cyrilzakka/clinical-trials huggingface dataset:
Weaning From Noninvasive Ventilation

Noninvasive ventilation (NIV) weaning strategies differ considerably from one another. These strategies have yet not been compared to each other. Therefore, the investigators planned to perform a prospective, randomized, pilot study involving hypercapnic acute respiratory failure patients ready to be weaned off from NIV. The investigators are going to compare the success rate of NIV weaning and the duration of NIV after randomization between 3 NIV weaning methods: gradual decrease in duration of NIV or level of ventilator support, and abrupt discontinuation of NIV.


Eligibility Criteria:
Inclusion Criteria:

Patients will be screened by the physician 24 hours (±6 hours) after initiation of NIV treatment if:

* Age ≥18 years old
* Hypercapnic ARF ( baseline pH\<7.35, paCO2\>45 mmHg, BORG\>4)
* Breathing frequency\< 25 bpm under NIV
* pH \>7.35 under NIV
* 10% or more decrease from baseline PaCO2 under NIV
* Kelly ≤ 2 under NIV (Alert. Follows simple/3 step complex commands)
* PaO2 between 60 and 70 mmHg under NIV
* No need for sedation
* Systolic blood pressure 90-180 mmHg without vasopressors
* Body temperature 36-38°C
* Heart rate 50-120 bpm

The patient will be enrolled to the study and will be randomized to one of the NIV weaning protocols, if passes daily weaning criteria listed below after 1 hour of spontaneous breathing (with supplementary oxygen),

* Respiratory rate 8-30 bpm
* Systolic blood pressure 90-180 mmHg without vasopressors
* Body temperature 36-38°C
* Heart rate 50-120 bpm
* Neurologic score of Kelly ≤2 (Alert. Follows simple/ 3-step complex commands),
* SaO2 ≥88-92% with a FiO2≤40%.
* pH≥7.35
* Absence of severe dyspnea (BORG\>4).

Exclusion Criteria:

* Age \<18 years old
* NIV use at home for chronic respiratory failure
* CPAP use for acute respiratory failure
* NIV use as palliative treatment
* Severe heart failure with cardiac index ≤ 2 L/min/m2
* Severe hepatic failure with bilirubin ≥ 34.2µmol/L
* Severe renal failure with creatinine ≥ 220 µmol/L
Maxillary Sinus Augmentation Using Different Size Bovine Bone Particles

The decrease in maxillary alveolar ridge bone volume and sinus pneumatization are a challenge to implant-assisted prosthetic rehabilitation. Guided bone regeneration using bone substitutes is an adequate alternative for maxillary sinus augmentation. Objective: To histologically and histomorphometrically compare bone repair response to 250 to 1000 µm and 1000 to 2000 µm anorganic bovine bone mineral (ABBM) particles as bone substitute in maxillary sinus augmentation (MSA).

Twenty patients were treated with SMA in two steps. They were randomly assigned to one of two groups (n=10): SPG (small particles group) and LPG (large particles group). Different size ABBM particles were implanted in their maxillary sinus, accordingly. A vertical bone core biopsy was obtained at the implant site using a punch trephine. The samples were processed for histological observation and measured histomorphometrically to determine the percentage onewly formed bone (%NB), bone substitute (%BS), bone marrow (%BM), and osseointegration (%OI). Results were statistically analyzed using Student's t test (p ≤ 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients over the age of 21 years
* Patients missing teeth in the maxillary sinus region (uni- or bilaterally) with a residual subantral bone height ≤ 4 mm and an alveolar ridge width ≥ 6mm.
* Patients who had not undergone tooth extraction within 6 months prior to enrollment.

Exclusion Criteria:

* Patients with diabetes, blood discrasias, a history of head and neck chemotherapy/radiation therapy, acute sinusitis or a history of allergic sinusitis, chronic polypoid sinusitis, or sinus tumors, or a history of Caldwell-Luc surgery
* Women who were pregnant or of childbearing age
* Alcoholics and drug abusers
* Patients requiring MS treatment showing anatomical features of the MS that contraindicated the surgical treatment
* Patients who refused to sign the informed consent form

Patients with a history of chronic periodontitis were treated and then enrolled in the study. Patients who developed post-operative maxillary sinus infection or showed allergic reactions attributable to the grafting material were eliminated from the study.
Evaluation of Pancreatic Steatosis in Patients With Cancer of Pancreas

Prognostic Importance of Quantitative Magnetic Resonance Imaging for Evaluation of Pancreatic Steatosis in Patients with Pancreatic Cancer

1. Finding patients with pancreatic cancer (in all stages), before any treatment.
2. Non invasively quantify fatty infiltration of pancreas using, MRI DIXON Scan in pancreatic cancer patient relatively to liver.
3. Measuring cell-free blood DNA in those patients for evaluating the aggressiveness of the disease.
4. Quantify the prognostic significance of pancreatic steatosis in comparison with clinical and pathological prognostic indexes used today.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with any pancreatic cancer, in any stage, before treatment.
* \>18 y.o

Exclusion Criteria:

* claustrophobia
* GFR\<30
* patients with non mri compatible devices (e.g. orthopaedic external fixation system)
* After chemotherapy treatment or surgical procedure
PROPHYSOME: Pilot Study on Safety of a Weekly Administration of 10mg/kg of AmBisome® in Antifungal Prophylaxis Treatment of Allogeneic Stem-cell Transplantation and Acute Leukaemia

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen, in a weekly administration schedule, during the aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.

This pilot study was designed in order to evaluate the safety and efficacy of an AmBisome loading dose regimen, in a weekly administration schedule, during the aplastic phase following induction or consolidation chemotherapy for acute leukaemia, and during the initial phase of allogeneic stem-cell transplant, which are both high risk periods as far as severe fungal infections development is concerned.

Eligibility Criteria:
Inclusion Criteria:

Male or female patients aged more than 18, Patients undergoing standard myelo-ablative, conditioning regimen and AGVHD ciclosporin prophylaxis for allogeneic stem cell transplantation, or Patients with acute leukaemia undergoing first induction therapy or second induction therapy after relapse, or consolidation therapy, Expected neutropenia \< 0.5 giga/l for at least 2 weeks, Normal chest CT scan and/or normal X-ray of the chest at baseline, Patients with no sign or symptoms of fungal infection and no previous proven or probable IFI, Females of childbearing potential must be surgically incapable of pregnancy, or practising an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline, Understanding of the study and agreement of the patient to give written informed consent, Ability and agreement to comply with all study requirements, Patient willing to attend hospital appointments for each injection (infusions will be performed in hospital, under strict medical supervision). All patients will be hospitalised prior to, and remain in hospital for at least one day, after the first infusion.

Exclusion Criteria:

Known hypersensitivity to amphotericin B, in particular known history of anaphylactic reaction to amphotericin B, Patients undergoing cord transplantation, Creatinine clearance \< 60 ml/min, Patient with moderate or severe liver disease as defined by AST or ALT \> 5 times the upper limit of normal (ULN), Patients who are unlikely to survive more than 1 month, Febrile patients (≥ 38.5°C), Patients who have received systemic antifungal therapy within 15 days prior to the inclusion, Any severe cardiovascular disease (such as arrhythmias, in particular) which may constitute a contra-indication to AmBisome® administration, Any severe disease other than the haematological diseases described in the second inclusion criteria, which in the investigator's judgement may interfere with study evaluations or affect the patient's safety, Pregnant or nursing females, Patients previously included in this study, Patients who have taken any investigational drug in the last 30 days prior to the inclusion.
A Prospective Comparative Study Between Oncoplastic Breast Surgery and Standard Wide Local Excision

The aim of this study is to asses the oncological safety of oncoplastic breast surgery, and its impact on patient satisfaction.

This non-randomized prospective trial was conducted on70 female patients presented to tertiary breast unit-Ain Shams University hospitals with breast cancer during the period from September 2012 to February 2013. All patients sharing in the study signed an informed consent that was approved in the ethical committee held on April 2012. Patients were classified in two groups each one 35 patients: group (A) standard wide local excision and group (B) oncoplastic group. Standard wide local excision done by general breast surgeons while oncoplastic surgeries done by breast surgeon assisted by plastic surgeon. The following data were recorded: Age, family history, margin length, weight and volume of the specimen, margin status and patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with macromastia in oncoplastic group.
* Tumors \>20% of breast volume in oncoplastic group.
* Young patients in oncoplastic group
* Tumors in medial or central quadrants in oncoplastic group

Exclusion Criteria:

* Patients \>60 years.
* Patients with co-morbidities in oncoplastic group.
* Tumors \>20% of breast volume in standard group.
* Tumors in medial or central quadrants in standard group
Nano-Ceramic Coating for Laparoscope Lens

The investigator tests the effectiveness of nano-ceramic coating when applied (painted) on laparoscope lens to protect it from fogging or smearing during laparoscopic operations

A Ceramic Coating is a liquid polymer that is applied by hand to surfaces to make them resistant to scratching, staining, rust or oxidation, as well as "hydrophilic", meaning that water or mud doesn't stick to them and so, they become much easier to clean. It was publicly commercialized in recent years for use on automobiles to preserve their gloss, protect their paint, preserve the clarity of their wind shields and headlights so as to provide better lighting and vision.

On the other hand, lens fogging and other vision-obstructing events during laparoscopic or endoscopic operations(e.g. being smeared by blood or other body fluids during operation, or having a piece of loose tissue stick to its surface that require manual removal and wiping) have been an ever-lasting concern for operators ever since the advent of the respective devices. Many techniques and methods have developed, tested and compared regarding their effectiveness in protecting the lens from such events and preserving vision clear and uninterrupted during operations. Examples of such methods are (scope warmers, FREDTM, ResoclearTM, chlorhexidine, betadine and immersion in heated saline.

In this study the investigator seeks to apply the idea of nano-ceramic coating as a new technique for achieving that goal. to the investigator's best knowledge, this idea was never conceived or tested in the field before.

Eligibility Criteria:
Inclusion Criteria:

* Any patient requiring laparoscopic operation

Exclusion Criteria:

* Any intra-operative event or obstacle that requires conversion to open surgery
The 3 Years vs 1 Year DAPT After XINSORB BRS Implantation

The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
2. Written informed consent from the subjects
3. Qualified candidates for coronary bypass surgery
4. Lesions with reference vessel diameter 2.75 to 3.5 mm

Exclusion Criteria:

1. Age ≤ 18 years
2. Cardiogenetic shock
3. Chronic heart failure with a left ventricular ejection fraction ≤ 30%
4. Oral anticoagulation therapy
5. Known allergy or intolerance to the study medications
6. Malignancies and other comorbid conditions with a life expectancy less than 5 years
7. Subjects treated with both BRS and DES during the index procedure
8. Pregnant wowen
9. Planned staged PCI
10. Contemporaneous enrollment in a different clinical trial
11. Any revascularization within 1 year
12. Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
13. Unprotected left main artery
14. Lesions located at the ostium of the main coronary artery
15. bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy
Can Parental Activation Over the Internet Improve Pediatric Preventive Care?

This study is a randomized controlled trial of an evidence based, patient specific web site's ability to improve preventive practices in pediatric care. Parents visit the website within 2 weeks of a scheduled well child visit and are presented with a menu of age specific topics that they can read about as they wish.


Eligibility Criteria:
Inclusion Criteria:

* \<11 years

Exclusion Criteria:

* Non-English speaking
Treatment of Women After Postpartum Haemorrhage

The primary purpose of this study is to compare the efficacy of IV high single dose infusion of iron isomaltoside 1000 to standard medical care in women with PPH evaluated as physical fatigue.


Eligibility Criteria:
Inclusion Criteria:

1. Women with PPH ≥ 700 and ≤ 1000 mL or PPH \> 1000 mL and Hb \> 6.5 g/dL (4.0 mmol/L) measured \> 12 hours after delivery
2. Willingness to participate and signed the informed consent form

Exclusion Criteria:

1. Women aged \< 18 years
2. Multiple births
3. Peripartum RBC transfusion
4. Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
5. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
6. Women with a history of active asthma within the last 5 years or a history of multiple allergies
7. Known decompensated liver cirrhosis and active hepatitis
8. Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
9. Active acute infection assessed by clinical judgement
10. Rheumatoid arthritis with symptoms or signs of active joint inflammation
11. History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
12. Not able to read, speak and understand the Danish language
13. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
14. Any other medical condition that, in the opinion of the Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
Chronic Lymphocytic Leukemia Registry Study - Multicenter Prospective National Study

A prospective, multicenter national observational study for patients diagnosed as chronic lymphocytic leukemia across 25 centers in Turkey

The purpose of this study is to explore the history and real world management of patients diagnosed with CLL, provide insight into the management of CLL, and evaluate the effectiveness of first, second and subsequent therapeutic strategies employed in both the community and academic settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as CLL
* 18 years or older
* Able and willing to provide the written informed consent

Exclusion Criteria:

* Younger than 18 years
Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis

This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.

This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H\&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients with pathology and / or cytologic diagnosis;
* Age 18\~75 years old;
* The expected life is more than 3 months;
* The Karnofsky score (Karnofsky) ≥70 points;
* The first course of radiotherapy in patients;
* Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
* Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme;
* No history of oral ulcer and salivary gland diseases

Exclusion Criteria:

* That do not meet the above the inclusion criteria;
* Advanced critical cases, the expected survival is less than 3 months;
* The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
* The submandibular gland pathological changes;
* During radiotherapy taking other drugs in patients with treatment of stomatitis;
* The patients with serious heart, brain, liver, kidney function
The Diagnostic Yield of Cap Assisted Upper Endoscopy in Esophagus

Cap assisted colonoscopy, a simple technique of fixing a transparent plastic cap to the tip of the colonoscope, was proven to increase the adenoma detection rate during screening colonoscopy by helping to depress and flatten colonic folds, thereby improving visualization and decreasing blind mucosal areas. The usefulness of cap assisted upper endoscopy (CAE) is still under investigations. The aim of this study is to compare the diagnostic yield of the CAE to the standard endoscopy in esophagus.


Eligibility Criteria:
Inclusion Criteria:

* indication for upper endoscopy
* age over 18 years
* ability to provide informed consent

Exclusion Criteria:

* known or suspected upper gastrointestinal strictures
* upper gastrointestinal bleeding
* previous upper endoscopy during the last three months
* American Society of Anesthesiologists class III or higher
Repurposing Fenofibrate in Modulating mTOR/NLRP3 Inflammasome in Patients With Ulcerative Colitis

Fibrates, specific pharmacological agonists of PPARα, have been widely used to treat hypercholesterolemia and hypertriglyceridemia. Apart from their metabolic action, anti-inflammatory properties of fibrates have been described, including inhibition of NF-kappa B signaling and pro-inflammatory cytokine production. 4 Fenofibrate, an important peroxisome proliferator-activated receptor-a (PPAR- α) agonist, is widely used in clinical as a triglyceride (TG)-lowering agent


Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years Both male and female will be included Negative pregnancy test and effective contraception. Mild and moderate UC patients diagnosed and confirmed by endoscope

Exclusion Criteria:

Breast feeding Significant liver and kidney function abnormalities Colorectal cancer patients Other inflammatory bowel diseases (CD). Patients with severe UC Patients taking rectal or systemic steroids Patients taking immunosuppressives or biological therapies Addiction to alcohol and/or drugs Known allergy to the Fenofibrate
Dynamic Navigation vs. the Freehand Method

The purpose of the study is to evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.

Randomized clinical trial with 2 parallel treatment groups. Eligible patients will be randomized with a 1:1 ratio to one of 2 possible parallel treatment groups:

* Group 1: Nobel Replace Conical Connection® placed freehand.
* Group 2: Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA).

PRIMARY OBJECTIVE:

- To evaluate in novice surgeons the accuracy of the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.

SECONDARY OBJECTIVES:

* To evaluate overall surgical time with the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) compared to freehand implant placement in inexperienced surgeons.
* To evaluate Patient Reported Outcomes Measures (PROMs) during implant treatment with navigation systems performed by novice surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who agree to voluntarily sign the informed consent before performing any action related to the study.
* Men or women at least 18 years old.
* Single edentulous spaces or edentulous sections located in maxilla or mandible with a healing period longer than 12 weeks to rehabilitate with implant-supported fixed crowns ≤3 units.
* O'Leary plaque and/or bleeding on probing index ≤25%.

Exclusion Criteria:

* Systemic diseases that may interfere with dental implant placement.
* Any contraindications for oral surgical procedures.
* History of head and neck radiotherapy.
* Patients smoking \>20 cigarettes/day or tobacco equivalents.
* History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the opinion of the investigator, could interfere with the patient's ability to cooperate and comply with the study.
* Patients who have participated in a clinical trial within the last 30 days.
* Pregnant or lactating women.
* Patients with poor or unmotivated oral hygiene.
* Probing depth with bleeding of ≥4 mm in one of the teeth adjacent to the edentulous space or tract.
* Need to perform guided bone regeneration procedures simultaneous to implant placement.
* Cases where the use of transepithelial abutments is not recommended (reduced prosthetic space, high esthetic demand associated with thin gingival biotypes, etc.).