cyrilzakka/clinical-trials huggingface dataset:
The Effect and Mechanism of Hyaluronan on the Mucociliary Differentiation of Human Respiratory Epithelial Cells

The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. Therefore, it is important to maintain intact inner respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes. However, the feasibility of use as a scaffold for respiratory epithelial cells remained unexplored. The aim of the study is to investigate the effect of hyaluronan including concentrations and molecular weight on the mucociliary differentiation of human respiratory epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials for respiratory tissue engineering and tissue-engineered trachea in the future.


Eligibility Criteria:
Inclusion Criteria:

* PATIENTS UNDERWENT SEPTOMEATOPLASTY
Ultrasound Guided Regional Anesthesia for Acute Injury in Low Resource Settings

The purpose of this study is to determine feasibility, perceived utility and sustainability of training local providers in ultrasound guided regional anesthesia for acute pain management in a limited-resource conflict setting.

To the investigators knowledge, this is the first study of feasibility, perceived utility and sustainability of USRA as a pain management tool in a low-resource conflict setting and is one of the only large studies to date to assess USRA by local providers for emergent pain relief due to injury in patients presenting to an acute care center.

Eligibility Criteria:
Inclusion Criteria:

* participants were chosen by hospital administration

Exclusion Criteria:

* only chosen participants were included
Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis

This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)


Eligibility Criteria:
Inclusion Criteria:

* woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
* age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
* breast size suitable for detector size
* possible prior mastectomy
* security social covered
* signed informed consent

Exclusion Criteria:

* breast implant
* high genetic risk (mutation)
* under justice measures
* breast feeding or pregnant woman
Music for Sleep After Stroke

Sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. A small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia.

This study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke.

Six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within NHS Greater Glasgow and Clyde. A multiple baseline single case experimental design will be employed. Participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. Changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. Mood and fatigue will also be measured. The data will be analysed using visual inspection, Tau-U and multi-level modelling.


Eligibility Criteria:
Inclusion Criteria:

* aged 18+ (no upper age limit);
* clinically and/or radiologically confirmed diagnosis of stroke
* score of ≤16 on the Sleep Condition Indicator (SCI; (Espie et al, 2018))
* at least 3-months post-stroke

Exclusion Criteria:

* Transient Ischemic Attack
* subarachnoid hemorrhage
* sleep medication commenced within the last 2 weeks (stable medication accepted)
* significant receptive aphasia or major psychiatric/substance abuse problem preventing engagement in the intervention
* deafness or severe hearing impairment preventing engagement in the intervention (use of hearing aids does not lead to exclusion where these support sufficient level of hearing for engagement)
* unable to give informed consent.
* participation in another intervention study with risk of contamination of study outcomes (determined on a case-by-case basis)
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome

The purpose of this study is to investigate the dose-related effect of treatment with rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein cholesterol (HDL-C) concentration.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* male aged 30 to 70 years of age
* LDL-C \<6 mmol/L
* HDL-C ≤1.2 mmol/L
* at least 2 of the following:
* insulin resistance (fasting glucose \>6 mmol/L or insulin \>10 mU/L or HOMA score \>2.5)
* central obesity (waist circumference \>=94 cm).
* plasma triglycerides \>=1.7 and \<4.5 mmol/L.
* blood pressure \>=130/ \>=85 mm Hg or on drug treatment for hypertension

Exclusion Criteria:

* LDL cholesterol \>=6 mmol/L
* pre-existing or history of cardiovascular disease, diabetes, renal dysfunction, anaemia, history of significant dyspepsia or gastrointestinal disease
* apolipoprotein genotype E2/E2
A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to Epidermolysis Bullosa

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study i. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages. (interest is given to children who present with autism or Crohn's and whose parents wish to analyze their children's gut flora. Also of interest analysis of development of the child's microbiome. In the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome)
3. Diagnosis of Epidermolysis by at least one of the following i. Biopsy ii. Genetic testing

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-VEGF standard of care therapy. Active-control will be 2 mg intravitreal injections of aflibercept dosed per the EYLEA Prescribing Information. Only one eye will be chosen as the study eye.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of neovascular age-related macular degeneration (nAMD) in the study eye within 36 months of Visit 1.
* Subfoveal choroidal neovascularization (CNV) secondary to nAMD of any lesion type in the study eye that shows total lesion area ≤30 mm2, CNV component area of ≥50% of the total lesion area, and and CNV must not be associated with subfoveal hemorrhage, subfoveal fibrosis, or subfoveal atrophy.
* Previous treatment in the study eye with between 2 and 4 anti-VEGF intravitreal injections for nAMD (faricimab, ranibizumab, bevacizumab, brolucizumab, or aflibercept) per standard of care within 6 months of Visit 1.
* History of response to prior intravitreal anti-VEGF treatment in the study eye.
* ETDRS BCVA of between 20 and 80 letters (inclusive) in the study eye.

Key Exclusion Criteria:

* ETDRS BCVA \<20 letters in the study eye.
* Central subfield thickness \> 400 μm or retinal pigment epithelium detachment thickness \>400 μm on SD-OCT in the study eye.
* Subretinal hemorrhage, fibrosis or atrophy of \>50% of the total lesion area and/or that involves the fovea on fundus fluorescein angiography and/or color fundus photography in the study eye.
* CNV due to causes other than AMD, such are ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis, in the study eye.
* Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function

The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male volunteers
* Body Mass Index between 19 and 29

Exclusion Criteria:

* Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
* Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
* Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
* History of allergy to NMDA antagonists or other clinically significant drug allergy
* Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
* Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
* Smokers of more than 5 cigarettes or equivalent per day
* Subjects who cannot complete the neuropsychological test battery
* Any clinically significant health deficit
Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice


Eligibility Criteria:
Inclusion Criteria:

* Primarily patients of both gender, older than 30 years, who suffer from chronic obstructive airways disease
* Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion

Exclusion Criteria:

* Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg
The Effect of Chlorohexidine Gel on Tissue Healing Following Surgical Exposure of Dental Implants

The aim of this study is to evaluate the healing of peri-implat tissue following surgical uncovering with the adjunctive use of Chlorohexidine (CHX) gel.

Patients who received implants in our department, and scheduled for surgical uncovering of the implants will be asked to participate in this clinical trial (40) Patients from Department of periodontology, Rambam Health campus, Haifa in Israel will be recruited to Randomized clinical trial; patients will be divided randomly in to 2 groups:

1. Control: following uncovering of the implant a 4 mm height healing abutment will be screwed to the implant (the standard treatment modality) without using Chlorohexidine gel or any other gel.
2. Test group: following implant exposure this group will receive Chlorohexidine 1% gel (Corsodyl®) the gel will be applied on the abutment as well as on the implant internal hex and then a 4 mm healing abutment will be connected.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are willing to participate and willing to provide an informed consent.
2. Males and females between the ages 18-80
3. In good general health.
4. Patients who received dental implants and require implant uncovering (if there is more than 1 implant, a minimum radiographic distance of 3 mm will be required between implants).

Exclusion Criteria:

1. Uncontrolled Type 1 or type 2 diabetes patients( HbA1C\>7).
2. Subjects treated for at least 2 weeks with any medication known to affect soft tissue condition within one month prior to baseline examination (e.g., Phenytoin, Cyclosporine, and chronic use of Bisphosphonates).
3. Patients who underwent guided bone regeneration during implant placement.
4. Patients who used antibiotic during the study or 4 weeks prior to the baseline.
5. Active periodontitis patients.
6. Subjects with presence of active systemic infectious diseases such as: Hepatitis, HIV, history of tuberculosis.
7. Pregnant or lactating females.
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers

This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of single ascending doses in healthy volunteers

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Key Inclusion Criteria:

* Healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg

Key Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency

This is a Phase 2 prospective open-label treatment study of the safety and efficacy of doxecitine and doxribtimine in study participants with thymidine kinase 2 (TK2) deficiency who participated in the retrospective study MT-1621-101 \[NCT03701568\] or who were receiving nucleos(t)ide treatment and were approved by the Sponsor.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by the parent(s) or legally authorized representative (LAR) and/or assent by the study participant (when applicable).
2. Confirmed genetic mutation in the TK2 gene.
3. Absence of other genetic disease or polygenic disease.
4. Current treatment with nucleos(t)ides for TK2 deficiency. Study participants who were not previously enrolled in MT-1621-101 \[NCT03701568\] will require Sponsor approval to ensure that collection of clinical and functional measurements prior to treatment are sufficient to serve as baseline assessments for purposes of evaluating safety and efficacy.
5. Female study participants must not be breastfeeding, have a negative pregnancy test at screening (females ≥10 years old), and have no intention to become pregnant during the course of the study. Female study participants who are of childbearing potential (ie, following menarche until ≥1 year post-menopausal if not anatomically and physiologically incapable of becoming pregnant) must agree and commit to the use of highly effective methods of birth control for the duration of the study and for 30 days after the end of the study. Acceptable methods are defined as those that result, alone or in combination, in a low failure rate (ie, \<1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, or hormonal contraception in combination with a barrier method. In certain countries (if permitted by law), women of childbearing potential may instead agree to abide by heterosexual sexual abstinence during the study and for 30 days after the end of the study.
6. Male study participants with sexual partners should use condoms for the duration of the study and for 30 days after the last dose of study drug to prevent passing study drug to the partner in the ejaculate. Male participants should be advised not to donate sperm for 30 days after the last dose of study drug.
7. Willingness to maintain current treatment regimen and current exercise regimen for the duration of the clinical study.
8. Willingness to comply with the study protocol, including but not limited to, all study procedures, study visits, and study drug compliance.

Exclusion Criteria:

1. History of liver disease, or liver function test results (ALT, AST, or total bilirubin) ≥2× upper limit of normal without prior Sponsor approval.
2. Other significant medical condition that, in the opinion of the Investigator or Study Sponsor, may confound interpretation of the clinical course of TK2 deficiency.
Prevention of Violence Against Children

Beside the home, the school is often the second important setting for the development and education of children and adolescents. Students spend a large part of their life at school. However, there is recurrent occurrence of violence against children and of harsh discipline measures used in home and school settings. These may result into negative consequences. Hence, prevention strategies against the use of harsh discipline use in schools become a priority.

In the baseline of this study the investigators will therefore examine the prevalence and consequences of violence against children in Southwestern Uganda. The study will be conducted in schools and common disciplinary measures used by teachers, and the perceptions of teachers' and students' in relation to commonly used and experienced disciplinary measures we will be investigated.

In the second phase, the investigators then will implement and assess the effectiveness of an intervention aimed at reducing the use of harsh and violent disciplinary measures in schools. ICC-T training in the long-term aims at fostering better relations amongst students and teachers. Based on feasibility studies, ICC-T intervention is expected to result into better teacher-student relationships, change in teachers' attitudes and behaviors concerning the use of violent disciplinary measures in the school setting.

Study participants (i.e., teachers and students) will be recruited from six districts in southwestern Uganda. The sample will include 12 government-aided secondary schools from which 60 students and 15-25 teachers will be recruited. The final sample will have 720 students and 180-300 teachers. Investigators will assess data in the baseline (i.e., prior to intervention) and three months after the intervention.

Study measures will cover the following topics: socio-demographic data, common disciplinary measure used at home and at school, students' mental health problems, students' and teachers' attitudes towards violent discipline measures, and students' exposure to peer and sexual violence. Questionnaire for teachers will have additional items that measure attitudes towards teaching and teacher stress. Additionally, the investigators will also assess the demand, acceptance and feasibility of the training.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (if underaged by parents \& minors)

Exclusion Criteria:

* Acute drug or alcohol intoxication
* Acute psychotic disorder
Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT)

The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new CARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.

The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAM Cone Beam Computed Tomography (CBCT) scanner ("investigational device") against the commercially available 2D and 3D predicate devices. The study undertaken will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 2D imaging functionality by comparing against the predicate CARESTREAM DRX-1 GOS detector used on adult cadaver specimens to capture the image pairs.

The study will demonstrate the safety and effectiveness of the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) 3D imaging functionality by comparing against the reference PHILLIPS Multi Detector Computed Tomography (MDCT) scanner used on adult cadaver specimens (body part) to capture 3D volumetric exams using the anatomy of both upper and lower extremity specimens. The adult cadaver specimens will receive multiple x-ray exposures using the predicate devices for both 2D and 3D imaging. Target images from cadaver specimens will be reviewed by radiologist readers to rate diagnostic image quality, and the data will be included in a comparative evaluation.

The live human subject portion of the study will be performed on healthy volunteers. Each volunteer will sign an Informed Consent after which will receive only one 3D volumetric exam using the investigational CARESTREAM Cone Beam Computed Tomography (CBCT) scanner. Target images will be reviewed by radiologist readers to rate diagnostic image quality according to a radiologist reader scale applicable to 3D volumetric imaging.

Eligibility Criteria:
Inclusion Criteria:

* Subject 18 years or older
* Subject has provided informed consent
* Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion in the images.
* Subject(s) may have a metal screw, plate or artificial joint

Exclusion Criteria:

* Subject is pregnant
* Not able or willing to provide Informed Consent, or consent is withdrawn
* Not able to collect all required case information
* Subject has a history of high radiation exposure:
* Has undergone radiation therapy