cyrilzakka/clinical-trials huggingface dataset:
Analysis of the Epidemiology, Clinical Presentation and Therapy as Well as Therapy-associated Risk of Demyelination Syndrome in Patients With Profound Hyponatremia in the Emergency Department

Hyponatremia is a frequent cause for presentation to the emergency department (ED). While patients with chronic hyponatremia often exhibit minor symptoms, acute development of hyponatremia can lead to global cerebral edema, transtentorial herniation and death. The time course of hyponatremia development is usually not known to the treating physician at presentation. Hence, type and extent of therapy depend on the presence or absence of severe symptoms such as coma, seizures, obtundation or vomiting. It is believed that these are suggestive of increased cerebral pressure and indicative of cerebral edema. International guidance thus demands aggressive therapy with hypertonic saline at their occurrence. However, severe symptoms can also be found in patients with chronic hyponatremia (i.e., development in more than 48 hours) which are not at risk for developing cerebral edema due to adaptive counter measures in the brain. Although the percentage of patients with severe symptoms in chronic hyponatremia is considerably smaller than in acute hyponatremia, a higher incidence of chronic hyponatremia may lead to a larger overall number of severely symptomatic patients with chronic hyponatremia. The precise distribution of acute and chronic cases in the ED has not been established yet. In consequence, many patients with hyponatremia presenting with severe symptoms receive aggressive treatment in order to raise sodium levels, exposing them to the risk for overly rapid correction and osmotic demyelination syndrome (ODS). Current U.S. recommendations limit the sodium increase to a maximum of 8 mmol/L and 10-12 mmol/L in the first 24 hours in patients with high or low-to-moderate ODS risk, respectively. Similarly, the 2014 European Clinical Practice Guideline (ECPG) recommends a limit of 10 mmol/L in each 24h-period. These limits are often not accomplished in the real-world setting. In summary, weighing the risk of hyponatremia against complications associated with its (over-)correction constitutes a dilemma for the clinician. It will be strived to refine guidance on management of hyponatremia in patients with profound hyponatremia. Therefore, a better understanding of the proportions and characteristics of patients at risk for both cerebral edema and ODS is needed. The primary objective of this study is to determine the rate of hyponatremic patients who had already developed cerebral edema on admission and to identify patients who developed ODS during the index hospital stay. A secondary objective is a more detailed characterization of these subsets.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years
* Plasma sodium ≤125 mmol/L in the initial blood sample after admission to the Emergency Department

Exclusion Criteria:

* Lack of follow-up sodium analyses within the first 24 hours after admission
* initial blood glucose \>300 mg/dL
Development of Post Traumatic Stress Disorder After Natural Disaster

A survey (patient self-report) of patients presenting to UAB emergency room, outpatient trauma clinics and substance abuse center for symptoms of post-traumatic stress disorder and maladaptive coping responses after the widespread tornado disaster that occurred in Alabama in April 2011.


Eligibility Criteria:
Inclusion Criteria:

* 19 and older Able and willing to complete a questionnaire

Exclusion Criteria:

* Younger than 19 Unwilling or unable to complete a questionnaire
Glucose Variability in Subclinical Hypertrophy

Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.

Patients will be randomized and data interpreters will be blinded to two alternating six-day protocols where the patients will be advised verbally and by written instruction to inject insulin in sites of subclinical lipohypertrophy or normal subcutaneous tissue. Patients will be asked to monitor and record their capillary blood glucose with meals and prior to bedtime using their own capillary blood glucose monitor. A trained research nurse at the Diabetes Centre will instrument each patient with an iPro 2 glucose sensor (Medtronic Canada). These sensors continuously measure blood glucose for periods of up to 7 days. A trained nurse will clean the skin with a superficial disinfectant and a small catheter will be inserted in the subcutaneous tissue at a non-lipohypertrophic site. The catheter will then be attached to a glucose sensor. Patients will wear this sensor for two periods of 6 days each at different sites. At the end of each of the two six day periods, the sensor will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Participation in phase 1
* Type 1 or Type 2 diabetes for at least 2 years
* Using insulin to manage diabetes
* At least 19 years of age

Exclusion Criteria:

* Taking insulin secretagogues (gliclazide, glyburide, glipizide
* Taking other injectable diabetes medications (i.e. liraglutide, Victoza)
* Taking systemic steroids (e.g. prednisone)
* Not fluent in speaking and writing English (unless accompanied by a translator)
Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

The purpose of this study is to determine whether the Risk of Ovarian Cancer Algorithm (ROMA) is effective in the determination of a woman's risk of cancer when she is scheduled to have surgery to remove a pelvic mass.

After Informed Consent is obtained, an Initial Cancer Risk Assessment will be made. A blood sample will be collected within 30 days of the surgical procedure. Results of the surgical procedure will be collected and analyzed against the CA125 and HE4 results used in the calculation of the ROMA.


Eligibility Criteria:
Inclusion Criteria:

* Female, age ≥ 18 years
* Adnexal mass present documented by imaging
* Scheduled to undergo surgery based on a finding of adnexal mass (defined as a simple, complex or a solid ovarian cyst/or any mass in pelvis)
* Able to understand and willing to provide Informed Consent

Exclusion Criteria:

* Previous history of ovarian cancer
* Previous history of bilateral oophorectomy
* Currently known to be pregnant
* Unable to provide informed consent
Assessment of a New Protocol for Indirect Pulp Capping Procedures

The aim of the study is to assess clinically, radiographically and microbiologically a new protocol for indirect pulp capping procedures compared to the conventional protocol in painful teeth. It was postulated that there is no difference between both protocols in terms clinical, radiographical and microbial outcome measure after one year of follow up in painful teeth.

Indirect pulp capping is a common dental procedure carried out on painful teeth with deep cavities resulting from dental decay in an attempt to prolong the life of the tooth / pulp while relieving pain, This study aims primarily to assess the response of the pulp of the tooth to two different clinical procedures used in the treatment of deep caries. One group of patients will be treated with a standard clinical procedure which involve mechanical rotary burs with no magnification for caries removal, the other group will be treated with a more conservative clinical procedure using CarisolvTM gel with the aid of an operating microscope for caries removal. The study also involves taking of samples from the tooth decay for microbiological / biochemical analysis and evaluation to determine the species richness in the bacterial community associated with this condition. The study also compare the radiographical findings of 3D cone beam computed tomography (CBCT) scans with that of normal Xrays in detecting the presence of early bone changes associated with the roots of these teeth.

The study carried out at King's College London/ Dental Institute at Guy's Hospital and form part of the routine dental treatment done at the emergency dental clinics with the exception of the CBCT scans. Volunteers given written information about the process and given time to consider participation. Once any questions have been answered, fully informed written consent obtained if they are interested in taking part. At least one deep cavity causing toothache requiring indirect pulp capping detected and diagnosed through conventional clinical and Xray dental assessment. The procedure involves removal of the decay using one of the proposed clinical techniques and the placement of a pulp capping material according to manufacturer's instructions and the definitive filling will be placed, follow up will at 12 months. Radiographic assessment including cone beam computed tomography (CBCT) will be done at baseline and 12 months. It is hoped that data analysed from this study will provide a definitive clinical and radiographic evidence base for the outcome of the indirect pulp capping operative treatment procedure.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of reversible pulpitis with positive response to cold pulp test.

Exclusion Criteria:

Clinical diagnosis of irreversible pulpitis, Pregnant women, mobile teeth and teeth with tenderness to percussion.
Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke

Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients who received a combination of yoga and traditional physiotherapy were getting more improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga can improve post-stroke depression symtom.


Eligibility Criteria:
Inclusion Criteria:

1. The time of stroke onset is more than 91 days.
2. Able to stand for more than 1 minutes.
3. Between the ages of 30 and 80.

Exclusion Criteria:

1. Now receive others palliative therapy.
2. Significant psychotic disease.
3. Obvious language disorder.
4. Medical contraindication(clincans evaluate cannot included).
Mobile Health Application for Adolescents With Asthma

Mobile health applications (mHealth apps) are an opportunity offered by developing technology which in widely used among youths. The evidence regarding mHealth apps suggests that the apps can be safer and more feasible if are developed by healthcare team. Healthcare professionals have a major role to play in developing mHealth apps of good interventions.

This study aims at developing the mHealth application (YoungAsthma) and evaluating the effectiveness of YoungAsthma app on the mean score of the asthma control test and self-efficacy scale in adolescents with asthma. This study is a self-efficacy theory-based, 4-week, randomized parallel group study. Participants will be randomized to either the intervention or control group in a 1:1 ratio. Adolescents will be randomly allocated to intervention (YoungAsthma which is a user-focused mHealth app) or control group (Usual care). The study protocol is conducted in accord with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013 Statement) (Chan et al., 2013), the RCT is perform by the Consolidated Standards of Reporting Trials (CONSORT) (Moher et al., 2010) and the mHealth app is identified according to the mERA guideline (Agarwal et al., 2016).

Eligibility Criteria:
Inclusion Criteria:

* Having ability to speak, read and write Turkish at a sufficient level,
* Having a diagnosis of asthma for at least a year,
* Having an asthma control test score of 19 or below,
* Having ability to use mobile devices,
* Having a mobile device with an internet connection to login to the mHealth App.

Exclusion Criteria:

* Having an internet access problem,
* Having a psychiatric medical diagnosis
Urinary T Cell Biomarker for Prediction in Lupus Nephritis

Urinary T-lymphocytes may be predictive for clinical outcome in patients with lupus nephritis. The investigators hypothesize that the amount of CD4+ effector/memory T-cells in urine at time of diagnosis predicts the outcome of patients with active lupus nephritis (LN) after 6 months of therapy. In a prospective, six-months follow-up study patients' urine will be analysed by flow cytometry every 60 days (+/- 10d). Treatment will be performed to the discretion of the treating clinician. After 6 months of treatment response will be determined as either complete response or partial response.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven lupus nephritis
* In absence of a biopsy a SLEDAI of at least 10 \& at least two renal elements of the renal SLEDAI (rSLEDAI)
* Informed consent
* Diagnosis of SLE according to the American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* Biopsy-proven non-SLE related disease
* Urinary tract infection
* Active menstrual bleeding
* Kidney transplantation during observation time
Chemotherapy Combined With CIK Treating Colon Cancer

Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. The investigators aim to evaluate the clinical efficacy of chemotherapy combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.

Over the past decade, advances in combination chemotherapy regimens for colorectal cancer have led to significant improvement in progression-free and overall survival. Cytokine-induced killer cells (CIK) is an auxiliary antitumor treatment. Research has demonstrated the median overall survival (OS) in patients received CIK combined with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin \[FOLFOX4\] plan) was significantly increased compared with that in patients received chemotherapy alone. Furthermore, there was a trend toward superior progression-free survival time (PFS) in patients received CIK combined with chemotherapy compared with that in patients received chemotherapy alone. The investigators aim to evaluate the clinical efficacy of chemotherapy (FOLFOX4) combined with CIK in the treatment of postoperative colorectal cancer patients. And to provide useful reference for the clinical application of CIK in colorectal cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Tumor, Nodes, Metastasis (TNM) stage of II or III;
2. Patients received radical resection of colon cancer;
3. Pathological diagnosis of adenocarcinoma;
4. Patients not received radiotherapy and chemotherapy before surgery;
5. The preoperative examination confirmed without systemic metastasis;
6. Patient has the Karnofsky score more than 70 points;
7. Subjects signed informed consent.

Exclusion Criteria:

1. Patients who was serious allergy to any of the ingredients of drugs used in this study;
2. Patients who unable to comply with the treatment plan or research program;
3. Patients with severe systemic disease that the researchers judged will be unable to complete the study;
4. Patients have severe heart disease, such as myocardial infarction within 6 months;
5. Patients who have received chemotherapy or systemic antitumor therapy (such as monoclonal antibody therapy);
6. Patients received radiotherapy;
7. Having other malignant tumors in the last 5 years, but not including who has been cured through surgery and survived 5 year of disease-free;
8. Any unstable systemic diseases (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction, serious arrhythmias, liver, kidney or metabolic diseases within six months).
9. Patients who do not get effective treatment of inflammation, eye infections or predisposing factors;
10. Physical examination or laboratory findings evidence reasonable doubt who is ill or use of related drugs could affect the study;
11. Patients with serious active infections;
12. Woman who are pregnant or lactating.
Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma

This study is an open, multi-center phase I/II clinical study.

It will explore the tolerability (phase I) and effectiveness (phase II) of the Donafenib tosilate tablets combined with Toripalimab injection in patients with advanced HCC. The study is conducted in two phases, the first phase is the dose exploration phase (phase I), and the second phase is the dose expansion phase (phase II).

Eligibility Criteria:
Inclusion Criteria:

* Patients with locally advanced or metastatic HCC who are not suitable for surgical resection, who are clinically diagnosed or confirmed by histopathology and/or cytology according to the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2017);
* At least one measurable lesion (according to RECIST v1.1);
* ECOG performance status score of 0 or 1;
* Life expectancy ≥ 12 weeks；
* Have not received systemic therapy (systemic chemotherapy and/or molecular targeted therapy).If the patient has received adjuvant chemotherapy after local treatment, the chemotherapy needs to be over for more than 12 months, and disease progression or metastasis occurs；
* Fully understand this research and voluntarily sign the ICF。

Exclusion Criteria:

* Patients with diffuse liver cancer, hepatic encephalopathy that is difficult to control, and liver cancer patients whose lesion size accounts for 70% or more of the entire liver.
* Patients with intrahepatic cholangiocarcinoma (ICC) or HCC-ICC mixed type；
* Tumor invades inferior vena cava VP4.
Postpartum Hemorrhage After Shenghua Decoction Treatment

A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum hemorrhage after shenghua decoction treatment.

Exclusion Criteria:

* Nil
Pregnancy-Related Obesity Prevention Through Education & Communication Technology in AFRICA:The PROTECT-AFRICA STUDY

The purpose of this study is to investigate whether overweight but not obese pregnant African women having unlimited access to a health education-information technology (IT) based intervention package gain weight within the acceptable range of 8-12 kg during the pregnancy period.

Therefore, we hypothesize that unlimited access to health education via an IT-based intervention package has the potential to reduce the onset of obesity in African pregnant women.

To date (Aug 2015), 95% of patients have been recruited, 1320 potential subjects have been screened and 150 enrolled into the study


Eligibility Criteria:
Inclusion Criteria:

* body-mass index (BMI) range of 25.1-29.9 kg/m2
* Weeks of pregnancy: 16-20
* singleton pregnancy

Exclusion Criteria:

* Evidence of pre-existing cardiovascular disease or a metabolic disorder (i.e. gestational diabetes)
Intermittent Oral-esophageal Tube in Delayed Dysphagia After Radiotherapy for Nasopharyngeal Carcinoma

This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Palliation to delayed dysphagia after radiotherapy for nasopharyngeal carcinoma (NPC) continues to be a challenge. Although nasogastric tube feeding (NGT) has been adopted widely, the weaknesses have yet to be improved by another enteral nutrition support mode. This study aims to observe the clinical efficacy of intermittent oro-esophageal tube feeding (IOE) in the treatment of delayed dysphagia after radiotherapy for (NPC). This is a prospective multicenter study with patients with delayed dysphagia after radiotherapy for NPC. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received IOE while the control group received NGT for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life (QOL) after treatment as well as adverse events are compared.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* With the history of Nasopharyngeal Carcinoma and radiation therapy.
* With dysphagia occurred at least three years after radiotherapy (confirmed by videofluoroscopic swallowing study), in need of and feasible for enteral nutrition support.
* Conscious and with stable vital signs;
* Willing to participate and sign the written informed consent form either personally or by a family member.

Exclusion Criteria:

* Presence of other diseases that might cause dysphagia.
* With distant metastasis of tumors, or complicated with severe systemic disorders or malignancies.
* Concurrent participation in other treatments that could interfere with the trial.
* Inability to cooperate with treatment due to aphasia, mental health issues, etc.
* Received tube feeding for enteral nutrition support within the past three years.
Computer-Assisted Tobacco Interventions in Dental Offices

Electronic dental records (EDR) are a potentially powerful tool to incorporate current scientific evidence into clinical practice by providing key information at the point of patient care. The investigators know that disseminating evidence-based guidelines is not sufficient to change clinical practice so innovative approaches need to be tested in dentistry. The composite expertise of the investigators and consultants on this project and a large group practice with multiple clinics utilizing one EDR are essential to address the aims of this study. This project will examine whether dentists and hygienists will assess interest in quitting and deliver a tobacco intervention more frequently when provided with computer assisted guidance compared to a control group. Specifically the investigators will measure the delivery of questions assessing willingness to change and appropriate interventions based on willingness to change by measuring the recording of these activities in the EDR and patient receipt of these recommendations through a phone survey. In addition, the study will do a qualitative assessment of the patient perceived value of the provider-patient encounter to further inform us about patient perception of this interaction. The investigators want to know if dental providers will utilize these tools during the dental encounter. If they are used, the investigators would propose further studies examining smoking cessation rates. The investigators were not able to measure cessation rates due to the short two year timeline of this funding mechanism. This tool has potential application for other clinical topics, which makes this approach very innovative when considering the translation of evidence into the unique clinical practice of dentistry.


Eligibility Criteria:
Inclusion Criteria:

* Adult dental patient presenting for an exam visit whose most recent history reports the patient is a smoker. Patients had to agree to the phone survey.

Exclusion Criteria:

* Research opt out list
* Patients who discontinued the survey prior to completion(considered withdrawals)