cyrilzakka/clinical-trials huggingface dataset:
Single Tooth Implant-supported Fixed Prosthetic Rehabilitation Using PEEK.

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - used in single teeth implant-supported rehabilitations after one year of follow-up. The main question it aims to answer is:

- What is the survival outcome of single teeth implant-supported prosthesis using Poly-ether-ether-ketone? The participants already rehabilitated with a single tooth dental implant will receive a definitive prosthesis incorporating Poly-ether-ehter-ketone.

Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the partial rehabilitation using Single Crowns. To test this, the study design to be used will be a single centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 6 months and 12 months after dental loading and annually thereafter as long as the patient is willing regarding: prosthetic survival including repair and relining, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, abscess, fistulae), patient tissue reaction, aesthetic examination including staining, colour stability and anatomical form; patient in mouth comfort and quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; and assessment of prosthetic preparation (technician satisfaction), laboratory preparation time, clinical operative time and costs for economical purposes.

Eligibility Criteria:
Inclusion Criteria:

* Patients rehabilitated with a single crown supported by and implant in immediate function;
* Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups;
* Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

Exclusion Criteria:

* Female Subjects who are pregnant;
* Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes;
* Subjects who are currently enrolled in a clinical study;
* Subjects requiring or currently having ongoing orthodontic treatment;
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19

Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio).

* In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD
* In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD
* In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ARDS (Berlin Criteria)
* Hospitalized with at least severe COVID-19 (FDA 2020)
* Receiving support for acute lung injury/respiratory distress via supplemental oxygen
* Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine aminotransferase (ALT) concentration ≤ 150 U/L
* Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis

Exclusion Criteria:

* Greater than 72 hours since time of onset of ARDS.
* Greater than 7 days since start of mechanical ventilation.
* Currently receiving or anticipated to receive extracorporeal life support (ECLS), extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation
* Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6 mL/kg of predicted body weight and prone positioning) and fluid management protocol (Fluids and Catheters Treatment Trial \[FACTT\] Conservative or Lite) per local institutional standards (HFOV).
Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention

To monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.

Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter by directing blast waves into containers that are either partially or completely filled with blood and measuring markers of lysis.

These experiments are designed to better understand the demonstrated effectiveness of mild jugular compression according to the principle of the Queckenstedt Maneuver to reduce the likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is being developed by Q30 Labs, LLC (Q30), to accomplish this effect.

Eligibility Criteria:
Inclusion Criteria:

* • Normal healthy volunteer

  * Able to provide written consent
  * Must be 18 years or older

Exclusion Criteria:

* • Unable to provide written consent

  * Recent penetrating brain trauma (within 6 months)
  * Under the age of 18 years
The Effect of Behavioral Therapy Given to Men and Their Partners'

Premature ejaculation involves not only sexual problems but also relationship and communication difficulties, and behavioral approaches to the treatment of premature ejaculation are promising.

Introduction and hypothesis: Premature ejaculation potentially affects not only men but also their partners negatively. The null hypothesis for this study is Behavioral therapy given to men with premature ejaculation has no effect on the symptoms and their partners' sexual functions and quality of sexual life.

Methods: A quasi-experimental study. The current study was conducted in 84 men and their partners. The "Personal Information Form", "Premature Ejaculation Diagnostic Tool (PEDT)", "Female Sexual Function Index (FSFI)", and "Sexual Quality of Life-Female (SQOL-F)" were used to collect data. Behavioral therapy, consisting of a total of 6 sessions of 45 minutes, was applied once every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate
* Having no communication barriers
* Literacy
* Age 18-45 years
* Having no diagnosis of sexual dysfunctions
* Having no medical illnesses (psychiatric diseases, pelvic anatomical disorder, post-menopause, etc.) that might affect the sexual function
* Having a spouse diagnosed with premature ejaculation according to DSM-5 criteria
* Having a spouse without any prior behavioral therapy for premature ejaculation
* Being a man diagnosed with lifelong premature ejaculation according to the ISSM criteria.
* Being married

Exclusion Criteria:

-Men and their partners who did not meet all inclusion criteria were excluded from the present study.
Assessment of the Effects of Synbiotic on Gut Microbiota Composition in Scholars With Overweight

This study was a randomized, double-blind controlled protocol in children overweight aged 6-11 years. This study aimed to evaluate the effect of consuming fermented milk products containing Lactobacillus casei strain Shirota (LcS), as a probiotic enriched with prebiotic fructans from A. salmiana or inulin-like standard commercial prebiotic to improve the gut microbiota modulation. After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. Children were eligible for inclusion in the trial if they were overweight according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight). The trial took place in three full-time elementary schools in San Luis Potosí, México, and the screening of the prospective participants took place up to 1 week prior to the randomization. Children were evaluated over a 6-week intervention period receiving different fermented milk products

Male and female children between the ages of 6- 10 years old were recruited from three schools located in San Luis Potosi, Mexico. According to the World Health Organization, children with overweight were requested to participate and were voluntarily recruited.

After providing detailed information, written informed consent was obtained from parents and written and oral assent from participants before the initial test day. The trial investigated the effect of daily intake of fermented milk products containing Lactobacillus casei strain Shirota (LcS), LcS plus inulin (LcS+inulin), and LcS plus fructans from A. salmiana (LcS+fructans) on gut microbiota composition. The trial protocol was conducted according to the principles of the Declaration of Helsinki. It was approved by the Ethical Committee on Human Experimentation of the State Committee of Health Education and Research of the Health Secretary in San Luis Potosi (register number SLP/012-2017).

Eligibility Criteria:
Inclusion Criteria:

* Children were overweight or obese, according to the World Health Organization (≥85th body mass index (BMI) percentile for overweight, and ≥95th BMI percentile for obesity).

Exclusion Criteria:

* Any known infections, systemic diseases or metabolic diseases, and use of any prescribed medications or antibiotics in the one month before randomization and during the trial.
Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19

This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions

This study is to analyze the microglia reaction or direct neurotropic effects of CNS COVID-19 in pathogenesis and brain stem dysfunction in critically ill patients. A microglia-focused, brain-specific 50+ marker CODEX panel is used to assess the neuroinflammatory microenvironment in specific brain regions of deceased COVID-19 patients. The peripheral (cerebrospinal fluid and peripheral blood) cytokine response to SARS-CoV-2 is investigated in regard to CNS affection and consecutive blood brain barrier disruption leading to braininherent neuroinflammatory reactions. Primary endpoints of this project are the multidimensional integration of the analysis from the procedures described above and assessment of the correlation between the gained clinical data (MRI, mental/neurological state), the body fluid proteomic and mass-cytometric analysis (CSF and Plasma proteomics, peripheral blood mass cytometry) and the CODEX analysis of defined brain regions on autopsy specimens.

Non-critically ill COVID-19 patients and critically ill COVID-19 patients needing mechanical ventilation at the ICU are included. Autopsy specimens from medulla oblongata, cortex, cerebellum and olfactory bulb are investigated, including only tissue samples, which have been submitted to the Institute of Pathology, University Hospital Basel.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 positive tested

Exclusion Criteria:

* COVID-19 negative tested
* pregnant women
Use of 2-octyl-cyanoacrylate Together With a Self-adhering Mesh

The investigators prospectively studied the results of wound closure after abdominoplasty with randomized use of PrineoTM and conventional suturing to assess the possible difference in outcome between these two methods.Follow-up visits to the outpatient clinic were scheduled at 2 weeks, 6 months and 12 months after surgery. A panel consisting of three plastic surgeons and three plastic surgery residents assessed the wound and scar appearance during the three follow-up visits.

Abdominoplasty is one of the most commonly performed procedures in plastic surgery. The appearance of the scar is a major factor contributing to the aesthetic outcome of the procedure and depends largely on the technique of wound closure. The new PrineoTM wound closure system was introduced to combine the effectiveness of 2-octyl-cyanoacrylate (Dermabond TM) together with a self-adhering mesh.Fifty-two women and 8 men aged between 21 and 65 years scheduled for abdominoplasty were included in the study. Total operating time after abdominoplasty between the traditional wound closure technique and the PrineoTM-type wound closure technique was compared. Two weeks postoperatively, the wounds were examined and graded according to the Hollander Cosmesis Scale. At 6- and 12-month follow-up, the aesthetic outcome of the abdominal scar was evaluated with the Vancouver Scar Scale. Twelve months postoperatively, the patients were further asked to score their part of the Patient Scar Assessment Scale.There was a statistically significant shorter mean of total operating time for the new skin closure system compared with intradermal sutures. The Hollander Cosmesis Scale indicated a significantly more favourable overall result with PrineoTM at 2 weeks after surgery. The Vancouver Scar Scale demonstrated a better cosmetic outcome in favour of PrineoTM 6 and 12 months after surgery The Patient Scar Assessment Scale scores 12 months after surgery indicated that the patients noted significantly less pain, thickness and irregularity with PrineoTM.Based on our results, we conclude that PrineoTM is a safe and effective substitute for superficial skin closure, with good cosmetic results and no increase in wound complications. The use of PrineoTM decreases operative times and costs and enhances patients' postoperative comfort.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent an abdominoplasty without exclusion criteria

Exclusion Criteria:

* current intake of systemic steroids
* known HIV-positive or other immunocompromised status
* known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
* personal or family history of keloid or hypertrophic scar formation
Impact of SpHb Monitoring on Transfusion

Continuous and noninvasive hemoglobin (SpHb) monitoring provides clinicians with real-time trending of changes or lack of changes in hemoglobin, which has the potential to alter red blood cell (RBC) transfusion decision making. The objective of this study was to evaluate the impact of SpHb monitoring on RBC transfusions in high blood loss surgery. The investigators hypothesize that SpHb will improve blood transfusion practice in the for of change the number of blood unit per patient and improve the outcome regards the time to take decision of transfusion trigger.

Eligible patients scheduled for neurosurgeries were enrolled into either a standard care group (Control Group) or an intervention group (SpHb Group). The Control Group received typical anesthesia care including estimated blood loss (EBL) assessment and intraoperative hemoglobin measurements from the central laboratory (Hb). Blood samples were taken when EBL was ≥15% of total blood volume. RBC transfusion was initiated if Hb was ≤10 g/dL and continued until the EBL was replaced and Hb \>10g/dL was confirmed. The SpHb Group followed the same transfusion practice as the Control Group except the anesthesiologist was guided by the addition of SpHb monitoring with blood samples still taken pre- and post-transfusion. Additionally, the absolute and trend accuracy of SpHb compared to Hb was evaluated. Potential cost savings from reduced RBC utilization will be calculated if occured.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1,2 patients from 15 to 60 years old scheduled for neurosurgical procedure

Exclusion Criteria:

* Exclusion criteria included significant liver or renal disease, coagulopathy, pregnancy, anemia, and patients scheduled for procedures with excepted low blood loss.
The Impact of Distraction on Adenoma Detection Rate

The investigators will review video-recordings of three randomized, controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange during colonoscopy. These studies were all conducted at Buddhist Dalin Tzu Chi Hospital.

The investigators will review video-recordings of three randomized controlled trials (NCT01535326, 01699399, and 01894191) comparing air insufflation, water immersion and water exchange. These studies were conducted at Buddhist Dalin Tzu Chi Hospital. Permission will be obtained from the local Institutional Review Board (IRB) to review, analyze and report de-identified findings.

Two experienced endoscopists (YHH and CWT) performed all the recorded colonoscopies. Recordings will be selected for review if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers. Patients with incomplete recordings and a history of bowel resection will be excluded from analysis. The included video recordings will be edited to remove the insertion phase to blind the study reviewer to the insertion techniques. One blinded reviewer uninvolved in the performance of the colonoscopies will be in charge of evaluating the selected videos, using the criteria described by Yung et al

Eligibility Criteria:
Inclusion Criteria:

* if they are complete examinations; include clear identification of the appendiceal orifice and/or the ileocecal valve, indicating arrival at the cecum; available in the appropriate format for video editing; and contain no patient or endoscopist identifiers.

Exclusion Criteria:

* Patients with incomplete recordings and a history of bowel resection will be excluded from analysis.
Weight Management Aimed to Reduce Risk and Improve Outcomes From Radical Prostatectomy

The purpose of this study is to test how a weight management program affects substances in the blood called biomarkers that can show the presence or severity of cancer, compared to a standardized diet and exercise educational flyer.


Eligibility Criteria:
Inclusion Criteria:

* Men newly diagnosed with PCa who are scheduled for radical prostatectomy (RP) (T1 or T2)
* Body Mass Index (BMI) 25-45 kg/m2
* Has internet access

Exclusion Criteria:

* History of 5 alpha reductase inhibitors prior 3 months
* History of radiation therapy for cancer treatment
* Taking active cancer treatment
* Undergoing salvage therapy
* Castration-resistant PCa
* Evidence of metastasis
* Evidence of biochemical recurrence
* High risk medical condition (e.g. kidney disease, uncontrolled diabetes, etc.)
Genetics of Airway Responsiveness and Lung Function

To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.

DESIGN NARRATIVE:

Airway responsiveness and lung function, endpoints with a strong genetic basis, are central to the obstructive airway diseases (asthma and COPD). In contrast, the dissection of the underlying genes requires unique sample resources, accurate and comprehensive phenotyping, and an efficient study design. To address to this three-pronged challenge, a genomic screen brought together a large, homogenous, mostly untreated sample from Anhui, China, a wealth of expertise in asthma phenotypes, and a potent study design based on extreme discordant sib pairs.

Since this approach utilized an extant asthmatic family population, no support for data collection was required. The primary focus of the study was two intermediate phenotypes related to asthma and COPD: airway responsiveness (characterized by increased responsiveness to histamine methacholine or other nonspecific agonists and measured by the slope of the dose response relationship) and forced expiratory volume in 1 second (FEV1). Since both traits are continuous, the appropriate study design considered only siblings with extremely discordant phenotypes. For many studies, this strategy was not feasible due to the thousands of families that must be phenotyped to identify a sample of such siblings. The plan was to utilize the organization of a well-established network in China to collect 150 extreme discordant sib pairs of each intermediate phenotype. For airway responsiveness, the estimated power from this sample, equivalent to roughly 600 concordant sib pairs, was intended to surpass the power of all existing studies, including the U.S. Collaborative Study on the Genetics of Asthma. Further, with similar power, this was the first study to test for linkage to FEV1. Moreover, to further augment power, potential phenotypic heterogeneity was reduced by stratifying the analyses by total and specific serum IgE levels, skin test reactivity, peripheral blood eosinophilia, respiratory symptoms, age, gender, bronchodilator response, and cigarette smoking.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria