cyrilzakka/clinical-trials huggingface dataset:
Omarigliptin & Trelagliptin in Twelve Healthy Egyptian Volunteers

The proposed study will consider the LC-MS/MS quantitative determination of Omarigliptin \& Trelagliptin after administration to twelve Egyptian volunteers. The main aim of the study is to confirm that the developed LC-MS/MS method is applicable for the bio-assay of the drugs in the actual biological samples at the time of Cmax (nearly about 1.5 hours). The design of the study is open labeled, randomized, one treatment, one period, single dose study. The concentration of the drugs after 1.5 h will be determined in healthy human subjects according to the ethical regulations of World Medical Association Declaration of Helsinki (October 1996) and the International Conference of Harmonisation Tripartite Guideline for Good Clinical Practice. Written informed consent was provided (attached and signed by the twelve volunteers) in order to be approved by the ethics committee of the Faculty of Pharmacy, The British University in Egypt. The good health of the human subjects was confirmed by a complete medical history and physical examination. Samples from twelve, healthy, adult, male, smoking, Egyptian volunteers (age: 23-37 years, Average weight: 81.6 kg, Average BMI: 30.4) will be collected at 1.5 h, to be transferred to heparinized centrifuge tubes in order to be analyzed by LC-MS/MS study (developed \& validated) after single oral dose administration of one Marizev® tablet nominally containing 25 mg of Omarigliptin (first arm as 6 volunteers) or one Zafatek® tablet nominally containing 100 mg of Trelagliptin (second arm as 6 volunteers). The blood samples (0.5 mL of each sample) will be centrifuged at 3000 rpm for 5 minutes, 100 µL of the plasma will be separated and spiked with the internal standard working solution and then the sample preparation and LC-MS/MS determination will be applied. Blood glucose level will be determined for all volunteers at different time intervals to monitor any hypoglycemic effect to ensure their safety all over the study. The study will be conducted as per FDA guidelines \& the evaluation of safety of the study will be based on monitoring of blood glucose level, vital signs, pulse rate, monitoring of adverse events, and physical examination.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Type-2 diabetes
* Hospitalized within 1 week
Closed-loop Non-invasive Brain Stiumlation

Transcranial magnetic stimulation (TMS) is a widely used tool for exploring brain function in humans (Siebner et al. et al., 2022), which has led to new therapeutics for various psychiatric and neurological disorders (Lefaucheur et al., 2020). However, the open-loop use of this technique has raised questions about its operating principle, due to the high degree of heterogeneity of results and the small to medium observed effect sizes (Zrenner and Ziemann, 2023). To increase the response rate, it has been suggested to individualize stimulation, by adapting the TMS parameters (i.e. delivered dose, target dose, targeting, timing, etc.) to instantaneous estimates of brain brain state. Such an approach, known as closed-loop closed-loop stimulation, is currently one of the main challenges challenges in this field (closed-loop brain state-dependent stimulation). To this end, we are focusing on the combination of robotic TMS and electroencephalography (EEG) (Hernandez-Pavon et al. al., 2023). The closed-loop stimulations using this combination developed to date have two limitations: (i) they are not adaptive and focus focus mainly on calculating the phase of brain oscillations to trigger stimulation and (ii) are limited to central cortical (sensorimotor) areas, where the EEG signal-to-noise ratio is optimal.

This project aims to develop closed-loop TMS-EEG protocols that overcome these two limitations: (i) by incorporating adaptive decision modeling (AutoHS model, Harquel et al. 2017) to optimize several parameters in parallel (coil location, orientation, intensity) while using a wider range of EEG markers (evoked potentials, oscillatory activity strength, connectivity, etc.), and (ii) by integrating real-time EEG pre-processing to access any cortical target (including frontal, temporal and occipital lobes).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Having undergone a medical examination prior to participation in research
* Affiliation with or beneficiary of a social security scheme

Exclusion Criteria:

* Contraindications (CI) to MRI, EEG, TMS practice
* Existence of a severe general medical condition: cardiac, respiratory, hematological, renal, hepatic, cancerous,
* Regular use of anxiolytics, sedatives, antidepressants, neuroleptics,
* Characterized psychiatric pathology,
* Suspicion of alcohol ingestion prior to the examination,
* Participation in other interventional research protocols in progress with exclusion period or in the preceding week.
* Persons covered by articles L1121-5 to L1121-8 of the CSP (French Public Health Code) (corresponds to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L.

3212-1 and L. 3213-1 who are not covered by the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research, minors, persons under legal protection or unable to express their consent).

- Personnel with a hierarchical link to the principal investigator
The Effect of Having a Child Watch Musical Cartoons

The purpose of this study was to evaluate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation. This study was a randomized controlled experimental trial. The study sample consisted of 40 children, 20 of whom were assigned to the experimental group and 20 to the control group. Data Collection Form, Vital Signs Evaluation Form, and Child Anxiety Scale-Stateness were used as data collection tools. Data collection tools were used in both groups before, during, and after the procedure. In addition, the experimental group was shown musical cartoons during the procedure.

The present study was conducted as a randomized controlled experimental study to investigate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation. Does watching musical cartoons during rectal irrigation have an effect on children anxiety and vital signs? The answer to the question has been sought.The study sample consisted of 40 children aged 4-10 years who met the inclusion criteria and whose parents provided written and verbal consent for their participation in the study after being informed at the Pediatric Surgery and Pediatric Urology Department of a public hospital affiliated to the Provincial Health Directorate of the Ministry of Health in Istanbul. Because of the high power requirement and the potential for loss to follow-up, the study was conducted with a total of 40 children, 20 assigned to the experimental group and 20 to the control group, who met the eligibility criteria and consented to participate. The children were randomly assigned to the control or experimental group. Children enrolled in the study were assigned to the experimental or control group using the https://www.calculatorsoup.com. Data Collection Form, Child Anxiety Scale-Stateness, and Vital Signs Evaluation Form were used as data collection tools.After obtaining institutional approval and written consent from parents after informing them and their children, data were collected by the investigators through a face-to-face interview that took approximately 11-20 minutes per child. The intervention to be applied to the experimental group was carried out by the investigator after informing the children and parents and obtaining their written consent.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4-10 years
* Children who can count from one (1) to ten (10).
* Children who love cartoons with music.

Exclusion Criteria:

* Children without visual or hearing impairments
* Children without mental problems
Non-cancer Pain and Cognitive Impairment: A Disabling Relationship

To compare the efficacy of long-acting oxycodone to extended-release acetaminophen in older persons with no and mild to moderate cognitive impairment and persistent moderate or higher intensity non-cancer lower extremity arthritis pain; and Describe the association of change in non-cancer pain self-report with an older adults functional status (BPI and WOMAC and brief physical performance measure) and to determine if cognitive status modifies this relationship.


Eligibility Criteria:
Inclusion Criteria:

1. age over 65
2. Pain at least 3 months duration
3. Pain greater in lower extremity than other anatomical site with ambulation
4. Pain self-report of moderate intensity of higher on an average day
5. Community-dwelling
6. Ambulatory
7. Physician states participants have decision-making capacity to enroll into the trial
8. Participants with cognitive impairment have a reliable caregiver
9. Inadequate pain relief from NSAIDS and/or acetaminophen in the past

Exclusion Criteria:

1. Current cancer requiring chemotherapy
2. History of addiction to opioids or other controlled substance
3. Consumes more than 2 alcoholic drinks a day
4. Severe balance disturbance
5. Intra-articular steroid injection in the past 6 weeks
Three Birds With One Stone

The overall aim of the study is to increase participation rates in cervical cancer (CCU) and colorectal cancer (CRC) screening programmes in Denmark by offering home-based CCU and CRC screening to women who are overdue for one or both screening programmes when attending breast cancer screening

A cluster-randomised public health trial will take place in Central Denmark Region (CDR) targeting women attending breast cancer screening. Five breast cancer screening units serve women five days a week, and all five units will be included in the study and randomly allocated to an equal amount of intervention days. On the intervention days, the other four units will serve as the control group, providing a randomisation ratio of 1:4.

On the intervention days, a research assistant will ask the women aged 50-69 years if they are interested in having a check up on their screening status with CCU and CRC screening. If the woman has not participated timely, she will be offered to receive a test-kit corresponding to CRC screening and/or to receive a self-sample device for CCU screening (or reminded to call her general practitioner (GP) to have a conventional cervical cytology sample taken).

If the woman accepts a self-sample kit for CCU and/or CRC screening, she will receive it by mail together with written instructions, picturebased user instructions, information on national recommendation for cancer screening and a pre-paid, pre-addressed envelope for returning the sample to the laboratory.

The result of the test will be sent to the women by digital mail as well as passed on to her GP.

Clinical management in case of a positive test result will follow national guidelines corresponding to CCU and CRC screening programmes.

Women in the control group will receive standard screening offers according to the national screening programmes.

All women entering a breast cancer screening unit in CDR on a intervention day (intervention + control units) will be sent a survey asking their experience with breast cancer screening a few days after breast cancer screening. The women in the intervention group will be asked about the acceptability of the intervention as well.

27500 women must be included, of which 5500 women will be in the intervention group.

Eligibility Criteria:
Inclusion Criteria:

Women aged 50-69 years attending breast cancer screening in Central Denmark Region on selected days.

* In CCU screening: women aged 50-64 years will be classified as overdue if they have not had a cervical sample within the last 5 years and 6 months
* In CRC screening: women aged 50-69 years will be classified as overdue, if they have not had a FIT within the last 2 years and 4.5 months despite an invitation.
Development and Usability of an Adjustable Prosthesis for Aquatic Therapy

The initial purpose of this study is to develop a prosthesis which is adjustable to use with a variety of patients in aquatic therapy. Aquatic therapy is a beneficial rehabilitation tool for individuals with limb loss. The pool environment offloads body weight, which can improve comfort on a residual limb and increase confidence in activities outside of the pool. The properties of water also assist in strengthening exercises and reducing pain.

Currently, most individuals do not have a prosthesis to use in the pool. Water specific prosthesis are often not covered by insurance and can be expensive. For someone that doesn't have a water specific prosthesis, they may not be able to do therapy tasks on two legs, limiting what activities or exercises can be performed. Through creating an adjustable prosthesis, it will allow persons with limb loss to have access to a water specific leg in a time efficient, cost effective, and safe manner for rehabilitation.

This study involves a novel prosthesis for use in aquatic therapy. This novel design will have an adjustable circumference, residual limb length, and height, allowing a greater number of patients to use the prosthesis.

The goal of this project is to create and conduct a preliminary usability evaluation of a novel adjustable prosthesis for use in aquatic therapy for persons with a lower limb amputation at the transtibial level (LLTTA). It is hypothesized that this prosthesis will benefit both the patient and the therapist during aquatic therapy sessions, which will be evaluated through the following aims:

Aim 1: Create a non-custom, adjustable prosthesis for use in aquatic therapy by individuals with limb loss at the transtibial level.

Aim 2: Perform a pilot study (n=3) to quantity the usability of the prosthesis as a therapy tool.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-89 years
* Patients who have a unilateral transtibial amputation who are able to use a prosthesis
* Patients who currently participate in aquatic therapy at Shirley Ryan AbilityLab, or have completed aquatic therapy within the last six months, at Shirley Ryan AbilityLab

Exclusion Criteria:

* Pregnant women
* Children (\<18 years old)
* Prisoners or institutionalized individuals
* Individuals who have the inability to give informed consent
* Participants with complicating health conditions that interfere with the study
* Participants with contraindications to aquatic therapy, as listed in Shirley Ryan AbilityLab's policy on aquatic therapy participation
Erector Spinae Plane Block in Pediatric Hip Surgery

Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK

. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.

The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.


Eligibility Criteria:
Inclusion Criteria:

* ASA I II scheduled for hip surgery.

Exclusion Criteria:

* • Parent refusal

  * Coagulopathy
  * Patient with congenital heart disease
  * Infection at the site of puncture
  * Significant spinal anatomical anomaly
  * Patient with neuromuscular disorder
  * Any known allergy to the drug used
A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy

This prospective observational study aims to (i) asses intensive care doctors trigger for and the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients admitted to the intensive care unit will be included in the study.

Intensive care unit patients often receive a fluid bolus during their ICU-stay. ICU doctors use a variety of clinical triggers when deciding whether or not to give a fluid bolus. However, the type of physiological triggers used and their correlation to the anticipated physiological response of the patient to an administered fluid bolus is not entirely clear.

The investigators will perform a prospective observational study to evaluate the triggers for, expected physiological and actual physiological response to fluid bolus therapy in the intensive care unit. Specifically, the investigators will assess which of the the physiological trigger(s) intensive care doctors use when deciding to give a fluid bolus; the expected physiological response to the fluid bolus by intensive care doctors; and, to what degree the patients actual physiological response 1 hour after a fluid bolus correlate with expectations.

This study will involve a survey of ICU physicians to determine the physiological trigger and expectations and a medical audit to ascertain the physiological response to a fluid bolus. The investigators will evaluate a single fluid bolus in 100 separate intensive care unit patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit and prescribed a fluid bolus.

Exclusion Criteria:

* The intensive care physician declines to participate.
* Expected survival \< 24h
Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)

2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to the study.
* Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
A Study to Assess Adverse Events and Effectiveness of HAC 20L Injections in Adult Participants for the Treatment of Nasolabial Folds

Nasolabial folds (NLF) are the two skin folds that run from each side of the nose to the corners of the mouth. Prominent NLFs distort the contour of the midface, giving a fatigued and aged appearance. Soft tissue fillers can be used to reduce the depth of NLFs and restore a more youthful appearance. The purpose of this study is to evaluate how safe and effective HAC 20L is in the correction of moderate to severe NLF in adult participants.

HAC 20L is an investigational drug being developed for the treatment of NLF. There are 2 cohorts in this study. In each cohort participants are assigned to either the treatment group or no-treatment control group. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Around 75 adult participants with moderate to severe NLF will be enrolled in the study at approximately 20 sites worldwide.

Participants in the treatment group will receive an injection of HAC 20L to the NLF on Day 1 in Cohort 1 and Cohort 2 with the option of re-treatment after completion of Month 12 visit. The control group will receive no treatment but will be offered an optional HAC 20L treatment after 6 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be examined by completing effectiveness questionnaires by the subjects, evaluating investigator (EI) and central reviewers as well as monitoring safety assessments such as vital signs, blood tests, injection site responses and adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Has moderate or severe NLFs (NLFSS score 2 or 3) on each NLF based on EI's live assessment (both NLFs must qualify and need to have the same score).
* General good health, in the opinion of the TI, and no known current COVID 19 disease or previous COVID-19 disease-related symptoms within 30 days.

Exclusion Criteria:

* Atrophic skin in the facial area that makes it unsuitable for injection.
* History of anaphylaxis or history or presence of multiple severe allergies, including allergy to antiseptic solution, lidocaine (or any amide-based anesthetics), HA products, human recombinant collagen, bovine or porcine collagen products, gram positive bacterial proteins (including Streptococcal protein) or to any of the excipients.
* Prior fat injection or permanent implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face, or is planning to be implanted with any of these products at any time during the study.
* Received semipermanent soft-tissue filler treatment (e.g., calcium hydroxyapatite, poly-L-lactic acid) in the face below the orbital rim within 24 months before enrollment, or is planning to be implanted with any of these products at any time during the study.