cyrilzakka/clinical-trials huggingface dataset:
Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment

CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.

Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.

Eligibility Criteria:
Inclusion Criteria:

* normal nasal breathing
* dentition allowing for use of an oral appliance
* absence of mandibular joint pathology
* Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
* Patients using CPAP less than 3 hours/day as prescribed following CPAP titration

Exclusion Criteria:

* Clinical instability
* smoking cessation
* current weight loss strategy
* Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
* severe cardio-metabolic co-morbidity
Autonomic Effects of T4 Mobilization in Asymptomatic Subjects

The purpose of this study is to determine whether passive accessory intervertebral mobilization applied to the fourth thoracic vertebra produces autonomic effects.

Asymptomatic subjects will be recruited to this study. Pressure pain threshold, heart rate, heart rate variability and skin conductance will be measured before, immediately after and fifteen minutes after the intervention.

Subjects will be randomized into three groups: Passive accessory intervertebral mobilization one, passive accessory intervertebral mobilization two and placebo group.

The researcher that will do the intervention will be blinded to the outcomes measures, and the researcher that will do the measurements will be blind to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects
* Aged between 18 - 40 years old
* Portuguese readers and writers

Exclusion Criteria:

* History of lesion or surgery to the spine
Clinical Evaluation of Two Frequent Replacement Soft Spherical Contact Lenses

This was a single-blind (participant masked), interventional, prospective, direct refit, bilateral wear short-term fitting study.

The aim of this non-dispensing fitting study was to evaluate the short-term clinical performance of two soft spherical contact lenses after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Has read and signed an information consent letter.
* Self-reports having a full eye examination in the previous two years.
* Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Habitual soft contact lens wearers who currently wear sphere contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum.
* Has refractive astigmatism no higher than -0.75DC.
* Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 logMAR) which participants also deem to be 'acceptable', with the available study lens parameters (powers +8.00 to -12.00DS)

Exclusion Criteria:

* Is participating in any concurrent clinical or research study.
* Has any known active ocular disease and/or infection that contraindicates contact lens wear.
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
* Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
* Has known sensitivity to the diagnostic sodium fluorescein used in the study.
* Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
* Has undergone refractive error surgery or intraocular surgery.
High Versus Low Dose Nitroglycerin in Acute Pulmonary Edema

The goal of this randomized controlled trial is evaluate the out come of:

* Low dose (\< 100 mic/min )versus
* High dose (\> 100 mic/min) of nitroglycerin in management of patients with acute pulmonary edema presented to Emergency Department of Alexandria University Hospitals.

The main questions it aims to answer is:

* Time of resolution of high blood pressure, hypoxia, tacchypnea
* Need for invasive mechanical ventilation, ICU admission

This single blind parallel randomized controlled trial will be conducted on (30 patients in each group) presented to Alexandria University Hospitals with acute pulmonary edema defined as: acute onset of dyspnea \< 6 hrs, tacchypnea ( respiratory rate ≥30 breaths/min), bilaterak crepitations, O2 saturation \< 90% on room air with associted sympathetic surge recognized by presence of tacchycardia, agitationa and blood pressure ≥ 160/90 mmHg

All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:

* Group (A): Low dose group Nitroglycerin at will be initiated at a rate \<100 mic/min (15)
* Group (B): high dose group Initial dose \> 100 mic /min (15) will be started Blood pressure will be measured for both groups every 15 minutes and dose adjusted accordingly, if the blood pressure starts to decrease continue infusion rate. In case of rising or constant blood pressure increase nitroglycerin by 20 mic/min every 15 min till blood pressure starts to decrease.

Initial, peak rate within the first hour, duration of IV nitroglycerin infusion will be recorded in both groups.

Initial and maximum dose of loop diuretic will be recorded in both groups.

Outcome:

Patients will be followed during ED stay to compare the two groups as regard:

* Time of resolution of high blood pressure.
* Resolution of hypoxia.
* Resolution of tachypnea.
* Need for invasive mechanical ventilation.
* Need for ICU admission.
* Length of hospital stay.
* Incidence of drug side effects as hypotension.
* Mortality.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\> 18 years) presented with sympathetic crashing acute pulmonary edema.

Exclusion Criteria:

1 - Patients indicated for emergency endotracheal intubation. 2-Patients with history of nitroglycerin allergy. 3-Preload dependent patients as patients with aortic stenosis. 4-Drug interaction with nitroglycerin as sildenafil, ergots. 5-Patients indicated for emergency percutaneous intervention.
Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK

This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws

Primary Objective(s)

1. To estimate progression-free survival (PFS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
2. To describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose interruptions, treatment cessation) in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting.

Secondary Objective(s)

1. To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
2. To describe reasons for olaparib dosage changes, dose interruptions and treatment cessation in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting
3. To describe surgical and chemotherapy outcomes (PR/CR) in patients with BRCA-mutated advanced ovarian cancer before initiation of real-world first line maintenance olaparib tablets
4. To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian cancer with partial response to real-world first line chemotherapy.
5. To describe treatment patterns and clinical outcomes in patients with BRCA-mutated advanced ovarian cancer who progressed during olaparib real-world first line maintenance therapy (including frequency of treatment interruptions, dosage reductions and treatment discontinuations and reasons associated with patterns)
6. To estimate second progression-free survival (PFS2) in patients with BRCA-mutated ovarian cancer who progress while on olaparib real-world first line maintenance therapy.
7. To describe healthcare resource utilisation in patients with BRCA-mutated advanced ovarian cancer treated with olaparib in real-world first line setting

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III - IV) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum-based chemotherapy, in PR/CR and treated with at least one dose of olaparib in first line maintenance setting
* Patients aged ≥18 years old
* Ability and/or willingness to provide a signed informed consent form (where required)

Exclusion Criteria:

* Withdrawal of informed consent (where consent required)
* Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
Biomarkers In Retinitis Pigmentosa (BIRP)

In this study, markers of oxidative stress will be measured in the aqueous humour and plasma of RP patients compared to controls.

People with Retinitis Pigmentosa have loss of night vision followed by loss of central vision due to damage and death of photoreceptors. One of the mechanisms causing damage is high levels of oxygen in the eye. This damage produces specific biomarkers which can be measured. In this study, these biomarkers will be assessed in people with Retinitis Pigmentosa and compared to controls.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent and authorization of use and disclosure of protected health information
* Age more than or equal to 18 years
* For the study group, patients diagnosed with Retinitis Pigmentosa by the investigators
* For the control group, patients undergoing vitreoretinal surgery for macular hole, epiretinal membrane, vitreomacular traction, retinal detachment, neovascular Age-related Macular Degeneration (AMD) and Diabetic Retinopathy will be eligible

Exclusion Criteria:

* Patients with active or suspected ocular or periocular infection
Emovi 3D Knee Assessment Device Intervention for Operational Readiness

This is a randomized clinical trial investigating the use of the Emovi Knee Kinesiography information in the treatment of anterior knee pain in physical therapy.

The purpose of this study is to assess the effectiveness of using a 3D medical assessment device versus usual care to help guide clinical decisions about the management of PFP. The objective is to determine if gathering objective biomechanical data from a three-dimensional (3D) motion capture device leads to more precise and optimal care, ultimately improving physical function and other outcomes compared to participants who receive routine care that is not guided by information from this device.

Participants will be recruited from primary care and physical therapy clinics at participating sites. Authorized study personnel will search electronic medical records (Genesis) to identify potential study participants diagnosed with knee pain.

After consent and enrollment, participants will complete baseline measures and then receive a Knee Kinesiography exam. The participant will be entered into the KneeKG system using a unique participant identifier. After the knee kinesiography exam with the KneeKG, participants will be randomized 1:1 into one of two different treatment arms: 1) KneeKG informed care or 2) usual care without any information from the KneeKG.

Knee mechanics during gait is assessed with a Knee Kinesiography exam. The participant will walk for 5 minutes on a commercial treadmill at their comfortable speed. Three-dimensional (3D) knee kinematics are captured on each leg using the KneeKG system (Emovi, Canada). With this validated FDA cleared medical device, there is an accurate quantification of specific knee biomechanical markers during gait in a clinical setting. There will be two 45-second trials to electronically capture the data which is immediately accessible through automatic reports. Biomechanical markers captured include but are not limited to varus/valgus alignment at stance, varus/valgus alignment at heel strike, knee flexion angle at heel strike, total knee excursion in sagittal plane, tibial rotation at heel strike and throughout gait cycle. The entire procedure will take approximately 15-20 minutes. This procedure will occur at baseline and also again at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50
* Active Duty Service Member stationed at Fort Liberty and Schofield Barracks
* Diagnosis of patellofemoral pain (ICD-10 codes: M25.2 (pain in unspecified knee), M25.561 (pain in right knee), and M25.562 (pain in left knee)

Exclusion Criteria:

* Pregnancy
* Known to be leaving that duty station within next 3 months
* Concurrent lower limb injuries (examples include but are not limited to ankle sprain or HS strain)
* Previous knee surgery
* History of traumatic knee injury, such as a ligament tear or meniscal tear
* Presence of rheumatoid or neurological disease
Effect of Touch Methods in Preterm Infants During Endotracheal Aspiration

The purpose of this study was to determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

Background: Preterm infants in the neonatal intensive care unit are exposed to various painful procedures, so different non-pharmacological pain control techniques are used to alleviate pain.

Aims: To determine the effect of gentle human touch (GHT) and Yakson methods during endotracheal suctioning on pain, comfort and physiologic parameters response in preterm infants.

Design: A randomized controlled crossover trial. Setting: This study was conducted in the neonatal intensive care unit between July 2022 and June 2023.

Methods: Thirty neonates were enrolled in this study based on inclusion criteria. The samples were randomly received a sequence of suctioning with Yakson and GHT and routine care. Neonatal Pain Agitation and Sedation Scale and COMFORT neo were used to collect the data.

Eligibility Criteria:
Inclusion Criteria:

* Infants in the 26-36/6 gestational week and at appropriate gestational age (AGA)
* Infants undergoing ventilator support with an endotracheal tube

Exclusion Criteria:

* Infants taking opiates and sedatives within four hours, having undergone a painful procedure at least one hour before
* Infants congenital anomalies, sepsis or haemorrhagic disease that might prevent Yakson and GHT
* Infants who underwent surgery and had a chest tube
* Infants with intracranial hemorrhage
Breast Milk and Breastfeeding Education Given in the Antenatal Period

We aimed to examine the influence of breast milk and breastfeeding education given in the ante-natal period on LATCH score and breastfeeding self-efficacy score.

Practices for increasing breastfeeding self-efficacy are of vital importance and they increase the level of breastfeeding self-efficacy. Breast milk and breastfeeding educations have given in the ante-natal period are another way of increasing the success of breastfeeding.

In this experimental investigation, 80 pregnant women who attended a baby-friendly hospital were randomly assigned to the education (n = 40) or control (n = 40) groups. The pregnant women in the intervention group received 4 hours of human milk and breastfeeding educational sessions along with routine care and furthermore, a brochure prepared by the researcher was given. All women whose estimated delivery date had approximated were questioned about whether they had given birth or not, and the sociodemographic data form, the LATCH Breastfeeding Assessment Tool and the Breastfeeding Self-efficacy Scale-short form were applied to the subjects in the education and the control group by visiting them at home when the post-partum first week had been completed.

Eligibility Criteria:
inclusion criteria Being above 18 years of age, Having completed the 26th gestational week (At training phase), Having no problem with vision and hearing, Having no disease that can prevent breastfeeding, Having a pregnancy with no risk, Having no systemic disease, Planning to breastfeed after birth

excusion criteria the mother stops researching. treating the baby in neonatal intensive care
Effectiveness of Functional Electric Stimulation With Bicycle Ergometer and Mirror Therapy in Stroke Patients Lower Extremity

There are different methods in stroke rehabilitation. In addition to conventional techniques, functional electric stimulation with bicycle ergometer therapy and mirror therapy can be used. In this study, we will compare functional electric stimulation with bicycle ergometer therapy and mirror therapy in stroke patients.

Aim of study is to compare functional electric stimulation with bicycle ergometer therapy and mirror therapy applied to lower extremity in stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* 18-85 age
* Unilateral stroke
* First time stroke
* Time after stroke less than 6 months
* Lower extremity Brunnstrom stage: 2-4
* Lower extremity spasticity Modified Ashworth Scale: less than 3
* Patient with sitting balance
* Mini Mental Test Score higher than 23
* Patients signed approval form

Exclusion Criteria:

* Bilateral stroke
* Neurological disease other than stroke
* Psychiatric disease
* Lower extremity orthopedic problem
* Visual or audience problem
* Neglect
* Severe aphasia
* Contraindications of electrical stimulation (cardiac implantation etc.)
* Severe comorbidity (cardiac failure etc.)
* Seizure
* Acute deep vein thromboembolism
* Local infection
* Botulinum toxin injection of lower extremity less than 3 month
COVID-19 Pandemic: Perception, Attitude

: adherence to preventive control measures is influenced by perception, attitudes and practices toward the disease prevention.

METHODS Study design: A cross-sectional survey study was utilized in which data were collected following the Checklist for Reporting Results of Internet E Surveys (CHERRIES) guidelines during the period from March to July2021.

Study settings and participants The study conducted through an electronic anonymous online survey distributed among students from three health sector faculties (Medicine, Pharmacy, and Nursing) in six Egyptian universities (Cairo, Suez Canal, Tanta, Daria, Aswan, Kufr Elsheikh).

The self-administered online questionnaire was hosted in google form and the link was distributed through official university platforms and informal student groups on social media like Facebook and WhatsApp pages. Representatives of students were also engaged in distributing the questionnaire's link directly to their colleagues from each faculty. A non-randomized convenient sample of 1900 university medical students was included in the study.

Data collection The study questionnaire was developed based on the COVID-19 Rapid Quantitative Assessment Tool as part of the Risk Communication and Community Engagement (RCCE) Action Plan Guidance COVID-19 preparedness and response developed by the China International Famine Relief Commission publication, United Nations Children's Fund (UNICEF) and World Health Organization (WHO) \[14\]. Most of the questions were in the form of "yes and no" questions except for a few questions with the third "I don't know" option, a five-point rating scale question.

After the tool was developed, the application was tested by the EYI (Egyptian Youth Initiative) executive team at the National Population Council (NPC)/UNICEF to verify, confirm and skip patterns and follow them to guarantee the accuracy of data collection. To ensure the validity and accuracy of the data collected, the investigators settle detailed instructions regarding study objectives for all student counselors who distributed the questionnaire to the subjects in advance. The survey tool automatically verifies that all questions must be filled before submission and cannot be submitted twice.

Eligibility Criteria:
Inclusion creteria university students from health sector faculties

Exclusion Criteria:

-
Premedication to Reduce Amivantamab Associated Infusion Related Reactions

The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or severity of first-dose infusion related reactions.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have advanced or metastatic non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* A female participant using oral contraceptives must use an additional barrier contraceptive method
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 3 months after receiving the last dose of study treatment, oral lazertinib and intravenous (IV) Amivantamab
* Each participant, or legally authorized representative, where allowed, must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Progressed on or after prior treatment with osimertinib and platinum-based chemotherapy. Prior use of first-or-second generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) is allowed if administered prior to osimertinib
* Previously identified EGFR-mutated non-small cell lung cancer (NSCLC) (EGFR Exon19 deletion or L858R) (identified locally in a Clinical Laboratory Improvement Amendments \[CLIA\]-certified laboratory \[or equivalent\])

Exclusion Criteria:

* Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Prior treatment with anti PD-1 or anti PD-L1 antibody within 6 weeks of planned first dose of study treatment or immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment
* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have completed definitive therapy, are not on steroids, and have a stable clinical status for at least 2 weeks prior to study treatment are allowed. If brain metastases are diagnosed on Screening imaging, the participant may be enrolled, or rescreened for eligibility, after definitive treatment if above criteria are met
* Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to \[\<=\] 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement therapy)
* Prior treatment with amivantamab or lazertinib