cyrilzakka/clinical-trials huggingface dataset:
Effect Of Early Versus Delayed Laparoscopic Cholecystectomy In Patients With Grade II Cholecystitis

The timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade IIcholecystitis according to Tokyo 2018 guidelines.

The timing ofthe cholecystectomy in patients with acute cholecystitis is still controversial. In our study, we aimed toinvestigate the effect of early and delayed cholecystectomy on difficultcholecystectomy, morbidity and mortality in patients diagnosed with Grade II cholecystitis according to Tokyo 2018 guidelines.

Patients that applied to the emergency department and diagnosed with Grade II acute cholecystitis between December 2019 and June 2021 were included in this study. Cholecystectomy was performed within 7 days and 6 weeks after symptom onset. The effect of early and delayed cholecystectomy was observed. The study is single-centered and the patient group graded as Grade II according to the Tokyo 2018 guideline acute cholecystitis diagnostic criteria will be included in the study. Patients will decide on the treatment method to be applied with their consent. The patients will be divided into two groups as those operated in the early period (first 7 days) and those operated in the late period (\>6 weeks). The parameters to be compared were the rate of conversion from laparoscopic to open, bile duct injury and bile leakage rate, grade II-III complication rate in the Clavien Dindo complication scoring system, morbidity rate in the first 30 days postoperatively, and difficult cholecystectomy rate based on intraoperative imaging findings according to the Parkland scoring system. The research will be terminated when the number of 120 patients determined by the power analysis result is reached.

Chi-square and Student's t test will be used for the statistical evaluation of the results of the patients, respectively, for quantitative and continuous variables, and Mann-Whitney U test (two samples) or Kruskal-Wallis test (more than two samples) will be used for the analysis of abnormally distributed variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Grade II cholecystitis according to Tokyo 2018 guidelines
* Patients older than 18 years of age

Exclusion Criteria:

* Patients younger than 18 years of age
* Patients diagnosed with choledocholithiasis
* Patients with Grade I or Grade III cholecystitis
* Pregnancy
* Patients unable to comply with the treatment or who could not consent to the treatment due to their mental state
* Patients that refused the treatment
The Effect of Progressive Relaxation Exercise on Fatigue and Comfort Level After Major Orthopedic Surgery

This study was planned to determine the effect of progressive relaxation exercise to be applied after major orthopedic surgery on post-operative fatigue and comfort level.

The symptom of fatigue causes tension, anxiety, fear, and insomnia in the person. Fatigue also negatively affects the comfort level of the patient along with the symptoms experienced in individuals.Suggestions and evaluations of the professional healthcare team, especially nurses, are of great importance in the effective fight against fatigue of patients.In this study, it is carried out to determine the effect of progressive relaxation exercise applied after major orthopedic surgery on fatigue and comfort level.

Hypothesis

H1: Progressive relaxation exercise to be applied after major orthopedic surgery reduces the post-operative fatigue level of patients.

H2: Progressive relaxation exercise to be applied after major orthopedic surgery positively affects the comfort level of the patients.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in the study have undergone major orthopedic surgery (total knee or hip replacement, atroscopic surgery, vertebral surgery, shoulder surgery, amputation, etc.), Patients aged 18 and over Absence of speech and hearing problems Speak and understand Turkish

Exclusion Criteria:

* Being diagnosed with a psychiatric disorder, A complication developed in the patients before, during and three days after the operation,
Exploring Pathogenesis and Treatment of Hypercalcemia Caused by Intramuscular Injection of Paraffinoil

The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* previous intramuscular injection of paraffin or other oil

Exclusion Criteria:

* none
Incidence and Risk Factors of Early Onset Colorectal Cancer

Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.

The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.

Eligibility Criteria:
Inclusion Criteria: all patient who underwent colonoscopic examination clear indication for colonoscopy

Exclusion Criteria: not able to underwent colonoscopy
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Acute or Chronic Gastritis

The purpose of study is to confirm the efficacy of DWP14012 X mg QD, DWP14012 Y mg BID compared to placebo in patients with Acute or Chronic Gastritis

This study was designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to assess the efficacy and safety of oral administration of DWP14012 X mg QD, Y mg BID and placebo for 2 weeks in patients with acute and chronic gastritis.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who are diagnosed with acute or chronic gastritis with at least one erosion observed on upper gastrointestinal endoscopy
* Those who had experienced one or more subjective symptoms of gastritis

Exclusion Criteria:

* Those who have had surgery to reduce gastric acid secretion, or gastric or esophageal surgery
* Those with history of clinically significant hepatic, renal, neurologic, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that could affect the study results
3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations

The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient.

The use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.

Digital technologies have evolved exponentially in the dental medicine field endorsing a change between the conventional methods to virtually based methodologies in daily clinical and laboratorial practice.

Combining facial aspects and proportions with dento-gingival parameters are the basis when planning a new smile design and a final rehabilitationFacial surface images can be used for more predictable measurement and quantification of vertical dimension of occlusion and lip support before, during and after a full mouth rehabilitation. Besides that, the information obtained by facial scanners have a major impact in treatment planning process especially in multidisciplinary complex cases with the simulation of the treatment, identification of patient's expectations and the implementation of an effective communication tool.

The 4D-virtual patient is the future regarding the management of a patient in dental medicine, since the beginning of the process with data acquisition for the diagnosis to the definitive oral rehabilitation procedures. Similar to any methodology, it is important to understand what are the basis of the facial scanning and what protocols can obtain better results in terms of accuracy and reliability.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with at least a full-arch implant supported rehabilitation in the upper arch
* Individuals with a provisional or a definitive implant-supported prosthesis
* Individuals with a stable occlusion function
* Individuals with compliance to collaborate with the research protocol

Exclusion Criteria:

* Individuals with history of hypersensitivity to external light or any similar condition
* Individuals in an active surgical treatment period
* Individuals in an active orthodontic treatment in the opposite arch
* Individuals in an active facial treatment
* Individuals who did not attend the maintenance visits
Natural Killer (NK) Cells Following Bariatric Surgery

This study will determine the role of the NK cells before and after bariatric surgery. The investigators selected patients with NAFLD.

A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.

All morbidly obese patients who are candidates for a bariatric procedure in the investigators institution who has a fatty liver in their routine preoperative US will undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry (FACS) analysis.

The investigators will also collect other clinical data including comorbidities (hypertension, diabetes mellitus and hyperlipidemia) in addition to the following routine blood test( complete blood count, creatinine, urea, International normalized ratio, liver function test, HBa1C, cholesterol, HDL, LDL, triglycerides, vitamin D, vitamin B12, potassium, sodium, albumin, bilirubin, C- reactive protein, iron, ferritin and transferrin).

All of the above mentioned tests including the NK cells and the fibroscan will be examined for all participants in 3, 6, 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* age from 18-65
* body mass index above 30 with comorbidity or above 35 with or without comorbidity
* evidence of hepatic fibrosis in routine preoperative US

Exclusion Criteria:

* patient with known other liver disease such as autoimmune or alcoholic hepatitis
* patient that take hepatotoxic medication or hormonal treatment
* active alcohol abuse above 20 gram per day
* Drug abuse
* patient refusal
* pregnancy
Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy, such as trimetrexate glucuronate and leucovorin, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating children with recurrent acute lymphoblastic leukemia, recurrent osteosarcoma, or refractory non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the efficacy of trimetrexate glucuronate with leucovorin calcium rescue in children with recurrent acute lymphoblastic leukemia, recurrent osteogenic sarcoma, or refractory non-Hodgkin's lymphoma resistant to methotrexate.
* Evaluate the toxicity of this treatment regimen in this patient population.

OUTLINE: Patients are stratified according to disease (acute lymphocytic leukemia, non-Hodgkin's lymphoma vs osteogenic sarcoma).

Patients receive trimetrexate glucuronate orally or IV every 12 hours on days 1-21 and oral leucovorin calcium every 12 hours on days 1-24. Treatment repeats every 4 weeks. Patients with stable or responsive disease may receive up to 4 courses of therapy.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologic evidence of one of the following malignancies that has failed conventional therapy:

  * Acute lymphoblastic leukemia
  * Non-Hodgkin's lymphoma with bone marrow involvement
  * Osteogenic sarcoma
* In vitro transport resistance to methotrexate demonstrated by bone marrow aspirate assay

PATIENT CHARACTERISTICS:

Age:

* 21 and under at diagnosis

Performance status:

* ECOG 0-2

Life expectancy:

* At least 8 weeks

Hematopoietic:

* Granulocytopenia allowed with bone marrow involvement
* Thrombocytopenia allowed with bone marrow involvement
* Anemia allowed with bone marrow involvement

Hepatic:

* (unless due to disease)
* Bilirubin no greater than 2.0 mg/dL
* AST no greater than 100

Renal:

* Creatinine less than 1.5 mg/dL OR
* Creatinine clearance at least 60 mL/min

Other:

* No other serious medical illness
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior bone marrow transplantation allowed

Chemotherapy:

* At least 1 week since prior intrathecal treatment
* At least 2 weeks since prior systemic chemotherapy and recovered

  * At least 10 days for rapidly proliferating leukemia (i.e., WBC greater than 50,000)
* No concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior radiotherapy allowed and recovered
* No concurrent radiotherapy

Surgery:

* Not specified
Multimodal Pain Study in Free Flap Patients

This study will be fashioned as a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic.
* Patients with a new H\&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.

Exclusion Criteria:

* Prior treatment for head and neck cancer.
* Planned treatment with primary radiation or chemoradiation for their head and neck cancer.
* Pregnant or lactating women.
* Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively.
* Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively.
* Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes.
* Patients with documented history of kidney or liver disease.
* Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests.
* Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .
Recalling and Anticipating Specific Positive Events to Boost Resilience in Adolescents

Many young people are experiencing stress-related mental health problems, with some recent studies suggesting this number is increasing. Especially now, in the context of the COVID-19 pandemic, there is a significant increase in depression and anxiety in adolescents. An important way to help address this challenge is not so much to focus on trying to repair what makes young people vulnerable but to focus on building resilience. Resilience refers to the ability to successfully deal with stressful experiences. Recent research shows that being able to vividly remember and imagine positive events can buffer the negative consequences of stress, and makes a convincing case that training adolescents in recalling and anticipating positive events would promote resilience and thereby improve their mental wellbeing. And this is exactly what the current project sets out to do for the very first time. Adolescents will receive a playful group-training in school to make them better at recalling and anticipating positive events, which is expected to help them to bounce back more swiftly from challenging or otherwise stressful life events. The investigators predict that youngsters who follow our Positive Event Training will experience more positive emotions, will show improved resilience and report better mental wellbeing. The investigators will also develop a free online training protocol for teachers so that schools can provide this resilience program on their own, without the need of external professional trainers.


Eligibility Criteria:
Inclusion Criteria:

* All adolescents of the selected classes of the participating schools (12-16 years; 1st and 2nd grade of secondary school) who want to take part in the study and give informed consent (own informed consent and active parental informed consent) will be allowed to take part in the study.
* To minimize the risk of too much heterogeneity in our final sample, for instance due to context factors related to the type of education, the investigators will first recruit classes of adolescents that follow general secondary education. Future studies (after PET has been properly evaluated in this study) should also be conducted in samples of adolescents following other types of secondary education.

Exclusion Criteria:

-
Fingolimod Effect on Cytokine and Chemokine Levels

The main purpose of this study was to measure the serum levels of cytokines and chemokines that are known to increase during multiple sclerosis relapses.

Cytokines are a broad and loose category of small proteins that are important in cell signaling.

The second purpose of the study was to test the cytokine/chemokine changes measured in the 3rd and 6th months on the efficacy parameters.


Eligibility Criteria:
Key Inclusion Criteria:

1. Written informed consent must be obtained before the beginning of te study
2. Nonresponder RRMS patients
3. Last relapse of the patient should be at least 2 months before study entry.
4. Last interferon or glatiramer acetate dose of the patient should be at least 1 month before study entry.

Key Exclusion Criteria:

1. Patients with secondary progressive MS.
2. Patients with known contraindications for fingolimod treatment.
3. Other coexistent autoimmune diseases
4. Pregnant or nursing (lactating) women
Identifying New Genetic Causes to Development Disorders

Disorders of growth, puberty and sex development can have genetic causes. The exome analysis could detect new mutations responsible for these disorders and the frequency of these mutations in these disorders, their association with other malformations.


Eligibility Criteria:
Inclusion Criteria:

* congenital growth hormone deficiency
* puberty disorder
* gonadal dysgenesis or anorchia
* primary ovarian failure
* disorder of sex development
* subjects related to a patient with one of the above criteria

Exclusion Criteria:

* environmental or auto-immune cause
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate

The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is 18 years or older
2. Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
3. Patient is willing and able to comply with all study elements as indicated by their written informed consent
4. Patients with a pre-operative Lund-MacKay score of ≥ 6.

Exclusion Criteria:

1. Patient is pregnant or nursing
2. Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
3. Patients with a platelet disorder
4. Patients with a known or suspected allergy to device components
5. Patients with known hemophilia
6. Patients with insulin dependent diabetics
7. Patients with an oral steroid dependent condition
8. Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
9. Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
10. Patients that require nasal ointments or creams at time of device placement
11. Patients with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data
12. Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
13. Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
14. Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.