cyrilzakka/clinical-trials huggingface dataset:
Effect of Denture Adhesives on Complete Denture Patients

The effect of using denture adhesives on patient satisfaction with complete dentures; A randomized clinical trial.

The study evaluates the effect of using 3 types of denture adhesives on patient satisfaction and quality of life of complete denture patients

Aims: The aims of this study is to compare patient satisfaction and oral health quality of life without using denture adhesive and using 3 types of denture adhesives.

Materials and Methods: 60 completely edentulous patients attending the University of Jordan hospital seeking new sets of complete dentures will be randomly divided into 3 groups (n=20). At delivery of complete dentures, all patients will be given the dentures with no denture adhesive and will be given review appointments after one month of using the dentures. At review appointment, patients will be asked to rate their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also will fill out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group will then be given one type of denture adhesive to use; paste-based Corega denture adhesive (CO), Sea Bond maxillary and mandibular denture adhesive strips (SB) and oil-based Olivafix denture adhesive (OF). Patients will be given instructions on how to use each type of adhesive and will be provided with sufficient amount for 1 month. After 1 month, patients will be asked to fill out the same forms

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking new conventional complete dentures for first time
* Patients aged 40-85 years
* Must be completely edentulous for at least 6 months
* Must have well-developed to moderately resorbed maxillary and mandibular ridges
* Must have no denture fissuratum or any traumas from previous dentures
* Must be able to complete and sign the consent form

Exclusion Criteria:

* Patients with relevant medical issues, disorders of masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect response to treatment
* Patients with oral pathology, xerostomia, or tied tongue condition.
Treatment of Thrombosed Haemorrhoids in Pregnancy

Thrombosis of the external hemorrhoids (TEH) is one of the most frequent complain during pregnancy, particularly during the third trimester.

The paucity of the medical literature on this topic has recently been underlined in the European guidelines for hemorrhoid treatment .

The aim of this prospective study is to compare the efficacy and safety of conservative versus surgical treatment of TEH in pregnant women

Thrombosis of external haemorrhoids (TEH) is a quite frequent acute condition that affects women during the pregnancy arousing great concern and impacting quality of life. TEH may present as an acute hemorrhoidal crisis with severe pain and bleeding. Up to 21.8 % of pregnant females complaining of dyschezia present with a thrombosed external haemorrhoid and during last three months, 7.8 % of pregnant females experience a TEH.

Systemic changes in women body can be related to the onset of TEH and even if haemorrhoidal thrombosis does not represent a life-threatening condition during the pregnancy, on the other hand the pain can deteriorate the emotional and physical status arousing worries which affect the health system with high costs due to several accesses to the hospital.

Treatment of TEH is mainly directed to the relief of symptoms, especially pain control. Nowadays conservative and surgical management of TEH during the pregnancy have been demonstrated both effective and safe. Nevertheless, a conservative approach is more accepted as the patient's ability to tolerate the symptoms of her condition would dictate the need for surgery.

In the common practice most patients prefer to be treated conservatively experiencing resolution of their symptoms. On the other hand excision of thrombosed external haemorrhoids results in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals.

During the pregnancy the administration of conservative medications is quite limited due to the possible side effect of such drugs on the fetus.

The aim of this prospective study is to evaluate and compare the efficacy and safety of conservative and surgical treatment in patients affected by TEH during pregnancy. With regard to surgical management, thrombectomy and local excision of external haemorrhoids were compared.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Thrombosed external haemorrhoids
* Written consent

Exclusion Criteria:

* Inflammatory bowel disease
* Cancer
* Age lower than 18 years old
Prospective Study of Altis System With the TVTO Procedure for the Management of Stress Urinary Incontinence in Women

Prospective randomized comparison of minisling (altis) with the TVTO procedure for the management of women with genuine stress urinary incontinence.

Prospective randomized study double blinded. Two group of patients consisting group A of 40 patients being operated with altis minisling and group B with 40 patients operated with TVTO procedure. All patients will be operated with epidural anesthesia.

The patients participating in the study will meet the following requirements. a. Having genuine stress urinary incontinence proven by urodynamics, b. be willing to be operated and participate in the study. Exclusion criteria wil be the following: a.History of previous irradiation in the lower genital tract, b. BMI more than 30kg/m2, c.previous anti-incontinence surgery, previous vaginal surgery, e. having MUCP\< 20 cm H2O or Valsava leak point pressure less than than 60 cm H2O.

Patients will be allocated in each operation by an automatic system using a computer software.

Primary outcome measure will be the objective cure rate at 6 months as it is assessed with cough stress test during urodynamics. Secondary outcome measures will be the subjective cure rate, improvement and failure rate, the incidence of complications such as obstruction, voiding difficulties, hemorrhage etc. Patients will be asked to complete preoperatively and postoperatively the ICIQ-FLUTS, patient satisfaction questionnaire and the female sexual function index.postoperatively the patients will complete the PGI-I questionnaire.

Eligibility Criteria:
Inclusin Criteria:

* Having genuine stress urinary incontinence proven by urodynamics
* be willing to be operated and participate in the study.

Exclusion Criteria:

* History of previous irradiation in the lower genital tract
* BMI more than 30kg/m2
* previous anti-incontinence surgery, previous vaginal surgery
* having MUCP\< 30 cm H2O or Valsava leak point pressure less than than 60 cm H2O
* Mixed urinary incontinence.
Common Bile Duct Pressure After Surgical Exploration

A study that included patients of any gender between 15 and 70 years, with the diagnosis of choledocholithiasis who required a cholecystectomy with an exploration of bile ducts. Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six weeks to exclude residual stones.

A clinical, controlled, prospective, longitudinal, descriptive, observational and double-blinded study was designed. Patients of any gender between 15 and 70 years, with a diagnosis of choledocholithiasis, and who required a cholecystectomy with an exploration of bile ducts were included. Conventional cholecystectomy was performed and perioperative T-tube CBD pressure was registered immediately after the procedure, and weekly thereafter, with a 6-week follow-up.

Control T-tube cholangiogram was performed at six weeks to exclude residual stones. Data was analyzed with T-test for parametric values.

Eligibility Criteria:
Inclusion Criteria: Choledocholithiasis -

Exclusion Criteria: To not complete the follow-up period

-
Subsyndromal Delirium in Intensive Care Unit

Subsyndromal delirium (SSD) is a condition characterized by a less severe cognitive impairment in comparison to delirium. To date there is no published consensus on SSD definitions and has been commonly reported as an intermediate stage between delirium and normal mental states.

SSD encompasses some of the delirium symptoms, and has been diagnosed with Intensive Care Delirium Screening Checklist scale (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU).

The objective of this study is to identify subsyndromal delirium prevalence, the association between SSD and clinical outcomes and understanding the relationship between SSD and conversion to delirium.

The relevance of this study is understanding of subsyndromal delirium in ICU, namely the importance of early presentations of acute brain dysfunction in the patients outcome.

SubSynD is a prospective, observational, multicenter clinical study, involving 400 patients in Intensive Care Units, to assess subsyndromal delirium.

A systematic screening for delirium and subsyndromal delirium (SSD) is done with Intensive Care Delirium Screening Checklist (ICDSC) and Confusion Assessment Method-ICU (CAM-ICU). Scales are applied once per day until ICU discharge or for up to 14 days of being in ICU.

The investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) be administered once per day (i.e. with first assessment in the morning). All patients with abnormal CAM-ICU or ICDSC features, beside the underlying cause of delirium and SSD are included. In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF)).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Admission in Intensive care Unit

Exclusion Criteria:

1. Primary neurological diagnosis, with Glasgow Coma Scale (GCS) \<14 on ICU admission or in previous days;
2. Blindness or deafness;
3. Aphasia;
4. Inability to communicate in the native language of the country where the study is enrolled;
5. Death during the first 24 hours;
6. Limitation of therapeutic efforts in the Intensive Care Unit admission;
7. Refusal to participate;
8. Previous diagnosis of dementia or psychiatric illness;
9. Readmission in ICU;
Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler

The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations.

Administration of bronchodilator drugs with metered-dose inhalers (MDIs) is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly. Use of spacers seems to improve delivery in these patients. It is not clear, however, if there is any advantage to a spacer for patients who are able to use an MDI with correct technique.

The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations. The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator (2 puffs, 0.4 mg of fenoterol). Spirometry is performed before and after the inhalation.

The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement.

The outcome to be measured is the increase in forced expiratory volume in 1 second (FEV1) and forced expiratory flow rate (FEF25-75%).

Eligibility Criteria:
Inclusion Criteria:

* age \> 6 years old,
* subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry.

Exclusion Criteria:

* refusal to participate,
* negative bronchodilator test,
* poor performance of pulmonary function testing.
Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Metastatic renal cancer refractory to sorafenib or sunitinib therapy
* At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
* 18 years of age or older
* Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
* World Health Organization (WHO) performance status \<= 2
* Adequate bone marrow function
* Adequate liver function
* Adequate creatinine clearance
* Signed informed consent

Exclusion Criteria:

* Prior treatment with any investigational drug within the previous 4 weeks
* Chronic treatment with systemic steroids or another immunosuppressive agent
* Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
* Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* A known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
* Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
* Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
* Patients who have received prior treatment with an mTOR inhibitor.
* Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
* History of noncompliance to medical regimens
* Patients unwilling to or unable to comply with the protocol
Mesenteric Panniculitis : Review of Consecutive Abdominal MDCT Examinations With a Matched-pair Analysis

Mesenteric panniculitis is a benign inflammatory condition that involves the adipose tissue of the intestinal mesentery. Clinical manifestations are uncommon, non specific and atypical. Mesenteric panniculitis is thus most often an incidental finding during an investigation for other reason, mostly on computed tomography scans. The rate of malignancy in patients with mesenteric panniculitis, especially urogenital and gastrointestinal adenocarcinomas or lymphomas, has been reported to be as high, thus suggesting that there may be a relationship between mesenteric panniculitis and progression of an underlying malignancy or the risk of a future malignancy.

The aim was:

to estimate the prevalence of mesenteric panniculitis. to study relationship between mesenteric panniculitis and malignancy. to investigate the 5-year outcome of patients with mesenteric panniculitis for the development of malignancy.

Eligibility Criteria:
inclusion criteria:

* Patients with a CT scan from January to August 2008
* Patients with diagnosis of mesenteric panniculitis on CT scan

exclusion criteria:

* Patients with disease that may cause mesenteric infiltration
Usability and Utility of Mindfulness-based Life Management Social Robots for Children and Adolescents in the Long-term Treatment

The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.

\[Question 1\] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?

\[Question 2\] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?

The participants conduct a preliminary survey and use robot content at least 10 times for the two weeks. Afterwards, follow-up surveys and in-depth interviews will be conducted.

The purpose of this study is to apply social robot-based mindfulness-based life management content to pediatric and adolescent patients in the long-term disease treatment process and to assess usability and effectiveness of the social robot-based mindfulness-based life management content.

\[Intervention\]

* Intervention period: 15-20 minutes or more per day for 14 days (at least 10 times in 2 weeks)
* Content: Life management content for mindfulness play and disease understanding
* Method of provision: Robot interaction using chatbot and remote conversation (mindfulness-based living management content and remote content will be provided for a total of 15 to 20 minutes)

\[Question 1\] Effectiveness: Was the content on social robots effective in psychological adaptation of pediatric and adolescent patients?

(Measure) Pre-post comparison of survey result values

* Child Emotional and Behavioral Disorder Assessment Scale (Korea-Child Behavior Checklist: K-CBCL) ② Child and Youth Mindfulness Scale (Korean Child and Adolescent Mindfulness Measure: K-CAMM) ③ Child and Youth Optimism Scale (The Children's Life Orientation Test: C-LOT)

\[Question 2\] Usability: Is there any difficulty in interacting through social robots applied in the hospital environment?

(Measure) User Experience Questionnaire(UEQ), In-depth Interview

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 6 to 12 years old who is being treated after the diagnosis of a severe or chronic disease
* Pediatric patients who need hospital treatment, including inpatient or outpatient treatment, for more than 3 months
* Pediatric patients with a level of communication that can be understood and agreed to in this study

Exclusion Criteria:

* Those who disagree with this study
* Pediatric patients who are judged to be difficult to interact with robots due to communication difficulties
* Pediatric patients who has been diagnosed with or is being treated for mental illness with psychotic characteristics
Role of Doppler Ultrasound in Severe Peptic Ulcer Hemorrhage

The aim of study is to evaluate whether Doppler ultrasound can accurately identify patients who are at risk of recurrent bleeding, who will require endoscopic therapy, and who will fail endoscopic therapy.

Bleeding peptic ulcer is a life-threatening emergency. Endoscopic therapy is a proven technique in the acute hemostasis of bleeding ulcers. Currently there is no objective assessment of adequacy of endoscopic therapy. Endoscopic Doppler ultrasound enables endoscopists in detecting blood flow in a vessel beneath an ulcer. A persistent signal after endoscopic therapy predicts recurrent bleeding. The current study proposes to compare assessment of ulcer base using either Doppler ultrasound or endoscopists' interpretation of ulcer floors. The trial design is one of a prospective randomized controlled cross-over study in which patients with severe upper gastrointestinal bleeding and documented peptic ulcers at endoscopy are enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Clean base ulcer with severe upper GIB (defined as melaena, hematochezia, hematemesis, and/or gross blood in NG lavage), and any one of the following:

  1. SBP ≤ 90mmHg; P of ≥110 bpm; or orthostatic changes with SBP drops 20mmHg or P increases 20 bpm; or,
  2. Transfusion of 2 or more units of packed red blood cells within 12 hrs of admission; or,
  3. A documented HCT drop of at lest 6% from baseline.
* Endoscopically confirmed bleeding from GU, DU, pyloric ulcer, or anastomotic ulcer
* Pt can either have primary or secondary acute UGI haemorrhage

Exclusion Criteria:

* Bleeding site from lesion other than GU, DU, pyloric or anastomotic ulcer
* there is more than one type of significant bleeding lesion
* Documented hx of cirrhosis / portal HT
* ESRF requiring any form of dialysis
* Expected or persistent (\>24hrs) coagulopathy with INR\> 1.5
* Platelet count is under 50000/mm3
* Aspirin User / Plavix \[Clopidogrel\] User
* If the ulcer is neoplastic
* Cannot obtained consent
* Age \< 18 or is pregnant
* Severe comorbid of which life expectancy \<30 days
Treatment With Autologous Skeletal Myoblasts

The purpose of this study is to determine the benefit of autologous skeletal myoblast injection in patients with old myocardial infarction and ventricular dysfunction versus conventional revascularisation therapy.

Ischaemic heart disease is one of the main causes of mortality and morbidity. In particular, myocardial infarction (MI) is of special significance, as the heart muscle cannot regenerate so a region's necrosis leads to the formation of a fibrous scar. Depending on the area affected by the scar, infarction can lead to a progressive and irreversible decline in cardiac function, giving way to heart failure (HF) syndrome. The molecular basis of congestive heart failure is the absence of cardiac stem cells capable of regenerating cardiac muscle. In the skeletal muscle, there are cells located beneath the basal membrane with are capable of regenerating muscle fibres; they are known as myoblasts. There are several studies with autologous myoblasts, either by direct administration during surgery or percutaneously, which could distinguish between the effect of revascularisation surgery and that of the myoblast injection. The objective of this study is compare improvement in global and regional cardiac function in patients with old MI obtained by aortocoronary bypass surgery with intracardiac administration of autologous skeletal myoblasts versus standard aortocoronary bypass surgery treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of coronary disease obtained by coronary angiography who require conventional aortocoronary bypass surgery.
* History of myocardial infarction with evidence of regional akinesis (or dyskinesia) for more than 4 weeks and less than 10 years.
* Ejection fraction from 25% to 45%.
* Evidence of no regional viability by dobutamine echocardiography.
* Aged from 30-80 years old.
* Negative serology to HIV, HBV and HCV.
* Patients without organ dysfunction.
* Negative pregnancy test (women of childbearing age).
* Informed consent granted.

Exclusion Criteria:

* History of myocardial infarction in the 4 weeks prior to the inclusion in the study.
* Prior history of tachycardia or ventricular fibrillation (except in patients with DAI device).
* History of cancer (except basocellular carcinoma) or prior treatment with chemotherapy.
* The patient should not suffer from any concomitant severe and/or uncontrolled medical condition.
* Patients who, due to their geographical, psychiatric or social status, have difficulties in meeting the conditions established in the protocol.
* Pregnant or beast feeding women.