cyrilzakka/clinical-trials huggingface dataset:
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena

It has been proven that tracheal tube inflated with lidocaine could decrease the post-intubation sore throat in nitrous oxide anesthesia. In the study, the investigators would like to evaluate the effect of lidocaine inflation in non-nitrous oxide anesthesia and compare the effect of tetracaine, the best mucosal local anesthetics with lidocaine.

The female patients receiving gynecological surgeries were divided into air, saline and 2% lidocaine and 1% tetracaine groups of 25 each using sealed envelope technique. The cuff of the endotracheal tube was inflated by the inflation medium (with the help of intracuff pressure monitoring device) to occlude the leak around the tube by the Minimal Occlusive Volume Technique. This was done by the same anaesthesiologist in all the patients. The cuff volume and pressure were then recorded. The primary outcome of the study was to evaluate the post-intubation sore throat using the visual analogue scale 6h, 24h and 48h after extubation. The secondary outcomes were incidence of complications during emergence of anesthesia and after extubation. Intra-cuff pressure monitoring was done with a pressure monitor, which consisted of the pressure gauge, three-way stopcock whose one end was attached to the pressure monitoring line. Net volume of the inflation medium was noted. Volume of the inflation medium, intra cuff pressure, duration from intubation to extubation and volume of the inflation medium withdrawn from the cuff was noted. Incidence (Yes/No) of tube intolerance, coughing on tube, restlessness, hoarseness, sore throat, breathlessness and laryngospasm were analyzed by the anaesthesiologist who did not know which group the patient belonged to.

Eligibility Criteria:
Inclusion Criteria:

* patients of the age group 18-60 years
* patients belonging to ASA grade I and II undergoing gynecological surgeries in supine position under general anesthesia with controlled ventilation using Poly Vinyl Chloride ETT (same type and make in all patients)

Exclusion Criteria:

* anticipated difficult intubation
* more than one attempt for intubation
* need for naso gastric tube
* episode of coughing and straining
* history of respiratory tract infection and smoking
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 3 years and \<30 years.
* Able to give informed consent.
* English speaking with no language impairment
* Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months

Exclusion Criteria:

* History of reaction to peanuts
* Major active medical problems of the oral cavity or use of medications that might change rates of salivation
A Study to Learn About the Medicine (Called Elranatamab) in People With Relapsed Refractory Multiple Myeloma

This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, we will use data from the phase 2 clinical trial (MagnetisMM-3). We will also use data from two real-world databases, representing the SOC in clinical practice. This study does not seek any participants for enrollment. We will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help us to know how well elranatamab can be used for RRMM treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older at index date
* Diagnosis of MM
* Measurable disease according to IMWG criteria
* ECOG performance status ≤2
* Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory \[TCR\])
* At least 1 treatment following their TCR eligibility

Exclusion Criteria:

* Acute plasma cell leukemia
* Amyloidosis
* Smoldering MM
* Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
* Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
* Administration with an investigational drug within 30 days prior to index
Autostereoscopic Dynamic Near Vision Testing

This is an analysis of tests of near vision.

Visual perception testing using a novel program on an interactive three dimensional electronic device:

Autostereoscopic dynamic near games for monocular visual acuity, stereopsis and color are compared with other conventional or similar tests.

Subjects with normal vision, exceptional vision, or visual deficits have near vision tested on the PDI Check game and compared to other clinical tests.

Interclass Correlation and Bland Altman analysis utilized for continuous data. Sensitivity and Specificity calculated for defined clinical entities. Subjects are not assigned to either one screening test or another; instead different tests are compared.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects, patients with deficient binocular vision, patients with color vision disorders

Exclusion Criteria:

* phthisis, enucleations
Impact of Local Steroid Application in Extreme Lateral Lumbar Interbody Fusion

Neural injury is a well-known complication following extreme lateral lumbar interbody fusion (XLIF). It has been found that up to 9.4% of patients will have either temporary or persistent neurologic deficit. This occurs with traversal of the psoas muscle or direct injury to lumbosacral plexus or sympathetic ganglion. While often temporary, it can cause hip flexor weakness, thigh numbness, or pain.

Several studies have demonstrated reduced patient reported pain scores following steroid administration, particularly in the early postoperative period. However, few studies have investigated the efficacy of intraoperative local injection of corticosteroid in reducing the incidence and duration of postoperative pain or neurologic injury for XLIF patients.

The purpose of this study is to determine if the incidence and duration of postoperative pain is reduced in the subjects receiving a local injection of methylprednisolone when compared to placebo following XLIF.

The investigators hypothesize that subjects undergoing XLIF who receive local methylprednisolone will have:

1. Reduced incidence and duration of postoperative pain and neurologic injury
2. Shorter hospital stay
3. Better short- and long-term outcomes

The study also aims to answer the following questions:

1. Do subjects who receive local corticosteroids have a reduced incidence and duration of postoperative pain and neurologic deficit compared to those who receive placebo?
2. Do subjects who receive local corticosteroids have a reduced hospital stay compared to those who received placebo?
3. Is local corticosteroid therapy associated with improved short and long-term outcomes?

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a 1- to 2-level XLIF
* Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis
* Patients able to provide informed consent

Exclusion Criteria:

* Allergies or other contraindications to medicines in the protocol including:
* Existing history of gastrointestinal bleeding
* Lumbar spine trauma
* Unable to speak, read, or understand English
ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH.

To assess the safety of alfuzosin in this population and health care consumption.

Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.

Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Eligibility Criteria:
Inclusion Criteria:

* Male aged over 50 years
* Having given his written consent
* Presenting with a first episode of painful acute urinary retention related to BPH
* With a catheterized urine volume between mL and mL at the time of retention

Exclusion Criteria:

* Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
* Iatrogenic causes of urinary retention
Satiety of High-Protein Ramen Noodles

The aim of this study is to determine if high-protein instant ramen noodles acutely increase satiety, reduce hunger, and improve blood sugar levels compared to standard instant ramen noodles in generally healthy young to middle aged adults. In addition, investigators aim to test if intake of high-protein instant ramen noodles reduces caloric intake at the next meal compared to standard instant ramen noodles.

The aim of this study is to determine if high-protein instant ramen noodles acutely increase satiety, reduce hunger, and improve blood sugar levels compared to standard instant ramen noodles in generally healthy young to middle aged adults. In addition, investigators aim to test if intake of high-protein instant ramen noodles reduces caloric intake at the next meal compared to standard instant ramen noodles. Subjects meeting the eligibility criteria will be recruited and offered a 2-condition, randomized, crossover postprandial study. Participants will be asked to limit physical activity to a specified level, consume a standardized meal at night and report to the clinic after a 12 h overnight fast. At our clinic, in random order, participants will consume: 1) one portion of high-protein instant ramen noodles (71 g; Chef Woo, Borealis Foods); 2) an isocaloric, weight matched portion of standard instant ramen noodles. The participants will have to finish consuming the noodles within 15 minutes. Water will be provided at the time of breakfast and for the next two hours. In the 4-hours following the ramen breakfast, blood will be sampled at regular intervals (0 minutes - before starting the breakfast, and 30, 60, 120 and 180 minutes after stopping breakfast) for hunger and satiety hormones (i.e., glucagon like peptide-1, peptide-YY, and ghrelin), and glucose and insulin. Visual Analogue Scales will also be administered to assess subjective hunger and satiety. At 4-hours, a buffet-style lunch will be provided and caloric intake at the meal will be covertly assessed. Subjects will leave the clinic at this point. The process will be repeated for the second condition after at least 7 d washout period.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index 20-30 kg/m2

Exclusion Criteria:

* Unwilling or unable to have an IV catheter inserted
* Body weight \<110 pounds
* Diabetes (any type)
* Fasting capillary glucose ≥100 mg/dL
* Unstable systemic medical condition

  •\>10% change in body weight in the prior 3 months
* Medications that affect appetite or glucose regulation
* Prior bariatric surgery
* Uncontrolled hypertension (i.e., unmedicated blood pressure \>130/90 mmHg)
* Intolerance, dislike or allergy to the study food
* Current or recent (within 6 months) tobacco use
* High alcohol consumption (\>14 drinks/week)
* Currently following a weight loss diet
* Irregular menstrual cycle
* Currently pregnant or lactating
* Principal investigator discretion (e.g., disrespectful or inappropriate interactions with study staff
Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning

The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.

The study will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded.

This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal \[1 g/Kg, orally\] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients will be followed up until discharge or death. All patients will be subjected to:

I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.

Eligibility Criteria:
Inclusion Criteria:

Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:

1. The typical clinical manifestations due to and following shortly after a single exposure to phosphide.
2. Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.

Exclusion Criteria:

* Patients less than 12 years of age
* Pregnant and lactating women
* Patients with ingestion or exposure to other substances in addition to phosphide.
* Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
* Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).
* Patients treated for acute phosphide poisoning in any medical center before admission.
Evaluation of Clinical and Molecular Biomarkers in Immunotherapy Treatment in Gynecologic Cancer

Background: Immunotherapy has changed the therapeutic approach for gynecologic gynecological malignancies such us endometrial and cervical cancer. Despite literature data support the strong effect of immunotherapy in these cancers, a share of patients do not respond to immunotherapy. Furthermore the extremely variable immune-related spectrum of toxicity in terms of events and timing makes it necessary to identify predictive factors for the development of these side effects.

Hyphotesis: To evaluate the presence of biochemical, bioumoral and or molecular predictive factors in patients affected by endometrial and cervical cancer treated with immunotherapy plus chemotherapy, immunotherapy plus tyrosine kinase inhibitors (TKI) or immunotherapy alone.

Methodology: We will retrospectively collect data about patients affected by advanced, recurrent or metastatic endometrial cancer (EC) and recurrent cervical cancer (CC) treated with immunotherapy.

We will investigate whether there is a statistically significant difference in the efficacy of immunotherapy according to biochemical, biohumoral and or molecular factors and survival outcomes. Moreover, we will evaluate whether there is a correlation between biochemical, biohumoral and or molecular factors and immune-related adverse events (irAE).


Eligibility Criteria:
Inclusion Criteria:

* Females aged ≥ 18 years at the time of inclusion in the study.
* Patients diagnosed with advanced, metastatic or recurrent endometrial and cervical cancer treated at the Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
* Patients with histological confirmation of endometrial and cervical cancer, according to the histotypes suitable for immunotherapy.
* Patients previously treated under Nominal Use and/or Expanded Access Program (EAP) programs can be enrolled in the study.
* Patients who have received at least 1 dose of immunotherapy after starting treatment.
* Signature of the informed consent or declaration in lieu of the consent form where applicable

Exclusion Criteria:

* Use of immunotherapy within an experimental protocol.
* Patients who continued therapy at another center.
Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication.

The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.

The study will evaluate and monitor use of ReX in respect of:

* treatment duration
* adverse events
* patient adherence and compliance
* engagement with ReX via patient-reported outcomes

Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.

The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:

* Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
* Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
* Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.

ReX manages and monitors medication-based therapy by means of:

* Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
* Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
* Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.

In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.

Data collected by the ReX Remote Digital Nurse include:

* medication name
* prescribed dosage
* doses taken per day
* pills taken per dose
* ePRO responses
* missed pill intakes

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Care team recommends the use of ReX as a standard of care.
3. Patients have 5th grade reading level.
4. Patient was prescribed oral medication.
5. Patient takes medication at home.

Exclusion Criteria:

1. Patient has significant physical disability including poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent or use the ReX dispensing unit effectively.
2. Patient failed to pass the learning module during ReX onboarding flow.
3. Patient is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence

In our study, we aimed to evaluate the effects of core stabilization exercises added to traditional Kegel exercises on incontinence and quality of life in women with stress and stress dominant mixed urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

1. Women between the ages of 18 - 55
2. Diagnosis of stress and stress predominant mixed urinary incontinence
3. Pelvic floor muscle strength ≥ 3
4. BMI ≤ 35 kg/m2
5. ≥ 1 complaint of urinary incontinence in the last month

Exclusion Criteria:

1. Pregnancy and postpartum first 6 weeks
2. Other types of incontinence and stress type 3 incontinence
3. Urinary tract infection
4. Pelvic organ prolapse advanced stage (Stage ≥ 2)
5. History of pelvic surgery or pelvic tumor
6. Surgical treatment for urinary incontinence
7. History of serious systemic or neurological disease (Severe cardiovascular disease, advanced COPD, CVO and/or Cancer, Parkinson's etc.)
8. Severe low back and/or pelvic pain
Hearing Program in Primary Care

During a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.


Eligibility Criteria:
Inclusion Criteria:

* speaks English or Spanish;
* capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants
Telemedicine in HIV Care in Buenos Aires

The aim of this investigation is to conduct an implementation research to facilitate and evaluate the implementation of VCT((Videoconsult through telemedicine) among HIV HCP(healthcare providers) and PLWH(people living with HIV)

Through prospective observational methodology the investigators are planning to evaluate VCT(Videoconsult through telemedicine) implementation. Both quantitative and qualitative analysis (mixed methods) will take part in the assessment. Quantitative data will be useful to obtain objective data in terms of proportion of subjects using the intervention, adoption by health care workers and measuring effectiveness. Additionally, qualitative methods will help to understand the outcomes focusing on the barriers and facilitators from both the HCW and patients, and their feedback on continuous implementation.

Hence, perceptions of a vast group of patients and HCW will take a critical point in the qualitative analysis. Finally, by evidencing effectiveness, the investigators will be able to generalize and maintain this intervention as a good clinical practice. Due to the scope of the outcomes, the investigators will use RE-AIM framework.

Eligibility Criteria:
Inclusion Criteria:

* 18 years-old or older
* Access to internet
* Willing to participate

Exclusion Criteria:

* do not understand the purpose and study procedures