cyrilzakka/clinical-trials huggingface dataset:
A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas

The study is researching an experimental drug called REGN5837 in combination with another experimental drug, odronextamab (called "study drugs").

The aim of the study is to see how safe and tolerable the study drugs are, and to define the recommended dose for phase 2.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)
* To find out how well the study drugs work against relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (B-NHLs)


Eligibility Criteria:
Key Inclusion Criteria:

1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol.
2. Measurable disease on cross sectional imaging as defined in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
4. Adequate bone marrow, renal and hepatic function as defined in the protocol
5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed
6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.

Key Exclusion Criteria:

1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab
2. Diagnosis of mantle cell lymphoma (MCL)
3. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol
4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol
5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol
6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab
7. Co-morbid conditions, as described in the protocol
8. Infections, as described in the protocol
9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicase

NOTE: Other protocol defined inclusion / exclusion criteria apply
Qutenza (Topical Capsaicin 8%) for Painful Arteriovenous Fistulae

Arteriovenous fistulae are artificial connections between the artery and vein in the arm which allow needles to be inserted for haemodialysising patients wit kidney failure. Occasionally severe debilitating pain can arise from these fistulae for which no cause can be found. Such pain can be very difficult to treat. Many commonly used used painkillers are known to cause significant side effects in patients with renal failure (drowsiness, confusion etc.

Qutenza (topical capsaicin 8%) is a new treatment made from chilli peppers which is applied to the skin as a patch and works directly at the nerve endings in the skin to prevent pain. It therefore should not have the systemic side effects of other drugs. It has been demonstrated to be beneficial in other painful conditions for example post-shingles pain and nerve pain from HIV. It has never been used for critical ischaemia before.

We propose to investigate the efficacy of Qutenza in treating patients with end stage renal failure and chronic pain from their fistulae (AVF). We will recruit 20 patients with painful AVF and treat them with Qutenza. We will follow them up for 12 weeks and monitor the change in their pain scores.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients \>18 years old with end stage renal disease on dialysis and significant chronic neuropathic pain arising from their arteriovenous fistula (defined as pain with symptoms to suggest a neuropathic element occurring most days for at least a month which has not responded to simple analgesia)

Exclusion Criteria:

* Pre-dialysis
* Underlying anatomical/ structural abnormality with AVF contributing to pain
* Diabetic neuropathy resulting in sensory loss
* Hypersensitivity to Qutenza, Emla or any of the excipients
* Broken skin or active ulceration at the site of application
* Severe uncontrolled hypertension (systolic BP \>200)
* Proven cardiac event during the preceding 3 months
* Women who are pregnant or breast feeding
* Lack of capacity or inability to provide informed consent
* Declines participation in the study
Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.

This study is aiming to look into patients' treatment preferences and their socio economic background as well as the exploration of thought processes leading to these preferences. It will integrate, in two exploratory questionnaires, the three most common treatment schema (standard of care, non-operative management, surgery alone) all of which have been demonstrated efficacious.

The primary study objective is to evaluate socioeconomic and demographic factors involved in patients' / physicians treatment preferences. The secondary objective is to assess the tradeoff level between the benefits versus quality of life.

This study will evaluate 192 participants: 14 physicians (group A) and 178 patients (group B).

Participants with operable rectal cancer or health professionals will be screened for eligibility. Subsequently, these participants will be offered to participate in this pilot study and provided a consent form. When a participant has consented to participate, he/she will be provided with a first questionnaire (socio-demographic characteristics, some clinical data and medical baseline information as well as details about their current knowledge about treatments).

An informational brochure will be given after answering the first questionnaire describing different treatment regimens, treatment duration, potential side effects and oncologic outcomes.

A second questionnaire will be provided (evaluating patients treatment preferences and tradeoff).

The consent form, brochure and questionnaires will be available only in an electronic format (Microsoft Form).

Eligibility Criteria:
Inclusion Criteria:

Group A

* New rectal cancer patient
* Operable patients
* Capable adults older than 18 years of age
* Capacity to sign a consent form
* Capacity to answer questionnaires on an online platform Group B
* Treating physician specialists
* Capacity to sign a consent form
* Capacity to answer questionnaires on an online platform

Exclusion Criteria:

Group A:

* Patient unable to sign a consent form
* Patients with metastasis
* Recurrent tumours
* Inability to answer questionnaires on an online platform
* Inability to communicate in french or english

Group B:

* Participant unable to sign a consent form
* Inability to answer questionnaires on an online platform
Bladder Outlet Obstruction Observation Using Dynamic Urine Vibration "Holter"

Current gold standard of bladder outlet diagnosis is pressure flow study. This study is invasive time consuming and requires expensive and complex set-up. In this study the investigators plan to evaluate an alternative technology that presumably is able to diagnose bladder outlet obstruction using a Dynamic Urine Vibration "Holter" based on a Urine Flow Vibration Analysis technology. The acoustic vibration sensor is a small device that records the vibration due to urine flow. The patient attaches the sensor to the penis using a disposable sensor patch for the duration of approximately one minute during one urination. The analysis is performed off-line and the results are compared to the results of a standard pressure flow study and to the standard free flowmetry test. The innovative technology for the diagnosis of bladder outlet obstruction is noninvasive, rapid and does not involve complex setup.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of benign prostatic hyperplasia (BPH)
* has indication for urodynamic evaluation
* Males 18 years and older
* Capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits.

Exclusion Criteria:

Any condition which, in the investigator opinion, makes the patient unsuitable
Working With Your Body in the Operating Room. The Case of Operating Room Nurses (RCIBO)

The undocumented observation, repeatedly observed in the operating rooms, of discomfort, including fainting, among medical and paramedical novices working in contact with surgical breaches raises questions about the mechanisms put in place to cope with what seems initially unimaginable. Indeed, accounts in the social sciences show that the surgical opening of a living person is, in some ways, a transgressive act, forbidden outside the operating room. By spilling blood, it induces a 'symbolic disorder' described by Mary Douglas, that is contained through ritualized practices, predispositions towards objectification, and injunctions to control affects. The use of surgical drapes allows for the partial erasure of the person being operated on, who is no longer seen as a subject, but as an object of care - a dehumanized body or 'image-object' described by Amandine Klipfel. It is possible that ORNs are gradually adapting to negotiate the reconfiguration of bodies in the operating room, the transgression inherent in the surgical opening of a living person, and the personal resonance this may have for them. The investigator questions the specificities of their profession and their physical, emotional, and cognitive relationships following the initial shock of confronting open bodies. Is it possible to grow accustomed to or adapt to open bodies to the point of no longer experiencing difficulties related to what was once unthinkable? The investigator aims to understand what becomes of these initially unrepresentable experiences and roles ORNs have in redefining the bodies present - the processes of objectification and rehumanization of patients in the operating rooms. This doctoral study grasps the cognitive and imaginary constructions they experience in France and Canada.


Eligibility Criteria:
Inclusion Criteria:

* operating room nurses
* Student nurses and operating room nurses
* Supervisors
* Doctors, interns and externs
* Surgeons
* Midwives and midwifery students
* Hospital cleaning staff
* Nursing assistants
* Biomedical staff

Exclusion Criteria:

* People not involved in surgical operations
* People refusing to take part in the study
Pre- and Post- Descriptive Data of Language Outcomes in Deaf Children

Deaf children between ages of 4-10 will provide pre and post data by responding to three prompts in sign language and written language at the beginning and end of a year. This data will provide information on the developmental trends and characteristics of deaf children who will receive SISI the following year.


Eligibility Criteria:
Inclusion Criteria:

* Deaf children between 4 and 10 years old attending deaf education programs

Exclusion Criteria:

* Non-deaf children
Use of Complementary and Alternative Medicine Among Older Mexican Americans

The purpose of this study is to examine complementary and alternative medicine use among older Mexican Americans and to determine how this use influences physical, functional, and mental health.

Alternative medicine has received increasing attention from both the scientific and public communities. While the majority of current alternative medicine use is the result of interest in replacing or augmenting formal medical treatments, several cultures have long-standing traditions of herbal medicine use, particularly among older, more traditional members. Research in this area has been limited primarily to small-scale studies that identify herbal remedies popular in specific cultures. This study observes older Mexican Americans because a substantial proportion of this population continue to utilize traditional herbal remedies in their everyday life.

Eligibility Criteria:
Inclusion Criteria:

* Mexican American

Exclusion Criteria:

* Unable to complete survey questionnaire
Frailty, Anesthesia and Complications.

Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.

Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.

Methods: prospective cohort study performed at Fundació Puigvert. Enrollment of 850 patients ≥70 y/o who undergo scheduled nephrourologic surgery. In the preoperative visit frailty is going to be evaluated using the Short Physical Performance Battery (SPPB), the Canadian Frailty Scale, the Mini-Cog test (Memory an executive functions), the Pfeiffer Test (Cognitive global screening), an involuntary loss of more than 4.5kg or 5% of weight in the previous year and physical activity using the Metabolic Equivalents of Task (MET). We will analyse the relation among frailty, medical, surgical postoperative complications and mortality at 30 days, 6 months and one year after the surgery.

The results will be adjusted by the possible confounding and interaction variables using a multivariate logistic regression model. The confounding /interaction variables will include demographic data, clinical and lab data and events arisen during the follow-up period.

Eligibility Criteria:
Inclusion criteria

* Patients who participate voluntarily
* Signed Informed consent
* 70+ years old
* Scheduled urological surgery with general or regional anesthesia and length of stay in hospital over 24 hours.
* Patients with preserved domiciliary deambulation without aid of another person. (walking sticks, or walkers are accepted)

Exclusion Criteria:

* No signing of the informed consent
* Surgery performed with local anesthetics
* Day surgery, extracorporeal wave lithotripsy or endourological catheterism
* Advanced diagnosed dementia
* Patients with chronic advanced disease or terminal oncological disease
Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

Glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. In order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. Despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. In this study we used a novel technique named short tunnel small flap (STSF) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft.

This randomized clinical trial, was performed at the Glaucoma Clinic of Labbafinejad Medical Center, Tehran, IRAN from September 2015 to January 2017 . The study was approved by the ethics committee at the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and followed the tenets of the Declaration of Helsinki. After explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent AGV implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. Primary outcome measure is Intraocular pressure(IOP) and Tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (IOP) \> 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. Outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Iranian patients with Caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma.

Exclusion Criteria:

* Primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.
Relative Risk of Hypertension Among Obese

Observational study was conducted to determine the relative risk of hypertension among young adult obese population of Pakistan with age between 25-40 years


Eligibility Criteria:
Inclusion Criteria:

Adult population with age between 25- 40 years having normal weight or Obesity of grade I and II, with or without hypertension.

Exclusion Criteria:

Patients with co-morbid like Diabetes mellitus, dyslipidemia, and cardiovascular disorder were excluded from the study
Safety and Feasibility Study of the Shockwave Lithoplasty System

To study the early safety and performance of the Shockwave Medical System in subjects to demonstrate that the device can safely and effectively deliver localized energy for the treatment of vascular disease.

Shockwave Medical, Inc. intends to conduct a prospective, single-arm, single-center, First in Human study designed to evaluate the early safety and feasibility of the Shockwave Lithoplasty System in subjects with heavily calcified infrainguinal arteries with 3.75mm to 6mm reference vessel diameter at target site. The Shockwave Lithoplasty System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to 10 subjects will be enrolled to undergo lihtoplasty.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed the approved consent form.
* Female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure.
* Patient is able and willing to comply with all assessments in the study.
* Peripheral arterial disease of Rutherford Category 2, 3, 4, and 5.
* Ability to tolerate an antiplatelet agent (i.e. aspirin, clopidigrel or prasagrel).
* Meets Angiographic Inclusion Criteria

Exclusion Criteria:

* Patients with peripheral arterial disease of Rutherford Category 6.
* Severe or infected gangrene of the lower extremity.
* Planned major amputation.
* Previously implanted stent at the treatment site.
* Patient with an externally-connected intracardiac catheter or pacemaker.
* Patient with an implantable pacemaker or defibrillator.
* Patient has connective tissue disease (e.g., Marfan's syndrome).
* Patient has a hypercoagulable disorder.
* Patient has allergy to imaging contrast media for which they cannot be premedicated.
* Patient is in acute renal failure or chronic renal insufficiency or failure as measured by a serum creatinine of \>19.5 µmol/L.
* Patient has active systemic infection.
* Patient has less than a one year life expectancy.
* Patient is pregnant or nursing.
* Patient is participating in another research study involving an investigational agent that has not reached the primary endpoint.
* Patient has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
* Chronic total occlusion of target vessel.
* Chronic total occlusion of inflow vessel.
* Highly tortuous arteries (bends greater than 30 degrees over the arc length of the balloon)
* Patients requiring concurrent intervention below the most distal target lesion.
* Inflow disease: Stenosis of \>50% in vessel proximal to the target lesion which requires treatment with Drug Eluting Balloon (DEB) or atherectomy.
* Prior procedure in target leg within past 3 months.
Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring

The extent and duration of tissue hypoxia is a major determinant of outcome following major, high-risk surgery and in critical illness. Prompt restoration of tissue oxygenation through resuscitation in all likelihood improves outcomes. There are currently no bedside monitors in clinical practice that track tissue perfusion per se, instead clinicians rely on crude surrogates such as heart rate and blood pressure, urine output, serum lactate of global flow (cardiac output) monitoring.

This is a first-in-man trial of a new device to measure tissue oxygenation in real time in a major, high-risk surgical and critical care cohort. The device consists of an oxygen sensing probe incorporated into a modified urinary catheter, which relies on photoluminescence technology and the quenching properties of oxygen.

Once inserted, the drained bladder collapses round and envelopes the probe which continuously measures tissue oxygenation of the bladder urothelium.

The investigators hope to (i) Establish that tissue oxygenation can be safely monitored using this technology, deployed in this way. (ii) Define a normal range for bladder tissue oxygenation in man as measured using this device. (iii) Compare tissue oxygenation against other markers of perfusion status in current clinical practice and assess its performance at detecting inadequate perfusion against these other modalities. (iv) assess the diagnostic and prognostic capabilities of the tissue oxygenation monitoring at detecting hypo-perfusion and predicting outcome. (v) Further assess the tissue response to an 'oxygen challenge' in identifying occult hypo-perfusion. (vi). Provide pilot work required to inform future, interventional studies where similar patients would be resuscitated to tissue oxygenation targets alongside routine clinical practice.

As above

Eligibility Criteria:
Inclusion Criteria:

* having major elective or emergency surgery (deemed to need invasive BP monitoring by anaesthetist) and a urinary catheter
* OR emergency admission to critical care (necessitating arterial line and urinary catheter).

Exclusion Criteria:

* age \<18
* pregnancy
* contraindication to arterial cannulation or urethral catheterisation
* surgery on lower urinary tract/bladder
* patient refusal
Plasma EBV DNA Monitoring in Post-treatment NPC Patients

Continuous regular monitoring of plasma EBV DNA in nasopharyngeal carcinoma (NPC) after treatment have rarely been investigated. The investigators try to analyze the long-term observational results (role in early relapse detection and impact on survival) in NPC patients after curative treatment.

The investigators enrolled 441 NPC patients who had finished finished curative radiotherapy with/without chemotherapy and no recurrence/metastasis before entry this study from five hospitals in Taiwan. Blood samples were collected on the day of enrollment and monitored once every 2-3 months for plasma EBV DNA measurement. After long-term observation, we analyze the impact of continuous plasma EBV DNA monitoring on the early dection of tumor relapse and do risk grouping for survival analyses according to the blood test results.

Eligibility Criteria:
Inclusion criteria

* histologically-proven nasopharyngeal carcinoma without distant metastasis (M0) at initial presentation
* finished curative radiotherapy (with/without chemotherapy) within 3 years

Exclusion criteria

* no occurrence of documented recurrence/metastasis before entry