cyrilzakka/clinical-trials huggingface dataset:
The Use of Leucocyte Platelet Rich Fibrin (L- PRF) Covered Perforated Guided Tissue Membrane for Treatment of Periodontal Intrabony Defects

This study is the first to investigate the effect of leucocyte platelet rich fibrin (L-PRF) combined with perforated membrane in order to treat infrabony defects and assess their combined effect in clinical attachment level gain and filling of base of the defect (BD). The main hypothesis was that if the L-PRF act as a chemoattracttant for a higher number of periosteal derived periodontal cells (PDPCs) and gingival mesenchymal stem cells (GMSCs) encouraging their passage through the membrane perforations.

A randomized (controlled) clinical trial which included forty sites with intrabony interproximal defects (2- or 3-wall) premolar/molar teeth assessed for clinical parameters. The four treatment modalities were randomly allocated by a predetermined computer generated randomization list (www.randomizer.org) into four equal groups; Group I (control group) open flap debridement (OFD): included intrabony defects treated by open flap debridement (OFD).Group II perforated membrane (PM): included intrabony defects treated by perforated membranes.Group III Leucocyte-platelet rich fibrin (L-PRF): included intrabony defects treated by leukocytes platelet rich fibrin (L-PRF). Group IV Leucocyte-platelet rich fibrin + perforated membrane (L-PRF + PM): included intrabony defects treated by Leucocyte platelet rich fibrin \& perforated membranes.

Eligibility Criteria:
Inclusion Criteria:

* Both genders aged from 18- 60 years.
* Patients free from any systemic diseases that may contra-indicate periodontal surgery (Ahmed Y. Gamal et al., 2014).
* Two- or three-wall intrabony defects in premolar/molar teeth without furcation involvement, that are measured from the alveolar crest to the defect bottom in diagnostic periapical radiographs of ≥ 3 mm (Reynolds et al., 2015).
* Probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm at the site of intrabony defects 4 week after the phase one therapy (Ahmed Y. Gamal et al., 2014).
* Free from any periapical pathosis.
* Patients willing and able to return for multiple follow up visits and perform oral hygiene instructions.
* Absence of occlusal interference, mobility and open interproximal contact.
* Good fulfillment to plaque control instructions following initial therapy.

Exclusion Criteria:

* Smokers.
* Pregnant and breast feeding females.
* Periodontal surgical treatment in the previous 12 months at the involved sites. (A. Y. Gamal et al., 2016)
* Persistence of gingival inflammation after phase I therapy.
* Vulnerable groups as handicapped, mentally disabled, prisoners and orphans.
A Clinical Study to Evaluate the Efficacy of Four Supplements on Improving Readiness for Intimacy

This study is to evaluate the efficacy of four supplements designed to help participants get ready for sexual intimacy through improving digestion, weight management, sexual drive and stamina, and physical endurance during workouts and overall mood and quality of life. This study will be conducted as a single group, virtual trial, in which all participants will take all four supplements and complete online questionnaires. Participants will take the indicated supplements for the indicated amounts of time over 12 weeks. Questionnaires will be completed at baseline, and then at indicated times throughout the trial.


Eligibility Criteria:
Inclusion Criteria:

* Male (biological at birth) within the LGBTQIA+ community
* Aged between 18-44
* Generally healthy - don't live with any uncontrolled chronic disease
* Generally active lifestyle or seeking to achieve health improvement
* Sexually active with a partner

Exclusion Criteria:

* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
* Anyone with known severe allergic reactions.
* Unwilling to follow the study protocol.
* Currently experiencing significant symptoms of a mental disorder that might interfere with study participation (e.g. eating disorder, obsessive-compulsive disorder, posttraumatic stress syndrome, bipolar disorder)
* Current substance abuse disorder
* Diagnosis of an autoimmune disease, such as multiple sclerosis and rheumatoid arthritis
* Self-reported or diagnosed high blood pressure or hypotension (BP \< 90 over 60)
* Currently, or in the past 6 months, undergoing hormone therapy
* Any medical condition that is unstable or uncontrolled
* A history of sexual trauma or abuse
* Has introduced any new prescription medication or supplements within the past 12 weeks that influence gastrointestinal issues, libido, or testosterone production.
The Effect of Identification Badge on Situation Awareness During High Fidelity Simulation

The purpose of this study is to evaluate if the use of identification badge (role and place) during high-fidelity simulation as an impact on situation awareness.

High-fidelity simulation is well recognized as an educational tool. Mr. Issenberg completed a review(2005) that determined features of high-fidelity simulation training that lead to effective learning. It this review, it is mentioned that the validity of the simulator (realism) is essential to help learners to increase their skills and sharpen their responses. It is essential to get and maintain engagement during high-fidelity simulation and it pass by an increase in realism and situation awareness. The purpose of this study is to evaluate if the use of identification badge (physical and conceptual realism) during high-fidelity simulation as an impact on situation awareness and engagement.

Eligibility Criteria:
Inclusion Criteria:

* anesthesiology residents (university of montreal) who participate to simulation course on crisis resources management

Exclusion Criteria:

* none
Clinical Evaluation of Toric Intraocular Lens Made by Aurolab

The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.

Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.

Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 65
* Senile cataract
* Posterior Sub Capsular Cataract (PSCC)
* Astigmatism 1.25 D or more
* Residence within 100 kms of Madurai

Exclusion Criteria:

* Traumatic \& Complicated cataract
* Poor mydriasis
* Amblyopia
* Severe Pseudo exfoliation (PXF)
* Dense posterior polar cataract (PPC)
* One eyed patients
* Uveitis
* Corneal pathology / Scar
* Retinal Pathology contributing to visual loss
* Intraoperative complication like PC rupture, Zonular dialysis
Safety Study of LY3041658 in Healthy Participants

The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.

Protocol amended in January, 2016 to include first generation Japanese participants.


Eligibility Criteria:
Inclusion Criteria:

* All:

  * Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
  * Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10\^3/microliter (uL), inclusive.
* First-generation Japanese:

  * Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
  * Are 20 to 65 years of age, inclusive, at the time of initial screening.

Exclusion Criteria:

- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
Cardio-vascular Energy Transfer and Ventriculo-arterial Coupling in Heart Failure

The goal of this pilot study is to investigate energy transfer fram the ventricle to the arteries in patients with heart failure, primary by investigating the total power.


Eligibility Criteria:
Inclusion Criteria:

Acute left ventricular failure due to:

* Myocardial ischemia
* Cardiomyopathy
* Myocarditis Sinus rhythm Age \>18 years

Exclusion Criteria:

Cardiogenic shock Mechanical circulatory support Respiratory treatment Inotropic infusions Tachyarrhythmias Lack of capacity to consent
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People

The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

Combined 6-part study. Part-1: Single Ascending dose Part-2: Multiple Ascending Dose Part-3: Relative bioavailability and food effect Part-4: Metabolism and Excretion Part-5: Drug-drug interaction with midazolam Part-6: Supratherapeutic exposure Part-1,2 and 6 are double blind, sponsor open and Part-3,4 and 5 are open label study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
* Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs). A body weight of \>45 kg may be considered in selected cases.
* Japanese subjects who have four Japanese biologic grandparents born in Japan
* Chinese participants who were born in mainland China and both parents are of the Chinese descent.

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)
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
* Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
* Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
* Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Effect of Fat Quality on Glycemic Regulation and Gut Microbiota After a Short-time Intervention in Healthy Individuals

The overall aim is to investigate effects of saturated versus polyunsaturated fat on glycemic regulation and satiety in a postprandial study with healthy individuals. The potential effects will be related to changes in gut microbiota, the circulating levels of short chain fatty acids, inflammation and gene expression in peripheral mononuclear blood cells.

The intervention study will have a randomized, double blinded, cross-over design with different test meals consisting of saturated or polyunsaturated fat. The amount of fat will be identical in the test meals, but the fat quality will vary. The test meals are in the form of muffin and spread.

All participants will consume two muffins and minimum 20 g of spread a day for three consecutive days, consisting of either a high proportion of saturated fat or a high proportion of polyunsaturated fat. At day one (visit 1 and 3) and day four (visit 2 and 4) of the intervention week, the participants will perform a postprandial glucose test (OGTT, 75 g glucose in 100 ml water) at Oslo Metropolitan University. Blood samples will be taken before and at different time points after the glucose test. One week prior to the intervention week and during "wash-out" (11 days), the participants will consume the control products which are high in saturated fat.

At the screening visit (visit 0) the participants will be asked to limit the intake of dietary fat and fiber from oat and barley one week prior to visit 1 and during the study. Otherwise, participants will be asked not to change their diet and exercise habits during the study period. Individuals fulfilling the inclusion criteria will also be invited to participate in a cross-sectional study for investigating the gut microbiota in a healthy population.

An OGTT will be performed at visit 1, 2, 3 and 4.

The participants will receive test meals after screening and before visit 1, 2, and 3.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18,5 and 27 kg/m2
* Fasting plasma glucose ≤ 6.1 mmol/l

Exclusion Criteria:

* Chronic metabolic diseases such as diabetes type 1 and 2, coronary heart disease and cancer the last 6 months.
* Intestinal diseases such as chron's disease, ulcerative colitis and irritable bowel syndrome.
* Food allergy and intolerances towards grain and dairy products.
* Pregnant and lactating
* Smokers
* Fasting blood glucose ≥ 6.1 mmol/L
* BMI \<18,5 and \>27 kg/m2
* Planned weight reduction and or ± 5% weight change over the past three months.
* Use of antibiotics last 3 months before study entry and during the study period
* Use of probiotics the last month before study entry and during the study period
* Blood donor last 2 months before study entry and or during the study period
* Not willing to end the use of dietary supplements, including probiotic products, fish oil etc. four weeks prior to study entry and throughout the study period
* Alcohol consumption \> 40g / day
* Hormone treatments (except contraceptives)
The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation

A randomised trial to determine whether e-cigarettes (with and without nicotine) combined with nicotine patches and behavioural support can assist smokers in remaining abstinent for at least six months.

A pragmatic, double-blind, three-arm randomised controlled trial undertaken in New Zealand to determine whether e-cigarettes combined with nicotine patches can assist smokers in remaining abstinent for at least six months. 1809 smokers who are motivated to quit will be recruited from the community using media advertising and randomly allocated to one of three groups, namely 1) 21mg nicotine patch daily, 2) 21mg nicotine patch daily plus a 'new generation' e-cigarette with no nicotine or 3) 21mg nicotine patch daily plus a 'new generation' e-cigarettes with nicotine. Participants will be instructed to start using the study products two weeks prior to their quit date, and continue for a further 12 weeks after their quit date. Participants will also receive a cessation behavioural support programme consisting of at least six follow-up telephone calls (10-15 minutes each) over the first six weeks. Outcome data will be collected on the participant's set quit date, then one, three, six and (for some but not all) 12 months post-quit date.

Eligibility Criteria:
Inclusion Criteria:

* Smoke and want to quit in the next three months
* Reside in New Zealand
* At least 18 years of age
* Able to provide verbal consent
* Have access to telephone (mobile and/or landline)
* Are prepared to use a nicotine patch or a nicotine patch and e-cigarette together.
* Only one person per household is eligible.

Exclusion Criteria:

* Pregnant women
* Women who are breastfeeding
* Current users of NRT products
* People currently enrolled in another smoking cessation programme or other cessation study
* People who have used an e-cigarette for more than one week in the last year for smoking cessation
* Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline).
* People who have had a heart attack, stroke or severe angina within the previous two weeks.
* People who self-report a history of severe allergies and/or poorly controlled asthma.
Sharing Histories: Test of a Teaching Method for Community Health Workers

The purpose of this study is to determine the effectiveness of an innovative methodology for training Community Health Workers that will improve their effectiveness in educating mothers to adopt best practice health behaviors in the home.

Objective: Training of community health workers (CHW) is a growing priority to close the gap between health services and mothers/families in resource poor communities. To address research needs on how to improve effectiveness of CHW training, the investigators tested an innovative CHW teaching methodology called "Sharing Histories" hypothesizing that this would empower and enable CHW to better teach mothers to improve health knowledge and behaviors that contribute to improved child growth.

Method: The study was a cluster-randomized controlled trial: 22 health facility jurisdictions were matched and randomly assigned as experimental or control. Health personnel Tutors and female CHW were trained using either the "Sharing Histories" methodology (experimental) or a standard but still participatory teaching method (control). Training content, materials, and other interventions were held constant between study groups. Impact on maternal knowledge and practices, and child growth and morbidity were measured in representative household surveys at baseline, midterm, and final evaluation, with 600 mothers interviewed - 300 in each study group - at each point in time.

Eligibility Criteria:
Inclusion Criteria:

* Adult interviewed must be mother or guardian of a child under two years of age.
* Child from birth (0.1 months-old) to under two years of age (23.9 months-old).

Exclusion Criteria:

* If a mother selected for interview had more than one child under age two years, only the younger child was considered for the interview and anthropometry measurements.
Assessment of Residual Paralysis in Patients Who Receive Mini-dose Atracurium During Supraglottic Airway Insertion

This study aims to establish the incidence of residual paralysis in patients following administration of a mini- dose of atracurium (less than ED95 i.e. \<0.23mg/kg or \<15 mg in most patients) during supraglottic airway insertion and correlate it with the duration of time from drug administration to arrival at PACU. The secondary aim is to compare the incidence of residual paralysis in patients who receive full doses of atracurium (per body weight) with those who receive mini-doses.

Post-operative residual paralysis may be defined as the incomplete recovery of muscle function following intra-operative administration of neuromuscular blockers (NMBs). This condition is associated with many negative patient outcomes such as: increased risk of aspiration; upper airway obstruction; and delayed Post-Anaesthetic Care Unit (PACU) discharge, amongst others. Despite the increasing use of shorter acting agents, the prevalence of residual paralysis in the PACU remains high at 20-50%. NMBs are commonly used to facilitate endotracheal intubation and insertion of the supraglottic airway by obtunding airway reflexes. Given the increasing use of mini-dose NMBs without post-operative reversal in clinical practice, there is a need to evaluate the incidence of residual paralysis in the patient population who have received mini-dose atracurium during the supraglottic airway insertion.

Eligibility Criteria:
Inclusion Criteria:

* Adults above 21 years old
* Received either a mini-dose of atracurium or full dose of atracurium during the placement of the supraglottic airway
* Did not receive any neuromuscular reversal agent at any point of the operation.

Exclusion Criteria:

* Patients with underlying neuromuscular disease
* Patients who received pre-operative medication that may affect neuromuscular transmission
* Patients who required additional doses of neuromuscular blockade at any point of the operation
a Retrospective Observational Study Comparing Outcomes of Retrocaecal Appendicitis With Non-retrocaecal Appendicitis

A retrospective observational study investigating whether retrocecal appendicitis associated with worse operative and postoperative outcomes than non-retrocecal appendicitis.

Acute appendicitis is the most common cause of acute abdomen requiring acute surgery. The prevalence of the retrocaecal position of the appendix varies significantly between studies from 14 to 36%. Appendectomy of a retrocecal appendix is generally considered to be more demanding procedure than appendectomy of appendices in other positions. The aim of this study is to investigate whether retrocaecal appendicitis is associated with a higher rate of perioperative complications and delayed diagnosis when compared with the other positions.

A retrospective analysis of prospectively collected data of patients undergoing surgery for signs of acute appendicitis from January 2015 to April 2020 at the University Hospital Kralovske Vinohrady. Two groups of patients were be formed: the retrocaecal group and the non-retrocaecal group.

The following data were recorded: sex, age, body mass index, length of hospital stay, abdominal drain placement, length of surgery, surgical approach (laparoscopic, open or converted), operative finding (normal appendix or catarrhal, phlegmonous, gangrenous, or perforated appendicitis), position of the appendix (retrocaecal or non-retrocaecal positions), histopathological findings (acute inflammation, chronic inflammation, appendiceal tumour or normal appendix), 30-day postoperative complications, 30-day postoperative mortality, symptoms (abdominal pain, nausea, vomiting, diarrhoea, body temperature above 37 degrees celsius, urological complaints and gynaecological complaints), duration of symptoms (from onset to surgery), serious comorbidities and diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing surgery for signs of acute appendicitis at the department of surgery of the University Hospital Kralovske Vinohrady between January 2015 to April 2020

Exclusion Criteria:

* Patients under 18 years of age