cyrilzakka/clinical-trials huggingface dataset:
The Turkish Version of the Shanghai Elbow Dysfunction Score

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate elbow function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties.

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties. Approximately seventy patients with elbow limitation will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 3-to-5-day period after the first assessment, the participants will complete the Turkish version of SHEDS (SHEDS-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the Turkish version of Mayo Elbow Performance Score, and Short Form-12 will be determined to check the validity. Responsiveness and floor and ceiling effects will be detected.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 55 years
* Elbow fracture in the six months before the study
* Elbow limitation in flexion or extension
* Fractures should be managed with surgically
* Being able to follow simple instructions
* Being able to read and write in Turkish

Exclusion Criteria:

* Malunion or Nonunion Fracture
* The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
* Non-healing wound or infection
* Previously received physiotherapy for elbow limitation
* Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
* Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity
Novel Risk Factors of Atrial Fibrillation in Patients With Chronic Heart Failure

The purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in clinical practice. Chronic Heart failure (CHF) has become a major clinical and public health problem. Both AF and CHF often co-exist and complicate each other's administration.Several risk factors have been demonstrated to be associated with the risk of AF in Patients with CHF.

Lopez et al. found that higher levels of low-density lipoprotein cholesterol (LDLc) and total cholesterol were associated with a lower incidence of AF independently of other risk factors from the Atherosclerosis Risk in Communities (ARIC) study.

Thus the purpose of this study is to determine whether lipid levels are related with incidence of atrial fibrillation in Patients with chronic heart failure. This study maybe provide a novel opinion on the prevention of AF in patients with CHF.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic heart failure

Exclusion Criteria:

* Use of statins
A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule

The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine \[IPV\], Diphtheria, Tetanus, whole cell Pertussis \[DTwP\]-Haemophilus influenzae type b \[Hib\]-Hepatitis B virus \[HBV\] and 13-valent Pneumococcal conjugate vaccine \[PCV13\]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
* Study participant has born after a normal term pregnancy (greater than or equal to \[\>=\]37 weeks) and with a birth weight of \>=2.5 kilogram (kg)
* Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
* Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window

Exclusion Criteria:

* Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
* Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
* Received polio vaccine or were previously infected with poliovirus
* Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
* Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)
DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE (The DISSIPATE Study)

The research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome (SIRS).

This is a prospective observational study. 150 subjects with the admission diagnosis of neurological haemorrhage (e.g. subarachnoid haemorrhage, intracerebral haemorrhage etc), admitted to SICU of National University Hospital, Singapore, who are expected to stay for more than 48 hours, will be recruited and enrolled. No adverse events are expected as a result of this study as patients do not deviate from the current standard of care. Frequency of blood sampling will be stipulated at day 1/2/3/4/5 to draw clinical relevance. An additional 0.5 tablespoonful (7.7ml) of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples. In total, an additional volume of 2.5 tablespoonful (38.5ml) of blood will be collected from each subject over a period of 5 days. Residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests. All ICU patients will have arterial lines inserted as part of routine care, so there will not be pain from the blood sampling. In the current study, measurements will be made on the routine laboratory haematology, coagulation and immunoassay analyzers. Research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis. In addition, the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study.

Eligibility Criteria:
Inclusion Criteria:

* Adults 21 years and above
* Clinical/radiological suspicion or confirmation of neurological haemorrhage

Exclusion Criteria:

* Age below 21 years
* Prisoners
* Known pregnancy
* Do-not-attempt resuscitation status
* Requirement for immediate surgery
* Active chemotherapy/neutropenia (Neutrophil count \<1.0 x 109/L)
* Immuno-compromised
* Haematological malignancy
* Treating physician deems aggressive care unsuitable
* Unable to provide informed consent or comply with study requirements
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.

This is a multicentre, randomized, double-blind, parallel group, placebo-controlled, phase 2 study to designed evaluate the effect of a 300 mg dose of tralokinumab administered subcutaneously every 2 weeks on airway inflammation in adults with asthma inadequately controlled on inhaled corticosteroids (ICS) with or without other controllers. Approximately 80 subjects will be randomized. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 12 week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years
2. Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
3. Documented treatment with an asthma controller regimen requiring treatment with ICS (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
4. Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
5. At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1\>50% and more than 1L.
6. Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).

Exclusion Criteria:

1. History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma.
2. History of anaphylaxis following any biologic therapy.
3. Hepatitis B, C or HIV
4. Pregnant or breastfeeding
5. History of cancer
6. Current tobacco smoking or a history of tobacco smoking for \>10 pack-years.
7. Previous receipt of tralokinumab
Maintenance Versus Reduction of Immunosuppression for Renal Transplant Patients Hospitalized With COVID-19 Disease

This will be a randomized trial of maintenance versus reduction in immunosuppression in adult patients (age \>18 years old) with functioning renal transplants admitted to hospital with confirmed COVID-19 disease.

The optimal management of immunosuppression in renal transplant patients with COVID-19 disease is unclear. On one hand, many centers advocate reduction of immunosuppression in infected patients, with the rationale that such an approach will unleash the anti-viral T-cell response. However, on the other hand, some centers advocate there may be rationale to maintain baseline immunosuppression in order to mitigate against development of an uncontrolled over-activation of the immune response. The investigators propose to address this knowledge gap by performing a randomized clinical trial that will test formal comparisons of maintenance versus reduction in immunosuppression.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years
* COVID positive by RT-PCR or serology
* ≥ 6 months post-transplant
* use of anti-metabolite (mycophenolate or azathioprine) and calcineurin inhibitor (cyclosporin or tacrolimus)
* informed consent; first admission during study period
* participation within 72 hours of hospitalization

Exclusion Criteria:

* ICU care or need for invasive ventilation or use of pressors at screening/randomization
* COVID-19 disease severity score more than 5 at screening/randomization
* Known donor specific antibody
* eGFR \<20ml/min/1.73m2
* hematocrit \<24%
* biopsy proven and treated rejection within last 3 months
* institutionalized individuals (prisoners)
* pregnancy
* participation in another clinical study with an investigational medicinal product within 30 days or within 5 half-lives of such, whichever is longer, prior to randomization and during the study
* any other conditions, which, in the opinion of the investigator would make the subject unsuitable.
Randomised Trial Comparing Metal and Plastic Biliary Stents Stents for Palliating Malignant Jaundice

Background:

When considering any malignancy with limited life expectancy, palliation and quality of life are paramount. Owing to the limited centres offering ERCP and endoscopic palliation in the South African state sector, patients often travel vast distances and spend large amounts of time away from family and social support structures, severely impairing their quality of life. Stent occlusion with resultant readmission to an ERCP accredited centre obviously compounds this problem.

The hypothesis we propose to test is whether metal stents as a primary procedure result in better patency rates, are more cost effective and improve quality of life than plastic stents. We propose to do this by means of a randomised trial determining the best method of palliation for inoperable distal common bile duct malignancies in the South African context.

Primary end-point Assessing the cost of metal versus plastic stenting in inoperable malignant distal common bile duct strictures in patients with expected survival of 3 months or more as palliation of symptomatic obstructive jaundice. Cost to be assessed in terms of hardware, hospital stay and readmissions for stent occlusion(patency) and complications Secondary end-point Assessing quality of life using a validated scoring system(EORTC QLQ 30) in patients receiving a metal or plastic biliary stent as definitive means of palliation of malignant obstructive jaundice

Hypothesis to be tested Metal stents are superior to plastic stents in terms of patency, resulting in more cost effective palliation of inoperable malignant jaundice and better quality of life due to fewer stent occlusions/episodes of cholangitis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic jaundice secondary to malignant distal CBD stricture
* Contra-indication to resection (advanced disease/advanced age/poor surgical risk)

Exclusion Criteria:

* Hilar/proximal CBD obstruction
* ECOG performance status 3 or 4
* Duodenal obstruction
* Previous stent placement
* Inability to comply with follow-up
* Ascites and liver metastases
* Not possible to stent endoscopically
Degenerative Consequences of Congenital Deafness

In this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). The investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. The investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. Lastly, The investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. The primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.


Eligibility Criteria:
Inclusion Criteria:

* Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users
* Native speakers of English
* Early onset of deafness (\< 3 years of age); no requirement for age at implantation
* Late onset of deafness (\> 3 years of age); matched in duration of deafness to the early onset group
* Has had device experience for at least one year
* Can be child or adult at the time of enrollment

Exclusion Criteria:

* None
Evaluation of Efficacy and Toxicity of Nivolumab Monotherapy for Advanced Non-small Cell Lung Cancer After First-line Treatment Failure Based on Second-generation Sequencing and Liquid Chip Platform

In order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. The second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。

In order to understand the efficacy and side effects of lung cancer immunotherapy, at least 30 patients with lung cancer who were treated with immunotherapy were enrolled. The second-generation sequencing technology and liquid phase factor platform were used for detection, and clinical imaging and other evaluation methods were used to explore the immunotherapy efficacy and side effects affecting lung cancer。

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing and able to comply with the schedule of visits, treatment protocols, laboratory tests, and other requirements of the study.
* PS \> 2, lung cancer in the elderly (less than 65 years old).
* subjects' characteristics and target disease characteristics Histologically or cytologically diagnosed as NSCLC (SQ or NSQ) and with stage IIIB/IV tumors (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, Version 8) or multimodal therapy (radiotherapy, surgical resection) Subjects who relapsed or developed disease after radical chemoradiotherapy for locally advanced diseases.
* Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatmen

Exclusion Criteria:

* Women with a positive pregnancy test at enrollment or prior to administration of study medication
* Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
* Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
* Participants with carcinomatous meningitis Other protocol defined inclusion/exclusion criteria could apply
Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement

MolecuLight is a device that utilizes a special light which, when used on wounds, helps identify the regions which pathogenic bacterial counts are the highest. The device applies 405nm violet light which is harmless to the human tissue. When specific components in bacteria catches up the light, a photoluminescent reaction is triggered and the fluorescence light is caught by the camera on this device in real time.

When treating an infected wound which requires debridement and/or reconstruction, traditionally surgeons rely on many clinical clues to judge the severity and region of infection. However, these clues, such as lab data, vital signs, bacterial culture growth, or infection symptoms/signs, are usually indirect and also require several days to be fully interpretated.

The advantage of MolecuLight is its simple, direct, real-time, and flexible application, which is very important and valuable when treating an infected wound. We aim to add this device to our routines and see if the treatment course for these wounds can be more rapid and effective, and also utilize the countless potential of immediate bacterial identification in numerous aspects of our work.


Eligibility Criteria:
Inclusion Criteria:

* Patients with wounds that present obvious symptoms or/and signs of infection, and chronic wounds that have failed to heal or improve for 14 days (Chronic wounds are often complicated or caused by wound infection)
* Patients that are scheduled for surgical treatment for the wound
* Patients that are older than (including) 20 years and younger than (including) 85 years.
* Wounds with a size larger than 1x1 cm2

Exclusion Criteria:

* Wounds that heal within 14 days.
* Patient is unable to continue further surgical treatment due to any reason
* The wound site is amputated
* Patient refuses further surgical treatment
* The patient has an active malignancy currently under treatment
* Patient is immunocompromised or currently under systemic steroid treatment
* The wound had been treated by radiation
* The patient refuses to participate in this study
HTEMS Treatment of Diabetic Polyneuropathy

So far, there are no sufficient pharmacologic therapies for the treatment of diabetic neuropathy. Therefore, we evaluated application of high-tone external muscle stimulation (HTEMS) compared to placebo treatment in patients with diabetic neuropathy.

Patients (n=80) with symptomatic diabetic neuropathy will be included into this randomized controlled trial. Each intervention will be administered for a period of at least 30 min on at leat 5 days in a week. Health impairments will be assessed using the neuropathy symptom score (NSS) before, during and after intervention.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic diabetic neuropathy
* stable oral analgesic regimen

Exclusion Criteria:

* history of drug or alcohol abuse
* cardiac pacemaker or defibrillator
* pregnancy
Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects 3 to 64 years of age

Exclusion Criteria:

* Receipt of other investigational products within 3 months or other vacine within 1 month;
* Allergy to eggs, egg products, or any other vaccine component;
* Laboratory confirmed influenza disease within 6 months;
* Have previously received an influenza vaccination (3 to 8 years only);