cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study on Pacemaker Interference From Peripheral Nerve Stimulator for Regional Anesthesia

In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation on cardiac pacemaker function.

The principle of the nerve stimulation technique consists of using a battery powered peripheral nerve stimulator to generate electrical stimuli through an insulated needle at appropriate anatomical locations. The electrical impulses then trigger depolarization as insulated needle approaches the target nerve bundles. Braun Stimuplex, a common nerve stimulator used for peripheral nerve localization, is currently being used in the United States and other countries. Previous studies have suggested it to be a reliable stimulator for the purpose of peripheral nerve blocks. The operational manual however indicated that this device should not be used in patients with cardiac pacemaker because malfunction of the pacemaker may occur. Literature search on the topic of pacemaker interference from peripheral nerve stimulator showed that there was one case of pacemaker interference caused by activation of a nerve stimulator, resulting in cardiac arrest in a patient with a fixed-rate ventricular pacemaker. Studies and case reports suggest that unipolar electrode seems to be most susceptible to interferences from electrosurgical equipment, TENS unit, spinal cord stimulators. Perhaps this is the reason why the manufacturer of the peripheral nerve stimulator recommends against the use of peripheral nerve stimulator in patients with pacemakers. With the advancements of modern pacemakers technology, it is our experience; interscalene nerve blocks and other peripheral nerve blocks using the nerve stimulator can be performed in patients with pacemakers without notable interferences with pacemaker functions and perhaps the initial recommendation by the peripheral nerve stimulator manufacturer can be modified. In this prospective pilot study, we proposed to evaluate the effects of left interscalene stimulation (most likely scenario to interfere with pacemaker function) by varying the configurations of the pacemaker leads (unipolar vs. bipolar pacer lead configuration) and by varying the positions of the positive electrode of the stimulator.

Eligibility Criteria:
Inclusion Criteria:

* age greater than 18, ASA II or III status

Exclusion Criteria:

* Pregnancy, unable to provide informed consent
Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

The goal of this interventional clinical trial is to learn about TNG348, a ubiquitin specific peptidase 1 (USP1) inhibitor, alone and in combination with olaparib in patients with BRCA 1/2 mutant or HRD+ solid tumors.

The main question\[s\] it aims to answer are:

* to evaluate the safety and tolerability of single agent and combination therapy
* to determine the recommended dose for Phase 2 of single agent and combination therapy
* to determine the pharmacokinetics of TNG348 as a single agent and in combination therapy
* to evaluate the initial antineoplastic activity as a single agent and in combination therapy

Participants will receive study treatment until they experience an undesirable side effect, their disease progresses or until they withdraw consent.

This is a first-in-human Phase 1/2, open-label, multi-center, dose-escalation and expansion study designed to determine the maximum-tolerated dose (MTD) and recommended Phase 2 dose(s) (RP2D) and evaluate the safety, tolerability, and preliminary antitumor activity of TNG348 single agent and in combination with olaparib in participants with BRCA1/2 mutant or other HRD+ advanced or metastatic solid tumors.

In Phase 1 (dose escalation), the single agent component will explore escalating oral doses of TNG348 administered alone and in combination with olaparib.

Participants in Phase 2 (dose expansion) will be dosed at the RP2D(s) determined from Phase 1 based on safety and tolerability demonstrated, along with the available PK data and studied during Phase 1, as applicable.

In the Phase 2 portion of the study, both single agent and combination therapy may be evaluated to assess an early signal of clinical benefit, as well as for confirmation of safety and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Is ≥18 years of age at the time of signature of the main study ICF.
* Has ECOG performance status of 0 or 1.
* Has advanced or metastatic solid tumor with measurable disease based on RECIST v1.1.
* All participants must have documented BRCA 1/2 mutant or other HRD+ in solid tumor, which is identified through a validated sequencing test
* Adequate organ and bone marrow function per local labs
* Negative serum pregnancy test result at screening
* Written informed consent must be obtained according to local guidelines

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to TNG348, olaparib or its excipients
* Uncontrolled intercurrent illness that will limit compliance with the study requirements
* Currently participating in or has planned participation in a study of another investigational agent or device
* Impairment of GI function or disease that may significantly alter the absorption of study drug
* Active prior or concurrent malignancy.
* Central nervous system metastases associated with progressive neurological symptoms
* Participant with MDS
* Clinically relevant cardiovascular disease
* Participant with known active or chronic infection
* A female patient who is pregnant or lactating
Long Term Outcomes After Surgery for Anal Fistula

Anal fistula is a common condition with a wide variety of clinical presentations, which can make evaluation and treatment challenging and surgical outcomes uncertain. This study was undertaken to identify lessons learned in the surgical treatment of 483 patients over a 20- year period leading to a pragmatic approach to treatment of this condition.

The wide array of variations of anal fistulas makes them challenging both to classify and to treat. The aim of the study is to determine if a systematic approach to their evaluation and surgical treatment, regardless of how one wishes to classify them, can be based on careful assessment of sphincter length and of the anatomical and etiological characteristics of the fistula.

Eligibility Criteria:
Inclusion Criteria:

* anal fistulas

Exclusion Criteria:

* none
Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.

Patients who are being screened under protocol 020221 who are not eligible for enrollment due to a) evidence of disease progression or pseudo-progression post chemo-radiation or b) insufficient (\<5 doses) vaccine manufactured, and for whom the DCVax-L treatment was manufactured and released are eligible for this study.

Treatment Schedule:

Open label vaccine injections will be give per the associated 020221 protocol. Injections will be given at days 0, 10, 20, and at months 2, 4, 8, 12, 18, 24 and 30. There are no therapeutic restrictions, but guidelines for drug administration are recommended as per the 020221 protocol.

Data collected includes vaccine administration information, and any vaccine related adverse event. Patient MRIs will be collected centrally for future review. Patients will be followed for disease progression and survival.

Eligibility Criteria:
Inclusion Criteria:

1. Screen-Fail for protocol 020221 due to either:

   * Radiographic evidence of disease progression or pseudoprogression at the Baseline visit under protocol 020221, as determined by central imaging review, OR
   * Insufficient vaccine manufactured for protocol 020221 (i.e. less than 5 doses).
2. Patients must have a KPS rating of ≥70 at the Baseline Visit (Visit 5) (refer to Appendix D, Performance Status Scales).
3. Patients may have received steroid therapy as part of their primary treatment. Steroid treatment should preferably be stopped; or if continued steroid use is clinically indicated, be tapered down to no more than 4 mg dexamethasone qd at least 7 days prior to the first immunization .
4. DCVax-L product manufactured and released.

Exclusion Criteria:

1. Active uncontrolled infection, or acute infection requiring antibiotic or antifungal therapy. Antibiotic and antifungal therapy should be completed approximately 7 days prior to the first immunization.
2. Fever ≥101.5oF. If considered possibly transient, retesting is allowed.
3. Unstable or severe intercurrent medical conditions.
4. Females of child-bearing potential who are pregnant or lactating or who are not using adequate contraception (abstinence, surgical, hormonal or double barrier, i.e. condom and diaphragm). 020221 Baseline lab results and or local lab results are acceptable.
Effect of Vagus Stimulation on Peripheral Glucose Metabolism

Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.

Transcutaneous auricular vagus nerve stimulation (tVNS) can be used on the outer ear to stimulate the auricular branch of the vagus nerve in humans. Heart rate variability (HRV) in healthy people can be significantly increased via tVNS, indicating a shift from sympathetic activity to parasympathetic activity.

The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.

To test this hypothesis, this study investigates the effect of vagal stimulation versus sham stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \<6.5%
* Must be able to understand the explanations of the study and the instructions

Exclusion Criteria:

* Any relevant (according to investigator's judgment) cardiovascular disease
* Neurological and psychiatric disorders
* Diabetes mellitus
* Active implants (e.g. pacemaker, cochlear implant, cerebral shunt)
* asthma
* skin diseases on the ear
The Effects of Passive Vibration in Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to examine the effects of passive vibration (PV) in improving balance and sensation in patients with diabetic peripheral neuropathy (DPN).

The study involves the following:

* Visit 1:
* Particpant's age, height, gender, and weight will be collected.
* Participant will fill out a questionnaire to assess participant's nerve function. This process will take approximately 2.5 minutes.
* Investigator will measure participant's balance, sensation, and skin blood flow (SBF).
* After completing the tests, participant will be randomly assigned by the computer to either the treatment group or control group.
* The treatment group will receive a passive vibration treatment for 15 minutes twice a week for 4 weeks.
* The control group will not receive any treatment and they will continue their usual lifestyle.
* Visit 2 through 8:
* The treatment group will receive a passive vibration for 15 minutes followed by SBF measurement.
* The control group will continue their usual lifestyle.
* In the fifth session, the treatment and control groups will come back for tests.
* Visit 9 (follow-up):

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Diabetic Peripheral Neuropathy
* Minimum age 40 years
* Maximum Age 75 years
* Ability to stand for a minimum of five minutes

Exclusion Criteria:

* Neurological Disorders
* Bleeding Disorders
* Leg Ulcers
* Cardiovascular Diseases
* Complete absence of sensation in lower extremities (i.e. 6.65 in monofilament test)
* Self-reported pregnancy
Interruption of TNFinhibitors and Endothelial Function

Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an initial step in atherogenesis. Treatment with TNFalpha inhibitors (TNFi) improve endothelial function in patients with RA. Discontinuation of TNFi could therefore worsen endothelial function even in the absence of recurrence of systemic inflammation or reactivation of arthritis. If stopping TNFi results in worsening of endothelial function this would strongly suggest a higher cardiovascular risk in association with TNFi-wthdrawal

Patients with rheumatoid arthritis (RA) have an increased risk of cardiovascular events. This increased risk is thought to be driven by inflammation-induced endothelial dysfunction, an initial step in atherogenesis. Both systemic as well as local (intra-arterial) treatment with anti-TNF-antibody therapy improves endothelial function in patients with vasculitis or RA as reflected by the vasodilator response to intra-arterially infused acetylcholine. Also other vascular functions that are (at least partially) endothelium-dependent such as flow-mediated dilation of the brachial artery and pulse wave velocity are improved when active RA patients are being treated with methotrexate plus TNFi, i.e. infliximab or etanercept. ( Therefore one may hypothesize that when TNFi therapy is stopped, endothelial function may worsen even in the absence of recurrence of systemic inflammation or reactivation of arthritis. Endothelial function tests are a marker of long-term cardiovascular mortality. If stopping TNFi results in worsening of endothelial function this would strongly suggest a higher cardiovascular risk in association with TNFi-wthdrawal. These findings would indicate an important drawback for stopping TNFi in RA patients.

To date it is unclear whether the worsening of endothelial function occurs within half a year following the (successful) cessation of TNFi, whether this decline occurs simultaneously, or prior to RA exacerbation and whether this deterioration process is delayed by additional use of statin and/or ACEi.

To improve cardiovascular prognosis in RA significantly it is important to increase our knowledge regarding these processes.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for POEET trial and this additional study
* On stable medication (except for TNFi-therapy)

Exclusion Criteria:

* Uncontrolled hypertension (RR \> 140/90 mmHg average of three measurements at screening after 5 minutes of supine rest)
* Diabetes mellitus
* Heart failure or any other cardiovascular disease that is expected to induce changes in cardiovascular medication during the study period.
* Expected to start or change medication that can alter endothelial function (lipid lowering drugs, blood pressure lowering drugs, NSAIDs, immunosuppressive therapy other than TNFi drugs)
Perception and Knowledge About Menopause Among Pakistani Woman

This study is conducted to find out perception and knowledge about Menopause among Pakistani Woman.

The survey for was conducted in various location and clinics all over Pakistan. 1200 numbers of questionnaires were distributed of which 910 numbers responded from 1st January 2018 to 28th February 2018. Those who agreed to be part of study where ask a self-structured questionnaire related to awareness and symptoms of menopause. Data was analyzed using SPSS Version 23.0. Frequencies were calculated for categorical data.

Eligibility Criteria:
Inclusion Criteria:

* Female aged 35 to 55
* Oral Informed consent

Exclusion Criteria:

* None
Evaluation of Psychological Status in Pregnant Women Complaining of Hypertension With Pregnancy

This study is a case controlled study comparing mental health status and some psychological impacts between two groups of patients first group is pregnant women without any other medical disorder during pregnancy,the second group is pregnant women complaining of hypertension with pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* Hypertensive pregnant women for diseased group
* Normal pregnancy with no medical disorders associated in controlled group
* singleton pregnancy
* spontaneous pregnancy
* patients who are not divorced or not widow

Exclusion Criteria:

* non-pregnant women
* any other associated medical disorder with pregnancy rather than Hypertension
* any known psychological or mental disorder prior to pregnancy
* non spontaneous pregnancy as those whom conceived by IVF
* Twin or more pregnancy
* patients who are divorced or widow
Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Children

Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.

Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.


Eligibility Criteria:
Inclusion Criteria:

* American Society of anesthesiologist physical status class I/II
* tonsillectomy or adenotonsillectomy under general anesthesia

Exclusion Criteria:

* obstructive sleep apnea
* developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy

The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.


Eligibility Criteria:
Inclusion Criteria:

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

* Advanced melanoma (Stage III/Stage IV)
* Histologically confirmed diagnosis
* Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken

For Cohort 3: (Recruitment ended by 08/31/2020)

* Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
* Treatment decision for adjuvant nivolumab therapy has already been taken

Exclusion Criteria:

For Cohort 1 and 2: (Recruitment ended by 02/20/2020)

* Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Previous treatment with nivolumab, for nivolumab monotherapy cohort only
* Current active participation in an interventional clinical trial

For Cohort 3: (Recruitment ended by 08/31/2020)

* Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
* Current active participation in an interventional clinical trial

Other protocol-defined inclusion/exclusion criteria apply
Improving Adherence to COVID-19 Prevention Behaviours: Test of Persuasive Messages

The goal of this randomized online experiment was to test the effectiveness of using various persuasive appeals (deontological moral frame, empathy, identifiable victim, goal proximity, and reciprocity) at improving intentions to adhere to prevention behaviors.

Participants indicated their intentions to follow public health guidelines, saw one of six flyers featuring a persuasive appeal or no appeal, then rated their intentions a second time. Known correlates of attitudes toward public health measures were also measured.

Adherence to non-pharmaceutical interventions (NPIs) for COVID-19, including physical distancing, masking, staying home while sick, and avoiding crowded indoor spaces remain critical for limiting the spread of COVID-19.

This study tests the effectiveness of using various persuasive appeals (deontological moral frame, empathy, identifiable victim, goal proximity, and reciprocity) at improving intentions to adhere to prevention behaviors.

A randomized online experiment using a representative sample of adult Canadian residents with respect to age, ethnicity, and province of residence was conducted between March 3-6, 2021. Participants indicated their intentions to follow public health guidelines, saw one of six flyers featuring a persuasive appeal or no appeal, then rated their intentions a second time. Known correlates of attitudes toward public health measures were also measured.

Eligibility Criteria:
Inclusion Criteria:

* Adult Canadian residents
* Target quotas for province of residence, age, gender, and ethnicity were set to obtain a demographically representative sample based on the 2016 census data

Exclusion Criteria:

* Province of residence, age, gender, and ethnicity once quotas are filled
A Study of LY3041658 in Healthy Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3041658 in healthy participants. The study will measure how the body absorbs, breaks down and gets rid of LY3041658.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and ECG.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Have Body mass index (BMI) within the range 18.5 - 35.0 kilograms per square meter (kg/m2) (inclusive).

Exclusion Criteria:

* Have a significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, immune, neurological, dermatological, or psychiatric disorder capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the Study intervention or interfering with the interpretation of data.
* Have self-perceived dullness or loss of sensation on either side of their abdomen.
* Have any condition that could affect pain perception from an injection.
* Have excessive tattoos or scars over the abdomen, or other factors (eg, rash, excessive folds of skin) that, in the investigator's opinion, would interfere with injection site assessments.