cyrilzakka/clinical-trials huggingface dataset:
Effects of Home-Based Exercise Program in Children After Acute Lymphoblastic Leukemia

This prospective randomized controlled study aimed to investigate the effects of a home-based exercise program on physical functions, inflammatory markers, and Brain-Derived Neurotrophic Factor (BDNF) in children followed after Acute Lymphoblastic Leukemia (ALL) treatments. Ankle dorsiflexion range of motion (ROM), dorsiflexion and knee extensor muscle strength, hand grip strength, aerobic endurance, and functional mobility were assessed using a goniometer, digital dynamometer; hand dynamometer, 6 Minute Walk Test (6 MWT), Timed Up and Go Test respectively. Interleukin-1 Beta, Tumor Necrosis Factor-Alpha, Interleukin-6 (IL-6), and BDNF values were examined using ELISA kits. 20 patients will be included in the study. The patients randomly divided into 2 groups: exercise (n:10) and control (n:10). The exercise group performed a home-based exercise program consisting of aerobics 3 days a week and strengthening and stretching exercises 2 days a week, with videos and infographics, for 8 weeks. The control group was advised to increase physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 6-18,
* Having clinical diagnose of Acute Lymphoblastic Leukemia,
* Being completed medical treatment

Exclusion Criteria:

* Having a history of neurological, developmental, or genetic disorders,
* Communicating problems
* Medical conditions such as advanced cardiac damage, decreased bone quality, acute infection, and cancer recurrence.

Children who could not accomplish the exercises and evaluations, who did not want to continue the study, who could not be contacted for more than 2 weeks, and who disrupted the exercise program for more than 2 weeks were excluded from the study.
Arterial Doppler Waveforms Analysis in PAD

The main objective is to evaluate the differences of terminology used when describing arterial doppler waveforms.

To assess the impact of an educational process

Peripheral artery disease (PAD) is a common pathology that affects more than 200 million people worldwide. The prevalence of this pathology is estimated in France at 11% in patients over 40 years old. The Doppler arterial waveforms analysis is an important element to assess the hemodynamic state of a patient and contributes to the diagnosis of the pathology. A number of classifications have been proposed but their use varies from one university to another. We hypothesize that there is a great heterogeneity in the description of the arterial Doppler flow analysis. In addition, a new classification (Saint-Bonnet) has recently been proposed and we will evaluate the effect of the use of this one. The main objective is to evaluate the differences of terminology used when describing arterial Doppler waveforms.

The secondary objectives are: to understand the variations observed and expected (initial, continuous training, place of exercise ...) and to study the effect of a new classification on the heterogeneity of responses.

Eligibility Criteria:
Inclusion Criteria:

* Vascular physicians enrolled in the mailing list of French society of vascular medicine

Exclusion Criteria:

* No exclusion criteria
High-definition Transcranial Electrical Stimulation for Fibromyalgia

Transcranial electrical stimulation (tCES) is a non-invasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex. The tCES has been applied in clinical trials related to rehabilitation research in recent years, and the safety and effectiveness have also been established. However, the existing tCES products effect on the whole brain networks and lack special waveforms. The investigators developed a wearable high-definition tCES (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, the investigators will preliminarily examine the effects and safety of the HD-tCES in patients with fibromyalgia. The investigators expect that the HD-tCES will relief pain, improve sleep quality, emotion, and general health of the patients.


Eligibility Criteria:
Inclusion Criteria:

1. With a diagnosis of fibromyalgia.
2. Age ≥ 20 years.
3. A mean pain score ≥ 4 on a 11-point numeric rating scale during the 2 weeks preceding the trial.

Exclusion Criteria:

1. Intolerance to electrical stimulation.
2. A history of arrhythmia.
3. Implantable medical electronic devices (e.g., like pacemaker).
4. Metal implants in the head or neck.
5. Wounds on the skin of head.
6. A history of brain surgery or severe brain trauma.
7. Severe cognitive or psychiatric disorders (e.g., schizophrenia, depression or bipolar disorder).
8. A history of seizure or other brain pathology.
9. Drug or alcohol abuse.
10. Malignant neoplasm or rheumatism disorder (e.g., SLE, RA, AS, IBD)
11. Pregnancy.
12. Change in medication of fibromyalgia within 1 week prior the trial.
13. Pregnant or breastfeeding women.
14. Intra-cerebral lesions (such as brain tumors, arteriovenous tumors).
15. History of encephalitis or meningitis.
Comparison of Lornoxicam and Paracetamol for Pre-emptive Intravenous Analgesia for Elective Inguinal Hernia Repair

The purpose of this study is to determine whether lornoxicam or paracetamol is more effective in providing pre-emptive analgesia for adult patients undergoing elective unilateral inguinal hernia repair under general anesthesia.

Early postoperative pain is the major cause that may restric physical activity of the patients and delay in returning work. Newer non-steroid analgesic drugs (NSAD) can be helpful in overcoming this problem, especially in pre-emptive use. In this prospective randomized placebo controlled double blinded study we aimed to determine whether lornoxicam, as a NSAD, or paracetamol is more effective in providing pre-emptive analgesia for patients undergo elective unilateral inguinal hernai repair under general anesthesia. 60 patients above the age of 18, ASA score of I to III will be assigned into 3 groups. All the patients will be operated under general anesthesia. Recurrent hernia cases, pregnant or lactated women, patients allergic to the two drugs, patients with documented gastric disorders or bleeding disorder or under anticoagulent therapy will be excluded.

Group designs:

Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.

Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.

Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.

All patients will receive patient controlled intravenous analgesia with morphine for 24 hours postoperatively.

Postoperative pain levels will be determined by VAS (visual analog scale) and morphine consumption will be recorded.

Patients will be prescribed with oral paracetamol (300 mg) plus codein (15 mg)at discharge at the end first 24 hours.

Patients will be asked to record daily consumption of given analgesic, pain response to physical activity by using Likert scale, and VAS scores daily.

The first follow-up examination will take place on day-7. The patients will be asked to keep recording the same parameters until the second hospital visit at 4th week.

On the follow-up examination at 4th week quality of life will be determined by SF-36 form.

The results will be analyzed using SPSS for Windows software.

Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia
* unilateral hernia
* general anesthesia
* elective repair

Exclusion Criteria:

* drug allergy
* bilateral hernia
* local anesthesia
* local blockade
* regional anesthesia
* emergency surgery
* complicated hernia
* recurrent hernia
Adverse Events in the Tracheal Intubation in the Intensive Care Unit

The airway management is essential in the Critical Care setting, both normal and difficult airway patients. Intubation is a risk procedure in which a great number of complications may occur, including death. The poor physiological reserve of critical patients may suppose an additional handicap to carry out successfully intubation.

The purpose of this study is to analyze the prevalence and risk factors for major complications in the intubation process in the Intensive Care Unit (ICU). In addition, the investigators will assess the impact of preoxygenation and the use of videolaryngoscope on the occurrence of major and minor complications. Finally, this study will review the drug protocols used in each participant ICU during intubation process.

The correct airway and difficult airway management are essential in the Critical Care setting.

Intubation is a procedure frequently carried out by intensivist and a great number of complications have been related. Serious complications can occur, including the development of severe hypoxemia, arrhythmias, cardiac arrest with permanent anoxic brain damage or death. Additionally the poor physiological reserve of critically ill patients and the variable operator experience, means that this technique must be considered a risk event in critical patients.

In recent years, it has been taken more and more importance of preoxygenation as a strategy that can avoid major complications in the intubation process.

Similarly, the use of devices that facilitate intubation such as videolaryngoscopy, has been included in difficult airway management protocols. If the use of videolaryngoscopy compared with traditional laryngoscopy is associated with a higher success rate and a lower incidence of complications, still remains controversial.

The investigators want to know the prevalence and risk factors for major complications in the intubation process of patients admitted to Intensive Care Unit (ICU). In addition, this study will try to assess the use and impact of both preoxygenation and videolaryngoscope in the intubation process.

Eligibility Criteria:
Inclusion Criteria:

* Patients that are intubated at the participating Intensive Care Units.

Exclusion Criteria:

* Intubations carried out at other different areas.
* Patients under 18 years of age.
Safety Study of Combination of Hormone Therapy, Paclitaxel and Radiation Therapy to Treat Prostate Cancer

The purpose of this study is to determine if the combination therapy of Hormone, Paclitaxel and Radiation therapy are effective in treatment of locally advanced prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Any one or more of the following characteristics will qualify patient with T2/T3 prostate cancer for eligibility to current study:
* Biopsy proven prostate cancer with Gleason score \> 7
* Pathologic staging TXN1 (on MRI or CT)
* Prostate-specific antigen (PSA) \> 10 ng/ml done within a month prior to study entry (the day of first hormonal ablation) and \> 10 days after prostate biopsy.

In addition patients must also have:

* Performance status \< 2
* Hemoglobin \> 11 grams per deciliter (g/dL), White blood cell (WBC) \> 4000 and platelet count \> 100.000/l
* No evidence of other synchronous primary. Prior malignancies does not exclude if the patient is disease free \> 5 years.
* Prior or concurrent basal cell or non-invasive squamous carcinoma of the skin is eligible and
* Received hormone therapy with any of the following combination for less than 3 months
* Lupron / Flutamide
* Zoladex/ Flutamide
* Lupron/ Casodex
* Zoladex/ Casodex

Exclusion Criteria:

* Clinical stage T1N0, PSA \< 10, and Gleason score less than 7.
* Evidence of distant metastasis
* Previous surgery for prostate cancer (radical prostatectomy).
* Current treatment with ketoconazole, cimetidine or hormone therapy for more than 3 months prior to inclusion in the protocol for prostate cancer
* Major medical or psychiatric illness, which in the investigator's opinion may prevent completion of the study and interfere with follow up.
* Bilirubin \> 1.5
* Prior chemotherapy is not allowed
Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and prevent vascular from atherosclerosis. Investigators design this study to investigate exenatide's effect on the improvement of the coronary endothelial function by evaluating endothelium dependent diastolic function and testing the vascular endothelial active substance and related inflammatory factors.


Eligibility Criteria:
Inclusion Criteria:

* Females or males, and aged 20 to 65 years
* Newly diagnose type 2 diabetes mellitus with BMI\>25kg/m2.
* HbA1C\>8%.

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma.
* Hepatic insufficiency (ALT or AST\> 1.5\*ULN).
* Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation).
* Thyroid disease
* Use of any anti-diabetic, anti-hypertension or anti-dyslipidemia drugs.
* Pregnant or lactating woman.
* Severe anemia.
* Acute myocardial infarction or stoke.
* Other conditions at investigator's discretion.
Investigation of A Children's Beverage Containing Different Probiotics

Investigating different bioactive ingredients in children's beverages and the effect on blood serum markers.


Eligibility Criteria:
Inclusion Criteria:

* Children 2-4 years of age, weight and length for age within the 10th to 90th percentiles as plotted on the NCHS growth chart
* Consuming cow's milk for at least one month

Exclusion Criteria:

* Serious concurrent illness or acute infection
* Using systemic antibiotics or steroids
* Recent probiotic use
* Feeding difficulties or intolerance to cow's milk
* Conditions effecting normal growth and development
* Immunodeficiencies
Oral Colchicine in Men With Castrate Resistant Prostate Cancer

The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.

The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.

Eligibility Criteria:
Inclusion Criteria:

* Castrate resistant prostate cancer
* Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed
* Age \> 18 years and ability to provide informed consent
* ECOG performance status of 0, 1 or 2
* No prior use of colchicine within the last 2 years
* No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1

Exclusion Criteria:

* Inability to provide informed consent
* Hypersensitivity to colchicine
* Severe renal, gastrointestinal or hepatic disorders
* Pre-existing blood dyscrasia
* PLT \< 100K, ANC \< 1000
* Serum Cr \> 2 x ULN
* Bilirubin \> 2 ULN
* AST \> 2 x ULN
* Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity
Study on HRQOL and Cost-effectiveness Analysis in Management of Patients With <2cm Thyroid Nodules

Ideally randomized controlled trials should be carried out to compare the cost-effectiveness between FNAC and watchful waiting but such studies are very difficult to conduct in practice because they require following up very large number of subjects for a long period of time.

The aims are to determine the health-related quality of life (HRQOL) and HRQOL preference (utility) of patients undergoing watchful observation (no FNAC) and routine FNAC, and to determine the cost-effectiveness of two strategies in managing small incidental thyroid nodules for the Chinese population in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Have life expectancy of at least 6 months
* Have an incidental nodule which measures between 1.0 to 2.0cm in the largest dimension on ultrasound guidance (USG) and has benign ultrasonographic features such as spongiform or honeycomb appearance, purely-cystic, egg shell type calcification, iso-echoic or hyper-echoic in relation to the rest of the thyroid tissue and peripheral vascularity on Doppler USG. For subjects with more than one nodule on USG, provided that the other nodules are not \>2.0cm or have suspicious features (see below), they will still be eligible.
* Normal thyroid function (both serum thyroid-stimulating hormone (TSH) and free T4 levels within normal range)
* Given consent to take part in the study

Exclusion Criteria:

* Have suspicious ultrasonographic features such as microcalcifications, marked hypoechogenicity, irregular margins and / or taller than wide and intranodular vascularity on transverse view on Doppler USG that warrant a FNAC
* Nodule size \> 2.0cm
* Insisting or refusing FNAC or surgical intervention despite medical reassurance
* Inability to understand or communicate in Cantonese or Chinese
* Significant cognitive impairment judged by the doctor to be unable to answer the questionnaire
* Too ill to carry out interview
* Refusal to give consent
Ultrasound Assessment of Gastric Contents in Fasted Surgical Patients With Previous Subtotal Gastrectomy

Investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.

Investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. The frequency of visualization fully will be also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The preoperative fasted patients with previous subtotal gastrectomy

Exclusion Criteria:

* Other anatomical abnormality or mass of stomach except gastrectomy
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases

Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate.

Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.


Eligibility Criteria:
Inclusion Criteria:

* A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of \<= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer
* Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator
* Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician
* Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1
* Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (\>=) 20 ng/ml or; Gleason Score \>= 9 in any core on biopsy or; Gleason Score \>= 8 (4+4 or 5+3) in greater than (\>) 80 percentage (%) of 2 cores on biopsy or; Gleason Score = 8 (4+4 or 5+3) in 1 core as long 5 or more other cores with minimum Gleason Score of 4+3 on biopsy. The determination of high risk may be based on pathology report of biopsy or equivalent criteria from radical prostatectomy

Exclusion Criteria:

* History or presence of soft tissue/bone metastasis or metastasis in distant lymph nodes (pelvic lymph nodes below the iliac bifurcation that are less than (\<) 2 centimeter (cm) in diameter \[short axis\] either radiographically or pathologically are allowed.)
* History of bilateral orchiectomy
* Received an investigational intervention \<= 4 weeks before the planned first dose of study intervention
* History of seizure or any condition that in the opinion of the investigator may predispose to seizure or treatment with drugs known to lower the seizure threshold within 4 weeks prior to starting treatment with apalutamide
* Allergy or hypersensitivity to apalutamide, or excipients, unable or unwilling to take androgen deprivation therapy (ADT)
Comparison of Erector Spinae Plane Block and Penile Block in Hypospadias Surgery

In this study, we aimed to compare ultrasound-guided sacral erector spinae plane block and dorsal penile block on postoperative analgesic effect in hypospadias surgery.

ASAI-II, 1-9 years old patients with hypospadias diagnosis and operated in Kahramanmaraş Sütçü İmam University hospital and Kocaeli University hospital were randomized with closed envelope technique and divided into two groups as penile block or erector spinae plane block. Erector spinae plane block or penile block application (by Gözen Öksüz, Can Aksu) will be performed after the patients give standard general anesthesia and a laryngeal mask is applied. Vital signs such as pulse, sp02, blood pressure will be monitored before, during and at the end of the operation. At the end of the operation and after the patient is awakened 5. min., 30 min. 1., 2., 4., 6., 12., 24. hourly FLACC pain scores, number of analgesic use within 24 hours, patient family satisfaction (1: dissatisfied, 2: satisfied, 3: very satisfied), complication rates will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology Classification (ASA) I-II, 1-9 years aged patients patients who scheuled elective hypospadias surgery in Kahramanmaraş Sütçü İmam University Hospital and Kocaeli University Hospital

Exclusion Criteria:

* American Society of Anesthesiology Classification (ASA) III-IV, patients with coagulopathy patients with infection at the injection site
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial

The purpose of this study IS to

* explore the underlying pathophysiology of chronic fatigue syndrome (CFS) in adolescents, particularly focusing on genetics, infections/immunology, endocrinology, autonomic control and cognitions
* to assess the effect of clonidine (a drug that attenuates sympathetic nervous activity) in adolescent CFS.


Eligibility Criteria:
Inclusion Criteria:

* Persisting or constantly relapsing fatigue lasting 3 months or more.
* Functional disability resulting from fatigue to a degree that prevent normal school attendance

Exclusion Criteria:

* Another disease process or current demanding life event that might explain the fatigue
* Another chronic disease (in particular pheochromocytoma, polyneuropathy, Renal insufficiency)
* Permanent use of pharmaceuticals (including hormone drugs)
* Permanently bed-ridden
* Positive pregnancy test
* Evidence of reduced cerebral and/or peripheral circulation due to vessel disease
* Know hypersensitivity towards clonidine or inert substances (lactose, sakkarose) in capsula
* Abnormal ECG (in particular bradyarrythmias due to sick sinus syndrome or AV-block. Isolated ectopic beats do not lead to exclusion)
* Supine heart rate \< 50 beats/min
* Supine systolic blood pressure \< 85 mmHg
* Systolic blood pressure fall upon standing \> 30 mmHg