cyrilzakka/clinical-trials huggingface dataset:
A Study of RC48-ADC Combined with JS001 for Postoperative Adjuvant Treatment of Upper Tract Urothelial Carcinoma

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with JS001 in postoperative adjuvant therapy for HER2-positive upper tract urothelial carcinoma.

This is an open-label, single-arm clinical trial to evaluate the efficacy and safety of RC48-ADC, a recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate, in combination with JS001, a PD-1 monoclonal antibody, for the postoperative adjuvant treatment of HER2-positive upper tract urothelial carcinoma after radical nephroureterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* ≥18 years of age
* Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component-squamoid differentiation or mixed TCC/SCC is permitted.
* Histologically confirmed TCC staged pT2-pT4 pN0-2 M0 or pTany N1-2 M0 (providing all grossly abnormal nodes are resected).
* Pathological tissue immunohistochemistry HER2 2\~3+
* Fit and willing to receive adjuvant therapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
* ECOG(Eastern Cooperative Oncology Group) performance is 0\~2.
* Available for long-term follow-up

Exclusion Criteria:

* Evidence of distant metastases
* Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
* Un-resected macroscopic nodal disease
* Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
* Significant co-morbid conditions that would interfere with administration of protocol treatment
* Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
* Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.
mRNA Expression as a Biomarker of Omalizumab Response

Objectives: 1. Determine if mRNA expression could be use as a biomarker to predict and monitor the response to omalizumab in patients with difficult control asthma 2. Identify which genes are switched on and which are switched off by using Omalizumab.

Methods: This study is an open label clinical trial, with six patients. The patients will receive Omalizumab according to their age and weight (maximum dose: 375 mg every 15 days) for 4 months. There will be a run-in period of one month, when allergic asthma diagnosis will be confirmed and treatment will be optimized. Patients will be evaluated and will have blood sample collected on 3 occasions: in the beginning, 2 months after baseline and at the end of the study. Blood samples will always be collected one week after the last omalizumab dose. Primary outcome will be RNA expression of 20 genes measured by real time-PCR (high-affinity IgE receptor, IL-4, IL-5, IL-13, gama-IFN, quimokines, Fc epsilon, between others). Secondary outcomes will be ACT, ACQ and spirometry.

Study rational: There is not a biomarker that can predict which patients will respond to Omalizumab and those who will not respond. Nowadays, the monitoring of therapeutic response to Omalizumab is based on clinical and spirometric data.

On the other hand, when a medication is administered, it has its main expected effect, but also acts on other targets with various direct and indirect effects. We do not know all the genes that are switched on and those that are switched off by the use of Omalizumab. For example, anti-IgE has been developed to block serum total IgE and thereby improve control of allergic asthma. However, the studies noted that Omalizumab also reduces the receptors FcepsilonRI, which may have implications for the treatment of autoimmune urticaria.

Eligibility Criteria:
Inclusion Criteria:

* over 12 years
* severe asthma not controlled despite medication
* IgE between 70 and 1300 IU/ml and evidence of allergy clinical history and/or skin test or blood.

Exclusion Criteria:

* previous use of omalizumab
* smoke history
Identification of Gene Biomarkers in Aging Skin

This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to assess the gene expression profile from three different age groups.

The primary objective of the skin aging study is to investigate changes in gene expression patterns that occur during the aging process.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are willing to read and sign an informed consent form prior to participating in the study.
* Individuals who have a temperature of less than or equal to 100 degrees F at the time of biopsy collection.
* Individuals who had not applied any sunless tanning product on the arms within the past year.
* Individuals with no prior history of alcoholism (or who consume fewer than 2 to 3 alcoholic beverages per day).
* Individuals who have not consumed any anti-aging nutritional supplements (multivitamins and multiminerals are acceptable) or aspirin, NSAIDS, or other pain medication in the last 48 hours before biopsy.

Exclusion Criteria:

* Male gender
* Individuals who did not fit the 'inclusion criteria' above.
Harmonic vs HF Knife in Patients Requiring Abdominal Surgery

Prospective, non-randomized, controlled study to investigate the clinical outcome of surgery using the Harmonic knife vs the HF knife in patients requiring abdominoplastic surgery or body lift (Lockwood)

Aim of the study is to measure amount of seroma in each interventional arm.

Eligibility Criteria:
Inclusion Criteria:

* 18 years
* willing to give consent
* indication for abdominoplastic surgery
* no contraindication for general anaesthesia

Exclusion Criteria:

* Smoking more than 10 p/day
* Diabetes mellitus I or II
* known neoplasms
* not willing or able to conform with study requirements
A Simple Clinical Tool for Increasing Enrollment on a Kidney Transplant Waiting List for Patients Aged Over 70 and Initiating Dialysis

The main objective of this study is to show that the systematic use of a prognostic score as early as possible after the initiation of dialysis in patients over 70 years of age and with a good prognosis at 3 years of dialysis results in an increase in the number of entries on a kidney transplant waiting list at 12 months after the initiation of dialysis.

This prospective assessment is carried out as part of a historico-prospective before-after study in parallel with a survey of changes in national practices over the same time period via a here-elsewhere type study.

Historical data (i.e the. "before" period) will include incident dialysis cases during the calendar years 2013, 2014 and 2015 before the start of the prospective phase (i.e. "after" period, which is represented by the current declaration); since a preliminary study demonstrated that the data are comparable from 2011 to 2013, we will use the average of data thus obtained. Historical data will be retrieved from the REIN (The French Renal Epidemiology and Information Network) registry data and will be validated by investigators at each center.

The secondary objectives are:

A. To show that the systematic use of the score at the initiation of dialysis can shorten the registration delay on a kidney transplant waiting list; to evaluate the time between initiation of dialysis and registration on a national waiting list for kidney transplants, while assessing the duration of the pre-transplant assessment.

B. To identify barriers to registration on the kidney transplant waiting list as well as the related time delay in this population (medical and non-medical factors), the rates and causes of patient refusal for registration and the possible evolution this refusal over time.

C. To evaluate the economic impact of the introduction of the renal transplant clinical prognostic score.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 12 months of follow-up
* Patient initiating chronic dialysis (incident cases)
* Patients with a 3 year prognostic mortality score less than (\<) 10 points (Dusseux et al. 2015)

Exclusion Criteria:

* The patient is participating in another interventional study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* Patient on preemptive kidney transplant waiting list (before the initiation of a chronic dialysis program)
Epilepsy Cycles Longitudinal Monitoring to Inform Personalized Seizure-risk Estimation (ECLIPSE)

The occurrence of seizures in epilepsy is not entirely random. Temporal patterns that organize the occurrence of seizures over weeks and months were previously unraveled using intracranial EEG System (IEEG) that monitors epileptic brain activity chronically. Seizures typically recur with patient-specific periodicity and are preceded by increases of epileptic brain activity over days. Here, the investigators developed new methods to forecast seizure likelihoods at a 24-h horizon. In this trial, participants will be provided with daily estimates about their upcoming risk of seizures. As a primary outcome, the performance of forecasts will be evaluated against the occurrence of electrographic seizures. As secondary outcome, the forecast's potential benefit for users in conveying actionable information in real-life will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Adult with diagnosed pharmacoresistant epilepsy and at least one self-reported seizure in the last 12 months.
* Patients previously implanted with the RNS System, on stable detection settings enabling reliable detection of electrographic seizures.
* Patients willing and able to keep a diary, issue self-forecasts, and follow instructions.
* Home equipped with an internet connection.
* Informed Consent signed by the subject

Exclusion Criteria:

* Insufficient number of electrographic seizures or insufficient forecasting performance in the training phase.
* Women pregnant at the time of recruitment (later pregnancy not a contra-indication)
* Subjects with a history of psychogenic non-epileptic seizures
* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
* Vulnerable subjects, including severe cognitive impairment precluding informed consent
* Drug or alcohol addiction
* Subjects who are unable (i.e., mentally or physically impaired patients) or do not have the necessary assistance, to properly operate the device system.
Evaluation of Covid 19 Knowledge Anxiety and Expectation Levels of Turkish Physicians, Survey Study

It is aimed to measure the general health information of Turkish physicians about covid 19 pandemic, to evaluate anxiety levels and to evaluate future expectations in this period.


Eligibility Criteria:
Inclusion Criteria:

* turkish physicians
* work active in pandemic hospital

Exclusion Criteria:

* work in another country
* retired physicians
Effect of Hemifacial Spasm on Intraocular Pressure Measurement

Twenty-four consecutive patients with Hemifacial spasm and 25 age and gender-matched randomly selected eyes of healthy volunteers underwent corneal pachymetry and intraocular pressure measurements using Goldmann Applanation Tonometer and non-contact tonometer. An interval of 15 minutes was maintained between Goldmann Applanation Tonometer and non-contact tonometer measurements. Intraocular pressure measurements were performed before (during hemifacial spasm) and 2 weeks after Botox injections in Hemifacial spasm patients and in healthy volunteers without Botox injections. All the measurements with Goldmann Applanation Tonometer were carried out by a single physician while those with the non-contact tonometer were done by another physician who was masked to the results of the Goldmann Applanation Tonometer. All measurements were taken between 10:00 and 11:00 a.m.


Eligibility Criteria:
Inclusion Criteria:

* patients with hemifacial spasm

Exclusion Criteria:

* Subjects will be excluded if they have allergies to botulinum toxin or any component of the drug, previous eyelid, refractive or intraocular surgery, any abnormality preventing reliable tonometry in either eye, strabismus, contact lens wear, pregnancy, glaucoma, ocular hypertension and patients using agents that could interfere with neuromuscular transmission.
A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* histologically-proven mantle cell lymphoma;
* previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria:

* known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
* active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
* serious disorders interfering with full standard dosing chemotherapy;
* stage I disease.
The Effect of Different Ways of Sitting on Cognitive Performance and Muscle Activity

Academic educations concurs with a lot of sitting. Studies have shown that prolonged sitting not only has disruptive effects on physical health, but also influence mental health and cognition negatively. For physical health evidence grows that short light intense interruptions of sitting time effectively counterbalance the impact of prolonged sitting. It is not clear of light intense physical activity breaks have a similar positive effect on cognitive performance. Also, it is unclear whether cognitive loading might be able to compensate the impact of prolonged sitting.This study compares the effects of uninterrupted sitting with or without cognitive loading and interrupted sitting on cognitive functioning; muscle activation of leg and trunk muscles under various modes of sitting with walking, in order to calibrate the physical impact of different sitting modes.

healthy university students will attend three separate intervention visits with 6-days (no more than 14 days) washout in between: 1) uninterrupted sitting (SIT); 2) uninterrupted sitting with a cognitive task (COGN); 3) sitting interrupted by light physical activity (INTERRUPT). For the SIT and INTERRUPT conditions, subjects watch a series of documentaries while sitting. In the COGN condition, while sitting, participants undergo the online GED test as cognitive load. Four cognitive tests (D2 test, stroop test, trail making test and 2-BACK test) and mood states will be performed before and after each intervention. On a separate day, using surface electromyography, activations of major leg and trunk muscles of sitting on chair, active and passive sitting on a yoga ball and walking were assessed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-30 years
* BMI between 18-28
* steady dietary habits
* generally healthy
* Female on contraceptive pills/Male

Exclusion Criteria:

* High score (score: 11-21) in the Hospital Anxiety and Depression Scale
Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

Motor control includes postural control and voluntary movement. For an optimal motor control it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly, in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in relation to gravity and changes in its linear and angular acceleration. As vestibular central system, it plays an essential role in motor control and in orientation and spatial memory as well.

When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of inputs are deficient and therefore motor control is altered to a greater or lesser degree. As process progress in time, there is a natural neuroplasticity that facilitates recovery or compensate vestibular function, although sometimes this process is incomplete and requires vestibular reeducation This study aims to assess changes in balance control, orientation and handicap perception in one case group with symptomatic unilateral peripheral vestibular dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at the beginning and at the end of RV to those achieved by control group. Finally, this research aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic participants.

Intervention group: 30 people with a unilateral peripheral vestibular disorder (UPVD). Process lasting more than three months and symptomatic. Aged 18-66 years old.

Control group: 30 participants without UPVD, healthy for the purpose of study. No intervention group: 30 people with a unilateral peripheral vestibular disorder without symptomatology. Both groups also aged 18-66.

Balance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular reeducation in UPVD participants. Vestibular reeducation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week.

The aim is to compare data before and after intervention with those obtained in compensated patients and control group.

Eligibility Criteria:
Inclusion Criteria:

* People diagnosed of UPVD
* Length of process superior to three months
* Normal vision or corrected by lens or glasses.

Exclusion Criteria:

* Dizziness or balance alteration due to visual problem or lesion of CNS (central nervous system).
* Balance disturbance due to a locomotor cause
* Balance perturbation next to resolve.
* Sharpening or acute phase os symptoms.
* Difficulties with understanding commands.
Clinical Outcomes of Primary Versus Secondary Antiphospholipid Syndrome

Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome

Antiphospholipid antibody syndrome is an autoimmune disorder associated with positive antiphospholipid antibodies including the lupus anticoagulant, anticardiolipin antibodies IgG or IgM, and/or anti-ß2-glycoprotein IgG or IgM associated with thrombotic problems and pregnancy loss.

Antiphospholipid syndrome is one of the most frequent forms of acquired thrombophilia and is associated with an increased risk of both venous and arterial thrombotic events. Thirty to 40% of systemic lupus erythematosus (SLE) patients have associated antiphospholipid syndrome.

Antiphospholipid syndrome has estimated incidence in the general population of 2.1 (1.4-2.8) per 100 000, and the prevalence of 50 (42-58) per 100 000. APS is more common in female with a female to male ratio is 3.5:1 for primary and 7:1 for secondary.

Antiphospholipid syndrome is divided into two types primary syndrome without an underlying disease, and secondary antiphospholipid syndrome that is associated with another autoimmune syndrome, most commonly Systemic Lupus Erythematosus (SLE).

Patients with APS are more at risk of recurrent thrombosis (3). n a retrospective analysis of 160 patients with APS, venous thromboembolism (VTE) was found to be the commonest manifestation (47.5%) followed by arterial thromboembolism (43.1%) then materno fetal problems which were found only in 9.7% of patients, and finally, catastrophic antiphospholipid syndrome (CAPS) represented in only 2.5 percent of the cases (4).

The clinical manifestations of antiphospholipid syndrome include haematological (thrombocytopenia, venous thrombosis), obstetrical (recurrent pregnancy loss), neurological (stroke, transient ischaemic attack, seizures), cardiovascular, dermatological such as livedo reticularis, skin ulceration and necrosis, renal (glomerulonephritis and renal thrombotic microangiopathy), and orthopedic (avascular necrosis of bones).

the manifestation spectrum ranged from asymptomatic antiphospholipid antibodies positivity, various non-criteria manifestations, obstetric morbidity, thrombosis, to life-threatening catastrophic antiphospholipid syndrome. The wide manifestation spectrum led to a heterogeneous entity and brought challenges to management of the syndrome.

The aim of this study was to compare primary versus secondary effects of antiphospholipid syndrome on the development of thrombosis and its outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as antiphospholipid syndrome in clinical hematology or rheumatology units in internal medicine department, Assiut university hospital.

Exclusion Criteria:

* patients with other risk factor for thrombosis (malignancy, cocs, protein c or protein s deficiency etc
A Single Dose Study Of PF-04620110 In Healthy Subjects

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
Brachial Artery Pulsatility Index in Supraclavicular Block

Investigators aimed to evaluated accuracy of brachial artery doppler derived indices such as change in pulsatility index, resistive index, and waveform morphology in predicting successful supraclavicular block

supraclavicular brachial plexus block gives adequate anesthesia and analgesia for arm and hand surgeries. successful block was classically evaluated via assessment of both sensory and motor functions, However this carry disadvantages of subjective assessment including patient cooperation. objective monitors of successful block depend on sympasthetic mediated changes including perfusion index, thermography, and LASER doppler.

However most of these tools depend on complicated technology and special devices.

therefore it was assumed that the use of brachial artery derived indices such as pulsatility index, resistive index, and waveform morphology would provide simple, easy and economic assessment tool for successful supraclavicular brachial plexus block

Eligibility Criteria:
Inclusion Criteria:

- ASA 1 undergoing forearm or hand surgery

Exclusion Criteria:

* patient refusal allergy to local anesthetics fracture humerus Diabetes Melitus peripheral vascular disease