cyrilzakka/clinical-trials huggingface dataset:
Effects of Stress Ball Use for Patients Undergoing Local Anesthesia in Ambulatory Surgery

Preoperative anxiety begins from the decision-making of surgery to entering the operating room and may intensify as the surgery date approaches. Anxiety not only causes physiological effects but also psychological impacts, leading to negative outcomes for postoperative recovery. Ambulatory surgeries often employ local anesthesia, where patients remain conscious during the procedure, potentially causing specific anxieties and fears. The use of a stress ball is a non-pharmacological method that effectively distracts individuals consciously focusing on stimuli. This study is expected to be a randomized controlled trial, using convenience sampling to select patients receiving local anesthesia. They will be divided into two groups through computer-generated random number sequences: the stress ball group and the control group. The research aims to alleviate anxiety and pain levels in outpatient surgery patients receiving local anesthesia, with the goal of improving patients' postoperative mental health and quality of care.


Eligibility Criteria:
Inclusion Criteria:

- 1. Those who are over 18 years old, have clear consciousness and can communicate in Chinese and Taiwanese Hakka.

2. Patients undergoing outpatient surgery under local anesthesia.

Exclusion Criteria:

* Unable to cooperate
Seed Movement in Prostate Brachytherapy Implants: Clinical Measurement and Dosimetric Consequences

There are substantial uncertainties with contemporary seed placement techniques in prostate brachytherapy, particularly with the impact of seed movement after an implant due to edema and migration of seeds in the prostate and peri-prostatic tissues. This study will accrue 20 patients undergoing prostate brachytherapy implants and perform serial CT and MRI scans at specified intervals (pre-operatively, day 0, day 3, day 10 and day 28) to characterize these phenomena.

Prostate brachytherapy is an effective treatment option for men with localized prostate cancer with excellent cure rates and a favorable toxicity profile. Having a more detailed understanding of seed movement after an implant will provide clinicians with details about the clinical impact of these phenomena on implants and provide the detailed understanding of these phenomena that are necessary for more sophisticated brachytherapy implants that are envisioned in the future.

Eligibility Criteria:
Inclusion Criteria:

* treated with prostate brachytherapy
* low risk or intermediate risk prostate cancer
* ambulatory
* stable medical condition
* 18 years of age or older
* capable of informed consent

Exclusion Criteria:

* no use of any hormonal therapy
* unable to have MRI scans (ie. presence of metallic foreign object, aneurysm clip, cardiac pacemaker, internal wires, implanted pump, implanted cardiac device, claustrophobia, etc.
Effect of Telerehabilitation for Young Adults

It aims to examine the effects of video-based cervical posture and breathing exercises on the musculoskeletal system, pain and emotional stress levels in young adults. Control group (n: 15), study group (n: 15); It aims to examine the effects of video-based application support and breathing exercises and cervical posture exercises on the musculoskeletal health, which is important for individuals, pain affecting daily life and emotional stress levels, which we think have a great effect on social life, and to present them to the literature.

Primary Objective: To examine the effects of video-based cervical posture and breathing exercises on musculoskeletal health in young adults.

Secondary Objective: To examine the effects of video-based cervical posture and breathing exercises on pain in young adults.

Tertiary Objective: To examine the effects of video-based cervical posture and breathing exercises on emotional stress levels in young adults.

The study will include 30 randomly selected individuals between the ages of 18 and 30 who were directed to the Istanbul Gedik University Physiotherapy and Rehabilitation Department laboratory.

The individuals included in the study will be divided into 2 groups as a control group and a study group of 15 people with simple randomization. Only a brochure will be given to the control group, and the brochure will be distributed and explained to the study group, and telerehabilitation will be applied.

The study will be carried out in the Istanbul Gedik University Physiotherapy and Rehabilitation Department laboratory.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 30 years old
* having enough technological equipment
* female - male gender
* volunteering to work

Exclusion Criteria:

* Those with vertigo
* those with frequent nausea
* those with severe dyspnea
* those with rib fractures
Arnuity® Ellipta® Drug Use Investigation

The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as "Arnuity") in daily clinical practice. The investigation will include subjects with a diagnosis of asthma bronchial who are naïve to ARNUITY. The investigator will monitor the information about safety and effectiveness of ARNUITY for one year from the start date of ARNUITY administration and Pneumonia will be considered as the priority investigation matter. 300 subjects, from approximately 150 medical institutions, will be included in this analysis. ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.


Eligibility Criteria:
Inclusion Criteria:

* The investigation will include subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.

Exclusion Criteria:

* Not applicable
1.5T Intraoperative MR Imaging in Craniopharyngiomas

Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.


Eligibility Criteria:
Inclusion Criteria:

* complex craniopharyngioma \> 1cm extension within 2 or more cranial fossae or ventricular system
* Patient or legal representative able to provide written informed consent

Exclusion Criteria:

* tumor size\< 1 cm
* Patients with any condition considered a contraindication to MRI
* Patients with any condition considered a contraindication for surgery
* Hypothalamic disturbances
* Hypothalamic edema
Study in Participants With Acute Migraines Headaches

This is a Phase 2, multicenter, randomized, double-blind, placebo and active comparator-controlled study of LY2590443 in approximately 200 participants with migraines.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants between the ages of 18 and 65 years, inclusive.
* Participants who have migraine headaches, with or without aura (diagnosis according the International Classification of Headache Disorders-II), for at least 1 year.
* Participants who have had 2-8 migraine attacks on average per month for the last 3 months (but less than 15 headache days per month).
* Participants who are willing and able to comply with the study schedule and requirements.
* Participants who speak, read, and understand English sufficiently well and are willing to provide written informed consent.
* Participants who in the opinion of the principal investigator are in good general health.
* Venous access should be sufficient to allow blood sampling as per protocol.

Exclusion Criteria:

* Participants who do not or may not tolerate 5HT1 agonist treatments, with known hypersensitivity to sumatriptan (as discussed with the investigator).
* Female participants who have a positive pregnancy test at screening or pre- dose evaluation, or are breastfeeding.
* History or presence of significant medical illnesses as determined by the investigator.
* Participants with a current clinical diagnosis of major psychiatric disease.
* Regular use of known drugs of abuse; use of opiates for migraine rescue (no more than two times per month) is permissible.
* Blood donation of 500 milliliter (mL) or greater of whole blood products within 4 weeks of study commencement, during the study, or 4 weeks following the study.
* Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Consumption of more than three units of alcohol per day where one unit is defined as a 12 ounces (oz) beer, 4 oz wine, or 2 oz of alcohol spirit liquor.
* Are unwilling or unable to comply with the use of a diary to directly record data from the participant.
Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.

Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).

Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Undergoing anterior cruciate ligament surgery under general anesthesia
* ASA I-III

Exclusion Criteria:

* Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics,
* Neuromuscular disorders
Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

* Positive COVID-19 test
* Age \>/= 18 y.o.

Exclusion Criteria:

* Allergic reaction to Pentoxifylline
* Ongoing anticoagulation
* History of GI bleeding
* History of Seizures
* Cardiac or other vascular stents
* History of severe renal disease
* History of intracranial hemorrhage.
Acute Effects of Beetroot Juice on Locomotor Economy and Capacity in Chronic Stroke

The purpose of this study is to investigate if a beetroot juice supplement can improve oxygen capacity during walking tasks at a submaximal and maximal effort in people greater than 6 months following stroke.

During this study, participants will perform baseline measurements such as walking and balance tests. During baseline testing, participants will be asked to perform a maximal exertion test while walking on a treadmill to determine the speed for a submaximal walking test. One week after baseline testing, the participant will have an intervention session where they drink either a beetroot juice supplement or a placebo. The placebo will taste similar to the beetroot juice and participants may not be able to tell the difference between the two different supplements. After a week, the participant will return to the lab and drink the other supplement. For example, if the participant drank the beetroot juice in the first session, then they will drink the placebo in the second session. During each intervention session, the participant will be asked to perform two treadmill tests, one with submaximal effort and one with maximal effort. After the walking tests, they will drink either the beetroot juice or placebo and have their blood drawn. They will wait at the hospital for 2-3 hours and have their blood drawn again. The participants will then complete the two treadmill tests again. The two intervention sessions will last about 4-6 hours for each session. Participation in the study will last 4-6 weeks including screening and baseline testing.

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18-89 years
* diagnosis of chronic hemiparesis following unilateral stroke (greater than six months)
* ability to ambulate at least 0.3 m/s, with or without using an assistive device or bracing below the knee
* ability to read and understand English
* follow three-step commands

Exclusion Criteria:

* presence of cerebellar deficits
* any other neurological or orthopedic deficits that would limit walking ability
* smoking
* cannot receive physical therapy for gait-related impairments
* uncontrolled metabolic, respiratory, and cardiovascular disease
The Effect of Galvanic Stimulation on vHIT and VEMP Tests

Introduction: Galvanic vestibular stimulation (GVS) is a well-established technique with a history spanning over a century, primarily used to manipulate the vestibular system. Recent interest has surged in its potential for understanding human vestibular function and aiding in functional recovery. GVS applies electrical currents to the mastoid region, modulating vestibular afferents, and induces specific effects based on the participant's posture and current polarity. While GVS's impact on the central nervous system and its potential to aid in functional recovery have been studied, its immediate effects on vestibular reflexes remain less explored.

Methods: In this study, thirty healthy adult participants underwent ocular and cervical vestibular evoked myogenic potential (VEMP) tests, as well as the velocity Head Impulse Test (vHIT) before and immediately after one hour of GVS application. Statistical analyses were performed to assess changes in VEMP and vHIT results.


Eligibility Criteria:
Inclusion Criteria:

* No history of hearing loss and/or balance disorders
* No physical (neck) problems
* No history of psychological or neurological disorders
* Not using alcohol and/or vestibular suppressant drugs regularly
* Feeling balanced in daily life

Exclusion Criteria:

* History of hearing loss and/or balance disorders
* Physical (neck) problems
* History of psychological or neurological disorders
* Using alcohol and/or vestibular suppressant drugs regularly
Nasogastric/Orogastric Tube Placement Verification Study Using RightSpot pH Indicator to Verify Gastric Acidity

This study will evaluate the use of RightBio Metrics' RightSpot device used to determine if there is proper placement of a nasogastric or orogastric tube.

Primary objective:

To assess the level of accuracy of the RightSpot pH Indicator in determining correct placement of NG/OG tubes as compared to the gold standard of CXR in Emergency Department \& ICU patients.

Hypothesis 1: In greater than 90% of the cases, RightSpot pH Indicator will be successful in confirming the placement of NG/OG tubes by demonstrating a pH of 4.5 or less in patients with CXR proven tube placement.

Hypothesis 2: The time to confirmation of NG/OG tube placement will be significantly less using the RightSpot pH Indicator than using CXR. The time will be calculated by the start time consisting of the time that the NG/OG tube was placed until the end time, which will be when the device pH Indicator testing is performed. The time to confirmation using the gold standard of a CXR will begin when the NG/OG tube is placed and end when the CXR is available on PACS (picture archiving and communication system).

Secondary objective:

To determine via subgroup analysis whether gross blood in the stomach, presence of acid-reducing medications, or trauma affects the accuracy of NG/OG placement determination by the RightSpot pH Indicator.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Patient or proxy willing to provide informed consent
* Patients who require placement of a nasogastric/orogastric tube, in the ED or ICU, as standard of care, AND a member of the study staff is available and present for NG/OG tube placement.
* It is anticipated that the patient will remain in the ED/ICU in order to obtain RightSpot pH Indicator reading and verifying CXR

Exclusion Criteria:

* Patients less than 18 years of age
* Patient or proxy unwilling or unable to provide informed consent
* Patient with known or suspected pregnancy
Pharmacokinetics of Antimalarials in Breastfeeding Ugandan Mother-infant Pairs

Lactating women requiring treatment for uncomplicated malaria will be identified and invited for sampling. The decision to treat them with first-line treatment will have been made by the clinician, not by a member of the study team. The study team will not make any adjustments to the prescribed treatment. Artemether-lumefantrine comprises six doses of medication, with the initial two doses given 8 hours apart on Day 1, and dosing 12-hourly on Day 2 and Day 3. Intensive pharmacokinetic sampling will be undertaken after Dose 5, as indicated in the schema under Section 5: plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, 8 hours after dose. In addition, sparse sampling will be undertaken on either of these occasions; at pre-dose and between 1 to 6 hours after the first dose; a trough (pre-dose) sample after the Dose 3 or Dose 4 and lastly at 5, 7, and up to 14-days after the first dose. A heelprick sample will also be obtained from the breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit to characterize concentrations of these drugs over an 8-hour dosing interval. In addition, a single heelprick sample will be obtained from the infant whenever the mother returns after treatment for the late sampling time points (5, 7, and 14 days post the first dose). Due to the long half-life of lumefantrine of approximately 6 days plasma sampling will be performed up to day 14 to characterise the terminal elimination of the drug. Concentrations of total plasma and breastmilk lumefantrine and desbutyl-lumefantrine will be determined.

The endpoints of this study relate to the amount of antimalarial drug present in maternal blood, breastmilk and infant blood. The study is not powered for antimalarial efficacy, and therefore formal assessment of parasitological clearance is not required. The participants will be followed up until 30-40 days after completion of antimalarial therapy, and if recurrent symptoms occur, management will be as clinically indicated. Details regarding further clinical investigations and management required by either mother or infant during the follow-up period will be recorded on the CRF.

Eligibility Criteria:
Inclusion Criteria:

1. A personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.
2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
3. Woman is aged 18 years or older, and mothers between the age of 14-17, who are considered emancipated minors.
4. Receiving treatment for uncomplicated malaria
5. Breastfeeding at enrolment

Exclusion Criteria:

1. Severe maternal or infant illness which in the opinion of the patient's clinician would interfere with her participation in the study
2. Breastfed infant is aged over 12 months
3. Partner objection to participate in the study
4. Maternal objection to infant participation
General Anesthesia on Blood Pressure and Intraocular Pressure in Geriatric Patients Undergoing Cataract Surgery

The primary aim of the study is to investigate the correlation between preoperative hemodynamics and frailty scores in patients undergoing cataract surgery under general anesthesia. The secondary objective is to explore the relationship between preoperative and postoperative intraocular pressure changes and frailty scores.

Cataract stands as a significant cause of vision impairment worldwide, notably prevalent among the elderly. This study aims to explore the changes in intraocular pressure (IOP) and blood pressure under general anesthesia during cataract surgery in frail geriatric patients. The research emphasizes the critical role of frailty assessment in determining surgical risks among elderly surgical patients. It focuses on the hypothesis that frail individuals undergoing cataract surgery under general anesthesia might experience more pronounced effects on IOP and blood pressure during the surgical procedure compared to prefrail counterparts. This study emerges as a crucial step in understanding the impact of preoperative frailty assessment on surgical planning and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 65-85 age
* ASA I-III
* cataract surgery with genel anesthesia

Exclusion Criteria:

* cerebrovascular disease,
* mental retardation and psychiatric illness,
* pulmonary infection, history of advanced COPD or respiratory failure,
* EF less than 40%, presence of cardiovascular disease,
* bleeding diathesis,
* renal and hepatic insufficiency,
* presence of diabetes mellitus, diuretic/mannitol users,
* substance abuse
* BMI \>30
High Altitude Residents With High Altitude Pulmonary Hypertension (HAPH), SDB Assessed at HA (3200 m) vs LA (760 m)

To study the effect of relocation from 3200m (Aksay) to 760m (Bishkek) in highlanders with High Altitude Pulmonary Hypertension (HAPH) who permanently live \>2500m on sleep disordered breathing

This research in highlanders with HAPH diagnosed by echocardiography and defined by a RV/RA \>30 mmHg who permanently live at HA \>2500 m will have nocturnal respiratory sleep studies near their living altitude in Aksay at 3200 m and on night 1 and 6 at 760m after relocation.

Eligibility Criteria:
Inclusion Criteria:

* Permanently living \>2500 m
* HAPH diagnosed with a minimum RV/RA of 30 mmHg assessed by echocardiography at an altitude of 3200 m
* Written informed consent

Exclusion Criteria:

* Highlanders who cannot follow the study investigations,
* Patients with moderate to severe concomitant lung disease (FEV1\<70% or forced vital capacity \<70%), severe parenchymal lung disease, heavy smoking \>20 cigarettes/day or \>20 pack-years.
* Coexistent unstable systemic hypertension or coronary artery disease that required adjustment of medication within the last 2 months
* Regular use of medication that affects control of breathing (benzodiazepines, opioids, acetazolamide)