cyrilzakka/clinical-trials huggingface dataset:
Internally Irrigated and Externally Irrigated Surgical Guide Design for Placement of Dental Endosseous Implants

Background: Patient specific surgical guides (PSG) have been widely used to achieve a precise 3D implant position. However, they prevent external cooling systems from reaching the osteotomy site sufficiently. So, heat generated during guided implant surgery is greater than free hand technique. Adding internal irrigation channel to the conventional surgical guides allows better diffusion of irrigation to the osteotomy site and reduces heat generation.

Aim of the study: Is to introduce a patient specific surgical guide design with internal irrigation system and compare it to the conventional surgical guide with external irrigation clinically through bone temperature, implant stability and radiographically by CBCT through crestal bone loss and bone density.


Eligibility Criteria:
Inclusion Criteria:

* Patient with missing mandibular posterior premolar or molar teeth.
* Tooth extraction at the implant sites was performed at least 4 months before the surgery.
* Residual alveolar bone height more than 10 mm.
* With minimum alveolar bucco-lingual dimension of 6 mm.
* Free from any systemic disease or local pathological lesions that may affect bone healing or contraindicate implant placement.

Exclusion Criteria:

* Severe atrophic alveolar ridge (height less than 10mm, width less than 6mm).
* Bad oral hygiene ( Silness-Löe index (score 2-3).
* Heavy smoker (smoke greater than or equal 25 cigarettes per day).
* Presence of acute infections or periapical lesions in adjacent teeth.
* Parafunctional habits.
* Pregnant females.
Zürich Pulmonary Hypertension Outcome Assessment Cohort

PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigators intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters.

PH is a serious disease with a dismal prognosis and impaired quality of life when left untreated. Advances in medical therapy have improved survival according to recent registries, but are associated with high healthcare costs. Most treatment trials and clinical follow-up assessments rely on the 6 minute walk distance as main outcome parameter although submaximal exercise performance reflects only one disease aspect.

Reliable patient centered and prognostically relevant outcome measures are highly warranted in the field of PH. With this prospective cohort study the investigator intend to gain important information on the course of the disease and knowledge on the value of different new and already established outcome parameters. New outcomes to be assessed will be home based activity monitoring, novel physiological measures, namely cerebral and muscle tissue oxygenation at rest and during exercise testing, stair ascent on mechanograph, sit to stand test and several serum markers and micro-RNA. All these assessments will be compared with hard endpoints events (death, lung-transplantation, hospitalization for PH), and with traditional outcome measures such as NYHA functional class, 6 minute walk distance, generic quality of life, cardiopulmonary exercise tests, sleep studies, health preference (utility) and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with precapillary pulmonary hypertension
* Adult male and female patients of all ages referred to our center for evaluation/treatment of PH
* Written informed consent by the subject after information about the research project

Exclusion Criteria:

* Patients with severe concomitant left heart disease (left ventricular ejection fraction \<40%).
* Patients with restrictive lung disease (FVC\<60% predicted); obstructive lung disease (forced expiratory volume (FEV) \<60% predicted, with FEV 1/FVC\<70%).
* Patients with any other disease limiting their ability to move (skeletal disease, neurological disease, etc.)
The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy

The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.

The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone \>2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* body mass index \<35,
* renal stone size \>2.0 cm.

Exclusion Criteria:

* patients having supra-costal puncture.
* excessive intraoperative bleeding.
* renal stones requiring more than a single puncture.
* surgical procedure extending more than 3 hours.
* urinary tract infection.
* severe cardiopulmonary disease.
* abnormal renal function tests.
* allergy to local anesthetics.
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors

This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.

This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.

Eligibility Criteria:
Inclusion Criteria:

* Completed NK-104-304 (NCT 00309738)
* Hypercholesterolemia or combined dyslipidemia
* 2 or more risk factors for coronary heart disease (CHD)

Exclusion Criteria:

* Withdrawn or terminated from NK-104-304 (00309738)
Observational Retrospective Study on Clinical Outcomes of Patients Receiving Benralizumab in Spain.

Primary Objectives:

1. To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma in Spain who received at least one dose of Benralizumab, after its marketing authorization
2. To describe background treatment patterns of severe eosinophilic asthma patients at baseline and after the index date (benralizumab initiation)

This is a descriptive, observational, multi-centre, longitudinal, retrospective cohort study in adults patients (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who, at the discretion of the physician, received benralizumab accordingly to the clinical practice, in the period after the marketing authorization of benralizumab in Spain, on January 1st 2019.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age ≥18 years)
* Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller.
* Patients with at least 12-month data available before index date (starting benralizumab treatment)
* Patients with at least 3-month electronic medical records data available from first benralizumab dose ("index date")
* Informed consent signed.

Exclusion Criteria:

* Patients who received benralizumab in a clinicaltrial, during the observation period.
A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

To determine the improvement in the self-esteem domain score of the Self-Esteem/Overall Relationship (SEAR) questionnaire and the improvement in erectile function (obtained from the Erectile Function \[EF\] domain of the International Index of Erectile Function \[IIEF\]). Furthermore, to determine if the improvement obtained in self-esteem was related to the main erectile dysfunction (ED) co-morbidities type and/or number.


Eligibility Criteria:
Inclusion Criteria:

-Men with a documented clinical diagnosis of ED confirmed by a Sexual Health Inventory-Male (SHI-M) score of 21 or less and who have a sexual partner for the duration of the study were included.

Exclusion Criteria:

* Subjects who have previously taken, or it is suspected they have taken, more than 4 doses of sildenafil citrate, or any other phosphodiesterase type 5 (PDE-5) inhibitor, or apomorphine, at any time prior to the screening visit or patients who have taken any dose of these compounds in the last two months
* Subjects with resting sitting hypotension (BP \< 90/50mmHg) or hypertension (BP \> 170/110mmHg)
* Subjects with significant cardiovascular disease, including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischaemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias in the last 3 months
* Patients on nitrates.
Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome

Proteomics is used to identify prognostic markers after CPR. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Proteomics is used to identify prognostic markers after CPR, i.e. altered proteins on a 2G-gel. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Eligibility Criteria:
Inclusion Criteria:

* cardiac arrest

Exclusion Criteria:

* trauma
Effect of Airway Integrated Nasal Packing With Different Material

The purpose of this study is to determine the effect of integrated airway in nasal packing material foe patients receiving nasal septoplasty surgery.

Nasal packing with integrated airway had been claimed to improve body oxygenation following septal surgery. This randomized control study examined the effect of airway integrated with nasal packing, in terms of its improvement on oxygen saturation. Sixty patients with septal deviation and hypertrophic turbinate were randomized into three groups. Group 1 patients were packed with only nasopore@ after surgery. Nasopore@ with integrated airway was used for group 2 patients; and Vaseline gauze integrated with airway for group 3 patients. Hemodynamic parameters were sequentially checked. Nasal pain sensation was recorded using visual analog scale.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent septoplasty for septal deviation and chronic hypertrophic rhinitis

Exclusion Criteria:

* patients with comorbidities of coronary heart disease, arrhythmia, chronic obstructive lung diseases, and with past history of any nasal surgery were excluded.
Vitrectomy Retinal Oxygenation

Vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. Recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. In eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. However, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery.

Hypoxia is a the major trigger of vascular endothelial growth factor (VEGF), which is in turn the most important factor for the development of macular edema. It is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. However, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case.

To investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* male or female, at least 18 years of age.
* ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling.
* persistent diabetic macular edema
* written informed consent
* female patients of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

* uncontrolled systemic disease
* symptoms of a clinically relevant illness in the 3 weeks before the first study day
* any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure
* history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy.
* contraindication to pupil dilation.
* need for silicon oil or gas after the surgery
* advanced diabetic retinopathy with vitreoretinal tear and/or bleeding
Remineralization of Caries Affected Dentin

Remineralization of carious affected dentin

Remineralization of Carious affected dentin by using Pulpine alone and combination of Pulpine with Polyamidoamine Dendrimer.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one class one carious posterior teeth in both left and right side.
* Absence of spontaneous pain, Mobility and tenderness on percussion.
* Radiographically, the preoperative inclusion criteria are, no internal or external resorption and no widening of the periodontal membrane space.

Exclusion Criteria:

* Patients with poor oral Hygiene.
* Evidence of Rampant Caries.
* Teeth with periodontal involvement.
* Poor general health condition.
Salvage of Myocardial Infarction Documented by MRI in Patients Undergoing Rescue Percutaneous Coronary Intervention

Atherosclerotic disease is responsible for one third of all deaths annually and is a major cause of comorbidities. While atherosclerosis is by itself a benign disease, it often leads to complications such as acute myocardial infarction with ST-segment elevation. Rescue angioplasty is indicated if thrombolytic therapy fails. However, the benefits in reducing mortality and the amount of myocardium effectively saved are not well established. The development of new tools, including cardiac magnetic resonance imaging to identify myocardial area at risk and infarcted increased diagnostic accuracy. However, unlike the context of primary angioplasty, little is known about the relation between coronary epicardial and microvascular flow after rescue angioplasty and myocardial salvage. The objective of this study is to evaluate whether there is a relation between these flows and myocardial salvage identified by Magnetic Resonance Imaging (MRI). At the end of this research, the investigators hope to contribute to a better understanding of coronary flow and its relation to the amount of heart muscle saved after rescue angioplasty. This is an important information that can help understand which cases benefit most from rescue angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ST segment elevation myocardial infarction (STEMI) who underwent Thrombolysis within 12 hours of chest pain and present clinical and/or electrocardiogram (EKG) signs of failed thrombolysis with indication of rescue percutaneous coronary intervention (PCI).

Exclusion Criteria:

* Patients with contraindication to Cardiac Magnetic Resonance Imaging (MRI) (pacemaker, aneurysm clip, claustrophobia, hemodynamic instability, etc).
* Allergy or contraindication to Gadolinium.
* Contraindication to dual anti-platelet therapy.
Open-label Treatment in Cushing's Syndrome

This is a long-term, open-label extension study of levoketoconazole in subjects with endogenous Cushing's Syndrome.

This is a long-term, OLE study of levoketoconazole in subjects with endogenous CS who have completed one or both parent studies or otherwise potentially qualify for this study, as defined in the eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Completed the Extended Evaluation Phase of Study COR-2012-01 (i.e. M12)
2. Completed the Restoration Phase of Study COR-2017-01 (i.e. RES2)

   NOTE: Subjects meeting criteria 1 or 2 above who have had a break in therapy may be eligible only after discussion with the Medical Monitor. If eligible, such subjects may require re-establishment of the Therapeutic Dose via titration. All subjects who have had a break in therapy should be discussed with the Medical Monitor to determine the starting dose of levoketoconazole. Prior to resuming treatment with levoketoconazole, other therapies for Cushing's Syndrome must undergo an appropriate washout period, with minimum durations as follows:
   * Ketoconazole or metyrapone: 2 weeks;
   * Dopamine agonists: bromocriptine (2 weeks), cabergoline (8 weeks);
   * Octreotide acetate LAR, lanreotide Autogel, pasireotide LAR: 12 weeks;
   * Lanreotide SR: 8 weeks;
   * Octreotide acetate (immediate release) or short-acting pasireotide: 1 week;
   * Mifepristone (RU 486, KORLYM): 4 weeks;
   * Megestrol acetate or medroxyprogesterone acetate (and selected other synthetic progestins): 6 weeks.
3. Currently in a named patient program or other Expanded Access Program receiving levoketoconazole
4. Were levoketoconazole-naïve prior to entry and received early rescue therapy with open-label levoketoconazole in Study COR-2017-01.
5. Achieved a clinically meaningful partial response (with reduction of UFC) in Study COR-2017-01 at dose level 7 or at a maximally tolerated dose of levoketoconazole but did not meet the randomization criteria for Study COR-2017-01 at the end of the Dose Titration and Maintenance Phase when randomization was open.
6. Were levoketoconazole-naïve prior to entry and were enrolled in Study COR-2017-01 in the Dose Titration and Maintenance Phase when randomization was closed. (NOTE: Such subjects must receive at least 1 dose of levoketoconazole before transitioning to this study.)

Exclusion Criteria:

1. Discontinued levoketoconazole while participating in Study COR-2012-01 or Study COR-2017-01 or a named patient program or other Expanded Access program, due to safety or tolerability concerns or lack of efficacy.
2. Scheduled for surgery for treatment of CS or received surgery for treatment of CS within the 6 weeks prior to Screening.
3. Treated with mitotane within 6 months prior to enrollment.
4. History of malignancy, including adrenal or pituitary carcinomas (other than low-risk, well-differentiated carcinomas of thyroid, breast or prostate that are very unlikely to require further treatment in the opinion of the treating physician, or squamous cell or basal cell carcinoma of the skin).
Abdominal Wall Closure With Triclosan-coated Suture (TCS09-10)

After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.

After open colo-rectal surgery the surgical site infection (SSI) is very high among abdominal surgeries. The goal of our randomized, prospective, multicentric, internet-based study is to compare rate of SSI after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. Two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated PDS suture (PDS vs. PDS-Plus). Triclosan is an antiseptic materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation.

attached website: www.itplan.hu/sebstudy/ Randomizing patients: 1. logging in (completing the ID pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events

* complications
* control examination

Eligibility Criteria:
Inclusion Criteria:

* Elective (subjected to bowel preparation) operations
* Benign or malignsnt colon or rectal disease
* Age: 18-80
* Bowel opening is made during operation

Exclusion Criteria:

1. Cannot be randomized:

   Systemic diseases influencing local surgical site healing Insulin-dependent diabetes mellitus Child B-C liver cirrhosis Kidney disease requiring dialysis Immune-suppression treatment IBD Acute surgery or unpreparated bowel After being informed patient does not sign the statement of consent
2. To be excluded later:

   Surgically incurable tumour Septic state or complication occurred in the post-operational stage Patient withdraws the signed consent before the examination is closed
3. Undesirable complication:

Sterile surgical site separation Suture break during the post-operational stage
A Study in Healthy Men to Test How Different Doses of BI 474121 Are Taken up and How They Influence the Amount of a Molecular Messenger (cGMP) in the Spinal Fluid

The main objectives of this trial are:

* To evaluate the effect of BI 474121 on cyclic guanosine monophosphate (cGMP) levels in cerebrospinal fluid (CSF)
* To assess the exposure of BI 474121 in CSF relative to plasma
* To determine the exposure effect relationship in CSF with different oral doses of BI 474121


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 to 65 years (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 150 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the investigator
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Endovenous Radiofrequency Versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

our aim is to compare early outcomes following EVL 1320 nm and segmental RF in a randomized study.

Endovenous Radiofrequency versus Laser Ablation for the Treatment of Great Saphenous Vein Reflux

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 60 years with incompetent GSVs documented on duplex ultrasound (US; B-mode and color Doppler imaging) were eligible

Exclusion Criteria:

* Exclusion criteria consisted of:
* Current deep vein thrombosis (DVT)
* Thrombus in the vein of interest
* Previous GSV treatment
* Pregnancy
* Known malignancy
* Significant arterial disease (ankle : brachial pressure index below 0•8)
* Use of anticoagulant medication.