cyrilzakka/clinical-trials huggingface dataset:
Validation of HC250 and HC240 Series.

This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.

All patients with suspected obstructive sleep apnea presenting at the Auckland Hospital Sleep Laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. From these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the HC254 Auto CPAP. An additional 20 patients will undergo titration with the HC244 CPAP.

The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI \> 15/hr) during this diagnostic component will then undergo one of the following:

* Treatment with the HC254 Auto CPAP during the second half of the study.
* Treatment with the HC244 CPAP during the second half of the study.

The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.

5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.

Eligibility Criteria:
Inclusions criteria:

* AHI \> 15 on the diagnostic night or portion of the split night study.
* ≥18yrs of age

Exclusion criteria:

* Significant Central Apnea
* CHF
* Co-existing obesity related hypoventilation
* Inability to give informed consent
* Patient intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate.
* Less than 3 hours in the titration period
* Under Land Transport New Zealand (LTNZ) investigation
Upper Airway Stability During Wakefulness and Sleep

Negative expiratory pressure is a technique that has been the focus of many studies in the last few years.

Airway response to the application of a negative expiratory pressure (NEP) can be used to detect the presence of upper airway collapsibility. In normal subjects, an increase in expiratory flow is observed while in patients with collapsible upper airway, the flow will show a transient decrease due to airway collapse.

The objectives of this study will be initially to investigate the diagnostic utility of this technique as a noninvasive measurement of the stability of the upper airway in sleep-related breathing disorders. Secondly, we aim to see the sites of airway obstructions, discovered by NEP, through nasal endoscopy. Finally, we aim at testing the utility of NEP technique in the evaluation of therapeutic response. For this purpose, we will apply it in patients before and after airway stabilization interventions like ENT surgery, oropharyngeal exercises, orthodontic mandibular advancement electrical stimulation of the hypoglossal nerve.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Patients with COPD
Phase 1 Every-3-Week Dosing of SCH 727965 in Patients With Advanced Cancer (Study P04630)

Part 1 and Part 2 of this trial will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered every 3 weeks as a 2 hour intravenous (IV) infusion (Part 1), and as an 8-hour or 24-hour IV infusion (Part 2). Each 3-week period is considered one treatment cycle. Part 3 of this trial will evaluate the effect of coadministration of antiemetic drug aprepitant on the pharmacokinetics of SCH 727965 administered as a 2 hour IV infusion once every 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years, either sex, any race.
* Subjects must have histologically proven solid tumors, non-Hodgkin's lymphoma, or multiple myeloma.
* There must be no known standard therapy, or disease must be refractory to standard therapy.
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
* Adequate hematologic, renal, and hepatic organ function and laboratory parameters.

Exclusion Criteria:

* Symptomatic brain metastases or primary central nervous system malignancy.
* Previous radiation therapy to \>25% of the total bone marrow.
* Previous treatment with SCH 727965.
* Known HIV infection.
Breastfeeding Advices on OTC Medicines With the Internet: What is the Best Medium

Pharmacotherapy for lactating women in Hungary presents a unique challenge. While certain medications may pose risks to the infant or reduce breast milk production, the unnecessary avoidance of treatment can also be harmful. Despite this, no dedicated Hungarian website currently provides guidance on the safe use of over-the-counter (OTC) medications for breastfeeding mothers.

To address this gap, the aim is to develop a website that not only meets clinical standards but also presents essential information in a clear, accessible format that helps mothers understand and retain key details by choosing the best medium.

Our main question is: What is the most effective way to educate lactating women about OTC medication use through an online platform?


Eligibility Criteria:
Inclusion Criteria:

* Target population is adult (\>18 years), 3rd trimester pregnant women; and breastfeeding women after childbirth (max. 7 days postpartum; 24:00), who intend to breastfeed.
* Participants have to have internet access with no regard to the type of internet connection.

Exclusion Criteria:

* A mother will not breastfeed, either because they cannot or do not want it.
* Anyone who do not want to participate in the study.
Self-Assembling Matrix Forming Gel to Prevent Stricture Formation

The study is designed as a multicenter prospective registry study evaluating the efficacy of the self-assembling peptide in the prevention of stricture formation after endoscopic resection as part of standard medical care. No experimental interventions will be performed.

In recent years, endoscopic resection by endoscopic mucosal resection(EMR) or endoscopic submucosal dissection(ESD) has become standard practice for the removal of superficial neoplasia (precancerous lesions and early cancer) throughout the gastrointestinal tract. These procedures are associated with lower morbidity and mortality when compared to conventional surgery.

Nonetheless, stricture formation following endoscopic resection of gastrointestinal lesions is a well-known risk, particularly in the esophagus. The main risk factor for esophageal stricture formation following EMR/ESD is resection size, with this increasing with the length and extent of the circumferential excision, reaching 100% stricture formation when the entire circumference is involved. Stricture formation is associated with significant morbidity and increasing health care utilization, as multiple endoscopies are often required as part of the management of these difficult to treat strictures.

Recently, a self-assembling peptide (SAP) forming gel (Purastat; 3D Matrix, Ltd, Tokyo, Japan) has been approved by the Food and Drug Administration (FDA) as an agent that that promotes healing, which may potentially reduce the risk of stricture formation. Initial small studies from Europe appear to show benefit but the magnitude of the effect has not been well defined. Furthermore, large prospective US based studies are currently lacking. Therefore, the aim of this study is to assess the efficacy of this novel SAP gel in the prevention of stricture formation after endoscopic resection in high-risk patients as utilized as part of clinically indicated standard patient care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients at high-risk for esophageal stricture formation defined as undergoing endoscopic resection in the esophagus involving more than 50% of the circumference

Exclusion Criteria:

* Any standard contraindication to anesthesia and/or endoscopy
* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.
Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone.

This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.

This study aims to assess the efficacy of Chloroquine alone, withholding Primaquine until day 28. Parasitic clearance and recurrence rates will be recorded. Patients whose blood stage of parasites are not cleared with the standard dose of Chloroquine, or any recurrences before day 28, will be treated with second line treatment (ACT).

The patients blood level of Chloroquine (drug concentration) at the time of a recrudescent infection will de determined to assess whether that could be due to resistance, or due to low level of Chloroquine.

Any relapses occurring after day 28 when not receiving Primaquine, or after completion of Primaquine dosage for a total of 14 days (from day 29 to 42), will be treated with repeat doses of the initial treatment. The recurrence rates will be recorded so as to develop the next phase of the study where the two different doses of Primaquine (high dose vs. low dose) will be compared.

Eligibility Criteria:
Inclusion Criteria:

* \>12 months of age
* infection with P.vivax parasitaemia monoinfection
* presence of axillary temperature \>37.5 degrees or history of fever during the past 24 hours
* ability to swallow oral medication
* ability and willingness to comply with the study protocol for the duration of the study, including 12 months follow up
* informed consent from the patient/parent/guardian in the case of children

Exclusion Criteria:

* Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
* Presence of severe malnutrition (defined as a child whose growth standard is below -3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference \< 110 mm);
* History of haemolysis or severe anaemia
* Acute anaemia \<7 mg/dL
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
* a positive pregnancy test or lactating
Generation of Normal Ranges to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

The aim of the study is to generate normal ranges for φ, BIVA and BCC. The calculation of FMI and FFMI is based on the results of two other clinical investigations: "Generation of prediction equation to analyze body composition of adults based on Bioelectrical Impedance Analysis (BIA)" (BCA-01) and "Application and adaption of device specific body composition formulas to various ethnic groups" (BCA-02). The aim of BCA-01 was to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice. The aim of the study BCA-02 was to apply and adapt device specific body composition formulas to various ethnic groups.


Eligibility Criteria:
Inclusion Criteria:

The study will cover 992 healthy adults. 496 men and 496 women in an age range of 18 to 65 years are planned to be recruited. All subjects need to be suitable for blood donation according to "Hämotherapie-Richtlinie nach §§ 12a und 18 TFG", chapter 2.1.4 "Untersuchung zur Eignung als Spender und zur Feststellung der Spendertauglichkeit".

Exclusion Criteria:

* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* extensive tattoos at arms or legs
Intubation of a Pediatric Manikin in Difficult Airway by Novice Personnel: A Comparison of Glidescope and Airtraq

Background and aims: Glidescope and Airtraq were designed to facilitate intubation and to improve teaching intubation. The investigators want to find their efficacy in normal airway, tongue edema and face-to-face orotracheal intubation models by novice personal.

Material and Methods: After Kocaeli Human Researches Ethics Committee approval, thirty six medical students who were on the beginning of their third year were enrolled in this study. After watching a video about the intubation of one of these devices, they attempted to intubate an adult manikin in three different airway models in a random order; first in normal airway, second, tongue edema and finally, in an entrapped manikin by face-to-face approach with Glidescope or Airtraq. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades, need of maneuvers of these devices were recorded.

Trauma victims mostly had to be intubated at the scene of the area with the paramedics. In a suspect of a cervical trauma, patients must be intubated with the least movement. Videolaryngoscopic techniques had several advantages at this condition. We want to investigate which can be used easily by novice personnel.

Eligibility Criteria:
Inclusion Criteria:

* medical students at their third year,
* novice personnel

Exclusion Criteria:

* anesthesists,
* anesthesia residents,
* skilled investigators of tracheal intubation
Effect of Active vs. Passive Voiding Trials on Time to Discharge, Urinary Tract Infection, and Urinary Retention

Urinary retention is a common problem, particularly in hospitalized patients. When a Foley catheter is removed, a patient must be monitored for urinary retention. The usual method is a passive voiding trial where the catheter is removed, the bladder fills with urine and the patient is monitored for voiding over approximately 6 hours. Another option is an active voiding trial where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void. This study seeks to determine the effect of active vs passive voiding trials on time to hospital discharge, rate of urinary tract infections, and rate or urinary retention in the general hospitalized population.

The intervention to be tested is an active voiding trial, where the bladder is filled with saline before the catheter is removed and the patient is immediately assisted to void.

Eligibility Criteria:
Inclusion Criteria:

* Admission to one of three hospital units at the University of Virginia (5 Central, 6 West, or the Short Stay Unit)
* Patient has a Foley urethral catheter in place
* The physician has ordered the Foley urethral catheter to be discontinued
* 18 years of age and older

Exclusion Criteria:

* Age less than 18 years
* Prisoners
* Women who are pregnant
SCD Use to Prevent Deep Venous Thrombosis (DVT) in Patients With PICC Lines

The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.

In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group.

Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement.

Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.

Eligibility Criteria:
Inclusion Criteria:

* Subject's age is greater than or equal to 18 years
* Subject is patient in neuro intensive care unit at time of PICC placement

Exclusion Criteria:

* Acute trauma to the upper extremity harboring the PICC
* Current use of prophylactic anticoagulation
* Inability to fit the SCD on the arm because of arm size
* Documented previous upper extremity DVT in the arm harboring the PICC line
Effect of OMM on Anandamide Levels in Saliva

The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.

The Endocannabinoid System is a signaling system composed of: 2 G-Protein coupled receptors (CB1 and CB2), substances acting on the cannabinoid receptors, and the enzymes and proteins involved in regulating endocannabinoids in tissue and at the receptors. The substances acting the cannabinoid receptors CB1 and CB2 are called endocannabinoids. The present study examines the effects of Osteopathic Manipulative Lymphatic Pump Techniques on levels of anandamide, an endocannabinoid, in saliva samples of adult subjects. Based on existing research, the investigators hypothesize that subjects who undergo osteopathic lymphatic treatment will have increased levels of anandamide. Establishing the levels of endocannabinoids in these subjects will allow for a direct measure of the efficacy of the Osteopathic Manipulative Lymphatic techniques. In addition to the quantification of endocannabinoid levels in saliva, a series of 16, 100 mm analog scales will be used to assess the cannabinomimetic effects in the subject pre and post OMM treatment/control and it will be correlated to changes in endocannabinoid levels.

Eligibility Criteria:
Inclusion Criteria:

* Accepts healthy volunteers.
* Able to read and understand scale for survey.
* BMI (Body Mass Index) TBD- BMI between 18 and 25 kg/m2 Signed informed consent No exercising on the day of or day before the appointment Age 18 and above.

Exclusion Criteria:

* smoker
* Neuropsychiatric disorders
* Autoimmune Disorders
* Unavailable 8AM-12PM
* No Illicit drug use, including exogenous cannabis.
Natural History Study of Patients With X-linked Retinal Dystrophy Associated With Mutations in Retinitis Pigmentosa GTPase Regulator (RPGR)

The rod-cone dystrophies (often referred to as retinitis pigmentosa (RP)) are a clinically and genetically heterogeneous group of disorders in which there is progressive loss of rod and later cone photoreceptor function leading to severe visual impairment. RP usually occurs as an isolated retinal disorder, but it may also be seen in association with systemic abnormalities.

X-linked Retinitis Pigmentosa (XLRP) is a severe form of RP with early onset of nyctalopia and progression to legal blindness by the 3rd to 4th decade. Most affected males show symptomatic night blindness before the age of 10 years, are often myopic and show fundus abnormalities and ERG changes in early childhood. Examination of close female relatives is helpful in the absence of a family history, as the recognition of the XL carrier state will confirm the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females aged 5 years or older
* Have RPGR-associated retinal dystrophy
* Are able to give informed consent or assent, with the guidance of their parent/guardian where appropriate
* Are able to undertake age-appropriate clinical assessments as specified in the protocol
* Have genetic mutation within the RPGR gene confirmed by an accredited lab or research lab.

Exclusion Criteria:

* Are unable or unwilling to undertake consent or clinical testing
Effect of an Online Video-Based Intervention to Increase HIV Testing in Men Who Have Sex With Men in Peru

Men who have sex with men (MSM) account for the greatest burden of the HIV and Sexually Transmitted Infection (STI) epidemic in Peru. Current interventions that promote early identification and treatment of these diseases target a limited number of this population because they rely solely on peer education. To assess the use of the Internet as an alternative tool to reach this population the investigators propose to conduct an online randomized controlled trial to compare the effect of HIV-testing motivational videos versus standard public health text, both offered through gay websites. The methodology the investigators will use is divided in: (1) the development period, where the investigators will select gay websites for banner advertisement, create and refine effective recruitment messages and design the online survey and the video-based intervention (2) the intervention period, where participants who meet the eligibility criteria will be randomized into a video or a standard public health text. The videos will be customized for three audiences based on self-identification: gay, non-gay and trans and will be framed within the health-belief model and the stages of change theory (3) in the outcome evaluation period we will compare the 'intentions to get tested' and 'time to HIV testing at the clinic' among MSM of each of the trial arms. If the Internet is an effective venue to reach MSM for HIV testing, Peruvian health programs that target this population may start considering the delivery of web-based interventions and other online prevention services to this under served and hard-to-reach population.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Be a man and report having had sex with a man
* Be a resident of Lima, Peru
* Answer the survey from Lima, Peru
* Have not been tested for HIV during the last year
* Have an email address that when typed twice matched and
* Do not report being HIV positive

Exclusion Criteria:

* Do not meet the inclusion criteria specified above