cyrilzakka/clinical-trials huggingface dataset:
Host RNA Profiles to Detect Infections in Young Infants

This study seeks to identify and test host RNA expression profiles as markers for infections in young infants. Preliminary studies have shown high sensitivity and specificity for the discrimination of bacterial from non-bacterial infections in children, but the method has only been investigated in a limited number of young infants. The study aims to include 65 young infants with serious bacterial infections. The samples will be analysed by RNA sequencing. New diagnostic tools may help reduce unnecessary antibiotic treatment, antibiotic resistance, side-effects, hospitalisation and invasive procedures.

Background:

Infections in young infants is a challenge as 1) it is often not possible to distinguish serious bacterial infection (SBI) from viral infection by clinical appearance alone, 2) a causative organism is often not identified and 3) due to relatively low sensitivity and specificity of current biomarkers. The consequence is overtreatment with antibiotics being prescribed to as many as 50% of febrile young infants presenting to emergency departments. However, the majority of these children does not have a bacterial infection. Host RNA expression profiling has shown high sensitivity and specificity for discriminating bacterial from non-bacterial infections in preliminary studies of febrile young infants.

Methods:

A prospective multicentre observational study including young infants admitted and evaluated due to suspected infection at the 4 paediatric acute care units in the Capital Region of Denmark (Rigshospitalet, Hvidovre Hospital, Herlev Hospital, Nordsjællands Hospital - Hillerød). Whole blood will be collected in PAXgene blood RNA tubes and analysed by RNA sequencing at the Centre for Genomic Medicine, Rigshospitalet. Host RNA expression profiles will be identified in a discovery cohort and the diagnostic performance will be tested in a validation cohort. A control group of healthy and afebrile young infants will be included.

Time frames:

Patient recruiting: May 15th 2020 to February 28th 2022. Sample analysis (RNA sequencing): March 1st 2022 to August 31st 2022.

Perspectives:

New molecular-based diagnostic tools complementary to conventional methods may optimise infection management in young infants by improving early diagnostics and allowing early modification of antibiotic treatment. This will reduce antibiotic resistance, side effects, unnecessary hospitalisation and invasive procedures.

Eligibility Criteria:
Inclusion Criteria:

1. age 0-3 months
2. admitted from home
3. suspected of infection
4. having routine blood sampling done
5. gestational age or corrected gestational age greater than or equal to 37+0
6. informed consent

Exclusion Criteria:

1. not possible to draw blood tests
2. withdrawal of consent
3. sampling \>48 hours after admission
Effects on In-Game Decision Making Processes

This study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

This study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

Eligibility Criteria:
Inclusion Criteria:

* Accepting the voluntary basis
* To be between the ages of 18-35
* To take part in professional football clubs
* Not having suffered any serious injury in the last 6 months
* To be able to participate in the Tampa Kinesiophobia Scale
* To be able to actively participate in technology-based tests such as decision-making simulations and Blazepod

Exclusion Criteria:

* Not accepting the voluntary basis
* Individuals who have had a surgical procedure in the last six months
* Use of NSAIDs and similar disease modifying drugs in the last month (Diaserein, Glucosamine etc.)
Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approximately 30-32 patients.

Study Hypothesis:

The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal.

Comparison(s):

PRIMARY ENDPOINT:

Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale).

SECONDARY ENDPOINT (S):

1. Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale.
2. Participating doctors assessment of tolerance.

Eligibility Criteria:
1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.

1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.
3. Counting of white blood cell in blood routine examination exceeds 10?109/L.
4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).
6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.
7. Previous and/or existing tumour condition.
8. Pregnancy and/or breast-feeding.
9. Alcohol, and/or drug abuse.
10. Simultaneous participation in another clinical trial.
Supracondylar Femur Fracture After DDH

incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery


Eligibility Criteria:
Inclusion Criteria:

* Age 1-7 years old
* Primary DDH

Exclusion Criteria:

* • Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)

  * Recurrent cases of DDH
  * Past history of ipsilateral distal femoral fractures
A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression

Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a large burden of disease in the community, often due to inadequate treatment. Thus there is interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such as transcranial direct current stimulation (tDCS). Two small studies have been published in the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).

This study will extend previous findings, testing a more definitive tDCS approach (also left prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger sample (N=68), using a placebo-controlled design.

It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause any significant adverse effects or cause decline in neuropsychological functioning in comparison to a sham control.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for DSM-IV Major Depressive Episode

Exclusion Criteria:

* Diagnosis (as defined by DSM-IV) of: any psychotic disorder except bipolar disorder(lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
* History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
* Inadequate response to ECT in the current episode of depression.
* Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
* Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
* Neurological disorder or insult, eg recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
* Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception
Root Canal Treatment Outcome in Patients Under Bisphosphonate Therapy

The aim of this study was to evaluate the survival rate and healing time of compromised teeth and seriously compromised teeth that were endodontically treated in patients which received bisphosphonate therapy . Clinical complications, success and survival rate was reported. Mean clinical parameters, clinical symptoms and presence of periapical radilucency were recorded.

The study was conducted in one University Endodontic Clinical Department - Dental School between January 2009 and December 2017.

Root canal treatment was performed according previously reported operative protocols.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by endodontic disease and able to attend a hygiene recall program

Exclusion Criteria:

* inability to attend a recall hygien program
A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer

The role of preoperative chemotherapy as standard therapy is well-established for advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of preoperative immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of preoperative chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as esophageal squamous cell carcinoma
* KPS≥80
* Adequate organ function
* No distant metastasis
* The diseases could be resected or potentially resectable after immunochemotherapy assessed by a thoracic oncologist

Exclusion Criteria:

* incomplete medical record which affects statistical analysis
* have participated in previous interventional clinical trials
* other situations evaluated by investigators not meet the enrollment
Stepping Training Using External Feedback in Spinal Cord Injury Patients

Does a 4-week stepping training program with or without external feedback clinically change functional ability and reduce risk of fall of ambulatory patients with iSCI?

Are there significant differences between 4-weeks stepping training with or without external feedback in ambulatory patients with iSCI?

To compare effects of 4-week stepping training with or without external feedback on functional ability and incidence of falls in ambulatory patients with iSCI (between-group comparison).

To compare the change of functional ability in a group of 4-week stepping training with or without the utility of external feedback (within-group comparison).

Eligibility Criteria:
Inclusion Criteria:

* Independent ambulatory patients with iSCI
* Non-traumatic or traumatic causes
* Independent walking with or without assistive devices at least 17 meters (Functional Independence Measure Locomotor (FIM-L) scores 5-7)
* Age at least 18 years
* Body mass index (BMI) between 18.5 - 29.9 kg/m2.

Exclusion Criteria:

* Any conditions or disorders that might affect ability to participate in the study and/or ambulatory ability of the subjects such as

  * Brain function disorders
  * Visual deficits that cannot be corrected using glasses or contact lens
  * Musculoskeletal pain (with an intensity of pain more than 5 out of 10 on a numerical rating pain scale)
  * Deformity of the musculoskeletal system
  * Unable to follow a command of the tests
  * Unstable medical conditions
  * Color blindness
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio

evaluate the degree of association, and the predictive accuracy of the REPS (as a predictive tool) compared with the TOFr as a quantitative assessment tool for (rNMB) in surgical patients in the early postoperative phase. The TOFr will be measured at 0, 15, 30, 45, and 60 min after extubation.


Eligibility Criteria:
Inclusion Criteria:

1. Age group 18-65 years old
2. Both genders
3. Patients with American Society of Anesthesiologist physical status classification of 1 or 2.

Exclusion Criteria:

1. Patients who are less than 18 years old or more than 65 years old.
2. Patients with planned scheduled recovery in the intensive care unit or if more than 10 minutes had elapsed since tracheal extubation until NMB monitoring at the PACU.
3. Patients on medications that interfere with muscle activity.
4. Known allergy to neuromuscular blocking agents.
5. Pregnancy or suspected pregnancy.
6. Neuro-muscular diseases.
7. Patients refusing to participate in the study.
German Observational Multicenter Study of Patients With Fabry Disease Under Enzyme Replacement Therapy With Pegunigalsidase-alfa

Pegunigalsidase-alfa may represent an advance in ERT for FD, based on its unique pharmacokinetics and apparent low immunogenicity. The objective of the study is to document long term data on treatment with pegunigalsidase-alfa under "real world" conditions. 60 patients with FD (therapy-naïve or pretreated with agalsidase-alfa or agalsidase-beta) will be recruited in 8 German Fabry centers. The treatment duration/patient will be 2 years. All patients will be followed-up by the above listed Fabry expert centers.

Pegunigalsidase-alfa, a novel PEGylated, covalently crosslinked form of α-galactosidase A developed as enzyme replacement therapy (ERT) for Fabry disease (FD), was designed to increase plasma half-life and reduce immunogenicity, thereby enhancing efficacy compared with available products.

The rationale of the current project is that disease progression of patients with FD can be stabilized comparable to patients under current ERT, leading to a validation of the clinical phase 3-studies and a transfer of these previous outcomes to a nationwide "real world" designed study in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, ≥18 years, diagnosed with Fabry disease.
* ERT naïve (patients with signs of organ involvement (kidney, heart and/or CNS signs) to be considered for ERT following the European Consensus Guidelines on ERT (Biegstraaten et al. 2015) or patients with neuropathic pain not controlled with pain medication or patients with GI symptoms not relieved with standard medication or ERT switch patients (under ERT for ≥12 months).
* Subjects taking ACE inhibitors, ARBs, or renin inhibitors on a stable dose for at least 4 weeks before screening.
* Subjects taking analgesics/antidepressants on a stable dose for at least 4 weeks before screening.
* Female patients must have a negative pregnancy test and use a medically accepted form of contraception throughout the study.

Exclusion Criteria:

* Patient is unwilling to give informed consent.
* Patient is unable to comply with the clinical protocol.
* Patients on dialysis.
* Patient has a clinically significant organ disease (e.g., cancer in the past 5 years) that in the opinion of the investigator would preclude participation in the trial.
* Patients with a history of organ transplantation.
Impact of Adjuvant Statin Therapy in Patients Who Underwent Radical Prostatectomy for Locally Advanced Prostate Cancer

Biochemical recurrence develops in approximately 30-40% of men with locally advanced prostate cancer who undergo radical prostatectomy. To date, the effect of statins on prostate cancer recurrence has been investigated in several retrospective studies with inconsistent results. The purpose of this study is to determine the impact of statin on biochemical recurrence after radical prostatectomy for locally advanced prostate cancer.

Estimated Enrollment: 354

Study start date: October 2012

Estimated Study Completion Date: October 2015

Statin Group: Treatment with Atorvastatin 20mg daily after radical prostatectomy during 1 year.

Control Group: Treatment with Placebo daily after radical prostatectomy during 1 year.

Follow up: every 3 months for the first year. Check PSA, Total/LDL-cholesterol and Triglyceride.

Primary End Point Rate of Biochemical recurrence

Secondary End Point Clinical progression of prostate cancer Change of Total/LDL- cholesterol and Triglycerides 5 year-Biochemical recurrence free survival

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have correspond to one of the following three pathologic criteria.

   A. Gleason scores 8 or greater B. Positive resection margin C. pT3-T4
2. Patients must have pathologically adenocarcinoma
3. Patients must be enrolled within 60 days after radical prostatectomy
4. Patients must be able to provide written informed consent

Exclusion Criteria:

1. Patients who have received neoadjuvant androgen deprivation therapy
2. Patients who have the participation of other clinical trial within the past 3 months
3. Patients who have treated with statin
4. Patients who have lymph node metastasis or distant metastasis
5. Patients who have 10 year risk of cardiovascular disease over 10% based on NCEP ATP III guideline.
Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema

The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).


Eligibility Criteria:
Inclusion Criteria:

All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria

Exclusion Criteria:

1. Patients with Uncontrolled hypertension
2. Patients with Proliferative diabetic retinopathy
3. Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
4. Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
5. media opacities
6. evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
7. Pathologic myopia \> 6 Diopter
8. Patients with poor fixation or cooperation
9. Patients with renal or cardiac disease
Cognitive and Cerebral Blood Flow Effects of 2-week Caffeine Abstinence or Maintenance

The purpose of this study is to determine the effects of 2 weeks caffeine abstinence as compared to 2 weeks caffeine maintenance (300mg per day)on cognition and mood. Cerebral blood flow effects will also be assessed in a subset of participants. The role of caffeine abstinence/maintenance in the acute effects of caffeine will also be explored.

The current randomised, placebo-controlled, double-blind, parallel groups study aims to explore the behavioural effects of 2-weeks caffeine abstinence as well as establishing the role of abstinence in the effects of caffeine administration by administering caffeine or placebo to those in a state of chronic and acute abstinence. This research also aims to explore, in a subset of participants, the cerebral blood flow effects of caffeine abstinence and caffeine administration using Near Infrared Spectroscopy (NIRS). Cerebral blood flow will be measured both at rest and during performance of cognitive tasks.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female
* 18 - 40 years
* Healthy
* Consume ≥ 150 mg caffeine daily
* No herbal supplements/prescription medications (excl. contraceptive pill)
* Non smoker
* Native English speaker

Exclusion Criteria:

* Diagnosis of any significant medical condition or disorder
* Any known allergy or hypersensitivity to food.
* BMI \>29.9 or \<18.5
* Blood pressure \>139/89
Methotrexate Versus Triamcinilone Acetonide in Treatment of Recalcitrant Alopecia Areata

Alopecia areata is the second most common cause of hair loss following androgenic alopecia.

It is affecting 2% of global population with an increasing prevalence. Briefly, it is a chronic, immunomediated disease characterized by acute onset of non-scarring hair loss ranging from small circumscribed patchy areas on the scalp to complete scalp and body hair loss. Until recently our understanding of the pathophysiology of alopecia areata is scarce, despite being so common.

Methotrexate is an immunosuppressant drug that has been widely used for a range of inflammatory and immune-mediated skin disorders.

Methotrexate has been recently proven to inhibit Jak/STAT Pathway. Triamcinolone acetonide as another type of treatment of alopecia areata either intralesionally or topically remains the first line of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age groups: \> 12 years old.
* Sex: both sexes.
* Co-operative Patients.
* Recalcitrant or resistant cases to treatment (meaning that all patients had received various modalities of treatment in the past with poor/partial response or relapse after discontinuing therapy.

Exclusion Criteria:

* Patients \<12 years.
* Pregnant and lactating women.
* Patients with any underlying Systemic disorders.
* Patients with HBV or HCV.
* Patient with active infection of T.B.
* Patients with bone marrow suppression (leukopenia, thrombocytopenia)
* Patients who had received any other modalities of treatment in last 3-6 months.
Effect of Different Local Anesthetic Volumes of Serratus Anterior Plan Block After Video-Assisted Thoracoscopic Surgery

Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery. Severe postoperative pain may be encountered in patients undergoing VATS. Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB), and erector spinae plane block (ESPB) are widely used for VATS. Among these methods, ultrasound (US) guided TPVB is the most preferred method. In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased. ESPB and SAPB are some of them. In addition, SAPB application is increasing in patients who underwent thoracotomy and VATS. There is no consensus on the dose of analgesia in these studies. There are studies on volumes between 10 ml and 40 ml in the literature. In this study, it was aimed to compare the volumes of 20 ml and 30 ml containing local anesthetic at the same concentration (0.25% bupivacaine) of SAPB block to be performed with USG in patients who underwent VATS.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years old
* ASA physical status I-II-III
* BMI 18 to 30 kg/m2
* Elective video assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use