cyrilzakka/clinical-trials huggingface dataset:
Children Participation Assessment Scale

Increasing the number of Turkish versions of questionnaires evaluating participation will increase the variety of assessment methods. This study aims to evaluate the Turkish version, validity and reliability of the Children Participation Assessment Scale.

This study was designed to examine the validity and reliability of the Turkish version of the Children Participation Assessment Scale. Translation and cultural adaptation of the questionnaire will be designed according to an appropriate procedure. The original English version of the questionnaire is fluent in English; It will be translated into Turkish by two people, one a physiotherapist and the other a linguist. Translators will come together and combine the questionnaires translated into Turkish into a single translation. The questionnaire translated into Turkish will then be translated back into English by two sworn translators whose mother tongue is English and who know Turkish well. The questionnaire, which was translated from Turkish to English again, will be synthesized by the translation team and turned into a single translation and its compatibility with the original will be evaluated. 250 children between the ages of 6 and 12 with physical disabilities and their parents will be included in this study. Children and parents with serious visual and auditory problems and who do not volunteer to participate in the study will be excluded from the study. While examining the validity of the scale in children, it was planned to use the Child Health Questionnaire scale, which had previously been shown to be reliable and valid in healthy children with different disability levels. The questions in the data collection form will be asked to the parents in the form of face-to-face interviews.

Eligibility Criteria:
Inclusion Criteria:

* 6-12 years old
* physically disability
* adequate cognitive level

Exclusion Criteria:

* severe visual or auditory problems
* children and parents who did not volunteer to participate in the study
Sensation and Skin Pressures Under Blood-Draw Tourniquets

Purpose: This research study seeks to determine whether surface pressures generated by elastic tourniquets used by phlebotomists during blood-draws can penetrate to deeper tissues where major arteries and nerves lie. Additionally, investigators will also determine the effects of prolonged tourniquet application on hand sensation using a controlled, reproducible force stimulus. In conjunction, the investigators will also track changes in skin surface pressures and pain levels over this prolonged tourniquet application. Hypothesis: The investigators hypothesize the use of common elastic tourniquets used for blood draws does not significantly impact sensation and will not elicit nerve or tissue damage. Technologies used: Monofilaments and Pressure Sensor

The objective of this study is to investigate the reproducibility and consequently the safety of common elastic tourniquet methods for blood draws. Specifically, the study will investigate whether the surface pressures produced by blood draw tourniquets when applied by experienced phlebotomists are significant enough to penetrate to deeper tissue near bone where major arteries and nerves lie. By relating factors including tourniquet width and patient arm circumference to our surface pressure measurements and comparing our results to previous literature, the investigators hope to determine the safety of current blood draw tourniquet procedures.

In addition, the investigators will track changes in skin surface pressures over time to determine if prolonged exposure to these tourniquet pressures has the potential to permanently affect nerve function and muscle in tissues near bone.

Hand sensation will be investigated during a prolonged tourniquet application trial of the study to test the effects of the generated pressures on median, ulnar, and radial nerve viability over time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* no history of abnormal heart conditions
* no history of coagulation disorders
* will not be on prescription medications that affect cardiovascular system (ex: medications that affect blood pressure or cardiac contractility etc.)\*\*
* does not have diabetes

  * Types of medications that affect the cardiovascular system and are part of the exclusion criteria include but are not limited to: anticoagulants, antiaginals, antiarrhythmic agents, anti-hypertensive/hypotensive agents, cardenolides, cardiac stimulants, hypolipidemic agents, inotropic agents, vasoconstrictors, as well as vasodilators.
Diurnal Triglyceridemia in Relation to Alcohol Intake

The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Patients with:

* Hyperlipidemia
* Type 2 Diabetes Mellitus
* Cardiovascular diseases

Exclusion Criteria:

* Renal disease
* Liver disease
* Thyroid disease
Stress Response Using Thin and Standard Size Endoscopy.

Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups.

1. transnasal gastroscopy with thin endoscope
2. transoral with thin endoscope
3. standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.

A substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. Recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .Hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. Furthermore the patient tolerance is markedly improved compared to the standard transoral route.

The aim of the present randomised study was to evaluate the ECG-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally.

Method and material Sixty patients were included consecutively after written and informed consent and were all over 18 years. Patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. Patients with known disease or trauma of the nasal cavity were not included.

Only intended diagnostic upper gastrointestinal endoscopies were included. The patients received standard medication during the endoscopy if required.

Immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups A) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced transnasally (T group), B) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced orally (O group) or C) Endoscopy with a standard gastroscope (6 mm Olympus GIF XV10) (S group). All patients received the same amount of a local anesthetic spray (Lidocaine 10 mg/dose, ASTRA Zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).

Eligibility Criteria:
Inclusion Criteria:

* diagnostic gastroscopy, age over 18, danish speaking,

Exclusion Criteria:

* use of beta blocking or any other heart rate modulating drug, antithyroid drugs
A Study Evaluating Vardenafil Compared to Placebo in Subjects With Erectile Dysfunction (ED) and Dyslipidemia

This is a study consisting of four periods (screening, run-in, treatment, follow-up). A four-week treatment-free, run-in period where the subject will make at least four attempts at intercourse on four separate days with at least 50% of the attempts must be unsuccessful. During run-in the subjects will be using a stopwatch to measure the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina. Next there are 12 weeks of treatment with either placebo or LEVITRA. Each subject will be required to visit the clinic on 5 occasions over a period of 4 months.


Eligibility Criteria:
Inclusion criteria:

* Males with ED for more than six months, according to the NIH Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
* Stable heterosexual relationship for more than 6 months.
* The subject must make at least four attempts at sexual intercourse (according to the question in the subject diary: Was sexual activity initiated with the intention of intercourse?) on four separate days during the untreated baseline period. At least 50% of attempts during this period must be unsuccessful, according to the following questions from the subject diary \[at least one question should be answered "No"\]: Were you able to achieve at least some erection (some enlargement of the penis)? Were you able to insert your penis into your partner's vagina? Did your erection last long enough for you to have successful intercourse?
* Diagnosis of dyslipidemia treated with a stable dose of a statin for 6 months at Visit 1.
* IIEF-EF domain score of 25 denoting mild to severe ED at Visit 2.
* Documented, dated, written Informed Consent.

Exclusion criteria:

* Premature ejaculator \<2 minutes
* Any unstable medical, psychiatric, spinal cord injury, penile anatomical abnormalities, or substance abuse disorder that MD feels subject will not be able to complete the study.
* Low sexual desire.
* Prior prostatectomy surgery
* Severe chronic or acute liver disease, history of moderate or severe liver impairment
* Clinically significant chronic hematological disease
* Bleeding disorder or significant active peptic ulceration.
* Cardiovascular conditions that prevent sexual activity.
* History of heart attack, stroke, or life-threatening arrhythmia within the prior 6 months.
* hypotension or hypertension at rest.
* cancer within the past 5 years. Use of these medications: nitrates or nitric oxide donors, anti-androgens, oral or injectable androgens, received any investigational drug (including placebo) within 30 days of screening (Visit 1).
* Use of any treatment for ED within 7 days of screening including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories.
* Subjects who are taking the following potent inhibitors of cytochrome P-450 3A4.
* Abnormal Laboratory Values:

  1. serum total testosterone level \>25% below the lower limit of normal
  2. serum creatinine \>3.0 mg/dl.
  3. AST and/or ALT \>3x the upper limit of normal.
Observational Study in Adults With Imatinib-resistant/Intolerant Chronic Myeloid Leukemia Treated With Nilotinib

The GIMEMA CML Working Party promotes an observational (retrospective and perspective) study of Imatinib-resistant or intolerant CML patients treated with Nilotinib in Italy. Enrollment will include all patients who started Nilotinib between January 2005 and December 2012. Patients will be followed for 4 years since treatment start. After this time, survival data, disease status and treatment will be recorded at 6-months-interval. This study will help the definition of guidelines for a proper management of Nilotinib in any-phase CML patients.

Follow-up is required until the end of treatment for the purposes of the study for all patients by standard hematologic, cytogenetic and molecular criteria. This study will not contemplate any additional expense beyond what is expected for a regular follow-up, according to the international guidelines for CML.

Sample Size: target accrual was not defined, all eligible patients observed between January 2005 and December 2012 will be included.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Imatinib resistant (failure + suboptimal) or intolerant chronic myeloid leukaemia in all phases, who started treatment with Nilotinib between January 2005 and December 2012 in Italy.
* Adult pts treated with Nilotinib as second line therapy after Dasatinib.

Exclusion Criteria:

* Patients less than 18 year old.
* Use of Nilotinib as first line treatment.
* Patients treated with Nilotinib before 2005.
Nafamostat Efficacy in Phase 3 Registrational CRRT Study

A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients undergoing CRRT who cannot tolerate heparin or are at higher risk for bleeding.

Patients in intensive care units with acute kidney injury are often too frail to undergo the rapid fluid shifts that accompany intermittent hemodialysis. Continuous renal replacement therapy (CRRT) allows a more gentle continual dialysis, more similar to regular kidney function. Anticoagulation of the CRRT circuit can reduce clotting of the filter, which can lead to less filter changes and possibly less transfusions. Niyad (nafamostat mesylate), an anticoagulant with an ultra-short half-life of 8 minutes, is approved for use in South Korea and Japan for anticoagulation of the CRRT circuit. For patients who cannot tolerate heparin or who are at a high risk of bleeding, nafamostat may be an optimal anticoagulant to infuse into the CRRT circuit as the short half-life should minimize patient exposure. The primary objective of this study is to measure the anticoagulation efficacy of Niyad in the CRRT circuit versus placebo. Evaluation of the safety of Niyad in patients undergoing CRRT versus placebo will also be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring CRRT or undergoing CRRT initiated within the prior 48 hours
* Patients who cannot tolerate heparin or are at high risk of bleeding

Exclusion Criteria:

* Patients weighing less than 50 kg
* Patients receiving systemic anticoagulation
* Patients with active bleeding
Medical Imaging in the Diagnosis of Ganglion Cysts of the Hand

The aim of this study is to investigate if inexpensive, readily available and portable wireless ultrasound devices can detect ganglion cysts of the wrist and hand in compare to a cart-based ultrasound device before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Flexor tendon sheath ganglion cyst
* Dorsal ganglion cyst
* Palmar ganglion cyst
* Male and female patients minimum age 18 years
* MRI of the affected area

Exclusion Criteria:

* Pregnancy, lactation
* Malignant disease
* Insufficient mental possibility of cooperation
* Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
Neurobiological Substrate of Social Context on Cognitive Control in Drug Users

The aim of the present project is to reveal, using Functional Magnetic Resonance Imaging (fMRI) in drug users, a specific modulation of brain structures and circuits involved in cognitive control (and especially those of inhibitory control) and reward while subjects are performing under the influence of drug-associated cues and in various social contexts.

This hypothesis, based on the animal work, is that the subthalamic nucleus (STN) should play a critical role in these processes. Addictive behaviour can be seen as a loss of control resulting from reduced inhibitory control, leading to compulsive drug use. These disorders are known to be associated with a hypoactivation of specific frontal regions such as the anterior cingulate cortex or the prefrontal cortex.

For the present experiment, it is chosen to use a procedure well established for neurophysiological and behavioural assessment of inhibitory processes : the " stop-signal reaction time task ".

This task requires to inhibit a motor response (press a button) at the onset of a stop signal (a tone) that occurs while the response is already engaged. In this task associated with fMRI, it was previously shown that the STN is involved in the control of inhibition. These results confirm our data in the rat, and especially those showing that STN lesions block the ability to stop. The stop signal task will thus be appropriate to study the effect of the social context on inhibitory processes in a population of cocaine users.

In cocaine abusers, it was shown that inhibitory processes are affected. Here we aim at testing this population of subjects while they perform the stop task, but adding an implicit cognitive load induced by visual cues associated or not with cocaine intake. Since it want to assess the influence of a peer on both the performance and the associated cerebral activities, it will also control the presence of a peer observer in the procedure.

There will thus be three experimental factors, one inter-subject factor (the experimental group, cocaine users or controls) and two intra-subject factors (cocaine associated or neutral cue; presence of a peer observer). The "stop-signal" task should induce increased activity of the STN that should be modulated by the cocaine-associated cues and by the presence of a peer.


Eligibility Criteria:
Inclusion Criteria:

Drug Users Group

* age between 18 and 65 years
* regular use of cocaine and crack
* willing to participate
* able to give consent
* not meeting any non-inclusion criteria
* right-handed

Healthy volunteers group

* age between 18 and 65 years
* non-drug user
* willing to participate
* able to give consent
* not meeting any non-inclusion criteria
* right-handed

Exclusion Criteria:

* protected persons
* lactating women
* intolerance to noise
* not a beneficiary of a social security scheme.
* no signature on the consent form
* significant psychiatric or neurological disorder
* known visual impairment and abnormal vision despite correction
* Contraindication to MRI examination
* Claustrophobia.
* Pregnant women
Calcium Electroporation for the Treatment of Keloids

The purpose of this study is to evaluate the effect of calcium electroporation on keloids.

The keloids wil be treated with intratumoral injection of calcium followed by electroporation. It is a once only treatment and the patients will be followed up for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 keloid available to electroporation.
* Patient should have been offered standard treatment.
* At least 8 weeks since other keloid treatment.
* Performance status \<2 (ECOG).
* Platelet count \>50 mia/l
* International Normalized Ratio (INR) \<1,2.
* Age \>18.
* Patient should be able to understand participants information.
* Signed, informed consent.

Exclusion Criteria:

* Clinically significant coagulopathy.
* Pregnancy or lactation.
* Participation in other clinical trial involving experimental drugs or participation in a clinical trial within 4 weeks before study treatment.
Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation

The purpose of the study is to assess timing of TTFields use as well as safety, feasibility and preliminary efficacy of treatment with TTFields in elderly patients with newly diagnosed GBM simultaneous to RT/ CRT.

The primary aim of the trial is to establish a safely conducted therapy rate higher than 0.8 in the treatment arm.

Despite the immense effort made over the years with different treatment modalities, the survival of patients with newly diagnosed GBM is still very poor; no treatment is curative; and the quality of life of patients with this tumor is compromised significantly, not only by their disease but also by side effects of these rigorous treatment plans. Especially in elderly patients, a treatment modality is needed that will improve the results of current standard treatments without further impairing the quality of life of these patients for their limited life span.

The objective is to test the feasibility and timing of treatment with the TTFields device in elderly patients with newly diagnosed GBM simultaneous or subsequent to RT/ CRT.

The primary rationale to conduct this study is to improve treatment in the segment of high-grade brain tumors with the highest medical need.

All procedures regarding TTFields are representing routine clinical care within the approved use of the medical product in Germany; the present trial aims to investigate the optimal timing of TTFields use in elderly GBM patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, newly diagnosed glioblastoma (astrocytoma WHO grade IV)
* Indication for hypofractionated radiotherapy or hypofractionated chemo-radiotherapy with temozolomide
* Open biopsy or resection
* Craniotomy or intracranial biopsy site must be adequately healed
* Informed consent
* Age: \>65 years
* KPS ≥50%
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent of participation

Exclusion Criteria:

* Concurrent participation in another competing interventional clinical trial studying a drug or treatment regimen.
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
* Prior RT of the brain
* Patients who have not yet recovered from acute high-grade toxicities of prior therapies
* MRI or TTFields contraindication (e.g. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants, patients with severe skull defects such as a missing bone flap, programmable shunts)
* Known hypersensitivity to conductive hydrogels
* Pregnant and lactating women