cyrilzakka/clinical-trials huggingface dataset:
Impact of Implant Insertion Torque on Peri-implant Bone Level.

Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.

The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.

The secondary outcomes would be:

* To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA
* To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates
* The patient satisfaction related to the implant treatment

Eligibility Criteria:
Inclusion Criteria:

* All partially edentulous patients requiring simple Implant placement,
* being at least 18-year-old and able to sign an informed consent,
* The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).

Exclusion Criteria:

* Heavy smokers (more than 10 cigarettes/day).
* Immunosuppressed or immunocompromised patients
* Uncontrolled diabetes
* Active periodontal disease
* Patients with a full mouth marginal bleeding score higher than 20%
* Addiction to alcohol or drugs
* Psychiatric problems
* Severe caries, periapical lesions, acute infection (abscess)
* Immediate post-extractive implants (at least 2 months after extraction have to elapse)
* Patients unable to commit to 3-year follow-up.
* Patients treated or under treatment with intravenous amino- bisphosphonates.
* Patients participating to other studies, if the present protocol could not be fully adhered to.
A Study of Enlicitide Decanoate (MK-0616) and Semaglutide in Healthy Adult Participants (MK-0616-023)

The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes.

Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2
* Medically healthy with no clinically significant medical history

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
* History of cancer
Microbial Analysis in Patients With Cholangitis

* To identify the microbial profile in bile and blood for patients with cholangitis.
* To explore risk factors of cholangitis and outcomes in those patients

Under physiological conditions, bile is sterile. Major factors maintaining sterility of bile are a competent sphincter of Oddi and antegrade flow of bile. Other factors are bile salts in the bile duct, Kupffer cells and tight junctions between the hepatocytes that guard against bacteria getting in from the portal circulation. Any break in these physiological barriers leads to infection of the bile. The main source of infection in most cases is the duodenum. Hematogenous spread through the portal venous flow is another route. In addition, bile duct obstruction e.g., stone, is associated with bacterial colonization within the stagnant bile and with increasing biliary pressure, bacteria may translocate into the circulation causing a systemic infection .

In patients without stone disease, previous biliary intervention is associated with high rates of infection. Bacteremia as a complication of biliary intervention tends to occur in patients with obstructed bile flow, especially those who have previously undergone orthotopic liver transplantation (OLT), surgery to the biliary tree, sphincterotomy, or placement of a biliary stent. The risk of systemic infection is high when adequate biliary drainage has not been achieved after intervention, which typically involves endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).

Acute cholangitis is acute inflammation and infection in the bile duct. It is diagnosed in 6-9% of patients with gallstone disease and 1-3% after ERCP. It can progress from a local biliary infection to advanced systemic disease with sepsis and multiple organ dysfunctions with significant mortality rates (10%).

Microbial infection causing acute cholangitis is mainly bacteria and fungi. Despite blood cultures provide an opportunity to detect the causative organism, they remain negative in more than half of the cases with cholangitis. The growth is often mono-microbial organism, predominantly Gram-negative organisms. However, bile cultures often have a poly-microbial growth especially in patients with an indwelling biliary stent where, Gram-negative bacteria, in particular Escherichia coli, are the most common pathogens isolated from infected bile.

The fungal infection of the biliary tract increase in the last years and can lead to biliary obstruction. The most common fungal infection in biliary tract is candidiasis.

Because of the rapid development of multi-drug resistant organisms, the choice of appropriate empiric antimicrobial therapy has become more complicated. Thus, knowledge of the common etiologic agents and their local susceptibility profile is essential to ensure the appropriate choice and timely administration of empiric antimicrobial therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with extrahepatic cholestasis undergoing biliary procedure (ERCP or PTD) will be included.

Exclusion Criteria:

* patients less than 18 years old.
Resistance Exercise, Muscle Mass, Strength and Body Composition

A plethora of trials reported the positive effect of resistance exercise on functional and morphological parameters. Although a large amount of the studies used suboptimum devices and obsolete methods the results of these older studies were still considered as golden standard. The aim of the present study is thus to determine the proper effect of different resistance exercise protocols with and without adjuvant protein supplementation on functional and morphological muscle and body composition parameters in male untrained subjects 30-50 years old under special regard of modern medical imaging and segmentation technologies.

Our general study hypothesis is that HIT-resistance exercise significantly impact relevant muscular parameters of the upper leg.


Eligibility Criteria:
Inclusion Criteria:

* males
* untrained (\< 2 h exercise/week, \< 1 h resistance exercise/week)
* 30-50 years old

Exclusion Criteria:

* medication/diseases affecting intervention or study endpoints
* history of intense resistance exercise (\> 3 h/week during the last decade)
* very low physical capacity (\< 100 Watt at ergometry)
* more than 2 weeks of absence during the interventional period
* contraindication related to MRI-assessment (i.e. magnetizable intracorporal artefacts)
* pathological changes of the heart
* inflammable diseases
COR-KNOT Versus Manually Hand-tied Knots

The COR-KNOT technology (LSI SOLUTIONS, Victor, New York USA) was developed to replace suture tying with a faster procedure during surgery. While preclinical studies confirmed the speed of COR-KNOT use, no clinical studies have quantitatively compared the speed of suture fixation delivered by the COR-KNOT device with the speed of conventional hand-tied knots. COR-KNOT is expensive, costing 189 $ per application. Given this added expense, it is important to quantify the time-saved by application of this technology.

The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails. This device has been accepted by cardiac surgeons for the recognized benefits of time savings, simplicity, and reliability.

While the device presents ergonomic advantages during minimally invasive cardiac surgery, it enjoys widespread use in sternotomy-based, standard heart surgery. The relative cost of the device as a function of time saved has not been assessed. The purpose of this trial is to determine the relative time savings and cost of COR-KNOT compared to standard hand-tied knots in patients undergoing mitral/tricuspid ring annuloplasty repairs via traditional open heart surgery. Valve repair surgery is a common setting for COR-KNOT use and therefore serves as an appropriate procedure for evaluation of the technology.

The investigators propose a prospective, randomized trial in patients undergoing mitral or tricuspid ring annuloplasty repair to 1) Determine the time require per knot for COR-KNOT versus standard hand-tied knots and 2) Quantify the relative cost of COR-KNOT versus that of standard, hand-tied knots. Data from this study will enable the investigators to determine the cost-benefit of using COR-KNOT technology in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for Valvular ring annuloplasty for mitral and/or tricuspid valve repair
* Age \> 18 years
* Able and willing to give informed consent

Exclusion Criteria:

* None
Local Treatment With RP for Newly-diagnosed mPCa

The objective of this study is to evaluate the role of local treatment with radical prostatectomy in patients with newly-diagnosed metastatic hormone-sensitive prostate cancer.

Patients recently diagnosed with metastatic prostate cancer (mPCa), and meeting the eligibility criteria, will be given the opportunity to enroll in this study.

Study Groups:

After inclusion, patients requesting local treatment can undergo radical prostatectomy (RP) with pelvic lymph-node dissection (PLND) after multi-disciplinary evaluation. This resulting in a local treatment group and a no local treatment group. For ethical reasons, no randomization will be done.

Follow-up:

Patients not undergoing local treatment will undergo the current standard of care in our institution. And besides the intervention of local treatment, the other patients will receive this same current standard of care.

Routine follow-up visits, with physical examination, laboratory tests and questionnaires, will be scheduled every 3 months. A CT-scan (abdomen-pelvis) and bone scan will be performed if a clinical progression is diagnosed or suspected and when Castration Refractory PCa (CRPC) is established.

Androgen Deprivation Therapy (ADT) will be initiated in case of one of the following:

* symptoms related to metastatic lesion(s)
* Prostate Specific Antigen (PSA) \> 50ng/ml and doubling time (PSA-DT) \< 6 months (starting 3 months after inclusion at earliest)

The estimated number of patients to be included in the local treatment arm is 40.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate adenocarcinoma, confirmed by histology
* Newly diagnosis of metastatic disease (stage TanyNanyM+)
* Life expectancy ≥2y based on comorbid conditions, WHO performance status 0-2
* Written informed consent, male ≥18yo
* Willing and expected to comply with study protocol and follow-up schedule
* Multidisciplinary Oncologic Consultation (MOC) approval

Exclusion Criteria:

* Previous local or systemic treatment for prostate cancer
* Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
* Symptoms clearly related to metastatic lesions
* Any other previous or current (malignant) disease which, in the judgment of the responsible physician, is likely to interfere with LoMP treatment or assessment
Klebsiella Pneumoniae Necrotizing Fasciitis: Clinical and Microbiological Features

This is a retrospective descriptive study on the clinical and microbiological features of Klebsiella Pneumoniae Necrotizing Fasciitis.

Background. Necrotizing fasciitis is a rapidly progressive, life-threatening infectious disease that primarily involves soft tissue. Traditionally, group A streptococcus is the major cause of this disease. In recent years, however, there are increasing case reports of necrotizing fasciitis solely caused by Klebsiella pneumoniae. There are limited data regarding clinical and microbiological features of K. pneumoniae strains causing this disease.

Methods. We plan to review the medical records of necrotizing fasciitis cases treated during 1997-2010 at National Taiwan University Hospital, and compare the clinical features of cases caused by K. pneumonia and cases caused by group A streptococcus. We also plan to retrospectively identify necrotizing fasciitis-associated K. pneumoniae strains stored at -80oC at National Taiwan University Hospital, and perform virulence-associated hypermucoviscosity phenotyping, wzy (magA locus) and rmpA genotyping, and detection of 20-kb kfu/PTS genomic region and other iron-uptake systems.

Expected Results. This study is expected to yield the following important information: (1) The prevalence of monomicrobial K. pneumoniae necrotizing fasciitis cases among all necrotizing fasciitis cases at our hospital during the study period; (2) The distinct clinical features of K. pneumoniae necrotizing fasciitis, using group A streptococcal necrotizing fasciitis as the comparison group; (3) The microbiologic characteristics of K. pneumoniae strains causing monomicrobial necrotizing fasciitis, including hypermucoviscosity phenotype, wzy (magA locus) and rmpA genotype, and the presence of iron-uptake systems.

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of necrotizing fasciitis depends on intra-operative findings characterized by a lack of resistance to blunt dissection of the normally adherent fascia, presence of necrotic fascia, and purulent malodorous discharge. Pathological findings of the involved fascia typically show neutrophils and bacterial clumps infiltrating between collagen bundles of with focal necrosis.

Exclusion Criteria:

* none
Endoscopic Ultrasound (EUS)-Guided Fine Needle Aspiration (FNA) With Rapid On-site Evaluation (ROSE) of Cytopathology vs. EUS-guided Fine Needle Biopsy (FNB) Alone in the Diagnosis of Pancreatic Solid Lesions

Currently, the best way to evaluate pancreatic masses is through endoscopic-guided needle sampling of the mass to determine the diagnosis by looking at the acquired tissue under a microscope. This is done by inserting a small camera (endoscope) through the mouth of the patient then advanced to the stomach and using ultrasound guidance a sample of the pancreas can be acquired through the stomach. The sampling is usually done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed immediately under the microscope and can give feedback to the endoscopist until enough cells has been acquired for a diagnosis. This method has been shown to increase the ability to diagnose pancreatic cancer but is expensive and requires significant amount of resources. New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology) and has been shown to be also very accurate in the diagnosis of pancreatic cancer.

The purpose of this study is to compare endoscopy-guided biopsy of pancreatic masses with the new core needle (FNB), which can obtain more tissue for diagnosis vs. using a traditional needle (FNA) with the help of an immediate assessment of the obtained samples under the microscope to determine whether enough tissue has been obtained (ROSE). Both approaches have been shown to increase the accuracy of diagnosis in solid pancreatic masses but it is unclear which one is superior. This is a randomized trial meaning that the participants would either undergo biopsy with the new needle or with the traditional needle plus the addition of on-site assessment of the obtained samples. The advantage of the new needle is that it is easy to implement and likely much cheaper. If the investigators can show in our study that the new needles are as accurate as FNA with ROSE then FNB could be implemented across hospitals worldwide in an easier and less expensive fashion.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients referred for EUS evaluation of a definite solid pancreatic mass noted on computed tomography(CT)/Magnetic resonance imaging(MRI)/EUS, in which malignancy is suspected with no previous histological diagnosis

Exclusion Criteria:

* Age \< 18 years, pregnant patients.
* Uncorrectable coagulopathy Prothrombin time (PT) \>50% of control, Partial Thromboplastin time (PTT) \>50 sec, or International normalized ratio (INR) \>1.5 and/or uncorrectable thrombocytopenia platelet count\<50, 000109/L.
Efficacy 、Safety and PK of SHR-1314 in Patients With Moderate-to-Severe Plaque Psoriasis

The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SHR-1314 in Patients with Moderate-to-Severe Plaque Psoriasis


Eligibility Criteria:
Inclusion Criteria:

1. Men or women at least 18 years of age at time of screening.
2. Chronic plaque-type psoriasis present for at least 6 months and diagnosed before randomization.
3. Moderate to severe psoriasis as defined at Baseline/ randomization by:

   PASI score of 12 or greater, and sPGA score of 3 or greater (based on a static scale of 0 - 5), and Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
4. Subject has moderate to severe chronic plaque-type psoriasis that is inadequately controlled by topical treatment and/or phototherapy and/or previous systemic therapy.
5. Body Mass Index (BMI) is 18 kg/m2 or above at screening

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis) at Screening or Baseline/randomization.
2. Drug-induced psoriasis.
3. Had a clinically significant flare of psoriasis during the 12 weeks prior to baseline (Week 0).
4. Presence of other skin conditions (e.g. skin infections, seborrheic dermatitis) that in the judgement of the Investigator could interfere with assessment of psoriasis.
5. History of inflammatory bowel disease or have other ongoing active autoimmune diseases.
6. At screening, history or symptoms of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
7. History of congestive heart failure (New York Heart Association \[NYHA\] functional classification ≥III), cerebro-cardiovascular events, or serious bleeding events at screening and / or randomization that in the judgement of the Investigator prevents the subject from participating in the study.
8. Active systemic infections (other than common cold) during the 4 weeks before randomization (e.g., hepatitis), or serious infections requiring hospitalization and/or intravenous injection of antibiotic treatment within eight weeks prior torandomization.
9. History of depression and/or suicidal ideation or any suicidal behavior based on an assessment with the Columbina Suicide Severity Rating Scale (C-SSRS) at screening and baseline (Posner K et al, 2011), The subjects will be exluded if any answer to question is "yes" in the questionnaire orare clinically judged by the investigator to be at risk for suicide.
10. All subjects will be tested for tuberculosis status using IGRA and X-ray test.
11. Have evidence of positive test for hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
12. Have a known allergy or hypersensitivity to any biologic therapy at screening that would pose an unacceptable risk to the subject if participating in this study.
Single Use Bronchoscopes for Interventional Pulmonology

The goal of this pilot single-arm crossover trial is to investigate the feasibility and safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic interventional pulmonary procedures instead of reusable flexible bronchoscopes (RFB). The main questions it aims to answer are:

Was a decision to crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) made ?

Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including:

1. Overall assessment
2. Scope quality
3. Scope handling
4. Scope maneuverability
5. Tool compatibility
6. Suction
7. Lavage
8. Safety
9. Image quality

Participants will undergo bronchoscopy with single use bronchoscopes.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Able to provide informed consent.

Exclusion Criteria:

1. Emergent procedure
2. Pregnancy
3. Study subjects have any diseases or conditions that interferes with safe completion of the biopsy including: cardiopulmonary instability; sensitivity to drugs that could be administered during bronchoscopy; active anticoagulation or antiplatelet therapy (warfarin, direct Xa inhibitors, thrombin inhibitors, low molecular weight heparin, unfractioned heparin, clopidogrel) not held adequately prior to the procedure; uncontrolled blood dyscrasias; concurrent pneumothorax or bullae.
Mammogram Mail- and Phone-based Interventions

The project aims to evaluate four different versions and modalities of interventions encouraging mammogram screening among all eligible women due or overdue for screening. The evaluation will compare among the following forms of outreach to help determine whether (a) live calls are more effective at increasing mammogram screening than other forms of outreach and (b) each form of outreach is more effective than no outreach: (1) a postcard, (2) a letter, (3) an auto-dialer phone message, and (4) a live call from a care gaps team. The interventions will be rolled out over many months, allowing for comparisons of effectiveness against those who have not yet been contacted.


Eligibility Criteria:
Inclusion Criteria:

* Female Geisinger Health Plan members between ages 52 and 74 as of December 31, 2023
* Overdue for annual mammogram
* Continuously enrolled with the Geisinger Health Plan as of October 1, 2021
* Can be contacted via both phone and mail

Exclusion Criteria:

* Geisinger Health Plan members on a do-not-contact list
* Had a mammogram as of October 1, 2021
* In hospice, using hospice services, or receiving palliative care as of January 1, 2023
* Medicare members 66 years of age or above at time of outreach, who are institutionalized or have both frailty and advanced illness
* Had a bilateral mastectomy at any time