cyrilzakka/clinical-trials huggingface dataset:
Early Induced Hypernatremia for the Prevention and Management of Brain Edema

The purpose of this study is to estimate the effect of an early induced hypernatremia protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145 milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain injury managed at critical care unit.

Severe traumatic brain injury is one of the main causes of death in young people. Additionally, it is considered a public health problem because of the high prevalence of motor and cognitive dysfunction in those who survive.

One of the cornerstones of management is the control of both intracranial pressure and brain edema. It is indicated to use osmotic active solutions to modulate the transit of fluids from the interstitial to the intracellular space. Not only mannitol but also hypertonic saline acts at this point. Currently there is no evidence in favor or against one of them.

Mannitol has been usually recommended for intracranial pressure control in patients with brain trauma. However, others recommend hypertonic saline to achieve a serum sodium level of 160 milliequivalent/L to modulate brain edema. It is not clear if these therapies have an impact on the neurologic prognosis and how frequently adverse effects occur.

Eligibility Criteria:
Inclusion Criteria:

1. Patient greater than 14 years old, who suffered severe non-penetrating Brain Trauma (Glasgow Coma Scale (GCS) equal or less than 8) and a motor GCS equal or less than 5.
2. Criteria time: admitted to the Hospital in the first 24 hours of the Brain Trauma (BT) and admitted to ICU in the first 48 hours of brain trauma.
3. Tomographic evidence of brain edema (one of the following criteria: deviation from the midline, obliteration of perimesencephalic cistern or altered cortico-subcortical differentiation).

Exclusion Criteria:

1. Patient with GCS 3 and bilateral mydriatic pupils and unreactive to light, in the presence of hemodynamic stability (systolic blood pressure equal or greater than 90 mmHg).
2. Patient with insipid diabetes at the ICU admission.
3. Patient with limitation of therapeutic effort.
4. Non-neurological Abbreviated Injury Score greater than 3.
5. Patient past medical history of kidney failure, liver disease or heart failure.
6. Serum sodium less than 135 or greater than 150 milliequivalent/L.
7. Pregnancy.
8. Terminal disease.
9. No authorization to be enrolled in the trial by the patient's caregiver
Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.

The primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. This included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture.

We conducted a prospective observational diagnostic accuracy study. Young infants less than 90 days of age presenting to the Royal Belfast Hospital for Sick Children with signs of possible bacterial infection were eligible for inclusion. Eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a BRAHMS assay on the Samsung LABGEO IB10® analyser.

Eligibility Criteria:
Inclusion Criteria:

* Suspected bacterial infection

Exclusion Criteria:

* None
Wrist Cartilage - High Resolution in Vivo MR T2 Mapping- a Feasibility Study

Purpose:Evaluate the feasibility of T2 cartilage mapping on MRI of the wrist and correlate with T2 mapping of knee cartilage.

Study protocol: Phase 1. 10 healthy volunteers, Phase 2. 10 volunteers with osteoarthritis of the wrist, Phase 3. 50 patients for studies for routine MR of the wrist.

MRI protocol: 3 T unit((Signa EXITE HDx),T1, T2 and T2 mapping sequences on axial and coronal orientation.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1. Age:18-40
* Phase 2: No age limit, known OA on pre-existing X-rays
* Phase 3: No age limit, routine MRI of the wrist

Exclusion Criteria:

* Phase 1, 2: wrist trauma/surgery
* All phases: any contraindication for MR: eg metals, claustrophobia, etc.
Clinical Evaluation of Internal Fit of Milled BioHPP Polyetheretherketone (PEEK) - Based Versus Zirconia-Based Single Crowns

All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . .

Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce.

Aim of the study:

- The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.


Eligibility Criteria:
Inclusion Criteria:

* From 18-50 years old, be able to read and sign the informed consent document.
* Patient Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patient Psychologically and physically able to withstand conventional dental procedures
* Patients with teeth problems indicated for single posterior crowns:

Exclusion Criteria:

* Patient less than 18 or more than 50 years
* Patient with active resistant periodontal diseases
* Patients with poor oral hygiene and uncooperative patients
* Patients in the growth stage with partially erupted teeth
* Patient with Psychiatric problems or unrealistic expectations
* Patient with Lack of opposing dentition in the area of interest
Periostin and Non-Surgical Periodontal Treatment

A total of 90 subjects, 30 patients with chronic periodontitis, 30 with gingivitis and 30 periodontally healthy subjects were included. Patients with periodontal disease received non-surgical periodontal treatment. Gingival crevicular fluid periostin levels were assessed at baseline, at the 6th week and the 3rd month after treatment.

Periostin is commonly found in collagen-rich tissues, which is thought to affect the production of collagen fibers. Additionally, periostin is synthesized in tissues exposed to constant mechanical forces such as the periosteum, periodontal ligament, tendon, heart valve and skin. Periostin mediates inflammation and fibrosis during diseases of various organs, including the heart, lung, kidney, skin, liver, skeletal muscle and retina.

This study evaluated periostin levels in gingival crevicular fluid from patients with chronic periodontitis, gingivitis and periodontally healthy as well as the effect of non-surgical periodontal treatment on gingival crevicular fluid periostin levels.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic periodontitis
* Clinical diagnosis of gingivitis
* Clinical diagnosis of periodontal health

Exclusion Criteria:

* have any systemic disease
* to be alcohol consumer
* to receive any periodontal therapy in the past 6 months
* to take any drugs regularly
* to be pregnant and/or lactate
"Efficacy Of 1.2% Rosuvastatin Gel In The Management Of Infrabony Defects"

Study aims to evaluate clinical and radiographic effectiveness of 1.2% Rosuvastatin gel in the treatment of Infrabony defects in chronic periodontitis patients.

Source from where the patients will be selected:

10 patients with chronic periodontitis having two or more infrabony defects will be selected from the Outpatient section of Dept. of Periodontology, Dr. D. Y. Patil Dental College and Hospital, Pimpri, Pune - 18.

A detailed clinical examination, case history and written consent will be obtained from all the participants.

Before surgery, each patient will be given careful instructions regarding proper oral hygiene measures. A full-mouth phase I therapy will be performed. A periodontal re-evaluation will be performed after 4 to 6 weeks of phase 1 therapy to confirm the desired sites for the study. The selected sites will be divided randomly by using a Sequentially numbered, opaque, sealed envelopes (SNOSE) randomization into control and test sites. The control site will be treated with Access Flap Surgery (AFS), whereas test sites will be treated with AFS and 1.2% Rosuvastatin gel. Suitable antibiotics and analgesics will be prescribed along with Chlorhexidine digluconate rinses (0.2%) twice daily for 14 days. Patients will be examined at 4 weeks, 3 and 6 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age group between 30-50 years
* Probing pocket depth ≥ 5mm following initial therapy.
* Suitable interproximal angular infrabony defects of ≥3mm.
* Involved teeth should be vital and asymptomatic.
* Systemically healthy patients.
* Patients who demonstrate acceptable oral hygiene prior to access flap surgery.
* Patients agreed to sign informed consent and willing to return for the follow up visits.

Exclusion Criteria:

* Systemic statin therapy
* Known or suspected allergy to the statin group
* Allergy to sulfur containing drugs
* History of aggressive periodontitis.
* Presence of gingival recession at the surgical site.
* Mobility of study teeth ≥ grade I.
* Use of tobacco in any form.
* Pregnant and lactating women.
* patients who have received any anti-inflammatory drugs and antibiotics in the previous six months.
* H/O osteoporosis.
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Small Cell Lung Cancer

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 restricted epitope peptides CDCA1 and KIF20A emulsified with Montanide ISA 51 for advanced small cell lung cancers.

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Eligibility Criteria:
Inclusion Criteria:

1. SCLC that can not undergo curative surgery and treatment, and is refractory to standard chemotherapy and radiotherapy
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4 weeks
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402
9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge
A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis

Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis.

This study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.

Participants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.

The doctors also regularly check participants' health and take note of any unwanted effects.


Eligibility Criteria:
Inclusion criteria

* Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,
* Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,
* Inadequate response, loss of response, or intolerance to treatment with biologic/targeted therapy or termination of treatment with biologic/targeted therapy for any other reason,
* Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,
* Further inclusion criteria apply.

Exclusion criteria

* Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),
* Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),
* Evidence of colonic moderate/severe mucosal dysplasia or colonic adenomas, unless properly removed,
* Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,
* Evidence of fulminant colitis or toxic megacolon at screening,
* Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,
* Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),
* Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,
* Further exclusion criteria apply.
CArdioSurgEry Atrial Fibrillation Register

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation.

CASE AF aims to describe the reality of medical care of patients in whom atrial fibrillation is treated by cardiac surgical ablation. In particular, the following questions should be answered:

* Indication: Which are the different indications for cardiac surgical ablation in patients with atrial fibrillation?
* How often and in which patients the different concepts of surgery and ablation procedures are used? At the same time, how often an intervention at the left atrial appendage is carried out?
* Safety: How secure is the cardiac surgical ablation of atrial fibrillation (periprocedural, during hospital stay and during the long-term follow up)?
* Effectiveness: How effectively is the cardiac surgical ablation of atrial fibrillation (procedural success)? How often are AF recurrences in the long-term follow up?
* What is the concommitant medical treatment after surgical ablation?

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrilation
* Treated by cardiac surgical ablation

Exclusion Criteria:

* Patient denies participation
The Effect of Systemic Dietary Instruction on Management of Plasma Phosphorus Levels in Peritoneal Dialysis (PD) Patients

Hyperphosphatemia is highly prevalent in PD patients, and it is an independent risk factor for all-cause and cardiovascular mortality in these patients. Effective treatments are limited in suppressing plasma phosphorous. Because of the nearly linear relationship between protein and phosphorus intake, high dietary protein intake (DPI, 1.2-1.3g/kg/d recommended by KDOQI) would load high phosphorus burden in PD patients. It is suggested that hyperphosphatemia is hard to avoid under such a DPI level, even as the patients take sufficient phosphorus blinders and receive high PD dosage. The present study is to investigate whether systemic dietary instruction would show effects on control of hyperphosphatemia in PD patients.


Eligibility Criteria:
Inclusion Criteria:

1. Stable on PD for at least three month
2. Aged from 18 to 75 years old
3. Informed consent approval

Exclusion Criteria:

1. Malnutrition (based on SGA results)
2. Infection or inflammation within 1 month
3. Concurrent wasting disease (i.e. cancer, tuberculosis)
Effects of ROFLUMILAST on Subclinical Atherosclerosis in Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease is associated with a low grade systemic inflammatory process. Systemic inflammation is hypothesized to maintain cardiovascular morbidity and mortality in COPD. Early changes of vascular integrity can be detected via markers of subclinical atherosclerosis.

Selective Inhibition of phosphodiesterase subtype 4 describes a promising therapeutic option in COPD with beneficial impact on lung function and exacerbation rate. Moreover, an anti-inflammatory effect of phosphodiesterase-4 inhibition was confirmed by recent data.

The aim of this study is to assess the effects of the phosphodiesterase-4 inhibitor Roflumilast on firstly surrogates of subclinical atherosclerosis and secondly markers of systemic inflammation in the peripheral circulation of patients with stable chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Over 40 years of age
* Smoking history of at least 10 pack years
* Chronic obstructive pulmonary disease at Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage II - IV diagnosed according to standard criteria.
* History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year

Exclusion Criteria:

* Insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period
* History of acute exacerbation 4 weeks prior to run-in period
* Diagnosis of alpha-1-antitrypsin deficiency
* Diagnosis of asthma
* Acute respiratory infections (e.g. pneumonia)
* Severe acute infectious diseases (e.g. active hepatitis, HIV)
* Lung cancer
* Bronchiectasis
* Interstitial lung disease
* Any other relevant lung disease
* Acute myocardial infarction
* Systolic left ventricular dysfunction
* Congestive heart failure New York Heart Association Functional Classification (NYHA) severity grade IV
* Haemodynamically significant cardiac arrhythmias or heart valve deformations
* Peripheral arterial occlusive disease
* Acute or chronic renal/hepatic failure
* Active malignancy
* Autoimmune disease
* Pregnant or breastfeeding women
* Women no using or not willing to use adequate contraceptive measures for the duration of the trial
* Hypersensitivity to study medication or placebo
* Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour
* Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption
Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patient related considerations
* Patients with diabetes mellitus
* Disease related considerations
* Diabetes mellitus

Exclusion Criteria:

* Prior admission screening within twelve months.
* Inability to sit for evaluation
Using Multi-looped Lingual Retainer to Relief Anterior Mandibular Crowding

this study aim to evaluate the multi-looped lingual retainer activated by a new method to relief the anterior crowding

1. patients preparation( photo- impression- x-ray- scan the lower cast to calculate the crowding )
2. The multi-looped lingual retainer was fabricated on the patient's lower cast
3. The lingual surfaces of teeth were etched with 35% phosphoric acid for 20 seconds The multi-looped lingual retainer was activated in the new way (Kattan method ) by tightening a steel ligature wire 0.010 inches, to the reinforcement 0.020-inch stainless steel arch-wire.
4. the bonding agent was applied on such surfaces after a good isolation and was light-cured for 20 seconds.
5. A flowable composite resin was applied. After checking its fit on the surface of the teeth, The lingual wire was bonded with a drop of flowable composite resin and was light-cured for 20 seconds.
6. follow-up the patients \* Outcomes: The improvement of lower incisors irregularity using Little Irregularity Index.

Eligibility Criteria:
Inclusion Criteria:

* Adult male and female patients, the ages of 16 to 25, the patients having class I canine with mild to moderate lower incisors crowding
* good oral hygiene.

Exclusion Criteria:

* Facial trauma, Oral habits such as onychophagia, pen biting, and tooth mobility.
Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment procedures. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:

Does 3-dimensional (3D) imaging device improve the correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy?

Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve classification and evaluation accuracy.

Participants will:

Undertake colonoscopy examination and polypectomy using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device.

Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 years;
* Endoscopically diagnosed with colorectal polyps;
* Signing the written informed consent.

Exclusion Criteria:

* Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
* Patients with severe cardiopulmonary insufficiency;
* Patients with severe coagulation disorders or high bleeding risk (platelets \<50×10⁹/L, INR \>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
* Patients with severe electrolyte imbalances;
* Patients with acute peritonitis or suspected intestinal perforation;
* Patients with severe inflammatory bowel disease/toxic megacolon;
* Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \[FAP\], Lynch syndrome, etc.);
* Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
* Patients with untreated severe abdominal hernia, intestinal obstruction, or advanced colorectal cancer;
* Patients with intestinal strictures of any cause;
* Cases requiring only endoscopic submucosal dissection (ESD);
* Pregnancy and lactation.