cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Surgery of Aortic Valve

Overall Goal: To study the outcomes of patients undergoing aortic valve surgeries, different approaches such as standard aortic valve replacement, aortic valve repair, novel techniques as Ozaki's procedure and their subsequent results and complications.

* Objective 1: Identify predictors of complications following different types of aortic valve surgery accordingly.
* Objective 2: Determine the value of each type in terms of advantages and disadvantages.
* Objective3: Assess outcomes such as postoperative life expectancy, hospital stay, prognosis and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with severe symptomatic aortic valve lesion.
2. Asymptomatic aortic insufficiency patients with left ventricular dysfunction or significant left ventricular dilatation (LV end diastolic diameter\>70 mm or LV end systolic diameter\>50 mm.
3. Patients with aortic regurgitation caused by:

   * a dilated aortic annulus
   * conjoined cusp prolapse in bicuspid aortic valves (BAV)
   * single cusp prolapse in tricuspid aortic valves
   * aortic valve cusp perforation from endocarditis

Exclusion Criteria:

* Patients with previous aortic root or valve surgery.
Validation of Aspiration Risk Assessment in Stroke Units

The purpose of the study is to test the validity of a modified Daniels swallow test. The original test serves as reference method, the swallow endoscopy (FEES) as "gold standard".

Furthermore, it will be examined whether the modified Daniels test can be performed by nursing staff. As a reference method, the test will be performed by experienced speech therapists and the swallowing endoscopy (FEES) by speech therapists and/or physicians.

For each included patient, the standardized Daniels test is performed by a speech therapist within the first 24 hours after admission, as well as the modified Daniels test by a second speech therapist who is blinded to the result of the first test. This is immediately followed by the administration of the modified Daniels test by a nurse. All investigators are blinded to the results of the preceding water swallow tests. The water swallow tests are not performed by physicians.

Following the water swallow tests, FEES is performed by an examiner (physician or speech therapist) experienced in FEES. The examination is digitally recorded and evaluated by an external examiner (physician or speech therapist) using validated scores.

Eligibility Criteria:
Inclusion Criteria:

* Acute (maximum 7 days old) cerebral infarction detected by cMRI or cCT
* Neurological deficits
* Written informed consent

Exclusion Criteria:

* Cerebral hemorrhage
* Pre-existing swallowing disorders of other etiologies
* Contraindications to clinical swallowing examination (lack of alertness as well as lack of compliance) - Contradictions to FEES (lack of alertness as well as lack of compliance)
Artificial Intelligent Clinical Decision Support System Simulation Center Study for Technology Acceptance

The purpose of this research study is to measure the effect on of a large language model interface on the usability, attitudes, and provider trust when using a machine learning algorithm-based clinical decision support system in the setting of bleeding from the upper gastrointestinal tract (upper GIB). Specifically, the investigators are looking to assess the optimal implementation of such machine learning algorithms in simulation scenarios to best engender trust and improve usability. Participants will be randomized to either machine learning algorithm alone or algorithm with a large language model interface and exposed to simulation cases of upper GIB.

The experiment will deploy a previously validated machine learning algorithm trained on existing clinical datasets within simulation scenarios in which a patient with acute gastrointestinal bleeding (at low, moderate, and high risk for poor outcome) is evaluated.

Prior to the simulation, a baseline educational module about artificial intelligence, machine learning, and clinical decision support will be provided to all participants. The investigators will establish psychological safety by detailing what is available in the room, the opportunity to call a consultant, and availability of laboratory and radiographic studies. Each clinical scenario will run for approximately 10 minutes based on real patient cases where vital signs change over time and laboratory values are made available at specific points in the assessment. The study will evaluate the effect of a large language model-based interaction with the machine learning algorithm with interpretability dashboard compared to the machine learning algorithm with interpretability dashboard alone. Each participant will receive three scenarios in randomized order of risk.

For the large language model interaction arm, participants will be provided the computer workstation a LLM chatbot interface of the algorithm and interpretability dashboard For the machine learning dashboard arm, participants will be provided the computer workstation with the algorithm and interpretability dashboard.

Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine residency trainees at study institution
* Emergency Medicine residency trainees at study institution

Exclusion Criteria:

* N/A
Evaluation of the Performance of Epidural Analgesia After Major Abdominal Surgery

Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Epidural analgesia is widely used for the treatment of acute postoperative pain, and currently represents the gold standard after open major abdominal surgery. However, several studies have reported a failure rate of APT of up to 30%. Its efficacy regarding pain control during coughing and mobilization is also inconsistent, with correct analgesia found in only 60% of cases in a Scandinavian multicenter cohort. Inadequate Epidural analgesia may be associated with more postoperative complications. This finding prompts a study in our institution to evaluate the performance of epidural analgesia after major open abdominal surgery.

Epidural analgesia does not guarantee total control of acute postoperative pain after major open abdominal surgery. The performance of epidural analgesia could vary according to predisposing factors and postoperative days. Inadequate epidural analgesia could be associated with greater morbidity after open major abdominal surgery.

In order to evaluate the performance of epidural analgesia after major open abdominal surgery, a prospective observational monocentric scheme seems relevant. The evaluation will be clinical based on questioning and a brief medical examination during the early postoperative phase of the operated patients.

Eligibility Criteria:
Inclusion Criteria:

* Major abdominal surgery patient operated by laparotomy (predicted operative time ≥ 2 hours)
* epidural analgesia accepted

Exclusion Criteria:

* Minor or protected patient
* Patients under guardianship, curatorship or safeguard of justice
* Pregnant or breastfeeding woman
* Contraindication or refusal of epidural analgesia
* Failure of the initial placement of the epidural catheter
* Major intraoperative complication requiring continued postoperative sedation
Comparison of Bone Mineral Loss in Prostate Cancer Patients Who is Receiving GnRH Agonist and -Plus Anti-androgen Agent

Comparison of bone mineral loss in prostate cancer patients who is receiving GnRH agonist and -plus anti-androgen agent

MC MD

Eligibility Criteria:
Inclusion Criteria:

* Korean prostate cancer over 50 years old with pathological confirmation
* Patients receiving GnRH antagonist or GnRH agonist plus anti- androgen combination within 6 months since starting.
* Patients measured bone density level before starting to receive hormone therapies above.

Exclusion Criteria:

* Patients who are treated other anti-osteoporosis drugs and who are treated bisphosphate due to BMD T score below -3.0.
* Patients who are hard to be analysed by attach to other bone disease.
* Patients who are hard to be analysed by limitation of chart record according to investigators'discretion.
The Effect of Stellate Ganglion Block on Intracranial Pressure Predicted by Ultrasonographic Assessment of Optic Nerve Sheath Diameter

The stellate ganglion block increase cerebral blood flow, as the consequence of that, it has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD after the stellate ganglion block.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (20-70 years of age)
* who were scheduled to receive stellate ganglion block at our pain management clinic

Exclusion Criteria:

* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery
* Patients with coagulation disorder
* Patients with severe obesity
* Patients with severe cardiovascular or pulmonary disease
* Patients with cognitive deficits or psychiatric illness
Rhomboid Intercostal and Subserratus Plane Block

Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.

In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study

Exclusion Criteria:

* bleeding disorders,
* mental incapacity,
* known allergy to the local anesthetics,
* body mass index ≥35 kg/m2
Investigating the Impact of Duration and Amount of Light on the Circadian System Response - Aim 3

Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score \<25
* Sleep disturbance with a Pittsburgh Sleep Quality Index score ≥5

Exclusion Criteria:

* Extensive brain vascular disease, traumatic brain injury, multiple sclerosis, Parkinson's Disease
* Obstructing cataracts
* Severe macular degeneration
* Use of sleep medication
* Use of oral melatonin
* untreated moderate to severe sleep apnea
* Severe restless leg syndrome - Blindness
Improving Flexibility With a Mindbody Approach

The objectives of this study are to investigate if Neuro Emotional Technique (NET) will impact back and leg flexibility over both the short-term and the long-term.

It is hypothesized that NET will improve flexibility and that these changes are durable.

General flexibility is a key component of health, wellbeing and general physical conditioning. In fact, lack of flexibility has been associated with an increased risk of developing musculoskeletal injuries and underperformance.

It has been previously shown that a regular stretching routine will improve flexibility relatively quickly. However, when the routine is discontinued or when stretching is not performed regularly, flexibility is also quickly lost. Therefore, an alternative intervention with longer retention would be desirable.

The reason for reduced flexibility, or a shortened muscle length, can be multifactorial. Reduced flexibility can be due to physical causes, such as an acute injury or strength training. Likewise, mental factors, such as anxiety and stress, can also significantly contribute to muscle tension, thereby reducing flexibility. It has been previously shown that somatic symptoms of anxiety can be lessened by treating the psychological symptoms of anxiety. It has also been previously shown that Neuro Emotional Technique® (NET), a chiropractic stress-reduction technique, is effective at reducing stress. Therefore, I hypothesize that NET may be effective at improving general flexibility. Therefore, the aim of this study is to investigate if NET can improve flexibility in the short-term, and if so, if these changes are durable in the long term.

Participants of this study will be randomly divided into three arms: (1) Experimental Arm - which will receive two 20-minute sessions of NET, (2) Active Controls - which will receive two 20-minute sessions of stretching instructions, and (3) Inactive Control - which will receive no intervention or instruction, but simply be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18 to 45 years.

Exclusion Criteria:

* A currently diagnosed physical or mental health problem
* Pain on forward bending
* Pregnancy

NOTE: For this study, no compensation is possible.
A Study of SHR-1210 in Combination With Carboplatin + Paclitaxel in Subjects With Squamous NSCLC

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with stage IV squamous non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of SHR-1210 + carboplatin + paclitaxel with placebo + carboplatin + paclitaxel in study population in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive cross over treatment of SHR-1210 monotherapy after confirmed disease progression. Treatment cycles of chemotherapy will be 4-6 which will be decided by investigators.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) and clinical stage IV
2. has not received prior systemic treatment for metastatic NSCLC.
3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
4. Has archived Tumor tissue samples
5. Subject must have a measurable target lesion based on RECIST v1.1 .
6. Has adequate organ function.
7. Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results. Female subjects of reproductive age and male subjects whose spouse is a woman of reproductive age must agree to effective contraception within 180 days after the study period and the last dose of the study drug.
8. Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Exclusion Criteria:

1. active brain metastases and meningeal metastasis
2. uncontrollable tumor-related pain
3. massive pleural effusion, peritoneal effusion or pericardial effusion which cannot be controlled by repeated drainage;
4. radiotherapy to lung that is \>30 Gy within 24 weeks before the first dose,
5. imaging (CT or MRI) showed that the tumor invading the large vessels
6. Known EGFR/ALK mutation.
7. subjects with any known or suspected autoimmune diseases
8. subjects with known or suspected interstitial pneumonia;
9. Subjects with severe cardiovascular and cerebrovascular diseases
10. arteriovenous thrombosis events, such as deep vein thrombosis and pulmonary embolism, occurred within 3 months;
11. female subjects who are pregnant or lactation or who plan to be pregnant during the study period;
12. positive HIV test;
13. active hepatitis B
14. evidence of active TB infection within 1 year before first dose;
15. severe infection occurred within 4 weeks before the first dose
16. patients with clinically significant bleeding symptoms or with obvious bleeding tendency in the first month
17. subjects who is on systemic immunogenic agents;
18. a history of severe allergic reactions to other monoclonal antibodies/fusion proteins;
19. History of severe allergic reactions to carboplatin or paclitaxel or their preventive drugs;
Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy

1. To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
2. To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.
3. To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
4. To find any possible correlation between clinical variables.


Eligibility Criteria:
Inclusion Criteria:

* only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.

Exclusion Criteria:

* Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.
Evaluation of a Genetically Determined Personalized Approach in Prescribing Biologically Active Substances in Patients With Elevated Blood Homocysteine Levels.

The clinical trial assesses the effectiveness and safety of a genetically-determined personalized approach to prescribing bioactive substances in patients with elevated blood homocysteine levels. Hyperhomocysteinemia (HHcy) is a risk factor for cardiovascular diseases (CVD), potentially exacerbating the effects of arterial hypertension and high cholesterol levels, increasing the risks of heart disease, stroke, and venous thrombosis. The trial aims to reduce plasma homocysteine levels to normal values (\<15 µmol/L) through a pilot, single-center, prospective, double-blind, placebo-controlled study. The study will involve a 6-month observation period with visits at 1, 3, and 6 months, assessing the efficacy of two composite bioactive substances not considered medicinal drugs. The primary endpoint is the reduction of homocysteine levels in patients with elevated levels, while secondary endpoints include lowering very low-density lipoprotein levels, absence of anxiety and depression (using the Spielberg Anxiety Scale), and the occurrence of major cardiovascular events. The sample size is planned for 111 patients across three groups, with a 1:1:2 distribution, considering a 40% reduction in homocysteine levels in the treated group and 5% in the control group, aiming for an 80% power and a 0.05 alpha. Inclusion criteria include adults aged 18-80 with elevated homocysteine (\>15 µmol/L) and LDL cholesterol levels (≥1.4 mmol/L), without taking any substances that could influence homocysteine levels for at least one month prior. The trial will also conduct an interim analysis after enrolling 55 patients, using statistical analysis to evaluate the results.


Eligibility Criteria:
Inclusion Criteria:

* Increased homocysteine level above 15 µmol/l;
* Increased LDL level \>=1.4 mmol/l.;
* Absence of taking medications or any other products that may affect homocysteine levels in the blood for at least 1 month before enrollment in the study;

Exclusion Criteria:

* Individual intolerance to the components of the substance;
* Pregnancy or breastfeeding;
* Severe concomitant disease requiring constant monitoring (estimated survival less than 1 year);
* Taking dietary supplements or medications containing one of the components: dietary supplements for at least 3 months before inclusion in the study.
Open-Label Dose-Ranging Study of Oral SM-001 in Healthy Adults

Phase I safety and dose finding study of a standardized Ayahuasca analog (SM-001) in healthy adult volunteers

The Investigational New Drug SM-001 is formulated as a hot water decoction of two clonal cultivars of the Peruvian plants, Banisteriopsis caapi (BC) and Psychotria viridis (PV). It represents a modern formulation of an ancient Amazonian botanical medicine, "ayahuasca" ("vine of the soul") that is used by many native South American indigenous and mestizo groups for both religious and medicinal purposes.

This initial Phase 1 study is to be conducted as an open label, dose-ranging safety assessment of a single dose of SM-001 taken orally by healthy adult volunteers. Twelve adult men and women, ages 25-65 years, will be consecutively assigned to one of three dose levels, 4 subjects per group (2 M; 2 F). In the presence of the Clinical Investigator(s), each subject will receive a single dose of SM-001, administered at the Clinical Study Site as a liquid at one of three dose levels: 0.25, 0.5, or1.5 ml SM-001 per kg body weight. To assess systemic exposure to SM-001, plasma levels of the four biomarkers, dimethyltryptamine, harmine, tetrahydroharmine, and harmaline will be measured. Blood samples will be drawn at baseline, HR 0 (pre-Study Drug dose), and then at HR 1, 2, 4, 8, and 24 post dose. Subjects will return to the Clinical Study Site at Study Day 28 for a final in-person assessment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults: men and women ages 25-65 years of age
* Previous experience with a psychedelic drug
* Vital Signs within normal limits for temperature (oral), respiratory rate, heart rate
* Normal blood pressure (for age) in the absence of antihypertensive drugs
* Normal complete blood count and differential, platelets, coagulation ((PT/PTT)
* Liver function tests ≤ 1.5X upper limits of normal
* Renal function (BUN, serum Creatinine) - within normal limits
* Able to understand and willing to comply with Study Protocol requirements.
* Willing to abstain from alcohol for at least 72 hours prior to and following Study Day 0
* No use of recreational drugs for at least 14 days prior to Study Day 0.
* Women who are not pregnant or lactating.

Exclusion Criteria (None can apply):

* Body Mass Index \> 30 or \< 20
* Systemic condition that includes, but is not limited to: hematological, immunological, hepatic, renal, cardiac, neurological conditions that is under current treatment or causes abnormal physical or laboratory parameters.
* History of seizures
* History of drug or alcohol abuse
* History of psychiatric disorder or history of significant trauma, as defined by DSM- V.
* Use of SSRIs, MAO inhibitors, or other psychoactive compounds either pharmaceutical drugs or botanical in origin (i.e., 5-HTP, St John's Wort)
* Any condition which, in the opinion of the Investigators, would preclude the use of the test article or the successful completion of the study.