cyrilzakka/clinical-trials huggingface dataset:
Feasibility and Effectiveness of Augmented Reality Assistance System for Pancreatic Surgery

Pancreatic cancer necessitates surgical resection for complete tumor eradication, serving as the primary curative approach. However, pancreatic surgery is still challenging due to the organ's retroperitoneal anatomy and proximity to vital vascular systems. Thus, precise preparation and dissection of peripancreatic vessels are crucial during pancreatic surgery to reduce perioperative complications and improve oncological outcomes. The integration of preoperative computed tomography-derived reconstructed images, along with augmenting the resulting 3D model during surgical procedures, holds significant potential in this context. Augmented reality-assistance systems (ARAS) have seen use in various surgical fields, including orthopedic, plastic, and neurosurgery. Nevertheless, the application of ARAS in abdominal surgery has faced challenges related to organ shifting and deformities. The retroperitoneal nature of the pancreas, characterized by minimal intraoperative organ shifts and deformations, makes pancreatic surgery a promising candidate for ARAS. Despite this, there is a limited number of studies exploring the impact of ARAS during pancreatic surgery. Notably, existing investigations have primarily utilized augmented reality technology with 2D-display-based modalities. This prospective study aims to fill this gap by examining the usability, feasibility, and effectiveness of wearable ARAS during pancreatic surgery. By leveraging advanced technology seamlessly integrated into the surgical workflow, this research seeks to provide valuable insights into the practical application of ARAS, potentially enhancing the precision and outcomes of pancreatic surgery. The preliminary findings of this study will also be submitted for publication in a peer-reviewed journal.


Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Aged above 18 years
* Undergoing any type of pancreatectomy

Exclusion Criteria:

* Unresectable tumors
Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.


Eligibility Criteria:
Inclusion Criteria:

* Adult ( \> 18 years of age)
* A diagnosis of medical recalcitrant CRS as defined by 2015 Adult Sinusitis Guidelines outlined by the American Academy of Otolaryngology
* Provide written informed consent and authorization.
* Study participants must be able to complete consent, all study evaluations, olfactory testing, and study-related health questionnaires written in the English language.
* Patients must self-select subsequent treatment option (endoscopic sinus surgery or continued medical therapy) to be dictated by the disease process and judgment and preferences of each individual, following counseling for each treatment option.
* Present to the enrolling site with indication for a CT scan or a CT scan completed, off-site, from another provider
* Complete appropriate standardized medical treatment by the Interim Assessment, 6-week follow-up period including, but not limited to, at least one course of either topical corticosteroids (\>21-days) or a 5-day course of oral corticosteroid therapy, and at least one course (\>14-days) of culture-directed or broad spectrum antibiotic therapy.

Exclusion Criteria:

* Children (\< 18 years of age)
* Any patient unable and/or unwilling to complete questionnaires or clinical testing or cooperate with all study protocols.
* Non-English speaking / English translation services required
* Unwilling or unable to provide informed, written consent.
* Contra-indications for any type of continued medical therapy required for treatment of symptoms related to CRS
* Patients who have not undergone previous prescribed medical therapy as described in Inclusion Criteria.
* Individuals of any vulnerable population including: children, pregnant women, neonates, decisionally impaired adults, or prisoners.
Can CT Enteroclysis Predict the Outcome of Crohn's Disease

Specific CT Enteroclysis findings with or without other clinical and laboratory variables, can identify Crohn's disease patients who will response to medical therapy versus those who will either fail and require surgery or have uncontrolled disease.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease with CT Enteroclysis during symptomatic treatment

Exclusion Criteria:

* Crohn's disease subjects who have had a follow-up less than 1 year, without surgery
* Crohn's disease subjects that were later diagnosed with a bowel malignancy
Adipose Tissue Inflammation in HFpEF

To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.

Heart Failure with preserved Ejection Fraction (HFpEF) is a growing public health concern with an increasing incidence, high morbidity and mortality and no proven therapy to date. Better characterization of individual pathophysiological implications is mandatory to develop effective therapeutic strategies or preventive programs. Obesity is an important risk factor for the development of HFpEF and also modulates its course possibly by its association with systemic inflammation. However, the role of adipose tissue (AT) inflammation in the development, maintenance and functional impairments in HFpEF has been under-investigated. Dysfunctional AT leads to a shift from a protective adipokine profile to an imbalanced production of pro-inflammatory, pro-oxidant and pro-fibrotic adipokines. Besides depot specific paracrine effects, the overall secretory activity or endocrine effect of AT can be evaluated in peripheral plasma.

The investigators hypothesize that adipose inflammation distinguishes obese HFpEF patients from obese patients without heart failure and that adipose tissue inflammation is a key driver the maintenance and development of HFpEF and determines functional capacity.

In addition the investigators hypothesize that the degree of myocardial inflammatory alterations is more closely related to epicardial tissue alterations than subcutaneous or visceral AT tissue inflammation or peripheral adipokine profiles.

Eligibility Criteria:
Inclusion Criteria:

* HFpEF: Left ventricular ejection fraction ≥ 50%, NT-pro-BNP ≥ 125ng/l, evidence of structural heart diseases (diastolic dysfunction, left ventricular-hypertrophy or left atrial-dilatation), BMI ≥ 30kg/m²
* Non-HF patients: No history of heart failure, Left ventricular ejection fraction \> 50% and NT-pro-BNP \<125ng/l

Exclusion Criteria:

* Previous cardiac surgery / coronary intervention / myocardial infraction
* Acute coronary syndrome (Serum levels of troponin T \>50 pg/ml)
* Left ventricular ejection fraction \< 50%
* Indication for concomitant valvular surgery
* Planned beating heart coronary bypass surgery
* Hemodynamic instability
* Contraindication for magnetic resonance imaging
* Pregnancy
* Age \< 18 years
* No informed consent possible
Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region

Objective: To compare the clinical efficacy of angulated screw-retained and cemented single implant crowns(SIC) in esthetic region.

Methods/Design: The study was a prospective, single center, randomized controlled clinical trial. Patients with the needs of single tooth restoration in esthetics region were recruited from Oct. 2018 to Aug. 2019. Sixty patients were enrolled in the present study and they were randomly assigned into two groups: angulated screw-retained group(AG, 30 patients) and cemented group (CG,30 patients). Clinical and radiological evaluations were performed on the day of final crowns delivery and 12 months later. Implant survival rate, marginal bone loss(MBL), pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)(TNF-α, IL-6), mechanical complications, peri-implant conditions(mPI, PD, BOP%), pink esthetics score/white esthetics score (PES/ WES) and patients satisfaction were assessed.


Eligibility Criteria:
Inclusion Criteria:

* 1) age≥18;
* 2) Single dental implant in the esthetic region;
* 3) adjacent to natural teeth;
* 4) absence of oral mucosal disease and oral infection;
* 5)implants withconical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
* 6)patients with the willingness of all-ceramic permanent restorations.

Exclusion Criteria:

* 1)Multiple implants in the esthetic region, or the restoration is a bridge;
* 2)Heavy smokers (\>10 cigarettes/day);
* 3) the angle between implant axis and restoration axis\>25°;
* 4) uncontrolled periodontitis;
* 5) with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose\>7.2mmol/L, Glycosylated hemoglobin \>7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region;
* 6) Unwilling to participate in the present study.
A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study

A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

Upon completion of the feasibility study, a prospective pilot cohort study would be performed to measure outcomes using the FACE-Q Skin Cancer module for patients receiving skin grafting or local flaps after excision of facial skin cancers.

Eligibility Criteria:
Inclusion Criteria:

Patients will be included in the study if:

* they are 18 years or older
* presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis),
* and scheduled to undergo reconstruction with either a skin graft or local tissue flap.

Exclusion Criteria:

Patients will be excluded in the study if they:

* present with altered level of consciousness,
* cannot provide consent,
* have facial nerve injury/previous facial nerve injury, have Melanoma skin cancer or Merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.
A Study of FF-10501-01 in Combination with Azacitidine in Patients with Myelodysplastic Syndrome

The primary objective of the study is to determine the response rate according to the International Working Group Response criteria for the combination of FF-10501-01 and azacitidine in patients previously untreated with hypomethylating agents, with Int2/High risk MDS according to the IPSS, and Intermediate/High/Very-High risk MDS according to the IPSS-R, or who are otherwise candidates for treatment with azacitidine.

This is an open-label, Simon 2-stage clinical study of the combination of FF-10501-01 and azacitidine in previously untreated patients with high-risk MDS, or in patients with myelodysplastic syndrome (MDS) who are otherwise candidates for treatment with azacitidine in the judgment of the Investigator. The Phase 2 portion of the trial will be preceded by a Phase 1 "run-in" to evaluate the safety of the combination of FF-10501-01 plus azacitidine.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ≥ 18 years of age
2. MDS as determined by bone marrow aspirate and/or biopsy according to the WHO Classification within 6 weeks of the first dose of study medication, with bone marrow blast counts of \< 20%.
3. Int2/High-risk MDS according to the IPSS, Intermediate/high/very high-risk MDS according to the IPSS-R, or otherwise eligible for treatment with azacitidine in the judgment of the Investigator
4. ECOG Performance Score of 0 or 1
5. Adequate hepatic function as evidenced by AST/ALT \< 3X the ULN and total bilirubin \< 2X the ULN for the reference lab
6. Adequate renal function as evidenced by serum creatinine \< 2 mg/dL or a calculated creatinine clearance of \> 50 mL/min

Exclusion Criteria:

1. A current infection requiring treatment with intravenous antibiotics, anti-fungal agents, or anti-viral agents
2. Previous treatment with a hypomethylating agent, an HDAC inhibitor, or any other drug intended for the treatment of MDS other than hematopoietic growth factors, immunosuppressive therapy or hydroxyurea. Patients with 5q deletions may have received prior lenalidomide.
3. Use of hematopoietic growth factors (erythropoietin, G-CSF, GM-CSF, thrombopoietin receptor agonists) or immunosuppressive treatments within 7 days of first dose of study medication
4. Administration of any investigational agent within 5 half-lives of the agent; if the half-life is not known, use of such an agent within 2 weeks of the first dose of study medication
5. Active infection with HIV or hepatitis B or C; patients with a history of such disorders should undergo serological testing to evaluate the activity of the infection
Assessment of Gonadal Functions in Uremic Male Patients

1. Study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) .
2. Study the effect of hemodialysis on the male patients sexual functions by measurement of serum prolactin and free testosterone levels.

: Gonadal dysfunction is a frequent finding in men with ESRD on chronic hemodialysis ,erectile dysfunction is one of the most common manifestation of sexual dysfuncion whitch has been reported to be as high as 70 -80 %of hemodialysis patients .

Testosterone deficiency and insufficiency are frequent findings in hemodialysis male patients that were found to be 66% and 24% respectively The Probleme is multifactorial , the most important factor is due to testesterone deficiency. total and free testosterone levels are typically reduced , that is usually accompanied by elevation of serum Gonadotropins concentrations due to hypothalamic -pituitary-gonadal -axis disturbance(uremic hypogonadism) .

Alterations in the pulsatile release of GnRH, which leads to a hypogondal state due to uremia, which occurs due to inadequate nutrient intake, stress, and systemic illness . Excess LH secretion is thought to result from the diminished release of testosterone from the Leydig cells, because testosterone normally provides a feedback inhibition of LH release. The metabolic clearance rate of LH is reduced due to reduction of kidney clearance ,Follicle stimulating hormone (FSH) secretion is also increased in men with chronic kidney failure.

Elevated plasma prolactin levels are commonly found in dialyzed men, it is thought to be due to increased its production , extreme hyperprolactinemia has been associated with infertility, loss of libido, low circulating testosterone levels, So,due to testosterone deficiency and hyperprolactinemia in ESRD as one of most important factors and exclusion of other factors , men on chronic hemodialysis shows different degrees of subfertility or infertility due to Erectile dysfunction , testicular damage and impaired spermatogenesis.

Eligibility Criteria:
* Inclusion Criteria

  1. Male patients.
  2. ESRD on chronic hemodialysis with GFR lower than 15ml/min /1.73 m2
  3. Age (18_60)years old
* Exclusion Criteria:

  1-Diabetic patients . 3-hypertesive patients . 3-Patients with primary infertility before the event of ESRD and Starting dialysis.

  4-Manifest hypothyroidism . 5-Patient with other causes that may lead to subfertility as varicocele . 6-patients with previous exposure to head and genital trauma , surgery or irradiation .
A Placebo-Controlled Study of Collagen Hydrolysate in Subjects With Knee Osteoarthritis (OA)

This study is designed to evaluate, by MRI, knee cartilage and structure in all subjects. Half the subjects in this study will take collagen hydrolysate each day for 48 weeks and the other half of the subjects will take a placebo dose, that looks like and tastes like the collagen hydrolysate, each day for 48 weeks. MRIs will be taken at Study Weeks -1, 24, and 48.

This is a single-site, double-blind, pilot study to evaluate the sensitivity of MRI to detect cartilage structure and composition in subjects taking daily oral collagen hydrolysate (a nutritional supplement) or placebo for 48 weeks. 30 subjects will be randomized to collagen hydrolysate or placebo (1:1 ratio). The goal is to evaluate, by MRI, knee cartilage and structure in all subjects. The primary functional outcome measure will be the WOMAC questionnaire and the primary pathological outcome measure will be knee cartilage structure and composition as measurements done by MRI imaging. Subjects will have contrast dGEMRIC MRIs done at Study Weeks -1, 24 and 48.

Eligibility Criteria:
Inclusion Criteria:

* age \> 49 years
* chronic knee discomfort based on the affirmative response to the question "During the past 6 months, have you had any pain in the knee more than half the days of the month ?"
* WOMAC pain subscale score ≥ 1
* tibiofemoral or patellofemoral osteoarthritis on anteroposterior weight-bearing semi-flexed or lateral knee radiographs with at least one osteophyte and no significant joint-space-narrowing
* clinical examination confirming knee pain or discomfort referable to the knee joint
* prepared to refrain from use of glucosamine, chondroitin, sAME and doxycycline
* stable medication and/or supplement use

Exclusion Criteria:

* use of glucosamine, chondroitin, diacerein or doxycycline within 14 weeks prior to randomization
* serious medical conditions or impairments that, in the view of the investigator, would obstruct their participation in the trial
* individuals who are expected not to comply with the study protocol
* plan to permanently relocate from the region during the trial period
* planned knee arthroplasty in the study knee
* active pathology of confounding origin which may cause pain, extending to the knee
* pregnancy
* any contra-indication to having an MRI scan
Laser Treatment for Fresh Surgical Scars and Mature Scars

The purpose of this study is to measure the effectiveness of the RevLite Laser in the treatment of both fresh surgical scars and mature/older scars.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I-VI and either a fresh surgical scar (with sutures still present \[or dissolving sutures within 7 days of surgery for facial scars or within 14 days of surgery for scars on the trunk or extremities) of at least 2cm in length or an erythematous and/or hypertrophic scar of at least 2cm in length and of greater than or equal to 18 months in duration
* Scar is easily divisible into two equal segments for the purpose of the study, or is bilateral in nature (e.g., inframammary)

Exclusion Criteria:

* Pregnant, lactating, or is planning to become pregnant
* history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
* any skin pathology/condition that could interfere with evaluation or requires the use of interfering topical systemic therapy
* coagulation disorder or currently using anti-coagulation medication (including but not limited to heavy aspirin therapy)
* any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in the study
* currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 30 days
* unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function
* unreliable for the study, including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits
* Isotretinoin therapy within 6 months
* need to be exposed to artificial tanning devices or excessive sunlight during the trial
* prior treatment with parenteral gold therapy
* does not agree to refrain from other laser treatment, (micro)dermabrasion or topical scar treatment creams for the duration of the study
* Diabetes Type 1 or 2
* Lupus, scleroderma or similar immune system disorder
* underlying silicone or other non-absorbable filler in the area of the scar
* phenol chemical peel or dermabrasion to the area of the scar within 3 months
* Fitzpatrick Skin Type IV, V or VI with a known sensitivity to hydroquinone or is unwilling or unable to comply with physician/manufacturer instructions for the use of this ingredient