cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Ultrasound (EUS) Guided-Celiac Plexus Neurolysis (CPN) in Unresectable Pancreatic Cancer

The purpose of this study is to examine endoscopic ultrasound guided celiac plexus neurolysis (CPN) with analgesic therapy in patients with unresectable pancreatic cancer as it applies to decreasing the severity of abdominal pain when compared to analgesic therapy alone.

The specific primary aim of this study is to evaluate the efficacy of EUS-CPN + analgesic therapy (Group 1) in pain relief of patients with unresectable pancreatic cancer when compared with analgesic therapy (Group 2). The hypothesis will be tested by comparing the changes in reported pain severity between those who receive EUS-CPN in addition to analgesic therapy as compared to analgesic therapy alone.

The secondary aims of this study are to evaluate the efficacy of EUS-CPN + analgesic therapy in improvement of quality of life (QOL) of patients with unresectable pancreatic cancer when compared to when compared with analgesic therapy alone, compare pain medication usage between Group 1 when compared to Group 2, and compare the referral for rescue block during the course of the study between Group 1 and Group 2

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Age ≥19 yrs old
3. Abdominal pain typical for pancreatic cancer ≥3/10
4. Abdominal CT radiologically consistent with the diagnosis of pancreatic cancer
5. Pancreatic cancer confirmed by FNA during EUS
6. Inoperability of pancreatic cancer as determined during EUS or prior CT

Exclusion Criteria:

1. Age \< 19 yrs old
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (prolongation of prothrombin time \> 18 sec, thrombocytopenia \<80,000 platelets/ml)
4. Previous CPN or other neurolytic block that could affect pancreatic cancer -related pain or had implanted epidural or intrathecal analgesic therapy
5. Another cause for abdominal pain such as pseudocyst, ulcer or other intra-abdominal disorder
6. Potential patient noncompliance (refusing to follow schedule of events)
7. Active alcohol or other drug use or significant psychiatric illness
8. Pregnant or breastfeeding
9. Unable to consent
10. Non-English speaking
Symptom Clusters in Hong Kong Chinese Children With Blood Cancer

Pediatric blood cancer is the most common childhood malignancy. Despite its survival has been substantially improved, children still have to pay a high price for numerous distressing symptoms resulted from chemotherapy. Previous studies related to symptom experiences mainly focus on individual symptoms, rather than on multiple symptoms. Understanding these distressing symptoms may help healthcare professionals to develop appropriate and effective interventions with the aims of alleviating symptom severity and thus promoting the child's psychosocial well-being and quality of life.

A longitudinal study design will be conducted. A sample of 120 patients age 5-17years, diagnosed with blood cancer but not yet receive any chemotherapy and able to communicate with Cantonese and read Chinese will be recruited in the pediatric oncology ward of Hong Kong Children's Hospital.

Eligibility Criteria:
Inclusion Criteria:

* aged 5 - 17 years old
* diagnosed with blood cancer but not yet receive any chemotherapy
* able to communicate with Cantonese and read Chinese

Exclusion Criteria:

* who are scheduled to have concurrent cancer treatment
* with recurrent malignancy
* medical condition, or cognitive and learning problems in their medical records
Nepal Undifferentiated Febrile Illness Trial

The purpose of the study is to determine whether azithromycin or cotrimoxazole is the best empirical treatment for undifferentiated febrile illness in Nepal

Fever is one of the most common presenting symptoms of patients presenting to health centers in Nepal. Many of the times, it is difficult to diagnose the cause of the fever by initial history, clinical examination and basic laboratory tests and the patents are treated as presumed enteric fever or fever without focus needing antimicrobials. In fact there are various causes of similarly presenting febrile illnesses including typhoid, paratyphoid, murine typhus, scrub typhus etc.

Many of the traditionally used drugs including fluoroquinolones are now resistant against enteric fever in south asia. Oral azithromycin is now commonly used to treat undifferentiated febrile illness and remains effective against enteric fever. Many physicians now also use co-trimoxazole as it was very commonly used in the treatment of enteric fever in the past. Resistance to co-trimoxazole emerged two decades ago, but has subsequently largely disappeared and nearly all Salmonella Typhi and Paratyphi A strains from Nepal are now susceptible. Anecdotal reports claim that it seems to work very well against undifferentiated febrile illness in Nepal; it is largely stocked in government health facilities and is a popular and cheap treatment option.

Both azithromycin and co-trimoxazole are available in Nepal and are extensively used in the treatment of undifferentiated febrile illness. Therefore it is important to know the better oral option to treat enteric fever and other febrile illnesses and also to have an alternative oral treatment in case resistance to azithromycin emerges.

The investigators purpose to conduct a head to head, parallel group, 1:1, double blinded randomized controlled trial to compare azithromycin and co-trimoxazole for the treatment of undifferentiated febrile illness and determine the best empirical treatment for undifferentiated febrile illness in Nepal.

Eligibility Criteria:
Inclusion Criteria:

* Fever of ≥ 38.0°C and for ≥4 days without a focus of infection
* ≥ 2 years and \<65 years of age
* Able to take tablets orally
* Patient residing in Kathmandu Valley
* Able to come for follow up
* Can be reached by telephone/mobile phone 24 hours a day.
* Written informed consent to participate in the study including assent for minors in addition to parental consent.

Exclusion Criteria:

* Fever \>14 days
* Pregnancy
* Obtundation
* Shock
* Visible jaundice
* Presence of signs of gastrointestinal bleeding
* History of hypersensitivity to either of the trial drugs
* Patient requiring intravenous antibiotic or hospital admission for any reason.
* Contraindication of drug for any reason (e.g. drug interactions).
* Any patient fulfilling inclusion criteria but already on antimicrobials and responding clinically to the treatment
Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients

Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects Hydroxyzine should be used in the prevention of these symptoms.

80 patients scheduled for elective transabdominal hysterectomy under combined spinal-general anesthesia. they were randomized to receive either hydroxyzine 75 mg and midazolam 7.5 mg (ATR group) or placebo and midazolam 7.5 mg (control group) as premedication at least half an hour before operation. Clinical data (vital signs, pruritic score, nauseous score, sedation score, etc) was recorded at preoperative, intraoperative and 48-hour postoperative periods. All patients had spinal block with 0.5% heavy bupivacaine 2 ml with 0.3 mg preservative free morphine and general anesthesia with thiopental sodium 250-300 mg as induction, intubated with atracurium 0.6 mg/kg and maintenance with nitrous oxide, oxygen and isoflurane. Conventional reversal technique was done in all patients. Fentanyl intravenous was used for pain as needed, chlopheniramine syrup 2 tsp (4mg/10 ml) every 4 hours was used for pruritus and ondansetron intravenous (8 mg) was used for nausea/vomiting in postoperative period. The results were reported in number of patients or percent of patients who were suffered from pruritus, nausea, vomiting or sedation.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification 1-2
* Age from 18-60 years old
* Body mass index (BMI) below 35
* Accepted combined spinal-general anesthesia

Exclusion Criteria:

* Previous history of Hydroxyzine allergy
* Underlying diseases of urticaria, pruritus, nausea vomiting and motion sickness
* Previous complications of procedure or anesthesia
The Effect of 40gr Okara on Gastric Emptying

The effect of 40gr Okara, on gastric emptying of standard meal (Muffin cake)

This trail will be a single blinded, cross-over design. The study population will include 10 subjects. The patients will be randomly assigned to receive one of two Muffin cakes, with or without 40 grams Okara on three occasions (three visits). In two visits the subject will receive a Muffin cake with 40 grams Okara (but with similar caloric value), and in one visit a Muffin cake without Okara.

Postprandial gastric emptying time will be measured for each subject, by 13C Breath Test.

Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 20-65 years old
* Written Informed Consent

Exclusion Criteria:

* History of gastro-intestinal surgery
* On medication that may influence gastric emptying, or medication for weight loss
* Patient on PPI treatment, H2 Blockers or medication for weight loss
* Known allergies to soy
* Pregnancy or breast-feeding
* Smoking
* Athletes
* Metabolic syndrome or diabetes mellitus
* Family history of metabolic syndrome or diabetes mellitus
* Weight loss \> 2 kg during two months before the study
Study of Urine Samples From Women With Newly Diagnosed Breast Cancer Enrolled on Clinical Trial UNMC-08105

RATIONALE: Studying samples of urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at urine samples from women with newly diagnosed breast cancer.

OBJECTIVES:

* To learn the effects of selected agents (tamoxifen and aromatase inhibitors) on the profile of estrogen metabolites, glutathione conjugates, and depurinating DNA adducts in urine from women with breast cancer.

OUTLINE: Previously collected urine samples are analyzed for 40 estrogen metabolites, conjugates, and depurinating DNA adducts by ultra-performance liquid chromatography with tandem mass spectrometric detection.

Patient information (e.g., race, body mass index, age at menarche, menopausal status, age at menopause if applicable, smoking history, alcohol consumption) is collected through medical record review.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ductal carcinoma in situ or invasive breast cancer
* Urine biospecimens available from participation in protocol UNMC-08105 (IRB#311-06), the Breast Cancer Collaborative Registry (BCCR), which included treatment with tamoxifen or an aromatase inhibitor

  o Urine specimens were collected at baseline, 6 months, and then annually
* Estrogen receptor or progesterone receptor positive
* ECOG performance status 0-2

Exclusion Criteria:

* Not pregnant or nursing
* No concurrent use of estrogen(s)
Immunological Characteristics of Maternal-fetal Transmission of Cytomegalovirus in Pregnancy

Analysis of several characteristics of blood from pregnant women with CMV infection according to maternal-fetal transmission. These include CMV viral load, cytokine profile in response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal DNA polymorphism and microarray of gene expression.

Maternal Cytomegalovirus infection in pregnancy may cause significant morbidity in the fetus. Intrauterine CMV transmission occurs mainly during primary maternal infections, with a maternal-fetal transmission rate of about 40%. The mechanisms dictating CMV intrauterine transmission are unknown, and transmission is currently thought to be dependent on multiple factors, including the maternal and fetal immune system.

To investigate the mechanism of transmission approaching laboratory prediction of transmission, the investigators collect blood from pregnant women with primary CMV infection, and analyze several characteristics. These include CMV viral load, cytokine profile in response to in-vitro stimulation with CMV peptides, meticulous analysis of anti CMV antibodies, maternal DNA polymorphism and microarray of gene expression.

These results will be analysed according to transmission as indicated by a positive culture / Polymerase chain transcription of amniotic fluid or newborns urine / saliva.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* CMV infection: primary infection: (1) CMV-specific IgG seroconversion or (2) demonstration of low avidity CMV-specific IgG antibodies, (3) the primary appearance of CMV-specific IgM with no previous IgG, and (4) CMV DNA or viral products in blood Secondary infection: appearance of CMV-specific IgM with positive IgG

Exclusion Criteria:

* CMV status unclear
* spontaneous or induced abortion
* unknown fetal outcome
Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis

The exact underlying mechanisms of ulcerative colitis (UC), an idiopathic, chronic inflammatory disease marked by diffused inflammation of the colon and rectum mucosa, are still unknown. Due to genetic, immune, and environmental factors, UC is highly dependent on cellular immune reactions and exaggerated inflammatory responses. The release of several cytokines, kinins, leukotrienes, platelet-activating factor (PAF), and reactive oxygen species is connected to immunological activity (ROS). Additionally, many of the cytokines will start an acute phase response, making the inflammation worse.


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception

Exclusion Criteria:

- Breastfeeding Significant liver and kidney function abnormalities Colorectal cancer patients Patients with severe UC Patients taking rectal or systemic steroids Known allergy to the studied medications
Subgingival Microbiota Following Mechanical Treatment and it's Effect on Peri-implant Sub-mucosa in Periodontitis Patients

The investigators planed to observe the microbiome of an aggressive periodontitis patient, during mechanical treatment, surgery(if indicated) and implant placement. The investigators designed to observe the changes after mechanical treatment.Then, the investigators will compare the sub-mucosa microbiome of implant and the subgingival community. The investigators expected a different community after treatment, and there could be similarity between implant and nature teeth.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects were between 18-35 years old and diagnosed with generalized aggressive periodontitis (GAgP) according to the 1999 International Classification of Periodontal Diseases (Armitage 1999);
2. At least 20 teeth in the first appointment and at least 3 teeth(other than first molars and central incisors)with a probing depth(PD) ≥ 6mm, clinical attachment level (CAL)≥5mm;
3. The clinical diagnosis was confirmed by evidence of inter-proximal bone loss on full-mouth periapical radiographs;
4. Family history of aggressive periodontitis.

Exclusion Criteria:

1. Uncontrolled systemic conditions including diabetes and hypertension;
2. Pregnant or lactating;
3. Smoking;
4. Received periodontal treatment within the previous 6 months or antibiotic medication during the previous 3 months.
Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )

Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice.

Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached.

This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).


Eligibility Criteria:
Inclusion Criteria:

* Patient with osteoarthritis

Exclusion Criteria:

* patient with contraindication for MRI
Effect of Acupoint Stimulation on Postoperative Delirium and Electroencephalogram

Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.


Eligibility Criteria:
Inclusion Criteria:

1. aged 65 years or older
2. American Society of Anesthesiologists (ASA) classification≤ Grade III
3. Patients scheduled for elective abdominal surgery under general anesthesia
4. Informed consent

Exclusion Criteria:

1. Patients with severe central nervous system injury or severe cerebrovascular disease
2. Patients with cognitive dysfunction assessed by Confusion Assessment Method before surgery
3. Patients unable to cooperate with studies, such as psychiatric disorders or difficulty in communication
4. Patients with severe hepatic and renal insufficiency
5. Patients with severe respiratory diseases
6. Patients with contraindication for transcutaneous electrical stimulation, such as implanted electrophysiological devices, skin infection and damage at acupuncture points
7. Anticipated duration of anesthesia shorter than 2 hours or postoperative hospital stay shorter than 3 days
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency

randomized study which include comparison rigid ring and band devices in treatment tricuspid regurgitation.

study include 308 patients. Patient will be randomized and 154 patient will receive band for treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1 year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV function, quality of life.

Eligibility Criteria:
Inclusion Criteria:

* moderate or severe tricuspid regurgitation

Exclusion Criteria:

* refusal to participate in the study
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery

This study will assess the bioequivalence of Loteprednol Etabonate and the reference listed drug (RLD)


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes.
* Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (hysterectomy; bilateral oophorectomy; bilateral tubal ligation with surgery at least 6 weeks prior to study initiation). Females of childbearing potential must have a confirmed absence of pregnancy according to a negative urine pregnancy test and must be using one of the following acceptable birth control methods: Intrauterine device in place for at least 90 days. Barrier method (condom or diaphragm) with spermicide. Stable hormonal contraceptive for at least 90 days prior to study and through study completion. Abstinence (if the subject becomes sexually active during the study she must agree to use the barrier method of birth control \[condom or diaphragm and spermicide\] for the duration of the study).
* Male subjects should use medically reliable contraception methods such as condom or vasectomy.
* Subjects are able to perform the activities required by the study protocol and have provided written informed consent.

Exclusion Criteria:

* Subjects having an IOP less than 5 mmHg or greater than 24 mmHg.
* Known or suspected allergy or hypersensitivity to loteprednol etabonate or any ingredient in the formulation or container, or to other corticosteroids, including an increase in IOP after steroid instillation.
* Subjects unable to tolerate instillation of study product by the investigator or qualified staff.
* Use of other investigational drugs within 30 days prior to dosing and for the duration of the study.
* Subject has used any medication, by any route, containing loteprednol etabonate within 7 days prior to Visit 1.
Combined Triple Procedure in Retinal Vein Occlusion (RVO)

The aim of this pilot study was to investigate the effects of an intravitreal combination therapy using triamcinolone and bevacizumab in patients with retinal vein occlusion (RVO).

This prospective study of a case series was conducted in 47 patients (n = 47 eyes; f/m: 21/26; mean age: 66.6 years) with ischemic central RVO (CRVO) (n = 15), non-ischemic CRVO (n = 7), or branch RVO (BRVO) (n = 25). A core pars plana vitrectomy with aspiration of 1.5 ml vitreous and infusion of balanced salt solution (BSS; 1 ml), 8 mg (0.4 ml) triamcinolone, and 1.25 mg (0.1 ml) bevacizumab was performed with a single sutureless sclerotomy and a 23 gauge probe tip. At baseline and follow-up, the best corrected visual acuity (BCVA; 6 m Snellen), and intraocular pressure (IOP; Goldmann tonometry), and central macular thickness (optical coherence tomography) were determined. In addition, the need for further treatment and adverse events were monitored.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic central RVO (CRVO)
* Non-ischemic CRVO
* Branch RVO (BRVO)

Exclusion Criteria:

* Visual deterioration due to acute or chronic inflammation
* Post trauma
* Macular edema of other origin
* Intravitreal drug treatment within last 4 months