cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Modulation of Spinal Cord Nociceptive Reflexes

The aims of this study are threefold. First, to investigate whether spinal nociceptive processing - represented here by the nociceptive flexion reflex (NFR) - is influenced by thoracic transcutaneous spinal direct current stimulation (tsDCS) in a spatially selective manner, i.e., whether effects are only observed for lower limb NFRs, but not for upper limb NFRs. Second, to investigate - in a double-blind, sham-controlled, within-participant design - whether anodal and cathodal tsDCS do affect the NFR in a polarity-dependent manner. Third, to investigate whether tsDCS effects observed on a spinal measure (NFR) are also observed in responses that are mediated supra-spinally, namely autonomic parameters and pain intensity ratings.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers between the ages of 18 and 40 years
2. Having participated in the MRI medical assessment session and consented to taking part in 3T MRI measurements in written form
3. Having participated in the magnetic/electric neurostimulation medical assessment session and consented to taking part in magnetic/electric neurostimulation experiments in written form
4. Voluntary participation and signing of the study-specific consent form

Exclusion Criteria:

1. Existence of any contraindications for MRI measurements and magnetic/electric neurostimulation experiments
2. Pregnancy or breastfeeding
3. Very dry or sensitive skin (e.g., intolerance to creams/shampoos)
4. Chronic skin diseases - such as eczema or neurodermatitis - in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
5. Scar tissue in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
6. Acute sunburn in the area of somatosensory / nociceptive stimulation (arm or hand, leg or foot) or electrophysiological data recording (upper body, arm, leg)
7. Current or recurring pain
8. Injuries to the nervous system
9. History of or current neurological or psychiatric disorders
10. Chronic diseases that require permanent medication (e.g., asthma, diabetes mellitus, etc.)
11. Persons not capable of giving consent (e.g., in case of dementia)
12. Lack of consent with regards to report of incidental findings
An Open Label Treatment Extension Study of AMG 706

This is an extension study to provide ongoing treatment with AMG 706 monotherapy for subjects with solid tumors who have completed the planned duration of AMG 706 treatment on a separate Amgen protocol and have been evaluated as having stable disease or better. Subjects who are no longer eligible to continue AMG 706 treatment on a separate Amgen protocol (for reasons other than AMG 706 intolerance), but who are receiving clinical benefit or have the potential to receive clinical benefit from AMG 706 per the investigator are also eligible to participate in this trial.


Eligibility Criteria:
Inclusion Criteria:

* Women and men 18 yrs or older with solid tumors, previously treated with AMG 706 on an Amgen protocol
* Subject must meet one of the following criteria: Subject has completed the planned duration of AMG 706 treatment on a separate Amgen protocol and has been evaluated as having stable disease or better or is no longer eligible to continue AMG 706 treatment on separate Amgen protocol for reasons other than AMG 706 intolerance, but is receiving clinical benefit from AMG 706 in the judgement of the investigator.
* Subject must meet one of the following criteria: Subject has received AMG 706 for at least 8 weeks or until the first protocol-specified tumor evaluation (whichever is longer) or
* Subject has received at least one dose of AMG 706 but did not receive AMG 706 for =/\>8 weeks.
* Sign informed consent prior to study specific procedures.

Exclusion Criteria:

* Discontinued from prior AMG 706 study due to AMG 706-related adverse event including intolerance to AMG 706 or for any other reason that a subject's safety could be compromised with continued AMG 706 treatment.
* Has been off AMG 706 treatment \>42 days prior to study day 1.
* Participating in any intervening investigational device or drug study between previous AMG 706 study and this AMG 706 study or is receiving any other investigational agent(s) other than AMG 706.
* Uncontrolled hypertension (resting blood pressure \> 150/90 mmHg). Anti-hypertensive medications are allowed if the subject is stable on their current dose at time of study day1
* Requires additional systemic anticancer therapy for primary tumor.
* ANC \< 1.0 x 10\^9/L; PLT \< 100 x 10\^9/L; Hgb \< 9 g/dL; serum creatinine \> 2.0 mg/dL or calculated clearance \< 40 mL/min; AST \>2.5 x ULN, or AST =/\> to or =/\>5.0 x ULN if secondary to liver metastases; ALT \>2.5 x ULN or ALT =/\>5X ULN if liver metastasis are present; Alkaline phosphates \>2.0 x ULN or =/\>5 x ULN if liver and bone metastases are present; total bilirubin =/\> 2 x ULN (except for subjects with UGT1A1 promoter polymorphism, ie, Gilbert's syndrome. Subjects enrolled with Gilbert's syndrome must have a total bilirubin \<3 x ULN).
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety

Objectives: Our study aimed to perform a Turkish validation study of the Child Drawing: Hospital (CD:H) Scale and evaluate the dental anxiety and pain experienced during the treatment by drawing.

Study Design: Pediatric patients between the ages of 4-13 who applied to the Pediatric Dentistry Department between 2018-2020 were included in the study. Following the translation of the CD:H Scale into Turkish and linguistic-cultural validation, the behaviors of pediatric patients during treatment were evaluated with the Frankl Behavior Rating Scale, the pain they experienced during treatment with the Wong- Baker Face Rating Scale, and their anxiety levels were evaluated with the pictures drawn by the patients at the end of the treatment. The data were analyzed with Statistical Package for the Social Sciences v23, and the significance level was taken as p \<0.05.

Results: Within the scope of the scale's reliability-validity study, the Intra-Class Correlation Coefficient (ICC) was evaluated with test-retest consistency. For section A,B,C and total score reliability was found to be positive and strong level correlation. Dental anxiety of boys was higher than girls.

Conclusions: The Turkish version of the CD:H Scale is a reliable and valid scale that can be used to evaluate the dental anxiety of Turkish pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have toothache and who have undergone dental treatment (filling and root canal treatment)
* Patients with deep dentin caries who need local anesthesia
* Children between the ages of 4-13
* Patients who are willing to paint and understand commands
* Patients without any mental or physical disability
* Patients whose parents agreed to participate in the study and signed their consent

Exclusion Criteria:

* Children not aged 4-13
* Patients with mild to moderate caries who do not need local anesthesia
* Patients who are not willing to paint
* Patients with inadequate hand coordination
* Patients with motor dysfunction
* Children with any systemic illness
* Patients with mental or physical disabilities
* Patients with any syndrome
* Patients with color blindness
* Children whose native language is not Turkish
* Patients whose parents refused to participate in the study
A Comparison of Local Infiltration Analgesia and Pecs Block for Analgesia in Mastectomy With Axillary Dissection - an Equivalence Study

The investigators aim to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance for patients undergoing mastectomy with axillary dissection.

Total breast removal with armpit dissection may be a painful surgery. Pectoral nerve block (Pecs block) is common pain relief method used to reduce pain after breast surgery.

The Pecs block is a pain relief method technique at targeted body part. The Pecs block numbs nerves which supply sensation to the upper chest wall, armpit and upper arm. This procedure is only possible under ultrasound guidance and is carried out by the anaesthetist (medical specialist who administers anaesthetics) after patients are put under general anaesthesia.

Despite the advantages of Pecs block in pain management, this method is not always available to all patients due to various reasons. These reasons include the availability of ultrasound machine to facilitate the method, presence of anaesthetist to carry out the procedure and additional time required to perform this method in the operating theatre.

Another method has been modified by our surgeons (medical specialist who performs surgery, a different specialty from anaesthetist) to achieve pain relief among patients undergoing breast removal surgery. This method is called local infiltration analgesia (LIA). The pain control is achieved by having the surgeons to deliver a pain control drug surgically during the breast removal operation. LIA could be a good pain control alternative when a Pecs block could not be performed.

The investigators hope to compare the quality of pain relief provided by local infiltration analgesia delivered by surgeon and Pecs block delivered by anaesthetist under ultrasound guidance. The investigators hope to show that LIA delivered by surgeon is as effective as Pecs block in patients undergoing mastectomy with axillary dissection.

Eligibility Criteria:
Inclusion Criteria:

* Age above 21 years old
* Able to give consent
* Body weight \> 50kg

Exclusion Criteria:

* Patient's refusal and inability to give consent
* Allergy or contraindicated to local anaesthetics, paracetamol, NSAIDS or opioids
* Background history of chronic pain
* Bilateral procedures
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients

All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with ages between 2 to 18 years old.
* Undergoing regular hemodialysis for at least 6 months.

Exclusion Criteria:

* Patients who weigh less than 10 kg.
Secondary Prevention Education After Acute Myocardial Infarction

The aim of this study is to examine the effect of secondary prevention education given to individuals after acute myocardial infarction on physiological parameters, anxiety and quality of life.

The aim of this study is to examine the effect of secondary prevention education given to individuals after acute myocardial infarction on physiological parameters, anxiety and quality of life.The population of the study will be the individuals hospitalized with the diagnosis of acute myocardial infarction in the Coronary Intensive Care Unit of Abant Izzet Baysal University Izzet Baysal Training and Research Hospital. The study will be conducted in a randomized controlled manner with two groups, 43 in the control group and 43 in the secondary prevention education group. CAG (Coronary Angiography) Procedure Training Form, Patient Identification Form, Physiological Parameters Form and Visual Analogue Scale, Spielberg State and Trait Anxiety Scale and Myocardial Infarction Dimensional Assessment Scale will be used to collect data. The data will be collected by face to face interview technique. For descriptive statistics, mean and standard deviation or median and minimum-maximum values for numerical variables, number and percentage values for categorical variables will be given. The Kolmogorov-Smirnov test (p \<0.05), skewness and kurtosis coefficients (should be ± 1) and X ̅ / SS \<4 inequalities will be examined at the same time, and the weight in which group will be preferred.

Eligibility Criteria:
Inclusion Criteria:

* First time AMI and inpatient treatment in the coronary intensive care unit,
* Not having received training after AMI \*
* Being 18 years or older,
* Speak Turkish,
* No problem in verbal communication,
* Absence of hearing loss,
* Not being diagnosed with a psychiatric illness,
* Being conscious,
* Being volunteer to participate in the study,
* Routine check of cholesterol, HDL, LDL, triglyceride results at the beginning of the study and at 6 months.

Exclusion Criteria:

Not having had AMI for the first time

* Having received training after AMI
* Not willing to participate in the study,
* Cannot speak Turkish,
* Problems in verbal communication,
* Having hearing loss,
* Having a diagnosis of psychiatric illness,
* Unconsciousness.
* Cholesterol, HDL, LDL, triglyceride results were not routinely checked at the start and 6 months of the study.
A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion for more than 12 months
* Body mass index (BMI) between 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
Acceptability and Efficacy of Enterade (VS001) in Children at Risk for Environmental Enteric Dysfunction in Bangladesh

This is a pilot study to assess the feasibility and acceptability of a trial of Enterade (VS001) to treat environmental enteric dysfunction in children from a low-income setting. Preliminary data on efficacy will also be obtained.

Primary Objectives

1. To determine tolerability of Enterade (VS001) in stunted Bangladeshi children between 1 and 2 years of age
2. To assess the efficacy of Enterade (VS001) in treatment of environmental enteric dysfunction by comparing improvements in 2-h lactulose mannitol ratio between Enterade (VS001) and a placebo.

Secondary Objectives

1. To assess the adherence to the regimen of 237ml (8 oz) of Enterade daily in children aged 1 to 2 years.
2. To assess Enterade (VS001) efficacy by comparing improvements in fecal measures of intestinal inflammation between Enterade (VS001) and placebo.

Eligibility Criteria:
Inclusion Criteria:

* Length-for-age Z score (LAZ) between -1 and -3 standard deviations
* Lactulose mannitol ratio \>0.09

Exclusion Criteria:

* Presence of known congenital or chronic diseases other than malnutrition
* Diarrhea (\> 3 unformed stools in a 24-hour window) in the 7 days prior to screening
* Anticipated unavailability for study visits
* A sibling previously enrolled in this study
Changes in Everydaylife Activity of Children With CP During HABIT-ILE

Studying in a RCT the changes in everyday llife activities of children with CP during HABIT-ILE or control period, changes being scored by parents and by experts.

Studying in a RCT the changes in everyday llife activities of children with CP (unilateral and bilateral) during HABIT-ILE or control period, changes being scored by parents and by experts on ABILHAND-Kids, the PEDI, the ACTIVLM-CP and the COPM. Investigate neuroplastic changes and correlation with everyday life changes.

Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy
* ability to make a few steps with a walking device
* ability to pick a light object from a table with the more affected hand
* ability to understand simple games

Exclusion Criteria:

* no active seizure
* no botulinum toxin in the 6 months previous to the intervention or during intervention time
* major visual deficit
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema

The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).

The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:

1. Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.
2. Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.
3. Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated per the approved product label for KALBITOR
* Patient or guardian is able to understand and sign the informed consent form
* Patient is willing and able to undergo a skin test procedure at screening (baseline)

Exclusion Criteria:

* Patient contraindicated per the approved product label for KALBITOR
* Patient confirmed pregnancy or active breastfeeding
* Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
Treatment of Negative Symptoms of Schizophrenia by rTMS

The purpose of this study is to assess the effectiveness of rTMS on the negative symptoms of schizophrenia in real conditions. It will also provide a regulatory framework to rTMS treatments under these conditions. 4 types of rTMS protocols are proposed, allowing to adapt to patients and their tolerances.Treatment lasts between 2 and 4 weeks, with a follow-up period of 3 months after treatment to observe relapses.To assess the evolution of negative symptoms between baseline and the end of treatment, investigators use SANS (Scale for the Assessment of Negative Symptoms).


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient diagnosed with schizophrenia according to the DSM-V criteria (Diagnostic and Statistical Manual of Mental Disorder V5, 2013)
* Stable drug treatment for at least 4 weeks
* Presence or persistence of negative symptoms in the foreground:

Negative PANSS score ⩾21, positive PANSS score ⩽24

* Patient (or legal representative) willing to participate in the study and having signed an informed consent
* Patient fluent in the French language
* Affiliation to a social security scheme

Exclusion Criteria:

* Present a contraindication to TMS: intracranial foreign body, unstabilized epilepsy, cochlear implant, pace-maker
* Presence of an unstabilized medical condition
* Pregnant woman
* Woman of childbearing potential and without effective contraception
* Breastfeeding woman
Foot Posture Index, Hallux Limitus in Patients With Chronic Low Back Pain. Gait With Optogait Sensor

Foot disorders have been recognized as being linked to chronic low back pain

Foot disorders have been recognized as being linked to chronic low back pain (CLBP), To improve knowledge of the relationship between the limitation of the movement range of hallux (HROML) is important about it can affect the back biomechanical . The aim of this research is to investigate if the HROML may appear as a risk factor of CLBP

HROML affect the foot position, and consecuently may induce to alter as compensatory mechanism the normal biomechanical of the leg, hip and back.

Eligibility Criteria:
Inclusion Criteria: males and females between 18 to 65 years old Hallux limitus in one or two feet -

Exclusion Criteria:

serious illness, current participation in another research study pregnancy previus foot or back surgery

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Evaluation of Additional Heidelberg Engineering SPECTRALIS With OCT Angiography Module (OCTA Module) Scan Types

Assessment of image quality and clinical relevance of OCT Angiography at different speed/ART combinations

The objectives of this study are:

1.) Compare the image quality between the predicate scan types and the corresponding investigational scan types.

2. Compare the visibility of key anatomical vascular structures between the predicate scan types and the corresponding investigational scan types.

3. Assess the agreement in identification of vascular abnormalities between the predicate scan types and the corresponding investigational scan types, where agreement is assessed by the vascular abnormalities identified from the predicate scan types.

Eligibility Criteria:
Inclusion Criteria:

* All Populations:

  1. Able and willing to undergo the test procedures, sign informed consent, and follow instructions.
  2. Age ≥ 22
* Normal Population:

  3. Subjects without uncontrolled systemic conditions, as determined by the Investigator 4. Subjects without ocular disease, as determined by the Investigator 5. Corrected visual acuity ≥ 20/40 6. No reported history of ocular surgical intervention (except for refractive or cataract surgery)
* Pathology Population:

  3. Subjects with vascular abnormalities such as retinal ischemia, microaneurysms, choroidal neovascularization, retinal neovascularization in at least one eye

Exclusion Criteria:

* All Populations:

  1. Subjects unable to read or write
  2. Subjects with ocular media not sufficiently clear to obtain acceptable study-related imaging
  3. Subjects who cannot tolerate the imaging procedures
  4. Subjects without an accompanying structural OCT and CFP image for an acceptable OCTA image