cyrilzakka/clinical-trials huggingface dataset:
The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus

The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.

Chronic sinusitis (CRS) with nasal polyps and thick mucin in the sinuses adversely affects results from endoscopic sinus surgery (ESS) because failure to clear the disease leads to ongoing inflammation and symptoms. In particular a subset of CRS patients with thick eosinophilic mucin (EMCRS) develop recurrent symptoms and require further surgeries. ESS techniques for the maxillary sinus requires a WMA in the side wall of the sinus and the use of curved debrider instruments to clear the polyps. Sometimes this doesn't provide access to the inferior/floor and anterior/front aspects of the maxillary sinus due to the fact that the maxillary sinus is on the side of the nasal cavity at an angle. The CFT through the front wall of the sinus was developed years ago as an alternative approach to improve access to these areas. Both techniques are acceptable standard treatments and which one is initially used to address the maxillary sinus currently depends on surgeon preference. The role of CFT has been studied by Sathanatar et al (Laryngoscope 2005) and Lee et al (Laryngoscope 2008) which provided conflicting results. Differences in their study patients and methodology could explain the different outcomes. Hence this study is proposed to clarify the role of CFT in patients with extensive maxillary sinus disease to see whether initial use of CFT is more helpful than WMA in the severely diseased maxillary sinus with polyps and mucin. Findings from this study may improve surgical outcomes for CRS patients in the future.

Eligibility Criteria:
Inclusion Criteria:

* Patients with extensively opacified maxillary sinuses on CT scanning undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
* Patients with Eosinophilic Mucin Chronic Rhinosinusitis or fungal sinusitis disease undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
* Patients with Recalcitrant Chronic Rhinosinusitis undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
* Patients over the age of 18
* Patients able to give informed consent to participate in the study

Exclusion Criteria:

* Patients will be excluded if they are unable to undergo surgery due to co morbidities.
* Patients with previous Caldwell-Luc procedures
* Patients with pre existing paraesthesia of the upper teeth or gums
* Patients with destructive lesions of the maxilla
* Patients with systemic disease affecting the paranasal sinuses (e.g. Wegener's granulomatosis)
* Patients immune compromised
Post Market Clinical Follow-Up Study on the Performance and Safety of Lyoplant®

Retrospective, single center, single arm PMCF study on the performance and safety of Lyoplant® used for the replacement and extension of connective tissue structures in neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Use of investigational device according to Instructions for Use (IfU)

Exclusion Criteria:

* none
Ultra Sound Guided Fine Needle Aspiration Cytology (FNAC) of Liver and Pancreas Tumours

Patients with tumors in liver or pancreas are randomized to ultrasound (UL)-guided FNAC biopsies with guidance method or UL-guided FNAC biopsies with free-hand method.


Eligibility Criteria:
Inclusion Criteria:

* adult over 18 years
* tumors in liver and/or pancreas

Exclusion Criteria:

* low coagulation factors
* mentally ill patients.
Unloading in Heart Failure Cardiogenic Shock

The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) has the potential to reduce the HF-CS related clinical events compared to the current standard of care.

To demonstrate the efficacy of timely temporary mechanical left ventricular unloading with the Impella 5.5® assist device in patients with acute decompensated heart failure complicated by cardiogenic shock (ADHF-CS) vs. current standard of (pharmacological) care

Eligibility Criteria:
Inclusion Criteria:

1. Evidence of HFrEF according to ESC HF guidelines (LVEF ≤ 35%) 2. Signs of (persistent) congestion (elevated CVP, edema, rales, ascites, pleural effusion) 3. Evidence of CS with presence of at least 2 of the 3 following:

1. Hypotension

   1. systolic blood pressure \<90 mmHg for at least 30 min OR
   2. mean arterial pressure \<60 mmHg for at least 30 min
2. Hypoperfusion

   1. lactate \> 2.0 mmol/L (two consecutive values \> 2 mmol/L with at least 30 min between samples, with non-decreasing trend on if on (steady doses of) inotropes and/or vasopressors)
   2. amino-L-transferase \>200 U/L (two consecutive values \> 200 Ul/L with at least 30 min between samples, with non-decreasing trend if on (steady doses of) inotropes and/or vasopressors)
   3. creatinine rise ≥ 0.3 mg/dl/24h ( 26,53 μmol/L)
   4. oliguria (≤ 0,5 ml/kg/h, ≤ 720 ml/24 h)
3. Inotropes/vasoactives (use of)

Exclusion Criteria:

1. Contraindications for Impella 5.5
2. Severe concomitant RV failure
3. Grade IV mitral regurgitation eligible for surgical treatment
4. Dialysis for end-stage renal failure
5. Acute coronary syndrome (type 1, AMI)
6. Bradycardia and AV blocks necessitating pacemaker implantation
7. HD parameters and biochemistry alterations as specifically defined for SCAI CS E
8. Combined cardiorespiratory failure
9. Resuscitated (OHCA/PEA)
10. History of CVA or TIA within previous 90 days
11. History of acute myocardial infarction within previous 30 days
12. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombo-cytopenia), any recent GU or GI bleed, or will refuse blood transfusions
13. Inflammatory
14. Active systemic infections
15. Acute myocarditis
Targeting Attention Orienting to Social Threat to Reduce Social Anxiety in Youth

This two-site study is a test of Attention Bias Modification Treatment (ABMT) among 260 youths ages 10 to 14 years with social anxiety disorder. One-half of participants will receive 8 sessions of computer administered ABMT and the other half of participants will receive 8 sessions of computer administered Neutral Control Task (NCT). The investigators hypothesize that a biomarker of attention to social threat measured using electroencephalography (EEG) and ratings of social anxiety severity will be lower in participants who receive ABMT compared to participants who receive NCT.


Eligibility Criteria:
Inclusion Criteria:

* Be between ages 10 and 14 years
* meet DSM5 criteria for a diagnosis of Social Anxiety Disorder
* presence of any coexisting psychiatric diagnoses must be of lesser severity than Social Anxiety Disorder
* have no current psychotropic medication other than a stable dose of stimulant or non-stimulant medication for coexisting ADHD

Exclusion Criteria:

* meet DSM5 criteria for Autism Spectrum Disorder, Intellectual Disability, Bipolar Disorder, Tourette's Disorder, Psychotic Disorders, or Substance Use Disorders
* show high likelihood of hurting self or others
* be a victim of undisclosed abuse requiring investigation/ supervision by the Department of Social Services
* have an uncorrected vision or physical disability that interferes with the ability to click a mouse button rapidly and repeatedly
* have a history of neurological illness, including seizures/epilepsy, or head injury with loss of consciousness \> 5 minutes
Treatment for Caffeine Dependence

Recent research has shown that some individuals become addicted to or dependent on caffeine and are unable to quit or reduce caffeine consumption despite a persistent desire to do so. The aims of the current study are to characterize caffeine use among individuals with physical or psychological dependence on caffeine and evaluate a manual-based intervention to promote caffeine reduction and cessation.

A large percentage of caffeine users in the general population (56%) report a persistent desire or unsuccessful efforts to stop or reduce caffeine consumption. The aim of Study 1 is to recruit and identify individuals who are interested in receiving treatment to reduce or quit caffeine consumption. Individuals will be recruited from Baltimore, MD and surrounding communities via flyers and newspaper and radio advertisements. Those who are eligible will be invited to come to the Behavioral Pharmacology Research Unit located on the Johns Hopkins Bayview Medical Center campus in Baltimore, MD. After consent is obtained at intake (consent form A), a series of questionnaires will be completed (e.g., demographics, caffeine history, medical and psychiatric history, mood), followed by a structured clinical interview that will assess caffeine use and dependence. Individuals who meet eligibility criteria will be offered the opportunity to receive assistance to reduce or quit caffeine. Those who consent (consent form B) to enroll in the second phase of the project will be randomly assigned to one of two conditions: 1) immediate treatment or 2) delayed treatment. The conditions will be identical with the exception of a 6 week delay for the delayed treatment group. Participants will receive a caffeine reduction and cessation treatment manual during a brief treatment session at week 1. Treatment progress will be assessed during a study session approximately 7 weeks post-treatment, during a telephone interview approximately 8 weeks post-treatment, and during a follow-up telephone call approximately 27 weeks after the treatment session. Progress will be assessed via questionnaires, food diaries, and salivary caffeine measures.

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Self-reported problem with caffeine use
* Moderate to heavy caffeine use

Exclusion Criteria:

* Pregnancy
* Current dependence on alcohol or illicit drugs
Description of the Appearance of Brown Fat in Scanner

The aim of this study is to investigate aspects of brown fat in scanner with injection via the PET-CT study.

Brown fat is metabolically active adipose tissue. It can be responsible in PET-CT of a fixation of 18-FDG and a look of pseudo-infiltration of fat. These aspects can be sources of false positives. The objective here is to gain a better knowledge of the scanner in areas of brown fat.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients since June 2014, who underwent a thoraco-abdominopelvic PET-CT examination with 18F-FDG in the University Hospital of Brest, in a clinical setting which warranted.
* Major Patients
* No opposition formalized

Exclusion Criteria:

* Refusal of participation
COVID-19 Vaccine Effectiveness in Albanian Health Workers

The purpose of this study is to evaluate the effectiveness of the COVID-19 vaccine in hospital based HWs in Albania. This will answer critical questions about the real-world performance of COVID-19 vaccines in one of the key target groups for vaccination.

This protocol describes a prospective one-year cohort study of hospital-based health workers in Albania to evaluate the effectiveness of COVID-19 vaccine in preventing laboratory-confirmed SARS-CoV-2 infection and COVID -19 disease.

The investigators will measure the effectiveness of COVID-19 vaccines against laboratory-confirmed SARS-CoV-2 infection in both symptomatic and asymptomatic hospital health workers.

SARS-CoV-2 infection will be diagnosed using symptom questionnaires and PCR testing. Additionally, serology testing will be obtained over the course of one year, to identify asymptomatic infections.

Eligibility Criteria:
Inclusion Criteria:

* All Health Workers eligible to receive the COVID-19 vaccination according to the national guidelines of Institute of Public Health.
* Health Workers working at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.
* Health Workers who have already been vaccinated against COVID-19 as part of the early COVID-19 vaccine rollout can be included, as long as information can be collected about the date and type of the vaccine that was administered. However, priority will be given to enrolling Health Workers who have received their COVID vaccine no more than 4 days prior to the day of enrolment in the study.

Exclusion Criteria:

* Health Workers who are not eligible for COVID-19 vaccination or have a contraindication to vaccination should not participate in the study.
* Health Workers who do not work at Tirana University Hospital "Mother Theresa", University Hospital "Shefqet Ndroqi", Durres Regional hospital and Fier Regional Hospital.
A Randomized Controlled Trial of Impact of Wearable, Wireless Breast Pumps on Frequency and Efficacy of Milk Expression in Mothers of Premature Infants

A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.

Randomized, controlled crossover study design. Non-blinded. Mother of infants born at or below 29+6 weeks of gestation will be eligible once their infant is 28 or more days old. Mothers will be provided with a wearable, wireless breast pump in addition to their usual hospital grade pump. Wireless pumps can be used while cuddling their baby, driving too and from the hospital, caring for other children, etc.

Eligibility Criteria:
Inclusion Criteria:

* Mother of infant born at 29+6 weeks or below
* Mother still pumping at 4 weeks since birth

Exclusion Criteria:

* Current use of mothers own wearable pump
Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration

The objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal Lucentis® (Ranibizumab) for the treatment of SRF and PED in neovascular AMD which is persistent to anti-VEGF (anti-vascular endothelial growth factor) monotherapy.

PEDs occur in up to 62% of eyes with advanced AMD. Numerous treatment options have been employed for PEDs in AMD, including laser therapies and intravitreal injections of anti-VEGF antibodies. However, eyes with PEDs were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular AMD; therefore, the efficacy of such options is still unclear for eyes with PEDs in neovascular AMD. Additionally, PED lesions have been reported to show less morphological and functional response to anti-VEGF monotherapy than eyes with other CNV lesions subtypes.

Based on the generally poor prognosis of PEDs and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of Lucentis® (Ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of Ranibizumab for the treatment of SRF associated with PED in neovascular AMD which is persistent to previous anti-VEGF monotherapy.

Eligibility Criteria:
Key inclusion criteria

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
2. Age equal to or older than 50 years.
3. Presence of SRF associated with PED in neovascular AMD (proven with OCT FA, and ICG) which is persistent despite consecutive anti-VEGF injections for at least 9 months (3 initial loading doses with 4 week interval followed by PRN regimen)

   * A "persistent PED" is defined as a subject with \< 50% reduction or increase in PED height

Key exclusion criteria

1. Administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye
2. Prior treatment with photodynamic therapy in the study eye
3. Previous subfoveal focal laser photocoagulation involving the foveal center in the study eye
4. Previous submacular surgery in the study eye
5. History of vitrectomy in the study eye
6. Epiretinal membranes (ERM)
7. Submacular hemorrhage or fibrosis within 50% of entire PED.
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s of Escitalopram Oxalate Tablets Under Fed Condition

Objective:

Primary objective of the present study was to compare the single dose bioavailability of Torrent's Escitalopram Oxalate Tablet 20 mg \[Test formulation, Torrent Pharmaceuticals Ltd., India\] Versus Lexapro® (Escitalopram Oxalate Tablet 20 mg) \[Reference formulation, Forest Laboratories Inc, USA\] . Dosing periods were separated by a washout period during fed study.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

The volunteers were included in the study based on the following criteria:

* Sex: male.
* Age: 18 - 45 years.
* Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
* Pulse rate less than 50/minute or more than 100/minute. Oral temperature less than 95°P or more than 98.6°P.
* Respiratory rate less than 12/minute or more than 20/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Blood Lactate and Excessive Post-exercise Oxygen Consumption (EPOC)

The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC


Eligibility Criteria:
Inclusion Criteria:

* with normal health (no known history of cardiovascular, pulmonary, metabolic or musculoskeletal diseases)

Exclusion Criteria:

* unable to communicate and follow the exercise procedures
Effects of Inspiratory Muscles Strengthening Among Coronary Patients on the Sleep Apnea Obstructive Syndrome

Obstructive sleep apnea (OSA) syndrome affects up to 5% of the general population. The prevalence is multiplied by 13 in coronary artery disease (CAD) patients. Many studies have shown that OSA syndrome was the main risk factor for cardiovascular morbidity and mortality (RR = 9.1 \[95%, 2.6 to 31.2\]).

If the value of treatment with Continuous Positive Airway Pressure (CPAP) in symptomatic CAD patients (daytime sleepiness and/or 2 clinical symptoms with Apnea Hypopnea Index (AHI) ≥ 20) appears to be established, treatment with CPAP in asymptomatic CAD patients (with AHI\> 30) may be too demanding. Alternative treatments are rare and results are highly variable. Therefore, it would be interesting to suggest other treatment modalities with moderate coronary and/or minimally symptomatic OSA syndrome.

This study aims to assess the relevance of inspiratory muscles strengthening on reducing AHI in CAD patients with moderate OSA (AHI between 15 and 30).

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate OSA (15 \<AHI \<30)
* Period between acute coronary syndrome and inclusion \<60 days
* Patients included in cardiac rehabilitation

Exclusion Criteria:

* Obstructive lung disease with Tiffeneau index less than 70%.
* Restrictive lung disease with a reduction of total lung capacity (TLC)
* Treatment for OSA or clinical context (comorbidity) justifying CPAP
* Congestive heart failure, thoracic surgery by sternotomy
* Spontaneous pneumothorax
* Severe Asthma
* Ruptured eardrum, or another disease of the middle ear, or acute sinusitis
Comparison of Follicle Diameter on hCG Day and Follicle Diameters on OPU (Oocyte Pick up) Day and the Effect of Follicle Diameters on Embryo Development and Pregnancy Outcomes

Evaluation of follicle diameters on human chorionic gonadotrophin(hCG) day and oocyte pick up (OPU) day of follicles developing after gonadotropin treatment, the relationship between follicle diameter and maturation in oocytes obtained after OPU and its effect on pregnancy outcomes will be investigated. In order to make it easier to measure and enumerate the follicle diameters with the help of vaginal ultrasound, patients under 35 years of age with at most five follicles in any ovary and at least four follicles in both ovaries will be included in the study.

In our study, patients with 5 and 10 follicles exceeding 11 mm will be included in order to define the follicles whose hCG day is measured more clearly on the day of OPU in patients with whom we performed controlled ovarian hyperstimulation for in vitro fertilisation(IVF). The localizations and diameters of these follicles in both ovaries will be drawn and the hCG day will be numbered and their measurements will be indicated. On the day of opu, the marked and numbered follicles will be measured, noted and aspirated one by one, the collected eggs will be followed in individually numbered culture dish and it will be evaluated whether they are mature or not prepared for microinjection. And mature oocytes will be followed in numbered culture dishes after microinjection. The relationship between hCG and OPU day follicle diameter will be evaluated by following the follicle diameter and follicle diameters on the day of egg collection, the relationship between the mature egg, the rate of reaching the blastocyst stage, the clinical pregnancy and live birth rates

Especially the relationship between mature egg and follicle diameter and the resulting clinical results may guide clinicians in practice.

Eligibility Criteria:
Inclusion Criteria:

1. Patient group with at least 5 and at most 10 follicles in each ovary whose hCG day exceeds 11 mm,
2. Patient group with BMI below 30.

Exclusion Criteria:

1. PCO patient group,
2. Male factor group with severe OAT,
3. Patient group with endometriosis,
4. Patient group with PGD indication,
5. The group under the age of 40 and legally deserving of double embryo transfer