cyrilzakka/clinical-trials huggingface dataset:
Trigger Point Injection in Reducing Pain Following Total Knee Arthroplasty

This study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. Given the current state of opioid dependency in the United States there needs to be a more focused attempt at treating post-operative pain without use of opioids. Given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. This study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. This is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). The procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. The sham injection will be completed by pressing the needle against the skin without injecting any fluid. There will be a "blind" between the patient and the needle with both arms of the study. These patients will be followed up on POD1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (MME).


Eligibility Criteria:
Inclusion Criteria:

* Aged 45 years or older
* Planned to undergo primary total knee arthroplasty
* Able to speak, read, and understand English
* Willing to complete a study questionnaires
* Willing to bring in their medications to be counted
* DoD beneficiaries
* No allergy to lidocaine
* Not fearful of needles.

Exclusion Criteria:

* Chronic opioid users (daily use of prescribed opioids for at least 90 days)
* Diagnosed with Fibromyalgia
* Non-English speaking
* Unable to read English
* Unable to understand English
* Pregnant
* Allergy to lidocaine
* Not willing to complete study questionnaires
* Not willing to bring in their medications to be counted
* Not a DoD beneficiary
* Fearful of needles
Blood Gas Analysis and Buffering In Cardiac Arrest

The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.


Eligibility Criteria:
Inclusion Criteria:

* prehospitally started cardiopulmonary resuscitation (CPR)
* advanced cardiac life support provided
* age \>18 years
* arterial pH \< 7,2
* arterial BE \< -12
* arterial pCO2 15-75 mmHg
* arterial pO2 \>35 mmHg

Exclusion Criteria:

* women of childbearing age
* traumatic cardiac arrest
BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation

The main goal is to investigate whether beta cell mass is correlated to beta cell function after autologous faecal microbial transplantation (FMT) in patients with newly diagnosed type 1 diabetes

The incidence of Type 1 Diabetes Mellitus (T1D) has tripled in the last thirty years, and T1D is associated with a lifelong increase of considerable morbidity and mortality compared to healthy subjects. As the increased T1D incidence is primarily observed in subjects who are not genetically predisposed, environmental factors including altered diet, antibiotic use as well as mode of birth have been suggested to play a role, and these factors have invariably been linked to changes in the gut microbiome. Indeed, an altered composition of the faecal microbiota composition was observed in adolescent T1D patients. A previous study by de Groot et al. (2021) showed that faecal microbiota transplantation stops the decline in endogenous insulin production in newly diagnosed type 1 diabetes patients. However, it is unknown whether this is due to an increase in beta cell mass, or increased function of the remaining beta cells.

In this study, the investigators aim to investigate whether beta cell mass (quantified by 68Ga-NODAGA-exendin-4 PET/CT imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Previously participated in ENCAPSULATE-DM1 or FMT preserve-DM1 trial
* Type 1 diabetes with the diagnosis being made in the last 4.5 years
* Presence of at least one autoantibody associated with type 1 diabetes (anti-GAD-65, anti-IA2, islet cell antibodies, insulin autoantibodies)
* Age ≥ 18 years
* BMI 18-30 kg/m2
* Insulin use

Exclusion Criteria:

* Inability to provide written informed consent
* Other medication use than insulin
* Smoking
* Evidence of compromised immunity
* Presence of a second autoimmune disease (other than type 1 diabetes); e.g. celiac disease, hyper- or hypothyroidism, inflammatory bowel disease. Vitiligo is allowed.
* Pregnancy or the wish to become pregnant within 1 month after the study
* Breastfeeding
* Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
* Renal disease defined as MDRD \< 40 ml/min/1.73 m²
Reinforcement Method in Laparoscopic Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy is a technically simple popular bariatric operation with acceptable results. Leaks can occur in long staple lines; therefore, variable reinforcement methods are used.

The investigator compared non-reinforced stapling with three staple line reinforcement methods (suturing, absorbable buttressing material and fibrin glue) in laparoscopic sleeve gastrectomy.

The resected stomach specimens were treated in the same manner of reinforcement as used in the surgeries of the corresponding patients and then insufflated until a burst occurred. The burst pressures of the resected stomach specimens and postoperative events of the patients were recorded.

Eligibility Criteria:
Inclusion Criteria:

* body mass index \>40 kg/m2

Exclusion Criteria:

* disruption of the resected stomach during extraction from the abdomen.
Neuropattern™ for Workplace Health Promotion

Neuropattern™, a new diagnostic tool for stress related disorders is being applied in a demanding workplace environment. Neuropattern™ aims at identifying stress-related bodily changes at an early stage. By identifying subgroups based on Neuropattern™ subjects gain access to online counseling specified according to their Neuropattern™ diagnosis. Efficacy is being assessed by several questionnaires in a follow-up.

100 employees of a company in Rhineland Palatinate employing approximately 2100 persons will be recruited.

This is a randomized, two-armed single center study. Persons interested in study participation receive a Neuropattern™ voucher according to occupational group together with other documents. As soon as the documents (signed informed consent, evaluation form, ERI, MBI, demographic questionnaire and the form for designation of the attending physician) are returned, the study manager contacts the employee and either tells him/ her that an appointment with the designated physician should be made within the following week (Neuropattern™ group) or that there will be a three months wait (control group). The employee attends the medical appointment with the designated physician and documents sent to the physician beforehand (NPQ-A, medical clearance form and prescription form for Dexamethasone) are completed. Upon return of these documents, the Neuropattern™ test kit (including the questionnaires NPQ-P, NPQ-PSQ, NPQ-S and PHQ as well as 16 Salivettes® for saliva sample collection, 0.25 mg Dexamethasone and a portable ECG device) is shipped to the subject and Neuropattern™ is conducted at home. After return of the test kit to DAaCRO, the subject is assigned to neuropattern and will gain access to individualized online counseling for three months. Evaluation (including an evaluation form, ERI and MBI) will take place at baseline as well as three and six months after onset of online counseling for assessment of efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Employees aged 18 to 65 yrs
* fluent in written and spoken German
* medical clearance by their attending physician
* signed informed consent

Exclusion Criteria:

* known intolerance to steroids
* intake of steroids or benzodiazepines
* pregnancy or lactation
* any psychiatric diseases or current psychotherapy
* acute somatic illnesses, that currently require medical treatment
* obviously unsuited as subject (lack of cognitive or verbal skills)
* arrhythmia absoluta
* decision against the intake of Dexamethasone by physician or subject (e.g. known intolerance to steroids, personal or medical reasons)
* participation in any other study
Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma

This is an open-label study divided in 2 parts and 3 cohorts to determine the concentration of Avibactam and Ceftazidime in the lining of the lungs and the blood.

A Phase I Open-Label, 2-Part, 3-Cohort, Single-Centre Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma Using at Least Two Different Dosing Regimens in Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and female subjects with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. Female subjects must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child-bearing potential
* Male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the IP
* Have a body mass index (BMI) between 19 and 30 kg/m2
* As judged by the Investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements

Exclusion Criteria:

* History or presence of any clinically significant disease or disorder (including a history of chronic respiratory disease eg, asthma, chronic obstructive pulmonary disease \[COPD\], cystic fibrosis or interstitial lung disease) which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Known allergy to lidocaine/lignocaine, midazolam, alfentanyl or other topical anaesthetics/sedatives in similar classes to these agents
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IP
* Any clinically significant abnormalities in physical examination, lung function test, ECG, clinical chemistry, haematology, coagulation screen, or urinalysis results as judged by the Investigator
Ultrasound-guided Nerve Block Training Model and Evaluation Method

The aim of this study is to assess emergency medicine physician knowledge and technical skill in performance of ultrasound-guided serratus anterior nerve block in a low-fidelity simulation model workshop and to determine the feasibility, acceptability, and usability of the training program. By performing this study, the investigators hope to create a standardized training model which could potentially facilitate POCUS and critical procedural performance and thereby improve patient care.


Eligibility Criteria:
Inclusion Criteria:

* Emergency medicine attending and resident physicians

Exclusion Criteria:

* ED nursing, ED technicians, and advanced practice physicians (APPs)
Use of Biodesign® Otologic Graft in Tympanoplasty

This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.

Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary tympanoplasty without mastoidectomy.

Exclusion Criteria:

* Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.
The Quality of Life in Individuals With Parkinson's Disease

This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. The differences between Parkinson's Disease Quality of Life Questionnaire, Nine-Hole Peg Test, grip and pinch strength values in the individuals with and without tremor in the study were investigated.

Evaluating the relationship between Quality of Life and tremor is needed to determine the best physiotherapy and rehabilitation approaches for individuals with Parkinson's Disease. This study aimed to examine the relationship of quality of life with tremor severity and upper limb functionality in individuals with Parkinson's Disease. Fifty-two individuals with Parkinson's Disease participated in the study. Quality of Life, tremor amplitude, upper limb functionality, grip and pinch strength were evaluated. The relationship of quality of life with tremor severity and upper limb functionality was examined in individuals with Parkinson's Disease. The results of individuals with and without tremor were compared.

Eligibility Criteria:
Inclusion Criteria:

* Definite diagnosis of idiopathic Parkinson Disease
* Age between 40 and 80 years
* Being literate
* Having a grade between 1-4 from the Modified Hoehn and Yahr Scale
* Having a score lower than 11 in Hospital Anxiety and Depression Scale

Exclusion Criteria:

* Who were with any other neurologic or orthopedic or rheumatologic disease affecting the upper extremity
* Using antidepressants
* Having vision loss
* Deep brain stimulation
Physical CAM Therapies for Chronic Low Back Pain

This is a pilot randomized trial intended to evaluate the effectiveness of acupuncture, chiropractic and massage for chronic back pain in older and younger adults.


Eligibility Criteria:
* Low back pain duration of at least 3 months;
* Low back pain occurring in the past week;
* No numbness or tingling in the lower extremities;
* No pain that radiates to below the knee;
* No use of massage, chiropractic or acupuncture for any reason in the past year;
* Able to attend scheduled appointments;
* Able to hear, read, and understand English;
* No low back pain surgery in the past 3 years;
* No unexplained weight loss;
* No previous vertebral or spinal fractures;
* No previous non-traumatic bone fractures;
* No other spinal pathology, including scoliosis, spinal stenosis, osteoporosis, or ankylosing spondylitis;
* No cancer (except simple skin cancers) in the past 5 years;
* No pacemakers;
* No bleeding problems or anticoagulant use;
* No major organ transplants;
* No oral corticosteroid use for more than 4 consecutive weeks during the past year;
* Cannot be pregnant;
* Must be able to get down to and up from the floor by yourself;
* Able to walk 2 flat city blocks unassisted;
* Willing to participate in periodic telephone interviews.
Trajectory of Immunosuppression-Caused Tremor In Kidney Transplant Recipients

Kidney transplant recipients (KTR) have to adhere to a strict immunosuppressive maintenance regime, generally including calcineurin inhibitors (CNIs). These CNIs, including cyclosporine and tacrolimus, are essential to prevent graft rejection, but are associated with multiple side-effects. One of the most frequently reported side-effects of CNIs is the development of tremor: rhythmic, sinusoidal oscillations of the limbs, head or trunk. CNI-induced tremor generally occurs soon after initiation of CNI maintenance therapy, and occurs in up to half of KTR using CNIs. To what extent tremor changes over time and whether this change is objective and/or subjective is currently unknown. In-depth investigation of the course of tremor is therefore warranted, which would add valuable information to previous studies on tremor prevalence.

The investigators aim to assess the course of tremor among KTR. The hypothesis is that tremor becomes less severe over time after transplantation, because CNI dosage decreases with time after transplantation. However, it may also be hypothesized that CNI neurotoxicity may accumulate with consequent worsening of tremor. More information regarding the course of tremor after transplantation is essential to increase understanding of CNI-induced tremor, as well as for patient counselling and future research to alleviate the burden of CNI-induced tremor.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 16 years old, who will receive a kidney transplant

Exclusion Criteria:

* patients who are unable to comprehend the questionnaires and tests
A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness

BACKGROUND:flight simulator have become an important component in pilot training. However, they are known to be associated with motion sickness like symptoms defined as Simulator Sickness (SS). Prevention countermeasures against motion sickness have been studied extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on prophylaxis against SS is sparse.

OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo for SS prevention in helicopter pilots.

DESIGN: a prospective, placebo controlled double-blind.

SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.

PARTICIPANTS: IAF experienced helicopter pilots.

INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before beginning of a 3 sortie simulator training


Eligibility Criteria:
Inclusion Criteria:

* age 21 to 50 years, qualified helicopter pilots
* history of average TS score in SSQ more than 7.48

Exclusion Criteria:

* known vestibular, visual or central nervous system pathology
* fever of more than 37.2 degrees
* any MS like symptom prior to simulator training
* any compromising acute health problem
Next Generation Cataract Surgery Study

The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe.

Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated.

Eligibility Criteria:
Key Inclusion Criteria:

* Able to understand and sign an IRB/IEC approved Informed Consent form.
* Willing and able to attend all scheduled visits as required by the protocol.
* Clinically documented diagnosis of age-related noncomplicated cataract.
* Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential as defined in the protocol.
* Planned postoperative procedures during the course of the study in the operative eye.
* Previous intraocular or corneal surgery in the operative eye.
* Diagnosis of glaucoma or ocular hypertension (IOP \> 21 mmHg) in the operative eye.
* Other protocol-defined exclusion criteria may apply.
Frequency of Perforated Appendicitis in Times of COVID-19

Appendicitis is one of the most common clinical conditions in general surgery. The diagnosis is usually made from clinical examination, imaging (sonography or CT) and laboratory parameters. The laparoscopic appendectomy without drainage has established as the gold standard. Patients usually leave the hospital two days after surgery.

In times of corona crisis, patients are unsure to visit the hospital because of fear of infection with SARS-CoV-2. A higher incidence of perforated appendicitis could be an indicator for fear-related delay of going to the hospital.

Methods: Investigators performed a retrospective analysis on the incidence of perforated appendicitis in a 10-week interval (mid-March to end of May) of the years 2018, 2019 and 2020 to evaluate possible changes in times of corona crisis. Intraoperative findings, procedures, complications and the length of hospital stay were considered.

The local ethics committee of the University Hospital of Tübingen, Germany, approved this study (AZ: 324/2020BO2). All patients treated for acute appendicitis in a ten week period from 16th of March to 31th of May in 2018, 2019 and 2020 were considered for the study. Investigators analysed the frequency of perforated appendicitis in the periods indicated. Informed consent was obtained from all individual participants. Patient's records as well as database were analyzed for therapy specific items.

Definition Perforation: Perforated appendicitis was defined as described perforation in the surgical or pathological results.

Delay between onset of symptoms and first presentation at the hospital: Patient's records were proved for self-declaration about the start of symptoms

Eligibility Criteria:
Inclusion Criteria:

* patients with acute appendicitis older than 16 years
* appendectomy in time frame 16th of march to 30th of May in the Years 2018, 2019 and 2020

Exclusion Criteria:

* patients with acute appendicitis younger than 16 years
* appendectomy not in the named time frames
Group Music Therapy for Acquired Brain Injury

The study aims to analyse the impact of music therapy-based treatment on the comfort and well-being of patients with acquired brain injury (ABI). To achieve this objective, it is proposed to validate and implement a music therapy-based assessment and treatment protocol. The protocol will be tested in a pilot sample to improve adaptation to the disease and promote integration with the usual health measures of patients with ABI. Implementing a group treatment programme based on music therapy applied to patients with ABI.


Eligibility Criteria:
Inclusion Criteria:

* Patient with acquired brain damage who has been admitted to the hospital for at least one week. The patient has experienced a sudden brain injury resulting in physical, psychological, cognitive, behavioural or sensory deficits that have reduced their previous functional capacity and quality of life. The patient is clinically stable enough to undergo rehabilitation and had a good functional situation prior to the episode (Barthel Index \> 60).
* Be over 18 years of age.
* The participant or their relatives have signed the informed consent form.
* They have completed the group music therapy intervention session, as well as the pre-test and post-test evaluations.

Exclusion Criteria:

* Failure to obtain informed consent
* The Barthel Index score is below 60, indicating functional dependency.