cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant of Tislelizumab Combined With Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC

The purpose of this conversion therapy study is to evaluate the safety and efficacy of neoadjuvant of Tislelizumab combined with platinum doublet for stage III unresectable locally advanced NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided.
* Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
* ECOG score is 0 or 1.
* Adequate hematological function, liver function and renal function.

Exclusion Criteria:

* Previously received systemic anti-tumor therapy for non-small cell lung cancer.
* history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
* History or active pulmonary tuberculosis.
* Active infections that require systemic treatment.
* History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
* Untreated active Hepatitis B.
* Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
* Grade 3 or above peripheral neuropathy.
* Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
* Underlying severe or uncontrolled disease.
* Malignant tumors other than NSCLC within 5 years.
* Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.
A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee

This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo).

Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 40 and ≤ 75 years of age.
2. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
3. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria:

1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
2. Patients with joint replacement in the affected knee.
3. Patients with peripheral neuropathy due to any reason.
Combined Spinal- Epidural Anesthesia in Patients With Dilated Cardiomyopathy

This study was conducted on 24 patients who have ischemic dilated cardiomyopathy, underwent non cardiac surgery in the lower half of the body under the effect of combined spinal epidural anesthesia at Assiut university hospital. Intraoperative Hemodynamic monitoring including invasive blood pressure, heart rate, and CVP was established, in addition to pre and postoperative, 12 lead ECG, echocardiography, and venous sampling for Brain natriuretic peptide measurement were done .

This study tried to assess the safety of this anesthetic technique on such group of cardiac patients along over the hospital stay period and up to 6 months postoperatively, in addition to the predictability of Brain natriuretic peptide as a cardiac biomarker regarding to the major adverse cardiac events and cardiac mortality for these group of patients .

Dilated cardiomyopathy (DCM) is characterized by ventricular dilatation and impaired systolic cardiac function. Anesthetic management, of patients with cardiomyopathy with reduced systolic function, is challenging and may be associated with high mortality.

Objective: The purpose of this study was to evaluate the hemodynamic effects of combined spinal epidural anesthesia (CSEA) in patients with dilated cardiomyopathy, underwent vascular surgery in the lower half of the body, in addition to assess the safety of this anesthetic technique in the early postoperative period.

Method: After approval by local research ethics committee of the Faculty of Medicine, and informed written consent obtained from all patients, 24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under CSEA. The effects of CSEA on hemodynamics; IBP, HR and CVP (measured at base line and then every 10 min), in addition to cardiac complications during the hospital stay period were studied.

Eligibility Criteria:
Inclusion Criteria:

* 24 patients Cardiomyopathy DCM underwent infra-inguinal vascular surgery under the effect of combined spinal epidural technique were included in a prospective trial single center observational study.

Exclusion Criteria:

* Patients with significant fluid and electrolyte imbalance, major arrhythmias or heart failure or unstable angina, systolic blood pressure at rest \< 100 mmHg, heart rate \< 50, serum creatinine \>2.0 mg /dl, and patients who required emergency surgery were excluded from the study.
Skin Surface's Temperature Change When Auricular Acupuncture at Jaw Point and Tooth Point

Auricular acupuncture is a method for diagnosing and treating physical and psychosomatic dysfunctions by stimulating a specific point in the ear. Some studies prove that the acupoints on the pinna have a corresponding relationship to the areas of the body. Some research also show that acupuncture acupoints on the body can change the temperature of the corresponding area. In our study, we survey the skin surface's temperature change when using auricular acupuncture at jaw point and tooth point in each side of the ear in heatlhy people.

Participants and Methods: A crossover study is conducted by comparing the in skin surface's temperature change before and after applying auricular acupuncture at Jaw point (LO1) and Tooth point (LO3) in each side of the ear in heatlhy volunteer. A total of 70 participants were randomly assigned to 2 group (A and B) and the allocation was 1:1. In group A: participants received auricular acupuncture at tooth point (LO1) three times: Left ear, Right ear and Sham accupunture. Similarly, LO1 point was replaced by LO3 point (Jaw point) for participants in group B. The primary outcome was change temperature of skin surface at the pinna and lower jaw when using auricular acupuncture at points: LO1 and LO3 in each side of the ear. This trial will be performed as 2-arm crossover design, randomized, controlled.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer with normal vital signs
* Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials
* DASS 21 score within normal limits
* BMI: 18.5 - 23 kg/m2

Exclusion Criteria:

* Inappropriate condition for auricular acupuncture due to skin disease (the skin of the acupuncture point is swollen, hot and red)
* Pregnant woman or breastfeeding woman or woman in period
* Other diseases that could affect or interfere with outcomes, including cardiovascular disease, thyroid disorder, facial disease.
* Taking vasodilators or sunscreen in the examined skin areas
* Taking stimulant (alcohol, beer, coffee, tobacco) within 24h
* Massage or cupping therapy or acupuncture in facial area within 24h
* Playing sport within 2h
The Effects of Performing a Motor Imagery Task on Cortical Excitability During Acute Experimental Muscle Pain and Acute Itch

The aim of this project is to determine the effects of performing a motor imagery task on cortical excitability during acute experimental muscle pain (induced by hypertonic saline), acute histaminergic itch (induced by histamine), and non-histaminergic itch stimulation (triggered by Cowhage). We hypothesize that motor imagery will counteract the alterations in cortical excitability observed during experimental muscle pain and both itch models.

Itch and pain share many similarities and dissimilarities in terms of the mechanisms and molecules involved. Many studies have been conducted to explain all the neurophysiological aspects involved in the pain process, and cortical adaptations have been provoked in healthy individuals using experimental pain models. Unfortunately, all these aspects still need to be clarified regarding itch. Has been previously demonstrated that motor imagery can counteracted the pain-induced decrease in corticospinal excitability observed during acute pain, and it has also been proposed as a potential intervention for individuals with pain to restore maladaptive neuroplasticity. However, whether motor imagery can similarly counteract the itch-induced cortical changes remains unclear. Therefore, the aim of this project is to investigate whether motor imagery would counteract the reduction in cortical excitability during acute itch, similar to the effects observed in the context of acute pain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
* Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder (e.g., heart stroke), or psychiatric diagnoses (e.g. depression) that may affect the results
* Current use of medications that may affect the trial, such as antihistamines, antipsychotics, and painkillers, as well as systemic or topical steroids
* Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
* Moles, scars, or tattoos in the area to be treated or tested.
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Unable to pass the "Transcranial Magnetic Stimulation Adult Safety Screen" (subproject 1 and 2)
* Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.)
* Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos
* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
* Lack of ability to cooperate
Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 yrs old
* pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment
* conservative treatment has failed and surgical intervention is recommend as standard of care
* ability to give informed consent

Exclusion Criteria:

* had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis
* congenital deformities, tendon ruptures or elbow fractures within the past year
* co-existing elbow diagnosis (i.e. osteoarthritis or instability)
* pregnant women, women trying to get pregnant, or breastfeeding mothers
* under the age of 18 or over 65
* incapable of giving informed consent
Tight Glycemic Control by Artificial Pancreas

Hyperglycaemia has been repeatedly associated with risk of mortality and morbidity in the intensive care unit (ICU). The evidence currently available is in favour of a 'normal ≤ 6.1 mmol/l' level for blood glucose control in ICUs according to two large randomized control trials of Van den Berghe G and is not supportive of J. Miles's viewpoint in this debate. In this study, the investigators would like to evaluate that the target of blood glucose level, whether is a normal level (80-110 mg/dL) or another level (140-160 mg/dL), should be set for the reduction of perioperative mortality and complications.

Our previous prospective randomized clinical trial suggested that the postoperative morbidities were reduced by tight glycemic control of a normal level for blood glucose using artificial pancreas. However, the most feared one is hypoglycaemia, which, when severe and prolonged, may cause convulsions, coma and brain damage, as well as cardiac arrhythmias. Recently, Ven den Berghe G report that the development of accurate, continuous blood glucose monitoring devices, and preferably closed-loop systems for computer-assisted blood glucose control in the ICU, will help to avoid hypoglycaemia. In our study, no hypoglycemia showed in more than 100 patients who performed perioperative tight glycemic control by artificial pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were suffering from liver, pancreas or cardio-vascular diseases, were informed of the purpose and details of the study, and written consent was obtained from them prior to enrolment.

Exclusion Criteria:

* Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery
* The presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.
Aqueous Mushroom Extract and Intraocular Pressure

The purpose of this study is to determine the effect of Aqueous mushroom extract (AME) on intra ocular pressure (IOP) in humans or as a potential anti glaucoma drug.

The Prophet of Islam (Peace Be On Him) was reported to have said that 'mushroom are like manna and their water heals eye diseases'(Sahih Bukhari 1985). This statement is being investigated in view of the link between blood pressure and intra ocular pressure.

Glaucoma which is a sight threatening disease and is associated with raised intraocular pressure has been treated for a long time with beta blockers. Nowadays the drugs of choice are prostaglandin analogs. This study seeks to discover the effect of pleurotus tuberregium on raised intraocular pressure and to compare its effect on I.O.P with that of known glaucoma drugs. This study also seeks to find out at what concentration pleurotus is effective significantly on raised intraocular pressure

Clinical Investigation will be conducted in the Ophthalmological unit of UBTH in two phases. In the first phase 21 relatively young healthy subjects aged less than 50 yrs will be recruited for this study after their informed consent. They will have no previous systemic or ocular diseases and have an intraocular pressure of 19mmHg or less and a visual acuity of 6/6. Base line investigations will include the systolic and diastolic blood pressure, horizontal pupillary diameter and applanation tonometry. The subjects will be divided into three groups of seven each (A1, A2 and A3).

The study will at first constitute two weeks mushroom treatment, two weeks no mushroom treatment and then two weeks mushroom treatment. Treatment will be with aqueous extract of Oyster Medicinal mushroom Extract (4g/100ml) dose: п gutt tid x 1/52 for A1, 2g/100ml dose: п gutt tid x 1/52 for A2 and 1g/100ml dose: п gutt tid x 1/52 for A3. Investigations of the baseline parameters will be done at the start and after each seven days. The subjects will be monitored to ensure full compliance with the designed protocol.

The second phase will involve an equal number of age matched ocular hypertensive or glaucoma patient undergoing treatment in UBTH. They will also be divided into three groups of seven each and the treatment regimen above repeated. The IOP in this case will be taken by a masked observer.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of open angle glaucoma
* intraocular pressure above 23mmHg

Exclusion Criteria:

* close angle glaucoma
* end stage of glaucoma visual field loss
* ocular disease other than glaucoma that will interfere with result
Neural Correlates of Working Memory Training for HIV Patients

Despite potent combination antiretroviral therapy, cognitive (memory and concentration) problems continue to occur in up to 50% of HIV-infected individuals, especially in older infected individuals, and those who abuse alcohol, marijuana or psychostimulants. Since no effective treatments are available to these individuals with cognitive problems, conservative estimates indicate that the cost of care for these patients could double in the next two decades. To address this urgent problem, this study will use a comprehensive approach (cognitive tests, functional MRI and several biomarkers) to evaluate whether a novel computer-based training program would improve the brain function, especially working memory and attention, in HIV-infected and infected individuals.

The Overall Goals are to perform a double blind placebo-controlled study using Cogmed™ to determine whether this adaptive WM training program will benefit HIV-infected individuals, and whether the investigators can identify individuals who might benefit most from the working memory (WM) training. Lastly, the investigators will explore how brain activation, neuroinflammation and cerebrospinal fluid (CSF) monoamine levels might be related to WM function before and after the training.

Eligibility Criteria:
Inclusion Criteria for HIV-infected participants :

1. Men or women of any ethnicity, ages\>18 years and able to provide informed consent,
2. HIV seropositive (with documentation from medical records),
3. Stable on an antiretroviral regimen for 6 months or will remain without antiretroviral treatment during the duration of the study.

Inclusion Criteria for Seronegative (SN) healthy participants :

1. Men or women of any ethnicity, ages \> 18 years and able to give informed consent,
2. Seronegative for HIV

Exclusion criteria :

1. Confounding co-morbid psychiatric illness
2. Confounding neurological disorders
3. Abnormal screening laboratory tests (\>2 SD) that might indicate a chronic medical condition (e.g. diabetes, severe cardiac, renal or liver disorders)
4. Medications that might influence outcome measures
5. Current or history of drug dependence within the past two years
6. Positive urine toxicology screen
7. Inability to read at an 8th grade level
8. Other contraindications for MR studies
Efficacy and Safety of Acenocoumarol for Treatment of Nontumor Portal Vein Thrombosis in Cirrhosis of Liver

After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into either interventional (acenocoumarol) or placebo group along with first five days of subcutaneous Low Molecular Weight Heparin inj. Enoxaparin in the interventional arm and placebo injection in the control arm. Every 3 monthly the Doppler screening for recanalization of portal vein thrombus will be done with monitoring of International Normalized Ratio (INR)with target INR 2-3. Both the groups will receive the therapy for one year irrespective of the Doppler findings in relation to portal vein thrombus re-canalization.Then one year drug free monitoring will be done in both the groups as per the primary or secondary outcome. .


Eligibility Criteria:
Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis
* Partial or total Portal vein thrombus (evidence of chronic thrombus)
* Informed consent to participate in the study

Exclusion Criteria:

* Acute thrombus in Portal vein
* Hepatocellular carcinoma or any other malignancy,
* Hypercoagulable state other than the liver disease related
* DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
* Base line INR \>2
* Child Turcott Pugh score\>11
* Recent peptic ulcer disease
* History of Hemorrhagic stroke
* Pregnancy.
* Uncontrolled Hypertension
* Age\>70 yrs
* Non responders to beta-blocker requiring Endoscopic Variceal Ligation
A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART

To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.


Eligibility Criteria:
Inclusion Criteria:

* Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept

Exclusion Criteria:

* None
Immunonutritional Supplement After Total Gastrectomy in Patients With Stage III Gastric Cancer

Gastric cancer patients with stage III will be randomized to immune nutrition support or control group at discharge after total gastrectomy. Patients will receive 6 months of immune nutrition support or normal diet after discharge. The primary and secondary outcomes will be collected.

Gastric cancer patients with stage III after total gastrectomy at discharge, if she/he has nutrition risk (NRS2002≥3), then she/he will be randomized to immune nutrition support (INS) or control (C) group after discharge. In the INS group, in addition to diet, and patients will also consume two bottles per day of a high-calorie, high-protein ONS and three capsules of fish oil lasted for 6 months. In the C group, patients will receive normal diet. Both groups will receive nutrition counseling.

The primary and secondary outcomes will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent of patients or their legal representatives to participate in this study
2. consecutive adult (≥18 years) patients underwent radical gastrectomy (total gastrectomy) with pathological TNM stage III
3. nutrition Risk Screening (NRS) 2002≥3 at discharge
4. eastern Cooperative Oncology Group (ECOG) score of 0-2 at discharge

Exclusion Criteria:

1. unable to oral or consume ONS
2. has received neoadjuvant chemotherapy
3. pregnancy
4. palliative surgery or gastric stump cancer or Borrmann type IV
5. oral anticoagulants cannot be stopped; congenital acquired immune deficiency disease
6. serious cardiovascular disease including chronic heart failure, angina pectoris, myocardial infarction, arrhythmias (such as atrial fibrillation), or uncontrolled hypertension
7. severe liver and kidney diseases including active hepatitis, cirrhosis, and uremia
8. diabetes has developed complications or uncontrolled by medications
9. previous use of drugs affecting immune function
10. previous use of fish oil capsule \> 2 times / week or contraindications to fish oil capsule
11. motor system diseases cannot complete grip strength measurement and 5-time chair stand test
Effect of Knee Mobilisation on Joint Position Sense and Tissues

The aim of this study is to evaluate the effects of traction mobilizations on position sense in the knee joint and on the biomechanical properties of the knee joint tissues.


Eligibility Criteria:
Inclusion Criteria:

* no lower extremity injuries within the past year,
* no pain within the past seven days and on the day of the study,
* feeling well on the day of the study,
* no intense physical exertion on the day of the study,
* no occurrence of delayed muscle pain on the day of the study and up to three days back.

Exclusion Criteria:

* chronic diseases affecting motor skills,
* lower extremity injuries occurring within a year and treated with a physiotherapist or physician,
* complaints of pain or malaise on the day of the study,
* knee pain within the last 7 days,
* the occurrence of delayed muscle pain up to three days back,
* participation in intense physical exertion on the day of the study.