cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Clinical Effectiveness of Bioactive Glass (S53P4) in the Treatment of Tibia and Femur Non-unions

Abstract Background: Treatment of non-union remains challenging and often necessitates augmentation of the resulting defect with an autologous bone graft (ABG). ABG is limited in quantity and its harvesting incurs an additional surgical intervention leaving the risk for associated complications and morbidities. Therefore, artificial bone graft substitutes that might replace autologous bone are needed. S53P4-type bioactive glass (BaG) is a promising material which might be used as bone graft substitute due to its osteostimulative, conductive and antimicrobial properties. In this study, the investigators plan to examine the clinical effectiveness of BaG as a bone graft substitute in Masquelet therapy in comparison with present standard Masquelet therapy using an ABG with tricalciumphosphate to fill the bone defect.

Methods/design: This randomized controlled, clinical non-inferiority trial will be carried out at the Department of Orthopedics and Traumatology at Heidelberg University. Patients who suffer from tibial or femoral non-unions with a segmental bone defect of 2-5 cm and who are receiving Masquelet treatment will be included in the study. The resulting bone defect will either be filled with autologous bone and tricalciumphosphate (control group, N = 25) or BaG (S53P4) (study group, N = 25). Subsequent to operative therapy, all patients will receive the same standardized follow-up procedures. The primary endpoint of the study is union achieved 1year after surgery.

Discussion: The results from the current study will help evaluate the clinical effectiveness of this promising biomaterial in non-union therapy. In addition, this randomized trial will help to identify potential benefits and limitations regarding the use of BaG in Masquelet therapy. Data from the study will increase the knowledge about BaG as a bone graft substitute as well as identify patients possibly benefiting from Masquelet therapy using BaG and those who are more likely to fail, thereby improving the quality of non-union treatment.


Eligibility Criteria:
Inclusion Criteria:

* pseudarthrosis of the tibia or femur
* bone defect \< 5 cc
* surgical treatment with Masquelet technique

Exclusion Criteria:

* age under 18
* disagreement
* patients who require amputation of the affected limb
A Study With Central Nervous System Metastatic EGFR Mutation Positive Non-small Cell Lung Cancer

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

This is a descriptive observational study, in which data are collected in an EGFR mutant NSCLC. Our research plan aims to use multi-omics approaches to predict the likelihood of patients developing brain metastases, assess the prognosis of brain metastasis treatment, and identify potential biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.
* Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None
Correlation Between the Microbiome and Type 2 Inflammatory Diseases of CRSwNP

Nasal microorganisms, exfoliated cells, nasal secretions, fetal microorganisms and blood were collected from patients with chronic sinusitis with nasal polyps before medication. Nasal polyp tissues of the patients were clamped for pathologic biopsy in the outpatient clinic. Methylprednisolone was then administered to the patients for 17 days, and the nasal microbial changes were observed after the administration of the drug. Patients underwent surgical treatment after the administration of the drug, and postoperative patients were followed up for a long period of time until polyp recurrence. During the follow-up, the microorganisms in the patients' postoperative nasal cavities were collected and the postoperative microbial changes were recorded

In this study, we retrospectively collected pathologic paraffin specimens and patient information from previous cases of sinusitis with nasal polyps, and prospectively collected specimens from newly enrolled patients with nasal polyps.

Eligibility Criteria:
Inclusion Criteria:

- The diagnosis of CRSwNP was based on EPOS20201 ECRSwNP was defined as EO accounting for more than 27% of the total infiltration Subjects undergoing septoplasty due to anatomical variations served as controls Discontinuation of steroid (oral or aerosol) and antileukotriene therapy for at least 4 weeks prior to biopsy or surgery

Exclusion Criteria:

- Exclude patients with a diagnosis of posterior maxillary sinus polyps, cystic fibrosis, allergic fungal sinusitis, primary ciliary dyskinesia, allergic rhinitis, immune deficiency, or coagulopathy Exclusion of patients with aspirin intolerance (AERD) Exclude smokers Exclude pregnant women

Healthy Volunteers:

Only patients with deviated septum without any other nasal diseases served as a control group, and the participants in this group were not treated with corticosteroids and went in for septal correction. The rest of the criteria were the same
Efficacy of Education With Balance Exercise in Improving Balance and Reducing the Fear of Falls in Elderly

The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population . In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.

Present study was an experimental design. A total of 60 elderly subjects were selected as per the selection criteria and they were randomly allocated in two equal groups i.e.Group A- (Experimental Group)- Balance Exercises and Education Program Group B - (Control Group) - Balance exercises.procedure of study was explained to each subject and written consent was taken from them.

Aim:

The aim of the study was to evaluate the Efficacy of Education With Balance Exercise in Reducing Fear of Falls in Elderly Population .

Materials and Methods In the present study the educational program along with balance training was delivered to group A, (Experimental group) and only Balance training was delivered to group B, (Control group) for 6 weeks for 1 hr duration once weekly. Education program included education about the risk factors of falls such as environmental hazards, importance of good nutrition, use of stick while walking, avoiding slippery surfaces. Balance training consists of stance activities and balance exercise program. The outcome measures for this intervention were Activities specific balance confidence scale and berg balance scale.

Eligibility Criteria:
Inclusion Criteria:

* Elderly
* Both males and females were included in the study.
* Individuals with Mini Mental Status Examination score \>23.
* History of falls in last 6 months

Exclusion Criteria:

* Any musculoskeletal disorder
* Any visual deficit
* Any systemic disease
* Any Neurological Disorder
* Any Cardiovascular and Respiratory Disorder
* Now cooperative Individuals
* Any Psychological disorder
Spine Registry University Hospital of Cologne- Department of Orthopedics

Between January 2008 and December 2020 all patients with spine diseases were registered prospectively in the former European Spine Tango registry and later german DWG registry at the department of orthopedics and trauma at the university of cologne.

The following data were prospectively collected after enrollment: age, sex, body mass index (BMI), length of hospital stay, affected spine segment, previous surgical procedures on the spine, conservative or operative treatment including type of surgical treatment and American Society of Anesthesiologists (ASA) Physical Status Classification System.

In addition the following quality of life scores were collected: Oswestry Disability Score (ODI), Core Outcome Measures Index(COMI), Short Form- 36 (SF- 36) and Euroqol- 5D (EQ- 5D).

Eligibility Criteria:
Inclusion Criteria:

* Spine disease

Exclusion Criteria:

* younger than 18 years
The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.

To investigate if glenohumeral arthroscopy and arthroscopic subacromial decompression is more effective than glenohumeral arthroscopy alone in improving patient-reported outcome at 12 months in patients with subacromial impingement syndrome (SIS) who are non-responders to non-operative treatment.

The trial is designed as a patient and assessor-blinded, randomized, controlled trial with two parallel groups. Participants are randomized 1:1 to either ASAD and glenohumeral arthroscopy (intervention group) or glenohumeral arthroscopy alone (control group). The two groups are subscribed identical postoperative rehabilitation consisting of 3 months physiotherapy in a municipally setting. The primary endpoint is the Shoulder Pain and Disability Index (SPADI) 12 months after surgical intervention. The study will adhere to the CONSORT guidelines.

All participants will be recruited consecutively from the outpatient clinic, Arthroscopic Center, Copenhagen University Hospital, Hvidovre. Consultant orthopedic surgeons will conduct the initial eligibility screening as part of their consultation. Eligible participants will be provided with thorough verbal and written information about the trial and their right to withdraw at any time. Patients given their written, informed consent to participate in the trial, will receive scheduled appointments for the baseline examination.

Eligibility Criteria:
Inclusion Criteria:

* SIS diagnosis (Consultant's clinical diagnosis of SIS + at least 3 out of 5 positive tests from the following: Hawkin's, Neer's, Jobe's, Painful arc and external rotation resistance test)
* Positive subacromial injection test
* Insidious onset of shoulder pain
* Considered a surgical candidate by an orthopedic shoulder specialist.
* Symptoms for at least 6 months
* Completion of at least 3 months supervised shoulder training
* No improvement in symptoms for at least 3 months
* The patient must be expected to be able to attend rehabilitation and post-examinations.

Exclusion Criteria:

* Terminal illness or severe medical illness (ASA score higher than or equal to 4), systemic musculoskeletal disease, inflammatory joint disease (e.g. rheumatoid arthritis), symptomatic cervical spine pathology or thoracic outlet syndrome.
* Full-thickness rotator cuff tear, calcified tendonitis, labral tear, frozen shoulder, biceps tendon pathology, acromioclavicular osteoarthrosis, glenohumeral osteoarthrosis or other concomitant shoulder pathology.
* Previous surgery or radiotherapy on the affected shoulder.
* Pregnancy
* Ongoing workers compensation case or job rehabilitation process
The Effect of Intravenous Lidocaine on Post-extubation Laryngospasm

In the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.

During anesthesia practice, one of the common complications of airway management is laryngospasm. The etiology of laryngospasm is unknown but may be due to insufficient depth of anesthesia during tracheal intubation, light plane of anesthesia during tracheal extubation, pain, or presence of airway irritant like laryngoscope blade, irritated volatile agent, suction catheter, surgical debris, mucus, blood, or other foreign body. Laryngospasm occurs in both genders and all ages. Incidence of laryngospasm was reported to the Australian incident monitoring study (AIMS) was 5% with of 22% of them without an attributable cause.

Currently, there is no proven prophylaxis for laryngospasm and the known treatments of laryngospasm are used post-occurrence. However, elimination of factors that lead to laryngospasm is the most indispensable item for reduction of its incidence.

Intravenous (IV) lidocaine interrupts nerve conduction by blocking sodium channels. Recent meta-analysis study showed that IV lidocaine was able to prevent laryngospasm in children. However, in the literature, we found no randomized clinical trials addressing the using of IV lidocaine as prophylaxis for postoperative laryngospasm among adults.

The aim of this study was to assess the effects of IV lidocaine on the incidence of postoperative laryngospasm of adults patients.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesia score are I or II
* Undergo for laparoscopic cholecystectomy

Exclusion Criteria:

* Patient's refusal
* History of upper respiratory tract infection (URTI) within 2 weeks
* Persistent type of hyper-reactive airway or asthma
* History of airway surgery
* History of gastro-esophageal reflex disease (GERD)
* Currently receiving sedating or analgesic medication
* Currently receiving the following medications:

  * Fluvoxamine
  * Erythromycin and Itraconazole
  * β -blocker or Cimetidine
* History of Lidocaine Allergy
* History of epilepsy disorder
* Pregnant or breastfeeding women
* History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
* History of increased salivation by a disease or medication
* History of difficult intubation
* Two or more attempts of intubation
Neural Bases of Phantom Pain After Amputation

The amputation of a limb results in chronic pain associated with the lost limb in the majority of patients, which persists over time. Despite a large number of studies conducted in an attempt to elucidate the neural basis of phantom pain, these are still not elucidated and current treatments often fail to relieve patients' pain.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 65 years old
* For the "amputees with phantom pain" group: patients who have been amputated for more than 2 years and have chronic phantom pain
* For the "amputees without phantom pain" group: patients who have been amputated for more than 2 years and do not have chronic phantom pain
* For the "healthy participants" group: healthy participants with no neurological history

Exclusion Criteria:

* Clinically significant pathology (gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory)
* Progressive psychiatric or neurological pathology
* On psychotropic medication
* Pregnant or nursing woman
* Inadequate level of French language
Effect of Anesthesia on Force Application During Colonoscopy

The aim of the study is to determine if more force is used during colonoscopy when patients receive monitored anesthesia with propofol versus conscious sedation. Force measurements will be performed using the colonoscopy force monitor (CFM). This device measures the magnitude and direction of force applied to the insertion tube of a standard colonoscope during colonoscopy.

Randomized factorial design of colonoscopy with either propofol administered anesthesia or conscious sedation. Twelve experienced endoscopists from community and academic centers will perform colonoscopy using either propofol or conscious sedation on a group of 12 patients for each endoscopist for a study total of 144 patients. An equal number of male and female patients will be included in each group.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age: 30-75 years
* ASA Class I or II
* All ethnic and racial groups will be included

Exclusion Criteria:

* Colonic pathology that in the opinion of the endoscopist could interfere with the colonoscopy. Examples include: colonic stricture, poor preparation, obstructing tumor.
* Specific pathology that would limit the extent of examination
* ASA class 3 or greater
* Pregnancy
* Monitored anesthesia using propofol for sedation.
* Vulnerable subjects. Students, nursing home residents, institutionalized patients, and those with psychological or physical incapacity
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease

This is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled SP513 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed six months of maintenance treatment in the SP513 double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from SP513 double-blind trial that was assessed as related to study medication
Evaluation of Low and High Nicotine Tobacco Free Nicotine Pouches

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

The proposed research project evaluates the potential for tobacco-free oral nicotine pouches (TFNPs) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. Specifically, in a randomized pilot study, participants who smoke will be recruited and sent TFNPs to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. Participants will report tobacco use behaviors and submit biological samples throughout the study. This design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (DNA damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.

Eligibility Criteria:
Inclusion Criteria:

* Age 21+
* current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes)
* have not used TNFPs more than 5 times during their lifetime
* willing and able to attend 2 in-person visits in Charleston (to assess biomarkers)
* have internet access

Exclusion Criteria:

* Lack of proficiency in English.
* Use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days.
* Current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy).
* Use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study.
* Medical conditions contraindicated to NRT use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).
A Simple Walking Program to Enhance Concurrent Chemoradiotherapy Delivery

By utilizing fitness trackers, this study aims to demonstrate that a simple walking program improves patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Patients will be given a commercially available fitness tracker to wear continuously throughout the course of the study. Per this study's inclusion criteria, all patients will be treated with concurrent chemoradiotherapy for a malignancy of the brain, head and neck region, lung, gastrointestinal tract, or cervix. Patients will be randomized to one of two arms: an experimental arm, where they will be instructed to meet a daily, customized step count goal, or a control arm where they will wear activity trackers but be given no specific instructions to increase their activity levels. Patients in the experimental arm who fail to meet their step count goal for three consecutive days will be contacted by a study coordinator and reminded to try to meet the activity goals. If the patient reports that his or her activity is limited by treatment-related toxicities, the patient's treating physicians will be notified to ensure that supportive care needs are being met. With such a program, this study aims to demonstrate the potential to improve patients' ability to tolerate curative concurrent chemoradiotherapy without treatment interruption.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* ECOG performance status 0-2
* Able to ambulate independently (without the assistance of a cane or walker)
* Diagnosis of invasive malignancy of the brain, head and neck region, lung, gastrointestinal tract, or uterine cervix
* Planned treatment with fractionated (≥15 treatments) external beam radiotherapy with concurrent chemotherapy (or cetuximab) with curative intent (including preoperative or postoperative treatment)
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy.
* All patients must sign study specific informed consent prior to study entry.