cyrilzakka/clinical-trials huggingface dataset:
Novel Form of Acquired Long QT Syndrome

The goal of this study is to determine whether anti-Ro/SSA antibodies are associated with acquired QT prolongation in subjects with connective tissue disease. The investigators will investigate whether gender or race influence correlation between anti-Ro antibody status and prolonged QT interval and the role of inflammatory cytokines in association with anti-Ro antibodies and QT prolongation. The investigators propose to add an additional objective to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.

There are two parts to this study. First, the investigators propose a prospective, observational study of subjects with connective tissue disease (CTD). Data on CTD diagnosis, disease activity, medications, electrolytes, anti-Ro Ab status, QT interval and serum for measurement of inflammatory markers and cytokines will be collected. Please see the research strategy for details of the protocol. The investigators expect that QTc prolongation will have a positive correlation with anti-Ro Ab positivity, elevated measures of inflammatory markers and higher levels of inflammatory cytokines, especially IL-6.

The second part of the study will include a subgroup of subjects who have QTc prolongation of more than 500 milliseconds. This is a proof of concept study to investigate whether immunosuppressive treatment with moderate dose of prednisone will reduce QTc in CTD patients exhibiting an excessive QTc prolongation of \>500msec. Patients enrolled in the prospective observational study with QTc prolongation of more than 500 msec will receive oral prednisone 40mg daily for 3 days followed by 20mg for eleven days (a total of 2 weeks) with the goal to shorten or normalize the prolonged QTc. Other factors that may cause prolonged QTc will be evaluated and corrected as needed. Inflammatory markers, cytokines, and QTc will be measured at baseline and serially at days 3 and 14 (end of treatment). The investigators will monitor changes in QTc during three 24-hour periods during treatment at baseline, day 3 and day 14. Risks of prednisone include elevated serum glucose levels, edema, increased risk of infection and blood pressure elevation. The dosage and duration of prednisone used in this study is similar to that given for a severe allergic reaction. The PI will monitor the patients for potential side effects which will immediately be addressed.

Eligibility Criteria:
Inclusion Criteria:

- Patients enrolled in New York Harbor Healthcare System with connective tissue disease

Exclusion Criteria:

* Atrial fibrillation
* Intraventricular conduction delay with wide QRS complex
* Acute medical conditions
* Drug overdose
* Hypothermia
* Known diagnosis or family history of hereditary Long QT syndrome, complete bundle brunch block, ventricular paced rhythm, profound bradycardia and tachycardia, and uncorrected hypothyroidism
Intraoral Cryotherapy in Root Canal Retreatment

The aim of this study was to evaluate the effect of intraoral cryotherapy application on postoperative pain in single and multiple visit retreatment of teeth with symptomatic or asymptomatic apical periodontitis. This clinical trial was also investigate the potential of intraoral cryotherapy application to reduce on postoperative analgesic use of patients in line with the results obtained.

A total of 118 patients who met the inclusion criteria were selected for the study. The patients were randomly divided into two groups as single visit and multiple visit (n=59). Then, each group was randomly divided into three subgroups as control (without cryotherapy), 15 minutes of cryotherapy, and 30 minutes of cryotherapy. Twenty two teeth were retreated in each cryotherapy group and 15 teeth in each control group. Visual analogue scale (VAS) was used to evaluate and compare postoperative pain. Postoperative analgesic use of patients was also recorded.


Eligibility Criteria:
Inclusion Criteria:

* 18 and 65 year-old patients.
* Patients with pre-treated teeth diagnosed with symptomatic or asymptomatic apical periodontitis.
* Patients who can tolerate the treatment physically and mentally.

Exclusion Criteria:

* The presence of any systemic disease,
* the presence of any allergic reactions or pregnancy,
* use of any analgesic or antibiotic medication within 7 days,
* use of corticosteroid within 6 months,
* severe periodontal disease (periodontal pockets \>3 mm) in the pretreated tooth,
* surgical endodontic treatment,
* having drainage,
* periapical index (PAI) score 1 and 2,
* excessively curved, excessively long or short roots, calcified or resorbed root canals,
* immature apices,
* complications like perforation, overfilling, broken files
A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder

The primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion Criteria:

* Total score of less than 22 on the HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.
Sedative and Hypnotic Effects Induced by EA

Insomnia is a common clinical disease.The serious patients could not sleep all night, often accompanied by headache, dizziness, forgetfulness and so on. All of these increase the mental burden of insomnia patients and seriously affected the normal work and quality of life of patients. Modern medical treatment to treat insomnia is using sedative and hypnotic drugs, mainly benzodiazepine, zopiclone. But long-term use of these drugs can induce the adverse reactions, including resistance, dependence and addiction. Many articles indicate that electroacupuncture can effectively improve insomnia, play the role of sedative and hypnotic effect and avoid many adverse reactions and side effects. Then there are no more objective indicators to affirm that which part of brain takes place the appropriate changes when electroacupuncture induces the sedative effect. So we designed this experiment.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to go with EA
* Can not have any disease

Exclusion Criteria:

* Overworked recently
Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)

The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S.

The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.


Eligibility Criteria:
Inclusion Criteria ():

* Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers)
* Consented to and provided a finger wipe
* Report being a smoker
* Smoking status verified by an exhaled carbon monoxide (CO) level of \>7 parts per million

Exclusion Criteria:

* Unwilling to comply with research procedures (i.e., finger wipes)
* Does not speak English.
Effect of EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer

This trial studies the effect of an eHealth coaching program (PACK Health) on patient reported outcomes of men with prostate cancer. An electronic health support program may affect prostate cancer patients' reported side effects and outcomes of care.

PRIMARY OBJECTIVES:

I. To model the trajectory of patient reported outcomes (PROs), as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (version \[v\]1.2), among men newly diagnosed with prostate cancer who are engaged in either active surveillance or active treatment, while enrolled in an e-health coaching program.

Ia. To compare the trajectories of (PROs) between men who are engaged in either active surveillance or active treatment, while enrolled in an e-health coaching program.

SECONDARY OBJECTIVES:

I. To evaluate the effect of digital health coaching program on:

Ia. Physical and mental health of men newly diagnosed with prostate cancer as measured by the subscales of the PROMIS Global Health Scale (v 1.2).

Ib. The global health outcomes of men with prostate cancer who are in active treatment by active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, or a combination of these methodologies).

Ic. The symptom experience of men newly diagnosed with prostate cancer as measured by the MD Anderson Symptom Inventory (MDASI).

Id. The frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.

II. To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).

OUTLINE:

Patients are contacted once weekly by a health coach by text message, phone call, email, or a mobile application, for 3 months. The total time interacting with the health coach is about 3.5-4.5 hours across the study. Patients also complete surveys over 30 minutes each time at baseline and every 30 days for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, speak and consent in English
* Newly diagnosed (within 6 months of diagnosis) with prostate cancer
* Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments

Exclusion Criteria:

* Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to hospice care
* Individuals who have a prior diagnosis of prostate cancer
* Individuals for whom there is documentation of inability to provide consent in the medical record
Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients

The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study

  * Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded)
  * Age more than 50 years
  * VA with habitual correction better than 20/60 in the study eye
  * Ability to speak, read and understand instructions in English or Hebrew
  * Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye

  * Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
  * Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  * Never been tested on the PHP device
  * Participation in another study with the exclusion of AREDS study
  * Patients diagnosed with geographic atrophy (GA)
ISe-santé, a Study Evaluating a Model for Implementing E-health in the Management of HIV Patients

It is a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital. The main objective of the study is to evaluate the effectiveness of follow-up of these patients by teleconsultation associated or not with health mediation.

The COVID-19 pandemic crisis has strained health systems, and chronic disease monitoring has often been put on hold, without yet really measuring the resulting health impact. In this context, e-Health has benefited from considerable momentum to overcome the shortcomings that have arisen, to allow remote monitoring of patients infected with COVID 19, to protect patients and caregivers and avoid nosocomial infections. Telemedicine is all the more relevant in Guyana as there are issues of geographic isolation, lack of specialists and critical mass of health professionals. In French Guiana, faced with the arrival of teleconsultation tools, a fear of professionals is their applicability for the most vulnerable populations, not knowing how to read or speak French and having restricted access to digital technology. Moreover HIV infection is an ever stigmatizing infection affecting populations that are often extremely precarious, requiring specialist monitoring and lifelong treatment.

The study team propose to carry out a randomized, controlled, open-label, parallel group study of 3 arms, among patients followed for chronic HIV infection at Cayenne hospital : 1/ Control group with classic follow-up at Cayenne hospital. 2/Teleconsultation only group: patients referred to the remote monitoring platform without specific support. 3/Teleconsulation group + mediator: patients referred to the remote monitoring platform with support from a health mediator Patients will be followed every 3 months or 6 months depending on the judgment of the investigating physician for 12 months in the study (primary endpoint evaluated at 1 year). Number of patients to be included: 450 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HIV infection.
* Patient with a regular follow-up for more than three months in the adult day hospital or in the infectious diseases department of the Cayenne Hospital Center.
* Patient of legal age.
* Patient having signed the consent form..

Exclusion Criteria:

* Pregnant patient
* Patient with a severe neurological or psychiatric history (significant cognitive disorders, intellectual disability).
* Patient with a physical disability that prevents communication via the e-Health platform (mute patient, visually and hearing impaired, specific manual motor disability, bedridden patient).
* Patient who does not master one of the languages available at the mediation.
* Patients under guardianship or trusteeship, people under protective measures
Impact of Exposure to Cosmetics on Sensitive Skin

The concept of sensitive or reactive skin was evoked in 1947 and developed in the 1970s and is now widely recognized. The international pruritus society has proposed an international consensus definition: sensitive skin is defined as a syndrome manifested by the occurrence of unpleasant sensations (tingling, burning, pain, pruritus, tingling) in response to stimuli that normally do not not cause such sensations. The triggering factors can be cosmetics, water, cold, heat, temperature variations, wind ... etc.

The physiopathological mechanisms are debated and several hypotheses exist. Sensitive skin can be considered as a decrease of the threshold of cutaneous tolerance. Sensitive skin is linked to abnormalities of the cutaneous nervous system, which becomes hyper-reactive. This hyperreactivity can be modulated by multiple factors. Exposure to cosmetics could be one of the main triggers for sensitive skin, especially for women. This can be explained by the wide use of cosmetics (in France women apply an average of 16 different cosmetics per day), by overconsumption of cosmetics, by exposure to potentially irritating ingredients. Sensitive skin would be less tolerant to the frequent and prolonged use of cosmetics. However, no precise information is available on the actual consumption of cosmetic products in the population with sensitive skin, in particular no data exists concerning the type of products used, the criteria of choice of products, the daily number of products used. and the ingredients contained in these cosmetics

Objectives are:

To compare the consumption of cosmetics qualitatively and quantitatively in a group of subjects with sensitive skin in the face and scalp, with a group of subjects with non-sensitive skin Study of triggers of sensitive skin Localization of sensitive skin in the face Resonance of sensitive skin Duration of onset of skin sensitivity after application of the cosmetic Use of organic products, formulated for sensitive skin, for children Shopping venues for cosmetics Advice from a professional for the purchase of cosmetics Impact of sensitive skin on the use of cosmetics Budget dedicated to the purchase of cosmetics

Eligibility Criteria:
Inclusion Criteria:

Women Between 18 and 65 years old -

Exclusion Criteria:

Men Less than 18 years old More than 65 years old Skin disease on the face: acne, rosacea, eczema Refusal to participate

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A Safety Study of SEA-BCMA in Patients With Multiple Myeloma

This trial will study SEA-BCMA to find out whether it is an effective treatment for multiple myeloma (MM) and what side effects (unwanted effects) may occur.

The study will have several parts. In Parts A and B, participants get SEA-BCMA by itself. This part of the study will find out how much SEA-BCMA should be given for treatment and how often. It will also find out how safe the treatment is and how well it works.

In Part C of the study, participants will get SEA-BCMA and dexamethasone. In Part D, participants will get SEA-BCMA, dexamethasone, and pomalidomide. Dexamethasone and pomalidomide are both drugs that can be used to treat multiple myeloma. These parts of the study will find out whether these drugs are safe when used together.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of MM
* Must have MM that is relapsed or refractory
* Has received a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
* Measurable disease, as defined by at least one of the following: (1) serum M protein 0.5 g/dL or higher, (2) urine M protein 200 mg/24 hour or higher, and (3) serum immunoglobulin free light chain (FLC) 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda FLC ratio.
* Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1
* Life expectancy of greater than 3 months in the opinion of the investigator
* Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

* Parts A and D: Prior treatment with a BCMA-directed therapy
* History of another malignancy within 3 years
* Active cerebral or meningeal disease related to the underlying malignancy
* Uncontrolled Grade 3 or higher infection
* Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR-T-cell therapy must be completed 8 weeks before first dose of study drug.
* Combination therapy only:

  1. Known intolerance to corticosteroids
  2. Uncontrolled psychoses
Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.

Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.

In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.

In order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.

In 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Eyes clinic patients presented with acute chemical or thermal burn.

Exclusion Criteria:other disease
Study of Biomarkers in Tissue Samples From Patients With Metastatic Colon Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is looking at biomarkers in tissue samples from patients with metastatic colon cancer.

OBJECTIVES:

* Determine the effect of surgical resection, in terms of physiological stress, on levels of tumor markers such as protein kinase A (PKA) expression in patients with metastatic colon cancer.
* Estimate variation among patients of baseline tumor markers in tumor tissue and sera.
* Correlate markers in tumor tissues with that in sera in these patients.
* Establish a tissue bank of these specimens for future studies.

OUTLINE: Biopsy and surgical specimens are obtained before and during standard surgery (patients may have had tumor tissue obtained before study entry and stored). Serum samples and tumor tissue are analyzed by immunohistochemistry and western blot. Tumor markers (such as PKA expression) are determined and marker levels are measured in serum samples and tissues.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of colon cancer

  * Metastatic disease for which surgical resection is indicated
  * Metastatic disease accessible for tissue biopsy OR previously biopsied tissue is available

PATIENT CHARACTERISTICS:

* Platelet count ≥ 80,000/mm\^3
* INR ≤ 1.3
* PTT ≤ upper limit of normal
* No history of bleeding disorders or abnormal clotting factors
* No extrahepatic biliary obstruction

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics