cyrilzakka/clinical-trials huggingface dataset:
Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell Lung Cancer.

This is a randomized, controlled, open-label, phase III trials. The main purpose of this study is to evaluate the effectiveness and safety of tumor treating felds (TTF) combined with stereotactic radiosurgery (SRS) in the treatment of brain metastases from non-small cell lung cancer (NSCLC) .


Eligibility Criteria:
Inclusion Criteria:

1. The age of the subject was between 18 and 75 years old (inclusive), regardless of gender;
2. The predicted survival time was ≥3 months;
3. Newly diagnosed with NSCLC brain metastasis;
4. MRI imaging showed 1-10 unresectable brain metastases;
5. Karnofsky performance status (KPS) score ≥70;
6. Able to operate the TTF independently or with the help of a caregiver;
7. Subjects of childbearing potential had to agree to use effective contraception for the duration of the trial;
8. Voluntarily signed the informed consent form.

Exclusion Criteria:

1. Positive driver genes;
2. Recurrent brain metastasis of NSCLC;
3. Suffering from severe cerebral edema;
4. Leptomeningeal metastases;
5. Participants had to meet certain criteria for bone marrow, liver and kidney function before enrollment, and were not eligible if they had any of the following:

   1. platelet count \< 100×103/μL;
   2. absolute neutrophil count \< 1.5×103/μL;

   d. AST or ALT exceeding 2.5 times the upper limit of normal; c.Total bilirubin more than 1.5 times the upper limit of the normal range; d.Severe renal impairment (serum creatinine \>1.7 mg/dL, or \>150 μmol/L);
6. There were infection, ulcer and unhealed wound in the skin where the electrode was applied；
7. Patients allergic to conductive hydrogels or medical adhesives;
8. Those who are pregnant or preparing to become pregnant or who are breastfeeding;
9. Patients with poor compliance, as judged by the investigator, or other factors considered by the investigator to be not suitable for the study.
Analysis of Internet Addiction, Musculoskeletal Pain and Body Awareness in High School Students

The study will investigate internet addiction, musculoskeletal pain and body awareness in high school students.

Internet addiction is generally defined as not being able to prevent excessive use of the internet, the time spent on other occupations is not as valuable as the internet, excessive irritability and aggressive behavior when deprived.This situation brings with it musculoskeletal pain. Pain in the musculoskeletal system can cause a decrease in body awareness.Long periods of time spent in front of the computer, the use of non-ergonomic tables and chairs affect body awareness by causing deterioration of posture. There are several studies in literature investigating internet addiction and pain, however internet addiction, body awareness and musculoskeletal system problems of high school students have not been investigated yet. In present study, internet addiction, body awareness and musculoskeletal problems will be investigated in high school students.

Eligibility Criteria:
Inclusion Criteria:

* Not having a mental disability that will prevent them from understanding and answering the questions
* 15-18 years old
* Having internet at home
* Volunteering to participate in the study
* Having an individual device that provides internet access

Exclusion Criteria:

* No family approval
* Having an orthopedic, musculoskeletal or neurological disease that will affect body awareness and musculoskeletal system.
A Pharmacokinetics Study to Evaluate Safety and Tolerability of JNJ-37822681 in Participants With Stable Schizophrenia

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics (explores what the body does to the drug) of JNJ-37822681 in participants with stable schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multi-center (conducted in more than one center), randomized (treatment group assigned by chance), and multiple-dose titration study of JNJ-37822681 in participants with stable schizophrenia. The total study duration will be approximately of 8 weeks per participant, consists of 4 parts: Screening (that is, 21 days before study commences on Day 1); Double-blind treatment (14 days); Follow-up (7 to 14 days after last dose administration). Participants will be randomly assigned to treatment with ascending dose levels of JNJ-37822681 once daily and twice daily. Efficacy will primarily be evaluated by Positive and Negative Syndrome Scale and Clinical Global Impression-Severity scale. Safety will be Barnes Akathisia Rating Scale, Abnormal Involuntary Movement Scale and Simpson Angus Rating Scale. Participants' safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* known history of schizophrenia of at least 12 months by the referring psychiatrist
* Positive and Negative Syndrome Scale score at Screening less than 70
* Body Mass Index (BMI) between 18 and 35 kilogram divided by square meter inclusive (BMI =weight per square height)
* Female participants must meet any one of the following: postmenopausal (amenorrhea for at least 12 months and Follicle Stimulating Hormone levels of greater than 40 milli-international unit (MIU ) per milliliter at Screening), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise be incapable of pregnancy)

Exclusion Criteria:

* Any medical condition that could potentially alter the absorption, metabolism or excretion of the study medication, such as Crohn's (serious inflammation of any part of the gastrointestinal tract) disease, liver disease, or renal disease
* Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine or immunologic diseases
* History of neuroleptic malignant syndrome
* Female participants of childbearing potential
* Significant risk of suicidal or violent behavior
Intraperitoneal Dexamethasone vs Dexamethasone Plus Magnesium Sulphate for Pain Relief in Laparoscopic Cholecystectomy

Laparoscopic cholecystectomy has become a standard technique for gall bladder surgery. Benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function and less postoperative pain . However, patients often suffer from considerable pain during the first 24 postoperative hours. Pain can prolong hospital stay and lead to increased morbidity, which is particularly important now that many centers are performing this operation as a day-case procedure. Administration of intraperitoneal local anesthetic, either during or after surgery, is used by as a method of reducing postoperative pain. Although a number of studies have reported a significant reduction in postoperative pain after the use of intraperitoneal analgesia, others have reported no benefit. Several investigations have been conducted in order to find the cause of this pain. According to some of these investigations, the pain is attributed to peritoneal inflammation due to carbon dioxide pneumoperitoneum. Since steroids have been used for reducing inflammation, they may be considered as alternatives for relieving pain. Dexamethasone is a strong long acting glucocorticoid and it is widely used after surgery. it has been established that steroids are effective in relieving postoperative pain in laparoscopic cholecystectomy. Also, administration of magnesium sulphate has been shown to have a potential to prevent postoperative pain and to reduce intra operative anesthetic and analgesic requirements being an antagonist of N-methyl-D-aspartate (NMDA) receptors and its associated ion channels. Some studies showed reduction of pain scores if magnesium sulphate was injected intra-articular and intraperitoneal with no serious adverse effects. In this study the investigators will use intraperitoneal dexamethasone vs dexamethasone plus magnesium sulphate to study their analgesic efficacy after laparoscopic cholecystectomy as the investigators assume that the combination of both drugs will provide stronger analgesia than dexamethasone alone


Eligibility Criteria:
Inclusion Criteria:

1. Age group and gender: between 18 to 60 years both males and females
2. American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

1. Age \< 18 years or \> 60 years
2. ASA physical status III or IV
3. Patients with diabetes
4. Patient refusal to participate in the study
5. Chronic respiratory disease
6. Advanced renal or hepatic diseases
7. Use of opioids, tranquilizers or steroids
8. Confusion or psychiatric illness
9. Acute cholecystectomy
10. Patients with peritoneal drain after surgery
JAK Inhibitor in Acquired Hemophagocytic synDrome in the Intensive Care Unit

Hemophagocytic syndrome (HS) is a rare condition that can be responsible for severe organ failure. Therapeutic guidelines are mainly based on observational studies and expert opinions: no therapeutic advance has been developed for years, explaining why mortality in HS remains high (Intensive Care Unit mortality ranging from 40 to 70%). If etoposide remains the gold standard in critically ill HS patients, nearly 20% of patients are refractory to this therapy: treatment escalation is common, most often requiring the administration of intensive treatments generating high toxicity. Ruxolitinib is the first approved JAK inhibitor. It has been associated with improvement of HS manifestations and survival in a pre-clinical murine model. Data in humans are scarce but promising.

The aim is to demonstrate that ruxolitinib, in association with standard of care, may reverse organ failure (as represented by Sequential Organ Failure Assessment (SOFA) score) better than standard of care alone in critically ill patients with acquired HS.


Eligibility Criteria:
Inclusion Criteria:

* adult patients older than 18 years
* acquired hemophagocytic syndrome, regardless of etiology, defined by the presence of 5 or 6 HLH-2004 criteria or HScore ≥ 200
* admission in the ICU
* need for symptomatic treatment of HS in relation with organ failure, as defined by SOFA score ≥ 4
* Informed consent signed:

  * by the patient,
  * Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent in written
* Or in an emergency situation and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow).
* The inclusion of women of childbearing potential requires the use of a highly effective contraceptive measure. Contraception should be maintained during treatment and one day after

Exclusion Criteria:

* Moribund, defined by a life expectancy \< 48 hours;
* Pregnant or lactating patients (women of childbearing potential must have a negative urine or blood Human Chorionic Gonadotropin pregnancy test prior to trial entry);
* No affiliation to health insurance;
* Known hypersensitivity to ruxolitinib;
* Lactose intolerance;
* Hypersensitivity to cellulose, microcrystalline; magnesium stearate; silica, colloidal anhydrous; sodium starch glycolate (Type A); povidone K30; hydroxypropylcellulose 300 to 600 cps,
* Pre-existing decisions of withholding/withdrawing care,
* History of progressive multifocal leukoencephalopathy
* Uncontrolled cutaneous cancer
* Persons under psychiatric care that would impede understanding of informed consent and optimal treatment and follow-up
* Adults subject to a legal protection measure (guardianship, curatorship and safeguard of justice)
* Patients deprived of their liberty by a judicial or administrative decision
* Participation in another interventional research
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy

This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age between18 years and 75 years.
2. Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
3. Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
4. Presence of at least one measurable lesion (according to RECIST v1.1).
5. ECOG performance status of 0 or 1.
6. Life expectancy of at least 3 months.
7. Adequate bone marrow, liver and kidney function.
8. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value

Exclusion Criteria:

1. Previous T cell co-stimulation or immune checkpoint therapy.
2. Previous received chemoradiotherapy for limited-stage SCLC.
3. Central nervous system metastasis with clinical symptoms.
4. Multiple liver metastases (patients with isolated liver metastases, metastatic lesions \< 3cm could be included).
5. Patients with spinal cord compression.
6. Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
7. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
8. In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
9. Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
11. Severe allergic reactions to any of the monoclonal antibodies are known to occur.
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2
* HbA1c less than or equal to 9.5%
* FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

* Treatment with more than 1IU/kg insulin daily
* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Red Ginseng Extract With Climacteric Symptoms

The purpose of this study is to investigate the positive effects of red ginseng extract on intestinal bacterial changes and immunity, free radicals, antioxidant capacity, and autonomic nervous system changes in age of 40\~75 men and women with climacteric symptoms for 24 weeks.

A screening test is conducted for those who have agreed in writing with a detailed explanation of the purpose of this study and research methods, and then a person who meets the selection / exclusion criteria is selected.

Give a registration number to the person selected as the subject through the screening, and take one pack of the product (3g) once a day for 24 weeks in a human body application test.

Prior to taking the registration number (1Day), the efficacy evaluation items and the safety evaluation items are carried out. At the 24 weeks after the starting point of taking the product of human application test, the evaluation items are conducted through outpatient visits.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 40\~75 men and women
2. Those who visited the menopausal clinic with complaints of climacteric symptoms due to functional deterioration of various organs such as fatigue, helplessness
3. Those who have agreed to voluntarily decide to participate and observe the instructions after hearing the detailed explanation of this human body application test

Exclusion Criteria:

1. Those who have suspected symptoms of acute disease (severe infectious disease, severe trauma, severe diarrhea, vomiting, etc.)
2. Patients with a history of antibiotic treatment for more than 1 month within the last 6 months
3. Those who have gastrointestinal diseases (inflammatory growth disease, active peptic ulcer, etc.) or gastrointestinal surgery (except for simple appendectomy or hernia surgery)
4. Those taking health functional foods, lactic acid bacteria, and red ginseng extracts for the past year
5. Those who are currently participating in other clinical studies or human trials, or participating in clinical trials or human application tests within the past month
Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.

Exclusion Criteria:

* Patients for whom this device would not normally be considered standard of care.
Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.

Autonomic regulation is disturbed in patients with major depressive disorder (MDD), indicated by a higher heart rate (HR) and lower heart rate variability (HRV). Moreover, the heart seems to be functionally connected via the vagus nerve (VN) to other brain structures that are dysregulated in depression, such as the subgenual anterior cingulate cortex (sgACC), and the dorsolateral prefrontal cortex (DLPFC), suggesting dysregulated network function in MDD. In line with this network dysregulation hypothesis of MDD, optimal transcranial magnetic stimulation (TMS) sites are currently thought to be those that show functional connectivity to the sgACC such as the DLPFC and multiple studies have shown that stimulation of the DLPFC, sgACC and nervus vagus decreased heart rate, suggestive of parasymphatetic action. It is hypothesized that this influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the DLPFC-sgACC network, similar to the motor evoked potential (MEP) as functional key measure for primary motor cortex stimulation. Recently, a pilot study was conducted, proposing a new functional neuronavigation method for localizing the frontal area representation of DLPFC-sgACC connectivity using HR, called: Neuro-Cardiac-Guided TMS (NCG-TMS), which is being replicated in the current study. .


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Between ages 18-60

Exclusion Criteria:

* No prior experience with epilepsy
* No pregnancy
* No metal in the head
* No cochlear implants
Show Me to Help Me

This cohort observation, randomized controlled trial is intended to provide data that icons and non-verbal communication improve communication and cooperation with children with Autism/communication delay and aid in the transition to an unfamiliar environment. It would lay the foundation for future studies and practices of using icons and pictures for the whole office visit to enhance communication between the patient and physician/nurse/medical staff and cooperation of the patient.

1. Use icons during triage/check in process to decrease time and increase patient compliance. Compare typical children to those with Autism/communication delay.
2. Use icons during blood draw to improve communication with patients, to help with patient understanding, and increase patient cooperation and decrease noise and length of procedure.


Eligibility Criteria:
Inclusion Criteria:

* established patients with a documented diagnosis
* 4-18 years old
* present to the NeuroDevelopmental Center during the study period
* Lab study: given prescription for lab work that will be following the visit or the next day in the Locust outpatient lab

Exclusion Criteria:

* \<4 years old or \>18 years old
* new patient
* diagnosis not documented
* Lab study: lab work will be drawn at another lab or more than 1 day later
NORepinephrine-Maintaining-individuaALIZEd Blood Pressure

This study compares the effect of individualized vs standard blood pressure management on postoperative myocardial injury in high-risk patients undergoing non-cardiac surgery by measuring the hs-cTnT levels. Continuous norepinephrine infusion is used to target a mean pressure of greater than 65mmHg and a systolic pressure less than 160mmHg in the standardized group while the target is 20% within the ward blood pressure in the individualized group. The pre- and postoperative hs-cTnT levels to detect myocardial injury are compared between the two groups.

Managing the blood pressure preoperatively is important in high-risk patients because hypotension can lead to perioperative myocardial injury. It has been reported that a systolic pressure of less than 50-55mmHg or greater than 40% decrease can lead to cardiac complications. The mechanism of hypotension leading to postoperative myocardial injury is due to hypoperfusion and ischemic reperfusion injury.

In this randomized controlled study, the blood pressure for participants in the standardized group is maintained as follows: mean blood pressure greater than 65mmHg and systolic blood pressure less than 160mmHg. The individualized group participants' blood pressure is maintained at a target of 20% within the preoperative ward blood pressure. Anesthesia and intraoperative management are the same in both groups to target a bispectral index level of 50. In order to quantitatively measure the myocardial injury, high sensitive cardiac troponin T (hs-cTnT) will be measured pre- and postoperatively. A level greater than 14ng/dl has been reported to be associated with myocardial injury and mortality. The objective of this study is to show that the standardized protocol of maintaining a mean pressure greater than 65mmHg is non inferior to the individualized management in terms of postoperative myocardial injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for general or urologic surgeries under general anesthesia at Seoul National University Hospital
* high-risk patients with a revised cardiac risk index of at least 2 points or more

Exclusion Criteria:

* severely uncontrolled hypertension (systolic blood pressure ≥ 180mmHg or mean blood pressure ≥ 110)
* severely uncontrolled hypotension (systolic blood pressure \< 80mmHg)
* arrhythmias with symptoms or use of pacemaker
* transplantation surgery
* acute or decompensated heart failure
* acute coronary syndrome
* sepsis
* end stage renal disease (GFR \<30ml/min/1.73m2)
* contraindications of norepinephrine infusion