cyrilzakka/clinical-trials huggingface dataset:
Prognostic Value of Different Nutritional Screening Tools in Acute Pancreatitis

The goal of this observational study is to compare the prognostic value of different nutritional screening tools to predict the course of acute pancreatitis.

The main questions it aims to answer are:

* Which nutritional screening tool performs best to predict length of hospital stay?
* Which nutritional screening tool performs best to predict clinical outcome (disease severity, length of hospital stay, mortality, need for rehospitalization)?

Participants will answer questions regarding their nutritional status and undergo basic anthropometric assessments (e.g. measurement of waist circumference) to evaluate their risk of malnutrition.

Malnutrition seems to be related to an adverse outcome of acute pancreatitis. However, it is still unclear which of the various available nutritional screening tools is suited best to predict the clinical outcome in hospitalized patients with acute pancreatitis.

Therefore, in this study we compare the predictive performance of 6 different nutritional screening tools that are commonly applied in clinical practice regarding their respective associations with severity of acute pancreatitis, length of hospital stay, mortality and need for rehospitalization.

To determine patients' nutritional status, subjects will be inquired about their recent food intake as well as body weight and undergo basic anthropometric assessments according to the different screening tools.

Six months after the initial diagnosis patients will be contacted via mail to report on need for rehospitalization due to acute pancreatitis during this time period.

Eligibility Criteria:
Inclusion Criteria:

* verified diagnosis of acute pancreatitis
* provision of informed consent

Exclusion Criteria:

* pregnancy
* inability to provide consent
Ilaprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Chinese Patients

This study is designed to evaluate the efficacy and tolerability of ilaprazole relative to that of esomeprazole in healing erosive esophagitis and resolving accompanying symptoms of GERD.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients will be eligible for enrollment if they:

  * are 18-70 years of age,
  * have at least one of the two symptoms, heartburn and reflux,
  * have photographically documented erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD), and graded according to the Los Angeles (LA) Classification (A-D), within 5 days before randomization to treatment. Female patients are required to be nonpregnant, nonlactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator. Women of child- bearing potential will receive a pregnancy test.

Exclusion Criteria:

* Patients will be ineligible if they:

  * have cancerous or peptic ulcers, Zollinger-Ellison syndrome, varices of esophagus or fundus of stomach
  * have a known history of gastric acid suppression operation, esophageal operation or peptic operation other than simple closure of perforation,
  * have severe complications, severe other diseases of digestive tract such as Crohn's disease and ulcerative colitis, and severe other systemic diseases,
  * have taken proton pump inhibitors within the 5 days or for more than three consecutive days within the two weeks immediately preceding start of study drug,
  * participated in a clinical trial with an investigational drug or device within the past three months,
  * have hypersensitivity or idiosyncratic reaction to ilaprazole, esomeprazole or any other benzimidazole,
  * have alcoholic intemperance, drug addiction or any other improper habits.
A Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Out-comes

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).

Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.

In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years of age,
2. Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
3. Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,
4. Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

Exclusion Criteria:

1) Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
The Effects of Yoga on Patients With Rotator Cuff Injuries

To determine if patients who undergo a 6-week online yoga exercise treatment differ from those who undergo a 6-week online standard exercise intervention and patients who do not undergo any treatment (the control).

Patients awaiting rotator cuff surgery spend months waiting for a doctor's consultation and even longer for surgery. The proposed study is to see if there is a difference between three groups: patients who follow an online yoga video, patients who follow an online standard exercises video and patients who do not undergo either treatment (control).

Eligibility Criteria:
Inclusion Criteria:

* minimum 18 years old
* rotator cuff injury
* access to YouTube

Exclusion Criteria:

* under 18 years of age
* patient has past yoga experience
* patient will/has undergone any surgery other than rotator cuff
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy

The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age ≥ 18 years
* diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer
* Karnofsky Performance Status ≥ 70
* life expectancy of at least 3 months
* Written informed consent are acquired

Exclusion Criteria:

* uncontrolled infection,Temperature is 38.0 ℃ or higher
* pregnancy
* Other situations that investigators consider as contra-indication for this study
Angiotensin Converting Enzyme Gene Polymorphism in Children With Idiopathic Nephrotic Syndrome

Aims This study was conducted to examine the association between the ACE insertion/deletion (I/D) genotype distribution in children with idiopathic nephrotic syndrome and the response to steroid therapy.

Patients and Methods The patients with idiopathic nephrotic syndrome were divided into 2 groups according to their clinical response to steroid: SS group including infrequent and frequent relapsers and non-SS group including steroid resistant (SR) and steroid dependent (SD) patients. Children without previous renal diseases and negative proteinuria were enrolled as control group in genetic study. The genotypes for ACE gene I/D polymorphism including DD, ID and II were analyzed by the newly developed automatic denaturing high performance liquid chromatography system (DHPLC).


Eligibility Criteria:
Inclusion Criteria:

* Total 59 children diagnosed as nephrotic syndrome at the age of 1 to 10 year-old were recruited in this study. These children with nephrotic syndrome were under follow-up at the Pediatric Nephrology Clinic in National Taiwan University Hospital. In addition, children without previous renal diseases and negative proteinuria were enrolled as control group in genetic study.
Comparative Study of NXL103 Versus Comparator in Adults With Community Acquired Pneumonia

The purpose of this study is to compare the efficacy, safety and tolerance of 2 different dose levels of oral NXL103 with oral comparator in the treatment of community acquired pneumonia in adults


Eligibility Criteria:
Inclusion Criteria:

* Community acquired pneumonia

Exclusion Criteria:

* severe CAP
* respiratory infections attributed to sources other than community acquired bacterial infection
* concomitant pulmonary disease
* history of hypersensitivity to study medication, macrolide or beta lactam antibiotics
Probiotics in Adults: do They Improve Atopic Dermatitis?

Probiotics are suggested to have beneficial effects in atopic dermatitis (AD) treatment and prevention but their precise role is not yet clear.

The aim of this randomized double blinded active treatment vs placebo study was to evaluate clinical efficacy of intake of a combination of two probiotics (Lactobacillus salivarius LS01 and Bifidobacterium breve BR03) for the treatment of adult AD patients.

The rationale for the use of probiotics in the treatment of atopic dermatitis would be due to some experimental hypotheses:

1. The use of these microbial agents at an early age seems to play an important role in inducing immunity T type 1 (Th1) and inhibit the development of a Th2 response IgE mediated
2. the normal intestinal flora (including probiotics) would play an important role in inducing immunological tolerance
3. the hygiene hypothesis that the reduced bacterial environment would favour a type 2 response T and the development of allergic diseases


Eligibility Criteria:
Inclusion Criteria:Adults aged 18-55 years between

* Diagnosis of DA moderate and / or severe, as assessed by the use of a standardized index of severity of AD (SCORAD = Scoring Atopic Dermatitis index) (42), prepared by the European Task Force for atopic dermatitis

Exclusion Criteria:Allergic contact dermatitis (ACD), active

* In the absence of known food allergy elimination diet
* Chronic diseases (autoimmune diseases, COPD, heart disease, IRC, CNS disease, chronic gastrointestinal diseases, diabetes, congenital or acquired immunosuppression)
* Pregnancy and / or lactation
* Treatment with probiotics in the 6 months preceding enrollment
* Treatment with steroids and antihistamines systemically in the three months prior to enrollment
* Topical treatments with immunomodulators (tacrolimus or pimecrolimus) in the three months prior to enrollment
* Acute or chronic infectious diseases
* Pre-existing hypersensitivity to components contained in the probiotic
DERM NMSC Validation Study

This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.

DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify Non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish how well DERM determines the presence of these conditions in images of skin lesions collected in a clinical setting.

Suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study,
* Male or Female, aged 18 years or above,
* Have at least suspicious skin lesion which is suitable for photographing (\<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing),
* In the Investigator's opinion, able and willing to comply with all study requirements.

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
Pre-treatment Factors for the Development of Chronic Pain in Low Back Pain Patients

The purpose of the project is to associate pre-treatment pain sensitivity level, levels of pain catastrophizing and levels of The Subgroups for Targeted Treatment (STarT) Back Screening Tool in patients with acute low back pain and patients' progression after 12 weeks of treatment by general practitioners.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low back pain, who have a mobile phone.

Exclusion Criteria:

* Pregnancy
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Alcohol addiction
* Lack of ability to cooperate
* Surgery to the spine
Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage IIIA non-small cell lung cancer.

OBJECTIVES:

Primary

* To assess the response rate to gefitinib treatment as preoperative induction therapy in patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer accompanied by epidermal growth factor receptor (EGFR) mutations.

Secondary

* To determine the complete resection rate in patients treated with this drug.
* To determine the overall survival rate in patients treated with this drug.
* To determine the disease-free survival rate in patients treated with this drug.
* To determine the pathologic complete response rate in patients treated with this drug.
* To determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients with resectable disease may undergo surgery. Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.

After completion of study therapy, patients are followed for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer

  * pN2 disease proven by mediastinoscopy
* Meets any of the following criteria:

  * Never smoked
  * EGFR mutations (in exon 18, 19, or 21)\*
  * FISH positive for EGFR\* NOTE: \*Irrespective of smoking history
* Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST
* Feasible to undergo pneumonectomy or lobectomy

PATIENT CHARACTERISTICS:

Inclusion criteria:

* ECOG performance status 0-1
* FEV_1 ≥ 2.0 L in preoperative pulmonary function test
* Hemoglobin ≥ 9.0 g/dL
* WBC 4,000-12,000/μL
* ANC ≥ 1,500/μL
* Platelet count ≥ 100,000/mm³
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3.0 times ULN
* AST and ALT ≤ 3.0 times ULN
* Creatinine ≤ 1.5 times ULN
* Negative pregnancy test

Exclusion criteria:

* Severe complications or infections
* Pregnant or breast-feeding women
* Clinically significant heart disease
* Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
* Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
* No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
Efficacy of External Oblique Intercostal Block in Laparoscopic Bariatric Surgery

Laparoscopic bariatric procedures nowadays are employed under ERAS protocol as an ambulatory surgery. Pain after laparoscopic procedures arises significantly from port site incisions in the anterior abdominal wall, and shoulder pain (referred from visceral pain). Narcotic medications are utilized to manage postoperative pain, but its disadvantages include, increased post-operative nausea and vomiting (PONV), ileus, sedation and delayed hospital discharge.

Oblique subcostal transversus abdominis plane block (OSTAP) had been studied before and found to be effective in reducing post-operative morphine usage and produce good analgesia for about 24hours postoperatively.

The ultrasound-guided external oblique intercostal (EOI) block is a new technique which proved to produce unilateral analgesia at thoracic dermatomes supplying the anterior and lateral aspects of the upper abdomen.

The aim of this study was to test the hypothesis that US-guided EOI blocks can produce more reduction in opioid usage during the first 24 h after of laparoscopic bariatric surgeries when compared to oblique subcostal TAP (OSTAP) block.


Eligibility Criteria:
Inclusion Criteria:

* age of 18 and 65;
* American Society of Anesthesia (ASA) class II or III
* elective laparoscopic bariatric procedure through trocars positioned at or above the um-bilicus (T10 dermatome).

Exclusion Criteria:

* preoperative chronic use or contraindication to opioid or NSAID
* allergy to bupivacaine
* local skin infection at the injection site of EOI or OSTAP blocks
* liver or renal insufficiency
* psychiatric, or neurological disease
* prior open abdominal surgery above T10 dermatome
* patients converted to open surgery; and patients expected to be subjected to more tissue trauma.
Pilot Trial of External Warming in Septic Patients

The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to a surgical or medical intensive care unit
* Age greater than 18 years
* Diagnosis of sepsis within 24 hours of enrollment
* Requirement for mechanical ventilation with expected duration of mechanical ventilation \> 48 hours
* Goal Richmond Agitation Sedation Scale (RASS) \< 0
* Maximum baseline temperature (within previous 24 hours) \< 38.3°C

Exclusion Criteria:

* Treatment with chemotherapy within 6 months of enrollment
* Treatment with corticosteroids at a dose \> 300 mg/day hydrocortisone (or equivalent)
* History of solid organ transplant on any immunosuppression medication
* History of immunological disease
* History of chronic infection with hepatitis B or C virus
* History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
* History of multiple sclerosis
* Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
* Moribund status
* Sepsis without source control
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation Following Cataract Surgery

The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are candidates for routine, uncomplicated cataract surgery.
* Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

* Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
* Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Acute Effects of Acupuncture in the Response of the Median Neurodynamic Test

The purpose of this study is to test whether the application of acupuncture alters the mechanical (range of elbow extension motion) and physiological (eg, intensity and onset of discomfort, tingling feeling and/or feeling of tension or restriction of movement) responses of the neurodynamic test of nerve median in asymptomatic individuals

To understand the potential of acupuncture therapy in pain syndromes that involve changes of the mechanics and physiology of the peripheral nervous system

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years-old
* normal mobility in the joints of the upper quadrant

Exclusion Criteria:

* pathology that may impair nerve function (eg, diabetes)
* complaints over the past 3 months in the upper quadrant
* significant deformities in the upper quadrant
Effect of Therapeutic Phlebotomies on the Triglycerides Concentration in Patients With Hypertriglyceridemia and Hyperferritinemia

The purpose of this study is to evaluate the effect of iron depletion with phlebotomies on blood triglyceride concentration, in subjects with hypertriglyceridemia and iron overload, compared with a dietary intervention alone.

All subjects in this study will follow dietary and lifestyle counseling in a period of 3 months.

A randomized group will receive phlebotomies every 3 weeks in this period.


Eligibility Criteria:
Inclusion Criteria:

* Hyperferritinemia: \> 300µgr/L for male and \>200µgr/L for female.
* Hypertriglyceridemia: \> 200 mg/dL in two determinations after at least ten hours of fasting and lipid-lowering diet.

Exclusion Criteria:

* Contraindications for phlebotomy: poor venous access, previous intolerance (hypotension or apprehension), heart disease, anemia.
* Subjects suffering from acute or chronic disease, including liver disease, diabetes, cancer, kidney disease or uncontrolled thyroid disease.
* Elevated C reactive protein (CRP) as a parameter of inflammation (\>10mg/L).
* Alcohol intake: over 30 gr. per day for men and 25 gr. per day for women.
* Lipid lowering drugs use.