cyrilzakka/clinical-trials huggingface dataset:
Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair

A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. The investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.

There is a controversy in timing of operation. The timing depends on clinical assessment, laboratory tests and radiological investigations. The cornerstone of this decision is to control sepsis and inflammatory condition before surgery. This issue made surgeons favor longer interval between incidence of ECF and definite surgical treatment. In some cases there may be a hidden place for infection or continuation of the inflammatory situation without clear signs, which necessitated the presence of a possible indicator helps in making the surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude inflammatory condition. Although its level is within normal range but some cases showed high recurrence rate when the level exceeded certain as the investigators believed in their study. Now the investigators can say that the perioperative serum C-reactive protein level can be used as an objective parameter for helping to make surgical decision and reduce recurrence of ECF.

Eligibility Criteria:
Inclusion Criteria:

* patients with ECF were included in the study

Exclusion Criteria:

* Cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. Other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis
A Novel Method of Non-invasive Ventilation in Children

The purpose of this study is to quantify the tidal volume generated by the pressure release immediately following the application of pressure to the chest.

Airway management in the pediatric population differs from the adult population because of differences in their respiratory physiology and anatomy. For example the oxygen consumption is about three times higher in children as compared to adults; therefore, if there is a problem ventilating a child there is a higher impact on oxygen delivery and oxygen reserve. Current guidelines recommend that in respiratory emergencies where one "cannot ventilate and cannot intubate" that a cricothyroidectomy (insertion of a needle through the cricothyroid membrane in the neck) be performed. This procedure is very invasive and difficult to perform, especially in a small child. Since timing and simplicity are essential to successful airway management it is hypothesized that the investigators could utilize the physiological principles behind breathing to ventilate these children using the release of applied pressure to their chest. During, inspiration, the vertical and transverse dimensions of the thorax are increased, generating a negative pressure between the intrapleural space and the chest wall, allowing for air to be drawn into the lungs. As children have a very compliant rib cage one of the theoretical ways to improve lung inflation is to apply external pressure on the chest. The intrathoracic pressure increases above atmospheric pressure and air preferentially flows out of the lungs according to the pressure gradient. When the pressure is released and the chest recoils passively, a negative intrathoracic pressure is generated, which allows for air to flow into the lungs according to the pressure gradient created. If a sufficient tidal volume is generated by the release of pressure from the chest this could potentially become a simple, non-invasive, life-saving technique in children with difficult airways. By adapting the principles described above, it is possible that tidal volume and therefore, gas exchange can take place on release of the pressure applied to the chest.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients under the age of 18 years old.
* All patients requiring a general anesthetic with an endotracheal tube (whether the patient will be intubated with an endotracheal tube will be decided by the anesthesiologist responsible for the case)
* ASA (American Society of Anesthesiologists Physical Status Classification) I to III

Exclusion Criteria:

* Failure to obtain parental consent or patient assent when appropriate (in general children over 8 years old)
* ASA (American Society of Anesthesiologists Physical Status Classification) IV
* Patients with any cardiac pathology
* Patients with any respiratory pathology
* Patients with any form of chest deformity (examples being pectus excavatum, pectus carinatum, scoliosis)
* Patients who had previous cardiac/thoracic surgery
GABA Antagonist to Improve Reversal of Anesthesia With High-density EEG Surveillance

For recent years, patients are more likely to accept sedation during endoscopic examination due to better quality and experience. Modest anesthetic state for different kind of procedure is important, but it is also not easy to maintain in the same state all the time. Thus, to prevent awareness during the procedure, monitoring the brain state is an important issue. Traditionally, anesthesiologists assess patients' brain state from heart rate, blood pressure and muscle tone. All these vital signs are indirect hint for the real brain state. Thus, electroencephalogram(EEG) was considered to be potential tool to directly monitor our brain during anesthesia. In 1937, EEG study was started in anesthetic patients. Until 1994, Bispectral Index, the first commercialized processed EEG monitor, was published for intra-operative brain state assessment. To perform EEG study on a surgical patient is not easy due to the complex circuits and lots of interrupts during the procedure. This might be the reason why most of the EEG studies under anesthesia are collecting from healthy volunteers. It takes longer preparation, better team cooperation, and support from hospital to start this study in endoscopy room.

The investigators would like to start from a preliminary study, 5 patients in each groups, and collect the EEG during peri-endoscopic period. The sedation steps follow the routine protocol of our practice. Flumazenil and placebo are given to the groups separately on the end of the examination. From this study, further understanding of human brain during sedation especially in such short periods is expected. And furthermore, to give safer and more comfortable anesthetic experience for the patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA I or II
* plan to do colonoscopy

Exclusion Criteria:

* existed CNS disease or injuries
* known allergy to propofol, midazolam or alfentanil
Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

This study is designed as a pilot, single-center, non-randomized, uncontrolled, clinical trial in which subjects will be consented, receive a baseline assessment, and receive tAN treatment and assessment every day during their 3 to 5-day detox treatment. Use of opioid-based medication assisted therapy (MAT) will not be permitted at any point during the study. Use of non-opioid-based MATs (i.e. comfort or rescue medications) will not be permitted until after the subject has completed the 60 minute COWS assessment to ensure changes in COWS score at 60 minutes are only the result of tAN therapy.

Eligibility Criteria:
Inclusion Criteria:

* Current opioid dependence; prescriptive or non-prescriptive
* COWS score is ≥ 13 or in the opinion of the investigator the subject is in moderate to severe withdrawal
* 18-65 years of age
* English proficiency
* Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements

Exclusion Criteria:

* Current evidence of an uncontrolled and/or clinically significant medical condition
* History of seizures or epilepsy
* History of neurological diseases or traumatic brain injury
* Participants using long-acting opioids such as methadone or buprenorphine for a period of five or more consecutive days prior to enrollment
* Recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
* Presence of devices (e.g., pacemakers, cochlear prosthesis, neurostimulators)
* Abnormal ear anatomy or ear infection present
* Women of childbearing potential not using adequate contraception as per investigator judgement or not willing to comply with contraception for the duration of the study
* Females who are pregnant or lactating
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Manual Therapy in Postoperative Breast Cancer

To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.


Eligibility Criteria:
Inclusion Criteria:

* surgery of breast cancer at University of Campinas
* axillary lymph node dissection
* injury of shoulder range of motion

Exclusion Criteria:

* bilateral surgery
* previous radiotherapy
* bone metastasis in homolateral upper limb
* axillary web syndrome
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS

The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
Oral Health, Microbial Burden and COVID-19

An observational study of patients with COVID-19 confirmed cases (with various degrees of severity) and controls.

Oral and nasal swabs will be taken from 150 patients (50 with mild form and 50 with severe form of COVID-19 with or without mechanical ventilation, 50 healthy controls).


Eligibility Criteria:
Inclusion Criteria:

1. Must provide written informed consent
2. Subjects have to be tested (PCR) positive or negative for SARS-CoV2 infection
3. Must be able to provide oral and nasal swabbing within 48 hours of polymerise chain reaction (PCR) test results

Exclusion Criteria:

a. Under the age of 18 years old
Urdu Translation Of Pediatric Version Of Eating Assessment Tool

Dysphagia encompasses challenges encountered during the many stages of swallowing, including the oral phase, commencement of the swallow, pharyngeal phase, and esophageal phase. The incidence of pediatric dysphagia is on the rise as a result of advancements in medical care that have led to higher survival rates among infants born prematurely, with low birth weight, and with complex medical disorders. The Eating Assessment Tool (EAT-10), consisting of 10 items, was first developed for infant patients.

(PEDI-EAT-10) will be translated into Urdu language by using forward backwards translation method. Two bilingual speakers expert in both Urdu and English languages will assist the researcher in the forward translation of the tool. This final translated version will be then tested for validity and reliability on all participants of the study. The psychometric properties of the tool will be assessed including reliability, internal consistency, and item discrimination.

A mix method approach will be applied

1. Forward translation
2. Reconciliation of items
3. Backward translation
4. Review of forward and backward translation
5. Pre-testing (cognitive interviewing)
6. Validation study The process of translation followed the guidelines in the translation manual. Translators translate the pediatric version of eating assessment tool (Pedi-EAT-10), independently from each other into the Urdu language considering the following guidelines: using natural language acceptable to the broader public, performing a clear, simple, and understandable translation, avoiding lengthy and complicated sentences. This will be followed by a backward translation to ensure that the content, from the conceptual point of view, had not been modified in the translation. A native English translator was requested to carry out the back-translation, and all discrepancies were identified and corrected. To show whether all items are easily understood and acceptable to the patients, pretesting the final translated questionnaire will be conducted by administering it to patients with a varying education level. The questions that were not easily understood were discussed and redrafted by a panel of researchers until all interviewees understood all items.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children diagnosed with eating disorders
* Age from 3 to 15 years

Exclusion Criteria:

* Parents with children Unable to understand the questionnaire
* Parents with children who have Intellectual disability and any organic type of incontinence, neurological or anatomical problems
* Parents with who have children Severe cognitive decline or dementia
* Parents with children cannot understand Urdu.
Vision Restoration Training in Glaucoma

Importance: Visual field loss after retinal damage in glaucoma is considered irreversible and methods are needed to achieve vision restoration. Behavioral vision restoration training (VRT), shown to improve visual fields in hemianopia and optic nerve damage, might comprise such a method.

Objective: To determine if behaviorally activating areas of residual visual (ARV) using VRT by daily one hour training for 3 months improves detection performance in perimetry compared to a vision discrimination task in the intact visual field sector.

Design: Prospective, randomized, double-blind, placebo controlled trial. Setting: Ambulatory care and home training Participants: Volunteer sample of glaucoma patients (25-80 yrs old) with stable visual fields and well controlled intraocular pressure (IOP).

Intervention: Computer-based home training with VRT (n=15) or placebo discrimination training (n=15).

Main Outcome Measures: The primary endpoint is change in detection performance in High Resolution Perimetry (HRP). Secondary endpoints are 30° white/white and 30° blue/yellow near-threshold perimetry. Further measures are eye movements, vision-related quality of life (vQoL) as assessed with (NEI-VFQ) and health-related quality of life (hQoL) using SF-36 Health Survey-Short Form.

Investigators hypothesize that VRT will improve visual performance in glaucoma

Eligibility Criteria:
Inclusion Criteria:

* Visual filed defect caused by glaucoma
* Presence of a reproducible and stable visual field defect inside 30° eccentricity in at least one eye in 2 consecutive ophthalmologic visits during the last 12 months before recruitment
* Well controlled intraocular pressure (IOP), and (iv) age between 25 and 80 years

Exclusion Criteria:

* History of any medical condition precluding scheduled study visits or completion of the study (e.g. unstable cardiovascular disease)
* History of any chronic degenerative or chronic inflammatory disease that could affect the visual field (e.g. multiple sclerosis, tumor
* History of trauma or any non-glaucoma ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration, macular detachment, vascular occlusion
* Severe cognitive or motor impairments
* Insufficient fixation ability
* Photosensitivity
* Intraocular surgery or laser treatment performed within the previous 12 months before recruitment; OR
* Scheduled intraocular surgery
DOTA-TOC in Metastasized Neuroendocrine Tumors

The investigators aim to explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Background: Systemic treatment with the 90Yttrium (90Y) labeled, tetraazacyclododecanetetraacetic acid (DOTA) modified somatostatin analog Tyr3-octreotide (TOC) was introduced in 1998 (Otte et al. Lancet 1998). \[90Y-DOTA\]-TOC is administered intravenously and binds to the somatostatin receptor subtype 2, located on the surface of the tumor cell, and exerts its cytotoxic effects by β-irradiation. The treatment has moderate acute hematologic and nephrologic toxicity and has developed into a promising therapeutic tool for tumors expressing its target receptor (Iten et al. Clin Cancer Res 2007, Iten et al. Cancer 2009).

Study Aim: To explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer.

Study Hypothesis: Response to DOTA-TOC is correlated with prolonged survival.

Study Type: Clinical phase II, single-center, open-label trial

Patients: 1500 patients

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed neuroendocrine cancer
* stage IVc disease by definition of the American Joint Committee on Cancer, i.e. occurrence of distant metastases
* visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111In-Octreoscan)

Exclusion Criteria:

* concurrent anti-tumor treatment
* secondary malignancies
* pregnancy
* breast-feeding
* incontinence
* severe concomitant illness including severe psychiatric disorders
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).

Study AMAG-FER-CKD-251 was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with dialysis-dependent CKD. Study AMAG-FER-CKD-252 (NCT01155388) was a study evaluating the efficacy and safety of IV ferumoxytol in pediatric participants with nondialysis-dependent CKD. Due to significant challenges with enrollment for both studies, Study AMAG-FER-CKD-252 was combined with Study AMAG-FER-CKD-251 and enrollment continued under Study AMAG-FER-CKD-251. The enrollment number (n=14) includes the number of participants for both AMAG-FER-CKD-251 and AMAG-FER-CKD-252 studies, combined.

Participants were enrolled by age cohorts in a stepwise manner following a safety review by the Data Safety Monitoring Board of 1 age cohort prior to enrollment of a subsequent age cohort, with progression from oldest to youngest: Randomization was stratified by the following age cohorts: 12 to \<18 years, 6 to \<12 years, 2 to \<6 years, and 6 months to \<2 years.

Eligibility Criteria:
Key Inclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

1. Males or females 6 months to \<18 years of age
2. CKD non-dialysis participants or dialysis-dependent participants who were on peritoneal dialysis or stable hemodialysis prior to Screening
3. Had iron deficiency anemia defined as: a) hemoglobin level ≤12.0 grams/deciliter (g/dL) and b) with either transferrin saturation level ≤40% or ferritin level \<100 nanograms/milliliter (ng/mL)
4. Female participants of childbearing potential who were sexually active must have been on an effective method of birth control for at least 1 month prior to Screening and agreed to remain on birth control until completion of participation in the study

Key Exclusion Criteria for the combined AMAG-FER-CKD-251 and AMAG-FER-CDK-252 studies include:

1. History of allergy to either oral or IV iron
2. Hemoglobin level ≤7.0 g/dL
3. Serum ferritin level \>600 ng/mL
4. Female participants who were pregnant or intended to become pregnant, or were breastfeeding, were within 3 months postpartum, or had a positive serum pregnancy test
Leaders Free Japan

Prospective, multi-center, non-randomized, open-label trial designed to enroll 139 patients in Japan. All patients will receive a DCS and will be followed for 2 years.

In this study all patients will receive the a Drug Coated Stent and will receive one month Dual Anti Platelet Therapy.

Eligibility Criteria:
Inclusion Criteria:

Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Reasons of unsuitability for \> 1 month dual antiplatelet treatment must include one or MORE of the following:

1. Adjunctive oral anticoagulation treatment planned to continue after PCI
2. Age ≥ 75 years old
3. Baseline Hgb \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to enrollment)
4. Any prior intracerebral bleed
5. Any stroke in the last 12 months
6. Hospital admission for bleeding during the prior 12 months
7. Non skin cancer diagnosed or treated \< 3 years
8. Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI
9. Planned surgery that would require interruption of DAPT (within next 12 months)
10. Renal failure defined as: Creatinine clearance \<40 ml/min
11. Thrombocytopenia (PLT \<100,000/mm3)
12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

1. Pregnant and breastfeeding women
2. Patients expected not to comply with 30 days DAPT
3. Patients requiring a planned staged PCI procedure more than one week after the index procedure
4. Procedure planned to require non-study stents, or stand-alone POBA or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter \<2.25 \~ \>4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. A known hypersensitivity or contraindication to aspirin, clopidogrel or other P2Y12 inhibitor (if applicable), stainless steel, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated
10. PCI during the previous 12 months for a lesion other than the target lesion of the index procedure
11. Participation in another clinical trial (12 months after index procedure)
12. Patients with a life expectancy of \< 1 year