cyrilzakka/clinical-trials huggingface dataset:
Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age on day of signing informed consent
* Histopathology confirmed non-small cell lung cancer
* Asymptomatic brain metastases
* EGFR/ALK ROS1 driver gene mutation negative
* RECIST 1.1 based available assessment of lesions
* ECOG 0-1
* Brain metastases 1-4
* Single lesion ≤4cm

Exclusion Criteria:

* Patients with contraindication of chemotherapy Pregnant or breast feeding women
Treatment of Discogenic Back Pain

Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects.

In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.


Eligibility Criteria:
Inclusion Criteria:

* MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;
* X rays: normal disc height, no instability;
* Back pain for at least 3 months, without argument for another etiology;
* Mean pain on 5 days VAS ≥ 5

Exclusion Criteria:

* age \<18 years or \> 50 ; concomitant radicular pain ;
* psychiatric pathology that may modify the perception or the evolution of pain;
* MR imaging: multi-level discopathy, MODIC 3 changes;
* X ray: loss of disc height \> 50%, segmental instability;
* previous history of lumbar surgery with or without instrumentation.
XELOX for 4 Months Versus 6 Months in Gastric Cancer (LOMAC)

Our study aims to compare the efficacy and safety of capecitabine and oxaliplatin for 4 months versus 6 months as adjuvant chemotherapy after D2 Gastrectomy in patients with gastric cancer.

Hypothesis: For gastric patients after D2 Gastrectomy, capecitabine and oxaliplatin for 4 months show noninferiority to capecitabine and oxaliplatin for 6 months in disease-free survival (DFS) and safety.

Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. Capecitabine plus oxaliplatin for 6 months after D2 gastrectomy is considered as effective postoperative adjuvant treatment for patients with operable stage II or III gastric cancer in the CLASSIC trail. However, because of adverse events discontinuations in the chemotherapy group occurred in 50 (10%) patients, mainly as a result of nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al reported the result of IDEA trail. For lymph node-positive colon cancer (stage III), some patients may need only half of the long-standing standard course of chemotherapy after surgery. In an analysis of 6 clinical trials with over 12,800 patients, 3 months of chemotherapy was nearly as effective as 6 months in patients with relatively lower recurrence risk and caused fewer side effects, particularly nerve damage. Based on IDEA trail, we postulate that the chemotherapy of capecitabine plus oxaliplatin for 4 months may also benefit patients after D2 gastrectomy and decrease adverse events compared with 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
2. Be proven to be primary adenocarcinoma of gastric cancer and staged II, IIIA or IIIB by pathological evidence
3. R0 resection and D2 Gastrectomy
4. Without any other malignancies
5. PS (ECOG) of 0 or 1 and expected to survive more than 6 months
6. No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L,PLT≥100 x 109 /L and HGB≥90g/L).

Exclusion Criteria:

1. Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
2. Patients with stage I, IIIC and IV.
3. Unavailable for R0 resection and D2 Gastrectomy.
4. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
5. With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension.
6. Any Known or suspected history of drug allergy test.
7. The researchers believe the patient is not able to complete the entire course of the experiment.
8. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
9. Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.
SHR-1316 Combined With Chemotherapy and Chest Radiotherapy in ES-SCLC

This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.

This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4\~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Extensive small cell lung cancer
* Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
* 18 to 75 years old
* The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 times ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
* have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
* The estimated survival period is more than 8 weeks
* With measurable lesion defined by the RECIST v1.1: Previously irradiated lesions may only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation and the previously irradiated lesion is not the only site of disease;
* Signed written informed consent prior to study entry

Exclusion Criteria:

* Active or untreated CNS metastases
* Leptomeningeal diseases
* Uncontrolled or symptomatic hypercalcemia
* Active, known or suspected autoimmune diseases
* have received any T cell co stimulation or immune checkpoint therapy
* Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug.
* Subjects had active infections.
* Failing to properly control the clinical symptoms or disease of the heart
* Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
* Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to cisplatin or etoposide
* According to the researcher's judgment, there are other factors that may lead to the termination of the study
IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women

FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.


Eligibility Criteria:
Inclusion Criteria:

* Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.

Exclusion Criteria:

* women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies;
* women who had had menarche less than 1 years before evaluation or who were older than 49;
* women who received hormones or drugs for major medical diseases within three months.
Exercise Effects in Children With Attention Deficit Hyperactivity Disorder

The study will investigate catecholamines responses, and cognitive effects of exercise in children with attention deficit hyperactivity disorder, and the effect of exercise training on these measures.

A leading pathophysiologic hypothesis of attention-deficit/hyperactivity disorder (ADHD) is based on the notion of a catecholamine \[CA; norepinephrine (NE), epinephrine (EPI), and dopamine (DA)\] dysfunction. This hypothesis suggests that the CA response to environmental stimuli is attenuated in ADHD and is derived primarily from observations that drugs such as methylphenidate and amphetamine - considered to be CA agonists - are effective in treating the symptoms of ADHD. Despite this compelling evidence, a definitive role of CA responsiveness in ADHD remains controversial. Physical activity is widely known to be a powerful stimulus of the hypothalamic-pituitary-adrenal (HPA) and noradrenergic systems. On the basis of the nation of a CA dysfunction in ADHD, we reasoned that the normal robust increase in circulating CA seen in response to exercise would be blunted in children with ADHD.

The objective of this study is to examine the possibility that exercise program and testing might be useful in differentiating CA responses to stress between children who had received a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and age- and gender-matched controls.

This study will take place in 'Children and adolescence health and sports center' in Meir Medical Center, Kfar-Saba, Israel. Forty-five children, boys and girls between the ages 6 and 18, with newly diagnosed ADHD that not receiving any drugs will be assigned to the intervention group. Age and gender matched children with ADHD, receiving Ritalin and not engaged in regular exercise, or healthy children's without ADHD will serve as controls. The intervention group will participate in an exercise program, including aerobic and anaerobic components, twice a week, for 3 months. Exercise testing, blood sampling and cognitive assessment will be performed at the start and in the end of this study.

Eligibility Criteria:
Inclusion Criteria:

* boys and girls between the ages 6 and 18, with newly diagnosed ADHD.

Exclusion Criteria:

* children with ADHD on medications
Scalp Blocks for Pediatric External Ventricular Drainage Placement

External ventricular drainage (EVD) provides cerebrospinal fluid drainage in hydrocephalus. In adults, the neurosurgeon can place EVD at the bedside. In children, it is mainly preferred to be placed in the operating room under general anesthesia. However, general anesthesia may negatively affect oxygenation (during the intubation period) or cerebral blood flow (due to hypotension). This study investigates the use of regional block methods (without general anesthesia) in children for EVD placement.

External ventricular drainage (EVD) provides cerebrospinal fluid drainage in hydrocephalus. In adults, EVD can be placed by the neurosurgeon at the bedside. In children, it is mainly preferred to be placed in the operating room under general anesthesia. However, general anesthesia may negatively affect oxygenation during a prolonged intubation period, leading to hypoxemia. Furthermore, hypotensive effects of general anesthesia may cause ischemia due to decreased cerebral blood flow.

Additionally, on the other hand, painful stimuli caused by surgical incisions or pins may cause hemorrhagic events due to a hypertensive period. Therefore, scalp blocks and local anesthetic infiltrations are recommended to prevent such adverse events. Although general anesthesia has been a routine for many anesthesiologists for EVD placement in children, this research hypothesizes that scalp blocks (along with sedatives) can be used as an anesthesia method for EVD placement.

This study investigates the use of regional block methods (to avoid general anesthesia) in children for EVD placement.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing external ventricular drainage

Exclusion Criteria:

* Children who were intubated preoperatively.
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.

The three metrics are:

1. the time taken to complete the operation
2. drainage volume in the days immediately following surgery,
3. patient pain in the days immediately following surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health.

Exclusion Criteria:

* under 18 years of age
A Safety Study of Mebendazole in Children 2 to 10 Years of Age

The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population. Mebendazole is a drug used for the treatment of soil-transmitted parasitic helminth (STH) (ie, parasitic worm) infections such as pinworm, whipworm, common roundworm, common hookworm, and American hookworm.

This is an open-label (identity of study drug will be known to study participant and investigator), single-center, single-dose, single-arm (ie, 1 treatment group) safety study. This study will consist of a screening visit on Day 1 at which time all study-related screening procedures will be performed. After all results are reviewed, children who meet all of the inclusion criteria and none of the exclusion criteria will be entered into the open-label phase of the study. A single mebendazole 500-mg chewable tablet will be administered on Day 1 and the children will remain at the study site so that adverse events can be recorded at approximately 30 minutes postdose. Study participants will return to the study site 3 days (plus or minus 1 day) postdose at which time adverse events will be recorded again. Safety will be monitored during the study by assessing adverse events by direct observation at 30 minutes after dosing and at 3 days (plus or minus 1 day) after dosing, by direct observation of the study participant, report by the parent or guardian, or both. On Day 1, a single mebendazole 500-mg chewable tablet will be chewed and swallowed by each study participant. If desired, study participants will be allowed to drink water when administered study drug.

Eligibility Criteria:
Inclusion Criteria:

* Be an otherwise healthy child based on medical history, physical examination, vital signs, and concomitant medications and live in a high-prevalence area where parasite infection is endemic (ie, Prevalent in or peculiar to a particular locality, region, or people)
* Have teeth and be able to chew the mebendazole chewable tablet
* Girls must be premenarchal
* Parent(s)/guardians of study participants (or their legally-accepted representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to have their child participate in the study

Exclusion Criteria:

* Have a history of clinically significant liver or renal insufficiency
* cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic (eg, anemia), rheumatologic, psychiatric, or metabolic disturbances that, in the opinion of the investigator, renders the candidate not suitable for mebendazole treatment
* Have a suspected massive intestinal parasitic infection, based on history and physical findings, as determined by the principal investigator
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the study participant or the study or prevent the study participant from meeting or performing study requirements
A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged over 18 years
* Histologically proven lung adenocarcinoma
* clinical stage IIIB/IV
* ECOG performance status 0-2
* Had no prior anticancer agent, radiation or surgical therapy for lung adenocarcinoma
* At least one measurable lesion (according to RECIST)
* Provision of written informed consent
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* History of malignant disease.
* Evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
* Expected life expectancy less than 2 months
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
* Aspartate aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x ULN if no demonstrable liver metastases (or \>5 x in presence of liver metastases)
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
* Pregnancy or breast-feeding women (women of child¬bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement

This single-arm, open-label study will assess the safety and tolerability of one daily tablet of a commercially available cardiovascular health dietary supplement by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Although the cardiovascular health dietary supplement being investigated has been on the market for over 20 years, prospective safety data and blood markers of end organ function have not previously been reported.

Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events, including myocardial infarction and stroke, and cardiovascular-related mortality with advancing age. Based on population based studies and clinical trials, both systolic blood pressure (SBP) and diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors for cardiovascular disease.

The product being studies is a cardiovascular health dietary supplement that has been commercially available since 1993. It is currently sold to healthcare practitioners as well as directly to consumers. Some healthcare providers use the product as part of a plan to treat high blood pressure in their patients. This is the first study collecting prospective safety data on this product.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg upon screening

Exclusion Criteria:

* Bradycardia
* Initiation of or changes to blood pressure lowering medications within the last month
* Initiation of or changes to thyroid medications within the last month
* Currently taking any of the following orally (or they were taken within the last month):

  * Rauwolfia serpentina, Terminalia arjuna, Tribulus terrestris, Convolvulus pluricaulis, Boerhavia diffusa, Rosa vinca, rose powder, or coral powder
  * Beta blockers
  * Alpha blockers
  * Propranolol
  * Digoxin
  * Levodopa
  * Anti-depressant medications
  * Anti-psychotic medications
  * Sedatives or tranquilizers
* Present or past history of any of the following:

  * Cardiovascular disease
  * Heart surgery
  * Cardiac arrhythmia
  * Abnormal EKG
  * Abnormal echocardiogram
  * Diabetes
  * Chronic liver, kidney or bowel disease
  * Ulcers
  * Gallbladder disease
  * Depression
  * Alcoholism
  * Obstructive sleep apnea and/or use of a continuous positive airway pressure device
  * Parkinson's disease
  * Pheochromocytoma
  * Cancer within the last 5 years
* Consuming more than fourteen alcoholic beverages per week
* Current smoking/tobacco use
* Current illicit and/or recreational drug use
* Women who are lactating, pregnant or planning pregnancy within the next six months
* Known intolerance or allergy to study agents
Psychological and Physiological Status of Former Prisoners of War

Assessing the psychological and physiological status of Israeli former prisoners of war (POW).


Eligibility Criteria:
Inclusion Criteria:

* Former POW

Exclusion Criteria:

* Was not defined
Accuracy of Handheld and Non-contact Tonometry

Monitoring the intraocular pressure (IOP) is one of the most important tests used in follow-up among glaucoma suspects and confirmed glaucomatous patients.

In tertiary hospitals, IOP screening is an important tool to confirm glaucomatous eyes. Inaccurate measurements may lead to missed diagnosis or false positive results that may affect patients' quality of life.

There are many devices produced to measure IOP, the commonest one is Goldman contact tonometry, the aim of this study is to compare the results of new developed tonometers to the standard applanation tonometer.

Eligibility Criteria:
Inclusion Criteria:

* All subjects seeking regular check-up in glaucoma clinic at banha university hospital.
* Glaucoma suspects and glaucomatous patients that visit glaucoma clinic for regular IOP measurements.

Exclusion Criteria:

* Patients that will refuse to measure IOP again with other devices.
* patients with previous corneal surgeries or scar that may alter the measurements of the tonometer s (as previous keratoplasty, trauma or opacities).