cyrilzakka/clinical-trials huggingface dataset:
Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the Pelvis

Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps.

The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients.

The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* Legal capacity, capacity to inform
* Presence of a written declaration of consent by the patient
* Age: ≥ 60 years
* Acute or subacute (less than 2 months) posterior pelvic girdle pain associated with low energy trauma or occurring spontaneously
* Diagnosis confirmed by CT and/or MRI
* The fracture corresponds to types OF3 and OF4 of the OF Pelvis classification.
* Prior to the fracture, there was free, non-wheelchair mobility (Functional Mobility Score of 2 or higher)

Exclusion Criteria:

* Diagnosed uncontrolled psychiatric illness (e.g. dementia, schizophrenia, major depression, personality disorder) that could affect study participation or reporting of findings
* History of pelvic fracture within one year with evidence of failure of fracture to heal or internal fixation of the pelvic ring of any type
* Patients unable to ambulate before the fracture
* Patient has had lumbar instrumentation of more than two vertebrae and/or instrumentation of S1 in the past
* Additional fractures that limit mobility
* OF-P associated with benign or malignant tumours of the pelvis
* Abnormal neurological condition that could affect study participation
* An unusual clinical condition associated with a high risk of not being able to follow up (e.g. COPD, severe heart failure, Parkinson's disease, autoimmune diseases)
* Any pelvic condition or anatomical feature that makes surgery impracticable
* Known allergy to titanium or titanium alloys
* Known opioid abuse for chronic pain syndromes
* Participation in other interventional trials
* Lack of surgical capability
* Persons in a dependent/employee relationship with the sponsor or investigator
* Placement in an institution due to court or administrative order.
Accuracy in Resection of Non-pedunculated Colonic Lesions 5-20 mm With/Without Using NBI

Interval colon cancers are an important clinical issue. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology. In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

Interval colon cancers are an important clinical issue. Literature dealing with technics and quality of polypectomy is scarce. A recent paper from Pohl et al focused on non-pedunculated polyps of 5-20 mm, evaluating non complete polypectomy and factors related to it, revealing that 10% of these polyps were not completely resected. This fact was attributed to size and histology (the majority of non completely resected ones, were polyps of 10-20 mm and with serrated characteristics at the histology). In this study the investigators want to evaluate the radical resection of non-pedunculated polyps of 5-20 mm by performing biopsies on the margins immediately after polypectomy, to establish if the use of Narrow Band Imaging (NBI) could be useful in the definition of the margins of the lesion before polypectomy.

Eligibility Criteria:
Inclusion Criteria:

* Every polyp ≥ 5 mm and ≤ 20 mm

Exclusion Criteria:

* Inflammatory bowel Disease and/or International Normalized Ratio \> 1.5
Pharmacokinetic Interactions in Combination Treatment of Valproic Acid and Ertapenem in Normal Subjects

* This trial is conducted to assess pharmacokinetic characteristics of valproic acid when valproic acid single treatment and valproic acid \& ertapenem combination treatment
* This trial is performed to evaluate safety of the combination treatment compare with single treatment
* The investigators carry this trial out to study mechanism of combination treatment


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are healthy volunteers, men 19\~50 years
* Subjects who have a weight more then 50kg and a condition ± 20% range of ideal weight

Exclusion Criteria:

* Subjects with evidence of clinically significant hepatic, pancreatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric or cardiovascular disease
* Subjects who have a GI disease (crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
* Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure≤ 100 mmHg or diastolic blood pressure≤ 65 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
* Subjects with known allergy, hypersensitivity (anaphylaxis-type reaction; especially penicillin antibiotics)
* Subjects with a history of drug abuse
* Subjects who received certain medication (include oriental medicine) within the past 3 weeks or certain OTC-drug within 1 week
* Subjects who participated in other clinical investigation within 2months prior to first administration Subjects who did whole blood donation (within 2months) or apheresis (within 1months) prior to first administration
* Subjects who are chronic drinkers
The Effects of a Polyethyleneimine-coated Membrane (oXiris™) for Hemofiltration Versus Polymyxin B- Immobilized Fibre Column (Toraymyxin™) for Hemoperfusion on Endotoxin Activity and Inflammatory Conditions in Septic Shock- A Randomized Controlled Pilot Study (ENDoX-study)

Septic shock has a high mortality risk despite the availability of various treatments. Endotoxin, that is present in the cell walls of gram-negative bacteria, is a potent trigger of innate immunity. Endotoxin leads to an activation of a cascade with an overwhelming systemic overflow of pro- and anti- inflammatory mediators at the early phase of sepsis with generalized vascular endothelial damage, tissue injury and multi-organ failure.

Extracorporeal blood purification therapies aim to reduce the circulating level of endotoxin. Different extracorporeal blood purification systems are available. The oXiris™ device comprises a surface treated AN69 membrane capable to adsorb a large spectrum of plasma cytokines, such as IL-6 and HMGB1 protein. The positively charged inner surface of the membrane allows absorbing negatively charged bacterial products such as endotoxin. From an historical perspective, filters containing AN69-based membranes have been the most commonly used products for CRRT in the management of critically ill patients and a substantial volume of published data exist.

Another extracorporeal endotoxin removal therapy is the hemoperfusion with ToraymyxinTM (PMX) filter, which is a cartridge selectively removing blood endotoxin. PMX is composed of polymyxin B covalently bonded to polystyrene-derivative fibres. It is well known that the polarity of the polymyxin B antibiotic binds endotoxin and has bactericidal activity. Therefore, the rationale underlying extracorporeal therapy with PMX is to remove circulating endotoxin by adsorption.

* Trial with medical device


Eligibility Criteria:
Inclusion criteria: • Patients with septic shock, defined as 30ml/kg of i.v. fluid administered within a period of 6 hours after initiation of vasopressor therapy with a vasopressor index =3, and at least one of the following criteria: metabolic acidosis, neurologic dysfunction, renal dysfunction, or acute hepatic dysfunction

* Male and Female patients =18 years
* Endotoxin levels =0.6 IU EAA (measured at ICU admission and repeated 24 hours later in case the initial value is =0.4 and \<0.6)

Exclusion criteria: • Endotoxin levels \<0.6 IU EAA

* Pregnancy or breast feeding
* Neutropenia (circulating neutrophils \<500/µl)
* Pre-existing immune deficiencies or immune-suppressive therapy, especially corticosteroids
* Use of Vasopressin (Pitressin?)
* Organ transplantation within the last 12 months
* Terminally ill patients classified as "do not resuscitate"
* History of sensitivity to polymyxin B or to anticoagulant (heparin) HIT or allergy to heparin
* Need for extracorporeal membrane oxygenation (ECMO)
Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara

The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.


Eligibility Criteria:
Inclusion Criteria:

* More than 20 natural teeth excluding the third molars
* Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
* Have a full mouth plaque score (FMPS) \<15% before surgery;
* Have a full mouth bleeding score (FMBS) \<15% before surgery;
* Ability and willingness to give written informed consent;
* Written agreement to participate in the trial.

Exclusion Criteria:

* Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
* Pregnancy or breastfeeding;
* Use of medication affecting the healing process;
* Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
* Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
* Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.
* Tobacco use (10 or more cigarettes per day)
* Inability to comply with protocol
* Uncooperative patient
Programme for Intervention in Paediatric Obesity

The PinPo program aims to carry out a comprehensive intervention for children aged 6 to 12 years with childhood obesity (with a BMI greater than the 99th percentile), fostering motivation and encouraging changes toward healthy lifestyle habits to achieve greater adherence and improved health. The program comprises 9 educational sessions designed by specialized professionals from various disciplines (pediatrics, psychology, nursing, nutrition), for a group of 10 children and another group of 10 family members and/or caregivers. These sessions are conducted in a hospital setting every 15 days, each lasting 90 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 and 12 years old, with a BMI greater than the 99th percentile according to Cole criteria (2004).

Exclusion Criteria:

* Children \< 6, or \> 12 years.
* Children with chronic diseases or following a therapeutic diet.
* Children with intervention in other centers.
Fertility and Pregnancy After Surgery IBD Audit

Crohn's disease and Ulcerative colitis are chronic disease that are usually diagnosed at young age. The diseases and the associated treatment can impact on patient's sexual function, fertility, pregnancy, and delivery. This study aims to assess the impact of inflammatory bowel diseases on these aspects in female patients.

This is a cross-sectional, international, multicentre study. Female patients diagnosed with inflammatory bowel diseases (Crohn's disease and ulcerative colitis) treated at several Italian centres will be retrospectively assessed for inclusion.

Those who underwent surgery below the age of 35 years between 2000 and 2020 will be included. The study aims to obtain information on female fertility, pregnancy and delivery, and to identify factors associated with infertility and problems to conclude the pregnancy.

For each nation, at least one centre will collect data on patients who were not treated with surgery.

Patients who meet inclusion criteria will be asked to prospectively fill a questionnaire on fertility and pregnancy.

Data on treatments and demographic will be retrospectively collected by the local investigators and uploaded on a secure online database.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease diagnosis
* ulcerative disease diagnosis
* operated on before 36 years of age

Exclusion Criteria:

* younger than 18 years old at follow-up
* no definitive diagnosis
* no surgical procedures performed

A subgroup of patients who did not undergo surgery will be used, at least one for each country.
Movement Quality and Balance Improvement in People With Chronic Low Back Pain Following Trunk Muscle Training

The goal of this project is to assess if Chronic Low Back Pain (CLBP) participant's movement quality and balance variables can change after training that decreases their pain and disability. It will also compare the difference between structural exercise (SE) and isolated trunk exercise (ITE). The main questions it aims to answer are:

1. What are the effect of the training on the participant's movement quality and balance.
2. What are the difference between different types of trunk muscle training on people with CLBP.

Researchers will compare SE, ITE and control. Control group will receive back school education that was shown not to be effective in reducing pain and disability.

Participants will:

1. Do home and in-lab based SE or ITE training, or maintain active daily living over 2 months.
2. Complete the pain and disability questionnaire and do several physical functioning tests while having their trunk and lower limb movement and muscle activation measured.

Both ITE and SE training are equalized in terms of training intensity based on rate of perceived exertion, training duration per session, training frequency, and intervention period. Training intensity measurement does not use other methods of quantification as ITE training does not increase heart rate or blood lactate significantly regardless of the intensity.

Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) 18-25 kg/m2
* experiencing intermittent pain lasting at least 3 months
* had Oswestry Disability Index (ODI) score ranging between 17% and 45%.

Exclusion Criteria:

* exercise contraindication based on physical activity readiness questionnaire
* indication or diagnosis of other chronic diseases (such as cancer, cardiovascular disease, diabetes, bone fracture, or infection)
* artificial lower limb joints, history of spinal surgery, walking aid use
* personal mobility restrictions (due to connective tissue diseases, rheumatoid arthritis, or central nervous system disorders)
* pregnancy or within 1 year post partum
Evaluation of the STOP-BANG Screening Questionnaire in a Sleep Clinic

Although obstructive sleep apnea (OSA) is common, most of the patients are undiagnosed. OSA is associated with a large number of co-morbidities, and thus, it is of great importance to identify the patients and start treatment in order to reduce the risks for complications. Current screening tools are quite unspecific and the golden standard methodology for diagnosis, polysomnography, is expensive and time consuming, thus not suitable for screening. In perioperative medicine the STOP BANG screening questionnaire is currently the recomended screening tool, however this questionnaire has only been evaluated in a sleep clinic in a very limited numbers of patients.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years old
* First or part of the first visit to a sleep clinic
* Planned or just conducted polysomography

Exclusion Criteria:

* Not able to understand the information and sign informed consent
Laparoscopic/Robotic-assisted Hysteropexy Versus Vaginal Hysterectomy for the Treatment of Uterovaginal Prolapse

* objective: aimed to compare laparoscopic/robot-assisted hysteropexy with vaginal hysterectomy for uterine prolapse
* prospective randomized clinical trial
* patient

  1. 60yrs or more women and
  2. POP-Q stage II with symptom or POP-Q III, IV regardless of symptom
* number of patient: 146
* randomize: laparoscopic/robot-assisted hysteropexy vs. hysterectomy
* follow up: postoperative 1 year
* primary endpoint: recurrence rate

  1. recurrence of uterovaginal prolapse POP-Q stage II-IV
  2. recurrence of associated symptom
* secondary endpoint

  1. postoperative 1 year QOL, degree of satisfaction evaluation
  2. operative time, estimated blood loss
  3. hospitalization period, postoperative pain, return to normal activity


Eligibility Criteria:
Inclusion Criteria:

* POP-Q stage II with symptom or POP-Q III, IV regardless of symptom

Exclusion Criteria:

* abnormal uterine bleeding
* significantly enlarged fibroid uterus
* postmenopausal uterine bleeding
* endometrial pathology
* on tamexifen
* concomitant medical problems precluding general anesthesia or surgery
* damaged agreement ability
The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy

It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness as well, which could result in better implantation and pregnancy rates after IVF or ICSI treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on pregnancy rate following frozen embryo transfer.

In the present randomized double-blind prospective study, the patients will be randomly assigned to the study and control groups. With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group will be given placebo. When endometrial thickness will be found between 8-14 mm, therapy with progesterone (100 mg IM daily) will be started and embryo transfer will be performed 48 to 72 hours later. Doppler ultrasonography also is done to calculate Resistive Index (RI) and Pulsatility Index (PI), the day after progesterone administration.

βHCG will be assessed 14 days after ET. If a pregnancy will be achieved, the patients in study and control groups will be instructed to continue the aspirin or placebo through 5 weeks and if the pregnancy test result will be negative, the treatment with aspirin or placebo will be stopped. The patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with "long or antagonist" protocol
* Women who did not achieve a pregnancy following a fresh embryo transfer or women whom their embryos had not been transferred due to OHSS
* The women who had frozen embryos available for another transfer no contraindications for aspirin

Exclusion Criteria:

* The patients with history of recurrent abortion
Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

To evaluate the efficacy of SPD489 when used as augmentation to an antidepressant in the treatment of major depressive disorder (MDD) as measured by mean change in total Montgomery-Ǻsberg Depression Rating Scale (MADRS) scores.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-55 with a primary diagnosis of nonpsychotic MDD

Exclusion Criteria:

* History of non-response to multiple antidepressants
Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients

The condition of sepsis patients changes rapidly, whom are often accompanied by impaired respiratory, circulatory, renal, and coagulation functions. So far, the prognosis of sepsis at home and abroad is not ideal. Participants was randomly included in this research project on the pathogenesis and prevention of sepsis due to typical sepsis symptoms. the investigators will collect appropriate clinical specimens for analysis of immune cell functions and pathogenic microorganisms combined with individual patient research. This study will enable sepsis patients to be identified early and receive earlier anti-sepsis treatment, which is expected to improve the prognosis of sepsis, shorten hospitalization time, and reduce treatment costs.

The above-mentioned tests and analyses do not increase the economic burden on the participants, and the required expenses are all paid from the project funds; they do not affect the prognosis and rehabilitation process of participants, and do not have adverse effects on the health of participants.


Eligibility Criteria:
Inclusion Criteria:

1. Temperature \> 38°C or \< 36°C;
2. Heart rate \> 90 beats/min;
3. Respiratory rate \> 20 breaths/min or PaCO₂ \< 32 mmHg;
4. White blood cell count \> 12.0 × 10⁹/L or \< 4.0 × 10⁹/L, or \> 10% immature neutrophils;
5. Initial septic shock diagnosis;
6. Organ dysfunction (cardiovascular, respiratory, or ≥ 2 other organs);
7. Complete clinical data.

Exclusion Criteria:

1. Cancer history;
2. Chemotherapy;
3. Radiotherapy;
4. Incomplete data.
5. Controls were free of infectious or inflammatory diseases and glucocorticoid use.