast MR angiogram (MRA). CTA is a "gold-standard" for identifying blockages in the kidney arteries or other blood vessel problems. CTA requires radiation and contrast to obtain useful images. Conversely, the MR abdomen technique being used for the study uses no radiation or contrast and is felt to be a safer option for individuals who have kidney problems. there is benefit to establishing non-contrast MRA as a clinically accurate test.

REACT is a prospective, minimal-risk, and multi-center international trial. The purpose of the study is to evaluate the safety and efficacy of non-contrast magnetic resonance angiography (MRA) for the diagnosis of renal artery stenosis (RAS).

The current "gold standards" for diagnosing RAS are non-invasive 3D angiography with contrast-enhanced CTA/MRA or invasive X-ray angiography. All of these techniques require the use of an intravenous injection of either iodinated contrast material or gadolinium based agents.

Iodinated contrast agents are contraindicated in patients with renal dysfunction and have increased risk of allergic reaction. Contrast-enhanced magnetic resonance angiography (MRA) with gadolinium has fewer risks associated with it, however, is currently contraindicated in patients with severe renal insufficiency because of concerns about developing a rare but often fatal condition termed nephrogenic systemic fibrosis (NSF).

Non-contrast MRA techniques are felt to provide an avenue for safer, effective vascular imaging in patients both with and without kidney dysfunction. In this trial we propose to validate the contrast-free MRA technique, T-SLIP (time-spatial labeling inversion pulse), for diagnosing RAS. This study will compare T-SLIP to the reference standard of contrast-enhanced CTA and is designed to test its efficacy, reproducibility, reliability, and safety.

Eligibility Criteria:
Inclusion Criteria:

* The abdominal CTA evaluation form has been completed and confirmed to fit criteria for study enrollment
* The research MRA will be completed within 3 months of abdominal CTA
* Subject signed and dated the informed consent form
* Subject agrees to a "research" abdominal MRA
* Subject is able to follow breathing and scanning instructions
* Subject is at least 18 years of age

Exclusion Criteria:

* Subject has had a significant change in clinical condition between the time of abdominal CTA and abdominal MRA (e.g. worsening renal function, renal vascular intervention)
* Subject has renal stents, or other known material that may affect MR image quality
* Subject has a contraindication to an MRI
* Subject had intravenous gadolinium media within the previous 24 hours
* Subject has a baseline heart rate \>90 beats per minute or respiratory rate \>25 breaths/minute
Spinal Fusion and Rehabilitation Study

The aim of the present study is to analyse the significance of postoperative combined strength and aerobic training for outcome of the lumbar fusion patients compared to usual care (patients with isthmic or degenerative spondylolisthesis).

Most of the studies published so far about lumbar fusion surgery have been interested in surgical procedure itself or in comparison of conservative or operative treatment. Less information is available about long-term outcome and exercise programs for operated patients. Therefore the investigators have developed "Spine fusion register", which include data on surgery procedure and outcome (pain, disability, back muscle function, quality of life, working capacity, reoperations and complications etc.) before and after surgery up to 5 years (started in January 1st, 2008). The main purpose of the present study is to analyze the significance of 12-month strength and aerobic training for outcome of the lumbar fusion patients compared to usual care. Patients (N=100) with lumbar fusion because of isthmic or degenerative olisthesis will be will be stratified by catchments area and randomized into combined strength and aerobic training group or into the control group.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* isthmic or degenerative spondylolisthesis

Exclusion Criteria:

* cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
* metabolic bone disease
* psychosocial instability
* malignant disease
Intra-arterial Neuroprotective Strategy for Ischemic STroke Patients With No Reperfusion Therapy (INSIST-NRT)

To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Major neurologic deficits: 6≤NIHSS≤20;
3. Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4);
4. Premorbid mRS 0 or 1;
5. Signed informed consent.

Exclusion Criteria:

1. Modified Rankin Score \>2 caused by a history of prior stroke;
2. Patients who underwent intravenous thrombolysis or Endovascular treatment;
3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<80000/mm3;
4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
5. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
6. Unsuitable for this clinical studies assessed by researcher.
Eyelid Position Interdependence in Involutional Ptosis Patients Submitted to 10% Phenylephrine

The primary aim of this study is to quantify eyelid position changes in tested and opposite eyes in ptosis patients submitted to 1, 2 or 4 drops of 10% phenylephrine in one eye. The secondary objective is to correlate the eye dominance, severity and laterality of ptosis with eyelid position changes in these 3 groups.

This is a prospective observational study conducted in involutional ptosis patients, which will be submitted to instillation of a single drop of 10% phenylephrine in one eye(Group 1), 2 drops (G2) or 4 drops ( G3).

Video camera will record the images of both eyes before and after drug application at 3, 10, 15 and 30 minutes. The images will be edited to analyze upper and lower lid height.

Eligibility Criteria:
Inclusion Criteria:

* Involutional blepharoptosis
* Upper Margin-reflex distance less or equal 2.0mm
* Good fixation and collaboration

Exclusion Criteria:

* Previous eyelid surgeries
* Use of adrenergic or sympathicomimetics drugs
* Myopathies
* Thyroid orbitopathy
* Non-controlled cardiovascular disease
Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity

The investigators specific aim is to compare the relationship between systemic fatty acid availability and insulin sensitivity in a relatively homogenous population of obese adults. The investigators anticipate 1) greater systemic fatty acid availability will be associated with lower insulin sensitivity and 2) greater systemic fatty acid availability will be associated with greater accumulation of fatty acid intermediates and pro-inflammatory markers.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \[BMI\]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

* Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding
The Impact of Integrated Preoperative Fascia Iliaca Compartment Block in Elderly Hip Fracture

This prospective randomized controlled study is aimed to determine the advantages of post-admission fascia iliaca compartment block (FICB) in geriatric hip fracture surgery combination with multimodal analgesia compared with no post-admission FICB. The primary outcome is incidence of delirium during hospital admission. Secondary outcomes are incidence of delirium at hospital discharge, pre- and post-operative pain intensity, peri-operative complications, opioid-related side effects, post-operative complications and length of hospital stay, and morbidities and mortality (in-hospital and 30 days).

Population: elderly patients age ≥ 65 years old, diagnosed with an isolated acute hip fracture within 7 days and plan to receive fast-track hip fracture. Statistic analysis plan surgery within 48 hours after hospital admission.

Study population: elderly isolated hip fracture patients who are admitted in those 8 hospitals centers in Thailand and have moderate pain or higher than moderate pain during movement since hospital admission.

Sample size : 210 patients per group (drop out 10%) total 420 patients

Statistical analysis: SPSS will be used for study analysis. The category variables will be present as number and percentage, and chi-square or fisher exact test will be used to compare between the groups.The continuous variables will be tested the distribution, data presentation will be mean and standard deviation (SD) for normal distribution while median and interquartile rang (IQR) for non-normal distribution. Student t test or Wilcoxson rank some test will be used as appropriate to test for different between the group. And p value less than 0.05 will be considered statically significance.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are aged ≥65 , \<85 years old and diagnose hip fracture in 8 hospitals
2. Planed for fast-track hip surgery
3. Isolated acute hip fracture
4. Pain on admission during movement ≥ 4 (moderate pain)

Exclusion Criteria:

1. refusal to participate the study
2. ASA physical status \>III

2. duration of fracture more than 7 days before admission 3. hip fracture after/at previous instrumentation 4. hip fracture causing by a traffic accident or high energy force 5. suspected pathologic fracture 6. unable to communication 7. abnormal consciousness or severe cognitive dysfunction that could not communication such as mental retardation, severe Alzheimer's disease and schizophenia 8. allergy to local anesthetic drug
Deep Learning Magnetic Resonance Imaging Radiomic Predict Platinum-sensitive in Patients With Epithelial Ovarian Cancer

Platinum-sensitive is an important basis for the treatment of recurrent epithelial ovarian cancer (EOC) without effective methods to predict.We aimed to develop and validate the EOC deep learning system to predict the platinum-sensitive of EOC patients through analysis of enhanced magnetic resonance imaging (MRI) images before initial treatment.Ninety-three EOC patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery from Sun Yat-sen Memorial Hospitalin China from January 2011 to January 2020 were enrolled. This deep-learning EOC signature achieved a high predictive power for platinum-sensitive, and the signature based on MRI whole volume is better than that on primary tumor area only.


Eligibility Criteria:
Inclusion Criteria:

* (1)Patients with epithelial ovarian cancer (2 )Patients received platinum-based chemotherapy (\>= 4 cycles) and debulking surgery

Exclusion Criteria:

* Patients with epithelial ovarian cancer received less than 4 cycles platinum-based chemotherapy or no debulking surgery
Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy

To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy

Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.

Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years.
* Both sexes.
* ASA (American Society of Anesthesiology) physical status II-III.
* Scheduled for open thoracotomy.

Exclusion Criteria:

* Contraindications to or failed paravertebral block .
* Body mass index (BMI) \>35 kg/m2.
* The likelihood of postoperative mechanical ventilation.
* Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
* Hypersensitivity to ketamine or levobupivacaine.