cyrilzakka/clinical-trials huggingface dataset:
Weight Gain in Extremely Premature Infant With Targeted Versus Adjusted Fortification

Investigation about the effect on weight gain in extremely low birth weight preterm with individualized fortification, according to human milk analysis versus fortification adjusted according to urea serum concentration.

1. Study design This is an interventional, randomized, controlled study.
2. Description of the study The very premature newborn will be identified by daily evaluation of the infants admitted for consultation in the income book.

   Informed consent will be requested from the infant´s father, mother or legal guardian between the fifth and tenth day of life.

   Fortification will be done according to the randomization group.
3. Outline of the study design

   * Excel calculation sheet of individualized supplementation according to the composition of breast milk in the target fortification group. Methodology of analysis of breast milk in FOSS analyzer.
   * In the adjusted fortification group, urea concentration levels will be kept between 19-30 mg / dL
   * Fenton curves or https://www.growthcalculator.org/ will be used for Z-scores calculation.
   * Growth speed calculation: Weight gain: (1000x ln \[Final weight / Initial weight\]) / number of days.

     4 Duration of the study for each participant The duration of participation in the study and the fortification intervention period will be a maximum of 132 days.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants born \<1000 g of birth weight that are fed with breast milk or donated milk.
2. Written informed consent signed by the mother, father or legal guardian.
3. To tolerate enteral feeding, at least 100mL / kg / day.

Exclusion Criteria:

1. Non-premature or premature patients weighing ≥ 1000 gr.
2. Patients with major malformations.
3. Patients with diagnosed chromosomal diseases or of high diagnostic suspicion.
4. Patients with short bowel syndrome or any surgery on the gastrointestinal tract.
Traumatic Brain Injury and Stroke Long Term Outcome

Investigators will determine the long-lasting effects of post-acute rehabilitation after traumatic brain injury and stroke. Investigators will also evaluate if the beneficial effects of rehabilitation continue after discharge from a rehabilitative program.

The long-term effects of rehabilitation will be evaluated on 60 patients with traumatic brain injury (TBI) and 60 patients that suffered a cerebrovascular accident (CVA) that underwent an comprehensive rehabilitative. These patients will be matched with subjects that received limited or no rehabilitation rehabilitative therapy. Thus, the total number of subjects in this study will be 240. Subjects will be contacted at least 1 year after discharge and will be lowed up every two-years thereafter for a total period of 10 years. Procedures will be performed in-person whenever possible. However, it is highly likely that the majority of participants will be contacted via phone interviews.

Aim 1: Determine if rehabilitation improves vocational status and living status after TBI and CVA.

Aim 2: Determine if rehabilitation improves life quality after TBI and CVA.

Aim 3: Determine if rehabilitation improves cognitive function after TBI and CVA.

Aim 4: Determine if rehabilitative benefits are sustained.

Aim 5: Determine if long-term outcome is dependent on the duration of rehabilitation.

Aim 6: Determine if long-term outcome is dependent on the nature of the rehabilitative treatment by comparing the effects of different types of rehabilitation. These will include the following: residential-multidisciplinary, day-treatment (i.e. full time multidisciplinary outpatient), outpatient (part-time), skilled nursing and no post-acute rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Endured a traumatic brain injury or stroke
* Subject or caretaker should be Fluent in English

Exclusion Criteria:

* Diagnosis of degenerative neurological disease prior to sustaining stroke or traumatic brain injury
* b) A history of major psychosis as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-V) prior to sustaining stroke or traumatic brain injury
Cohort Study for Gastric MALT Lymphoma

The goal of this observational study is to establish clinical data and tissue repository in patients with gastric MALT lymphoma and controls.

Participants will be asked to provide clinical information and various tissues (saliva, gastric mucosa, and feces).


Eligibility Criteria:
Inclusion Criteria:

\[MALT lymphoma group\]

* Newly diagnosed as gastric MALT lymphoma \[Control group\]
* Patients who underwent

  1. diagnosed upper endoscopy for dyspepsia and had chronic gastritis,
  2. therapeutic upper endoscopy for gastric hyperplastic polyps, or
  3. screening upper endoscopy without any symptoms.

Exclusion Criteria:

* History of gastric or other malignancy
* Use of antibiotics or probiotics within 4 weeks
* Uncontrolled chronic illnesses
Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

Monosialoganglioside Ganglioside in Cerebral Radiation Necrosis

A prospective phase II trial was conducted to test the efficacy of monosialoganglioside ganglioside for the treatment of cerebral radiation necrosis

Eligibility Criteria:
Inclusion Criteria:

* Undergone only one course of definitive radiotherapy for histologically confirmed nasopharyngeal carcinoma years before;
* At least two consecutive MRI study supporting the diagnosis of cerebral radiation necrosis(CRN) with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI;
* Progressive neurologic symptoms or signs;
* Mini-mental status examination(MMSE) score must be ≤27;
* Karnofsky performance status≥70 ;
* Supposed to live more than 6 months.

Exclusion Criteria:

* After the second course of radiotherapy for recurrent nasopharyngeal carcinoma;
* Local or regional relapse,or with distant metastasis;
* Cerebrovascular disease;
* Second primary malignancy;
* Diabetes.
BIBW 2992 in Patients With Advanced Solid Tumors

The primary objective was to collect safety data for BIBW 2992.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who have completed the prescribed courses of the 1200.1 or 1200.2 studies without clinical disease progression
* Age 18 years or older
* Life expectancy of at least three (3) months
* Written informed consent that is consistent with International Conference on Harmonization - Good Clinical Practice guidelines
* Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2
* Patients must be recovered from previous surgery

Exclusion Criteria:

* Active infectious disease
* Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea
* Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
* Patients with untreated or symptomatic brain metastases. Patients with treated, asymptomatic brain metastases are eligible if there has been no change in brain disease status for at least eight (8) weeks, no history of cerebral edema or bleeding in the past eight (8) weeks and no requirement for steroids or anti-epileptic therapy
* Cardiac left ventricular function with resting ejection fraction \>= CTC Grade 1
* Absolute neutrophil count (ANC) less than 1500 / mm3
* Platelet count less than 100 000 / mm3
* Bilirubin greater than 1.5 mg / dl (\> 26 μmol / L, Systeme International (SI) unit equivalent)
* Aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than three times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Serum creatinine greater than 1.5 mg / dl (\> 132 μmol / L, SI unit equivalent)
* Women and men who are sexually active and unwilling to use a medically acceptable method of birth control
* Pregnancy or breast-feeding
* Treatment with other investigational drugs; chemotherapy, immunotherapy, radiotherapy or hormone therapy (excluding Luteinizing hormone-releasing hormone agonists, or other hormones taken for breast cancer, or bisphosphonates), or participation in a clinical study other than 1200.1 or 1200.2
* Patients unable to comply with the protocol
* Active alcohol or drug abuse
* Patients not recovered from any dose-limiting toxicity

The patients are eligible for re-treatment after the previous course is finished. Patients will not be eligible if the following conditions are met:

* Patients with clinical signs of disease progression or if latest X-ray, CT, MRI or US reveals progressive disease
* Cardiac left ventricular function CTC Grade ≥ 2 at any time during the previous course
* Patients fulfilling any of the Exclusion Criteria listed in Section 3.3 on Day 29 of the previous course
* Patient not recovered from any dose-limiting toxicity (DLT) 14 days after the last administration of BIBW2992 in the previous course. Recovery is defined as return to baseline condition (Visit 1 of 1200.1 or Visit 1 of 1200.2) or CTC Grade 1, whichever is higher.
The Intraoperative Complication Assessment and Reporting With Universal Standards - Calculator (ICARUS-C)

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of intraoperative adverse events (iAEs). Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the 5 published iAE grading systems. We plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.

The purpose of this study is two-fold. First, the investigators hope to evaluate the utility of a web-based intraoperative adverse event (iAE) grading system known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) calculator. Second, the investigators plan to evaluate the difference in iAE grading outcomes of the ICARUS calculator compared with standard iAE grading.

Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure. Despite the availability of multiple intraoperative grading and classification systems, colloquiallary known as: EAUiaiC, iAE severity classification scheme, Modified Satava, EAES Grading system, and ClassIntra® (formerly CLASSIC) , the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest.

As part of the initiative known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) project, the investigators are working to develop a set of tools to aid in improving the homogenous reporting of iAEs. Accordingly, the investigators developed a web-based tool, known as the ICARUS Calculator, that integrates the four aforementioned iAE grading systems. The investigators plan to compare the consistency of grading responses between the ICARUS Calculator and the individual grading systems as presented in their respective publications.

Eligibility Criteria:
Inclusion Criteria:

* Documented understanding, willingness, and agreement to participate in this study
* Males and females; age 18 or older
* Must be either English speaking or fluent with English medical terminology
* Currently or formerly practicing surgeon or proceduralist, regardless of the domain

Exclusion Criteria:

* Activity restrictions that limit one's ability to engage in online survey
* Adults not competent to consent
* Minors, human fetuses, neonates Prisoners/Detainees
Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing PCNL
* age from 12-65 years
* normal renal functions
* no history of chronic pain
* ASA I, II \& III
* Both genders

Exclusion Criteria:

* history of local anaesthesia allergy
* Redo PCNL
* Multiple punctures during PCNL
* Excessive intra-operative bleeding
* Diabetes mellitus
* Coagulopathy
* Mental disorder
* ASA IV \& V
* Active urinary tract infection.
FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins

Varicose vein disease is a common health problem, which causes much discomfort to patients.

Nowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.

Choice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* incompetence of great saphenous vein for minimal 20 cm
* life expectancy at least 3 years
* open and competent deep venous system
* willing to undergo both treatments

Exclusion Criteria:

* active ulcer
* signs of deep venous thrombosis with duplex
* incompetence of the deep venous system
the Relationship Between Vertebral Body Length, Subarachnoid Space Width and Block Level

Spinal anesthesia technology has been widely used in various surgeries and multi-mode analgesia. Spinal ultrasound imaging has been proved to be a reliable tool for evaluating spinal parameters. Ultrasound-guided spinal puncture technology has also been skillfully applied in clinical practice. How to provide perfect nerve block effect for operation, provide good postoperative analgesia, and prevent unnecessary extensive block leading to other complications and related risks has always been the focus of anesthesiologists. Doses and the relationship between the anesthesia plane great individual differences, and previous research on the patient's own condition such as height, weight, 6 to the anesthesia plane have different results, the influence of clinical work often refer patients height adjustment of drug doses, this research attempts to evaluate ultrasound was used to assess spinal vertebral body in the plane of the length and width of subarachnoid and anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective lower limbs surgery
* ASA: grade I to III

Exclusion Criteria:

* There are contraindications to spinal anesthesia
* Allergic to local anesthetics
* Patient refused
Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis

The purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of soJIA.

Systemic onset Juvenile Idiopathic Arthritis (soJIA) is a type of arthritis (inflammation of the joints) that occurs with other symptoms including fever, swollen lymph nodes (glands), rash, and body aches. Because soJIA can be difficult to treat, children with soJIA can have severe problems from long-term use of steroids (prednisone). These problems include low bone density (weak bones), fractures, failure to grow properly, and large weight gain. The arthritis that occurs in soJIA often causes damage to many joints. This can make it hard to move around or do basic tasks like dressing. Also, a life-threatening illness called Macrophage Activation Syndrome (MAS) can occur when starting, stopping, or changing drugs that are used to treat soJIA.

SoJIA can be hard to treat and many children with soJIA do not respond to drugs that work for other kinds of arthritis. Research doctors have studied a chemical signal called IL-6 that the body uses to manage inflammation. This signal has been found to be very high in patients with active soJIA. A drug called tocilizumab (TCZ) has been designed to block IL-6. For about 6 years, TCZ has been tested in Japan for treating soJIA. It is now being tested in studies in the United States. These studies can have very strict rules for enrolling patients. This trial is a single-patient research study for a subject who otherwise does not meet the rules for enrollment in ongoing trials.

Eligibility Criteria:
Inclusion Criteria:

* Systemic Juvenile Idiopathic Arthritis according to ILAR criteria (2001)
* Duration of disease ≥ 6 months since onset
* Presence of active disease as determined by the presence of at least 5 active joints, OR at least 2 active joints if receiving prednisone at a dose \> 0.2 mg/kg/day or \> 10 mg/day (whichever is less)
* Incomplete prior response to methotrexate treatment for at least 3 months at a minimum dose of 15 mg/M2/week, or intolerance to methotrexate
* Discontinued treatment with other biologics prior to first tocilizumab infusion, for approximately two pharmacokinetic half-lives as per specific biologic (e.g. 48 hours for anakinra, 7 days for etanercept)
* Not receiving corticosteroids, OR taking oral corticosteroids and the dose has remained stable for 1 week prior to the first tocilizumab infusion at ≤ 2 mg/kg/day prednisone or prednisolone and no more than 80 mg/day

Exclusion Criteria:

* Concomitant administration of biologic therapies
* Serum creatinine \>1.5 ULN (upper limits normal)
* AST or ALT \> 1.5 ULN
* Total bilirubin \> 1.3 mg/dL
* Platelet count \< LLN (lower limits normal)
* Hemoglobin \< 6.0 g/dL
* WBC count \< 5,000/mm3
* Neutrophil count \< 2,000/ mm3
* Fibrinogen \< LLN
WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)

The study is designed to assess the association between steroid exposure and five potentially steroid-related adverse events within a cohort of individuals with systemic lupus erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i) diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis that is attributable to cumulative corticosteroid exposure in SLE patients. The study will consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases will be incident SLE cases who have developed one of the case outcomes (diabetes, hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of exposure to steroids. The extent of the risk associated with steroids will be explored through modeling of the relationship and through calculation of attributable risks of exposure (number of cases associated with the highest exposure quartile of each primary exposure).


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed SLE as per ACR criteria
* No history of "case" event of interest in follow-up time prior to SLE diagnosis (case) or during follow-up time since SLE diagnosis that is equivalent to length of case at-risk time period (controls)

Exclusion Criteria:

* None
Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines

The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>=30 kg/m\^2
* Type 2 Diabetes Mellitus
* 18-75 y/o
* Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017

For the GLP-1RA Group:

* Follow-up of at least 30 days after the assigned index date
* Did not meet any of the exclusion criteria for surgical patients (see below)
* Did not have metabolic surgery prior to assigned index date.
* Continuously received GLP-1 RA for ≥2 years (prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date)

Exclusion Criteria:

* History of solid organ transplant
* Cardiac ejection fraction \<20% any time before index date
* Active cancer
* Cancer code within 1 year before index date
* ED admission within 5 days before index date
* Dialysis or estimated glomerular filtration rate (eGFR) \<20 before index date.
* Received care in CCHS locations other than in Ohio and Florida.
Acceptability Dermacyd Wipes - Lactoserum - Hygiene

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Wipes


Eligibility Criteria:
The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

* Integral skin in the tested region

Exclusion Criteria:

* Pregnancy or breastfeeding women;
* Use of antiinflammatory or immunosuppression drugs;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynaecological disease which may interfer in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history.