cyrilzakka/clinical-trials huggingface dataset:
Evaluating Tocilizumab for Sever COVID-19 Infection in Breast Cancer vs. Non Cancer Pateints

To compare evaluating Clinical outcomes for patients treated with with or without breast cancer patients comorbidity for sever COVID-19 infection in breast cancer patients versus non cancer patients and evaluating Tocilizumab efficacy versus traditional therapy

Cancer patients considered to be one of the least population that can be considered lucky during COVID 19 pandemic attributed that to long term treatment with chemotherapy, immunosuppression and multi comorbidities . Women with breast cancer are more likely to get covid-19 infection rather than other type cancers . the co-existing of two diseases breast cancer and Covid19 are very challengeable due to confusion and similarities found in clinical biomarkers to evaluate both diseases as ferritin, D dimers and C-reactive protein and all other immune response and cytokine storm syndrome especially including interleukin-6 (IL-6) . using chemotherapy or any other cytotoxic drugs may exacerbate the severity of COVID -19 infection as well as poor clinical outcomes and even death are expected . The anti-human IL-6R monoclonal antibody (Tocilizumab) was used first in China in patients with severe COVID-19 and patients improved in different clinical outcome . In cancer patients particularly the issue is debatable about the benefits of receiving Tocilizumab.

Clinical studies are going on such medication role in treatment of patients with severe covid 19 infection however, studies have not clearly addressed the role of Tocilizumab breast cancer patient compared to non-cancer patients. This study aims to measure different clinical outcomes after using Tocilizumab in sever covid 19 infection in breast cancer patients vs. non cancer patients

Eligibility Criteria:
Inclusion Criteria:

1. patients admitted to ICU with or without breast cancer (non-metastatic) comorbidity
2. age 18-85 years' old
3. moderate to sever confirmed COVID 19 infection through PCR and CT
4. male or female
5. confirmed Covid-19 by PCR
6. Requiring ICU admission
7. WITH evidence of severe COVID-19 (at least 2 of the following):

   1. Fever \> 38C within 72 hours
   2. Pulmonary infiltrate on chest X ray /ground glass opacity
   3. Need for supplemental O2 to maintain saturation \> 92%
8. AND at least 1 of the following:

   1. Ferritin \> 500 ng/ml
   2. CRP \> 50 mg/L
   3. LDH \>250 U/L
   4. D-dimer \> 1000 ng/mL
9. all patient assigned informed consent

Exclusion Criteria:

1. above 85 years' old
2. metatastic breast cancer
3. autoimmune disease patients
4. Unable to provide verbal informed consent
5. preganncy
6. Subjects between the ages of 70 and 75 will be excluded if they have NYHA Class III/IV heart failure
7. Active TB
8. Receipt of IV tocilizumab for the treatment of a non-COVID condition within 3 weeks of the first COVID symptom
9. History of hypersensitivity to tocilizumab 7. ANC \<500, Platelets \<50,000\* 8. AST/ALT \> 5X ULN
TARGET-Metabolic Effects

The estimation of calorie needs during routine practice in critically ill patients is highly variable and the thermogenic effect of continuous delivery of enteral nutrition (EN) on overall calorie utilisation in critically ill adults is unknown. The TARGET-ME study is a substudy of the TARGET trial (NCT02306746). The TARGET trial provides the perfect opportunity to measure calorie utilisation via indirect calorimetry (IC) and ventilator-derived carbon dioxide production (VCO2) to compare measured calorie utilisation to estimation methods, determine the potential thermic effect of EN solutions with different energy concentrations and investigate any associations with outcome.


Eligibility Criteria:
Inclusion Criteria:

Patients must first meet the inclusion and none of the exclusion criteria for the TARGET main trail (NCT02306746). The following additional criteria applies for this study when indirect calorimetry is being used:

* Within 48 hours of randomisation to TARGET (first measurement only)
* Fi02 \< 50% for the past 1 hour
* Positive end expiratory pressure (PEEP) \< 12 mmHg for the past 1 hour
* The IC test can be conducted within 48 hours of randomisation to TARGET
* The patient is not considered agitated using the usual site assessment
* There is a clinician available to complete the test

Exclusion Criteria:

* There is an air leak in the ventilation circuit (ie bubbling inter-costal catheters, cuff leak at the endotracheal tube
* The patient is receiving renal replacement therapy or extracorporeal membrane oxygenation at the time of measurement
* Has had surgery in the last 6 hours (if enough time within the 48 hour window, consider waiting until this criteria is less than 6 hours)
* If the patient has a traumatic brain injury, for the previous 6 hours, their intracranial pressures have been unstable and in the opinion of the treating intensivist are not controlled
* The treating clinician believes that the IC test will pose risk to the patient
Quadratus Lumborum Block by Paraspinous Sagittal Shift Approach With Different Concentrations Of Bupivacaine in Hip Surgeries

The aim of this study is to evaluate the optimum concentration of bupivacaine in Paraspinous Sagittal Shift Approach for Quadratus Lumborum Block in hip Surgeries

With the patient in the lateral decubitus and the block side independent, a curvilinear ultrasound transducer (2-5 MHz) will be directed caudally in a sagittal plane 3-4 cm lateral to the lumbar spinous process of L4, which is almost opposite to the iliac crest, producing a longitudinal scan of the lumbar paravertebral region; and thus identifying the transverse processes of L3 and L4, with PM muscle in-between and erector spinae muscle posteriorly.

The probe is shifted slowly to the lateral side until the transverse processes disappear and the QL muscle is evident in its long axis attached caudally to the iliac crest with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, QL, and PM muscles respectively. After subcutaneous local infiltration with lidocaine at the cephalic end of the probe, the block needle is advanced in a cephalo-caudal direction, through the erector spinae and QL muscles, until it pierces the epimysium of the QL. LA is injected anterior to the QL muscle, observing its spread in a caudal direction towards the iliac crest between the QL and psoas muscles

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II undergoing hip surgery.

Exclusion Criteria:

* Contraindications for regional blocks (eg. Patient refusal Infection at the injection site, coagulopathy) allergic reaction to drugs. opium addiction, any drug or substance abuse
FitMi PD Home Therapy for Parkinson's Disease

The investigators will run an at-home usability study of a newly developed home exercise device (FitMi PD) for individuals with Parkinson's disease. FitMi PD uses embedded sensors that can track and record the user's direction and degree of movement while performing exercises described on a computer.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate PD (Hoehn and Yahr stage I to III)
* Mini-Mental State Examination greater than 28

Exclusion Criteria:

* Age less than 18 years old
Value of Capnography During Nurse Administered Propofol Sedation (NAPS)

Propofol is widely used by anaesthesiologists for deep sedation and general anaesthesia. During recent years nurses trained in the use of low dose Propofol sedation (NAPS) during endoscopy have been introduced. The method has been implemented at the endoscopic unit at Gentofte hospital since 2008(1). Propofol has a respiratory depressive effect which may result in depressed oxygen saturation in the blood (hypoxia). Due to a short acting half life this is prevented in the majority of cases. However, in spite of this, hypoxia is experienced in 4,4% of patients receiving propofol during endoscopy at Gentofte Hospital (unpublished data). It is well known that hypoxia constitutes a late expression of reduced oxygen tension in peripheral tissues. Whether the addition of capnography to standard monitoring during NAPS may be of benefit is widely unknown. The aim of this study is to examine whether the additional use of capnography to standard monitoring during endoscopy may improve patient safety in patients undergoing low dose Propofol sedation by reducing the number, duration and level of hypoxic events. The trial is a randomized clinical prospective case-control study.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or above
* compliant with the criteria of NAPS.

Exclusion Criteria:

* no signed written consent obtained
* American Society of Anaesthesiologists (ASA) physical status classification \> 3
* sleep apnoea
* allergy against soy, eggs and peanuts
* body Mass Index (BMI) \> 35 kg/m2
* mallampati Score ≥ 4
* acute gastrointestinal bleeding
* subileus
* ventricular retention
* severe COLD ((30% ≤ FEV1 \<50%)
* failed data collection
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

The mortality of chronic heart failure patients remains high, in spite of recent treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80, both sex.
2. Left ventricular ejection fraction (LVEF)≤40% (ECHO).
3. NYNA functional class III\~Ⅳ.
4. Clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain).
5. Capable of signing the informed consent form.

Exclusion Criteria:

1. Patients with acute pulmonary edema or acute hemodynamic disorder.
2. Patients with right heart failure caused by pulmonary disease.
3. Patients diagnosed with pericardial effusion or pleural effusion.
4. Patients with myocardial infarction during the preceding 3 months.
5. Patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension.
6. Unstable angina pectoris.
7. Cardiac surgery or cerebrovascular accident within recent six months.
8. Preparing for heart transplantation.
9. Serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia).
10. Serious hepatic or renal dysfunction caused by organic pathological changes (Cr\>3.0mg/dl, AST or ALT 10 times above the normal upper limit).
11. Serum potassium \<3.2 mmol/L or \>5.5 mmol/L.
12. Systolic blood pressure \<90mmHg or \>160mmHg.
13. Pregnant or plan to pregnant.
14. Patients who participated in any clinical trial in the recent three months.
15. Subject with a life expectancy less than 3 months as assessed by the investigator.
16. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism).
17. History of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg DICS or cervical atypia).
18. Evidence (physical examination,CXR,ECHO or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism.
19. Judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).
New Tumor Models in Three Dimensions and in a Human Skin Environment for Personalized Melanoma Therapy

The choice of treatment of patients with metastatic melanoma depends on the status of B-RAF of the tumor: in the absence of mutation, treatment with immunotherapy (currently anti-PD1) is proposed in the first line; When B-RAF is mutated, treatment with targeted therapies is retained: B-RAF and MEK inhibitors are prescribed in combination (vemurafenib + cobimetinib or dabrafenib + trametinib).

Patient response rates for targeted therapies range from 50 to 60%, and the occurrence of sometimes severe side effects is not predictable. There are currently no predictive biomarkers of patients' response to targeted therapy molecules. The in vitro evaluation of the intrinsic sensitivity of the cells of patients to different combinations of targeted therapy molecules would make it possible to propose the best therapeutic combinations. The cutaneous metastases are chosen in the model because of easy access to collect tumor tissue.

The most relevant in vitro models for mimicking cutaneous melanoma metastases are explant cultures and human skin equivalents.


Eligibility Criteria:
Inclusion Criteria:

* Major Patients,
* patients with melanoma (stage IV) with cutaneous metastases,
* seronegative HIV, HBV, HCV, HTLV1.

Exclusion Criteria:

* Absence of cutaneous metastasis or in transit
* HIV or HBV or HCV or HTLV1 seropositivity
* Patient minor, patient under guardianship or curatorship
PEG-ASP+Gemoxd vs. PEG-ASP+CHOP as First-line Chemotherapy to Treatment NK/T-cell Lymphoma With Early Stage

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive subtype of non-Hodgkin's lymphoma and shows extremely poor survival. Several retrospective studies and singe-arm prospective phase 2 studies have shown that pegaspargase combined Gemox or CHOP regimen achieved a promising efficacy in treatment of ENKTL. However, there is no prospective study to compare the efficacy of these two regimens. This prospective pilot study to compare the efficacy and safety of the P-Gemoxd chemotherapy regimen with those of the P-CHOP regimen for stage IE to IIE ENKTL.

Treatment PA-Gemoxd dosages were as follows: days 1 and 5, 30-min intravenous infusion of 800 mg/m2 gemcitabine; day 1, 2-h intravenous infusion of 85 mg/m2 oxaliplatin; day 1, deep intramuscular injection of 2000 U/m2 PEG-ASP at four different sites; d1-5, intravenous infusion of 15mg dexamethasone. The regimen was repeated every 3 weeks for four cycles followed by involved-field radiotherapy after got CR, PR or SD. Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.

Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed, previously untreated ENKTL with stage I/II (for stage I, the patients should have one of the following risk factors: EBV-DNA \> upper limit of normal, lesions beyond nasal, fever, LDH elevation);
2. age range from 18 to 70 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
4. at least one measurable lesion;
5. adequate haematologic function (haemoglobin \> 8.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l),
6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
7. Hepatitis B virus carriers should have normal HBV-DNA copies and should use antiviral drugs. For patients with elevated HBV-DNA, should use antiviral drugs until the HBV-DNA decrease to \< the upper limit of normal.
8. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
9. normal coagulation function and electrocardiogram results.
10. Prior chemotherapy and radiotherapy should have been completed \>4 weeks earlier,
11. willingness to provide written informed consent.

Exclusion Criteria:

1. mismatch the inclusion criteria
2. systematic central nervous system involvement, previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
3. primary lesion not from the upper respiratory
Thickness-Varied Soft Surface on Shoe-Insoles Based on In-Shoe Pressure Measurement

The goal of this cross-sectional study is to evaluate a new shoe insole manufacturing method with the goal of further preventing foot ulceration for people with diabetes. This is achieved by decreasing pressure under risk areas of the foot, often on the insole; the interface between the shoe and the foot. The main question it aims to answer is:

Does a thickness-varied surface based on plantar pressure measurement decrease pressure at high risk areas compared to even thickness surfaces.

Researchers will compare three different pairs of insoles for each participant.

Participants will partake in two sessions. The first one being a pre-measurement and foot status for manufacturing the insoles. During the second session, three pairs of insoles will in a random order be tested for each participant. The pressure measurement of the insoles will be made using F-Scan(TM), while participants walk.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age at the date of signing consent.
* Diabetes mellitus 1 or 2
* Diabetic foot risk group 2: Signs of distal neuropathy and/or peripheral circulatory disorder.
* Able to walk 10 meters without walking aids
* Able to speak and understand Swedish

Exclusion Criteria:

* Diabetic foot risk group 3: Distal neuropathy or peripheral circulatory disorder and foot ulcers, or amputation, foot deformity of clinical importance or skin pathology.
* Diabetic foot risk group 4: Occuring foot ulcer, severe osteoarthropathy or chronic foot pain.
Maintenance Transcranial Electrical Stimulation for Depression

Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.


Eligibility Criteria:
Inclusion Criteria:

* All participants will be ≥ 18 years old.
* Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).

Exclusion Criteria:

* Inadequate response to acute trial of TES.
* Suicidality.
* Clinically defined neurological disorder or insult.
* Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).
* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
* Treatment for depression is changed during months 3-9 of the trial.
A Study to Assess the Ability of 2% Lidocaine Gel to Reduce the Discomfort of Urethral Catheterization

Children 0-24 months of age requiring a urethral catheterization for urine collection will be randomized to receive either topical and intraurethral 2% lidocaine or standard of care to assess for the effectiveness of the former in minimizing pain during urethral catheterization. It is hypothesized that administration of 2% lidocaine gel both topically and intraurethrally will confer a greater degree of pain reduction compared to standard of care.

An estimated 10% of children 0-24 months of age that present to the emergency department (ED) with fever and/or vomiting have a urinary tract infection (UTI). An accurate diagnosis of a UTI ensures timely and appropriate treatment given to reduce the risk of renal scarring, which is the greatest in this age group. To ensure diagnostic accuracy, urethral catheterization is the preferred method to obtain a urine sample from a young child. In contrast to adults, most children do not receive local analgesia for urethral catheterization; despite growing recognition that children experience avoidable pain and discomfort during invasive procedures.

Following informed consent, participants will be randomized by block randomization in a concealed fashion to receive either topical and intraurethral 2% lidocaine or standard of care using a computerized random number generator. The research nurse will access a sequentially numbered, opaque sealed envelope that will contain the participant's group assignment. No adjunctive analgesic methods will be used. A research pharmacist will prepare 2% lidocaine gel in a 3 cc syringe attached to a 24 gauge angiocath. Children \< 7 kg and \> 7 kg will receive 1 cc and 1.5 cc, respectively (2).

The entire procedure will be videotaped and participants pain will be scored using a brow bulging score and visual analogue scale by independent, blinded raters.

Eligibility Criteria:
Inclusion Criteria:

* children 0-24 months of age presenting to the emergency department requiring a urethral catheterization to obtain a urine specimen

Exclusion Criteria:

* unstable
* external genitourinary anomalies
* lidocaine allergy and
* previous catheterization within 24 hours
A Study to Investigate the Effects of Acid Reducing Agents on Pharmacokinetics of PC14586 in Healthy Participants

This study will assess the effect of a Proton Pump Inhibitor (PPI) (rabeprazole) on the pharmacokinetics (PK) of PC14586 and the effect of an H2-receptor antagonist (famotidine) on the PK of PC14586

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. This study will investigate the effects of acid reducing agents on the pharmacokinetics of PC14586.

This is a 2-part, open-label, two-period, fixed-sequence study in healthy participants with each participant used as his/her own control to assess the effect of rabeprazole (Part 1) or famotidine (Part 2) on the PK of PC14586. The results from Part 1 will be analyzed before deciding to, if applicable, progress to Part 2. Part 2 of the study will only be initiated if the findings from Part 1 show an interaction or are inconclusive.

Approximately 25 participants will be enrolled in Part 1 and approximately 25 participants will be enrolled in Part 2. The Study timelines reflect both Part 1 and Part 2.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy, non-smoking males and females, 18-55 years of age, with BMI between 18.5 - 30 kg/m2 inclusive.
2. Agree to use a highly effective method of contraception from 14 days before check-in through 90 days after last dose of study drug.
3. Participants who are capable of giving signed informed consent.

Exclusion Criteria:

1. Participants with significant history or clinical manifestation of any medical condition, disease or disorder, as determined by the Investigator.
2. Positive hepatitis panel and/or positive human immunodeficiency virus test.
3. Use or intend to use any prescription and/or nonprescription medications/products within 14 days prior to check-in.
4. Participation in a clinical study involving last administration of an investigational drug within the past 30 days prior to screening.
5. Participant has blood pressure \> 140 mm systolic or \> 90 mm diastolic at Screening or Day - 1.
6. Participants with a germline TP53 Y220C mutation at Screening.
7. Participant has smoked or used other nicotine-containing products (snuff, chewing tobacco, cigars, pipes, vaporizer, or nicotine-replacement products such as nicotine chewing gum and nicotine plasters) during the 3 months before the Screening Visit.
8. Participant has history of alcohol and/or illicit drug abuse within 5 years of Screening.
9. Participant is unwilling to avoid use of alcohol or alcohol-containing foods, medications, or beverages, 48 hours prior to admission until discharge from the study center.
10. Participant has a history of hypersensitivity to the study drug (PC14586), rabeprazole (Part 1), or famotidine (Part 2) or any of the excipients or to medicinal products with similar chemical structures.
11. Female participant that is breastfeeding (or bottle feeding with their breast milk) or female participant with a positive serum pregnancy test at the Screening Visit or positive serum or urine pregnancy test at Day -1 (admission).