cyrilzakka/clinical-trials huggingface dataset:
Electro-acupuncture and Transcorneal Electrical Stimulation (TES) for Retinitis Pigmentosa

Measures of vision in RP patients receiving promising therapy using transcorneal electrical stimulation.

Retinitis pigmentosa (RP) is a slowly progressive retinal degeneration for which there is no proven treatment. Patients are interested in trying alternative therapies to try to reduce their vision loss, but only limited research evidence exists to support their use and potential benefit. The goal of this research project is to gain a better understanding of possible changes in ocular and retinal blood flow and measures of vision in RP patients receiving two promising therapies, electroacupuncture and transcorneal electrical stimulation. We are currently only doing transcorneal electrical stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Diagnosis of retinitis pigmentosa (RP)
* Best-corrected visual acuity better than 20/400 in at least one eye
* More than 20% loss of Goldmann Visual Field area (III4e test target) in at least one eye
* Able and willing to participate in all study visits for a \~4-6 month period
* Provide informed consent

Exclusion Criteria:

* Very severe vision losses in both eyes (e.g., hand motions or light perception only) with difficulty performing the proposed vision tests
* Vision loss due to ocular diseases other than RP, cystoid macular edema, or cataracts
* Schedules do not permit participation in all study visits
* Previous acupuncture or TES treatment for RP
* Inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment)
* Dementia; Long or short-term memory loss
* Unable to read or speak English
* Smoking, excessive alcohol, or illegal drug use
* Receiving current psychiatric care (i.e. unstable emotional and mental health status)
* History of excessive bleeding
* Reduced general health and/or systemic medications that may diminish the potential response to the electroacupuncture treatments
* Implanted cardiac pacemaker
* Pregnancy
Acute Hip Fracture and Spinal Anaesthesia Injection Time

The systemic effects of spinal anesthesia is not fully known. Our aim of this study is to assess whether there is a difference in hemodynamic effects if the spinal dose is given fast (15s) or slow (90s) in elderly patients with acute hip fracture (AHF). Ninety (n=90) patients with AHF planned for surgery within 72h at our hospital will be enrolled in the study and randomly devided into two groups. The patients will receive one predetermined dose of spinal anesthesia followed by an advanced minimally-invasive hemodynamic monitoring through an arterial line using FloTrac-system. The hemodynamic parameters will be conducted 10 minutes prior to the spinal anaesthesia and 30 minutes after the spinal block is given. Hypotension was defined as a fall in MAP \> 30 % or a MAP \<65mmHg.

Both general and spinal anesthesia is known for inducing hypotension, which may be a problem for the elderly patients, often with many co-morbidities, causing a risk of organ hypoperfusion. At our clinic the investigators have a great experience with the neuraxial technique when operating these patients. Based on clinical experience the investigators hypothesise that a slow injection rate of the spinal dos would reduce the incidence and degree of hypotension. The investigators also aim to study the changes in the hemodynamic response between the groups in more detail as mentioned below.

Patients planned for acute hip fracture surgery in spinal anaesthesia at our hospital and fulfills the inclusion criteria will be included in our study. The investigators plan to include 90 patients, randomized in two groups where Group A will be given a spinal anaesthesia in 15s and Group B in 90s.

After arriving to the preoperative area, the patients will be given 5 L oxygen on a face mask and a standard monitoring with ECG, pulse- oximetry will be started, followed by the placement of a venous cannula and a radial arterial line. The patients will also be given a fascia iliaca compartment block (FIC) with ropivacaine 3,75 mg/ml 35-40 ml for comfort. In addition, the FloTrac system will be set up, using the existing arterial line, for advanced hemodynamic monitoring including invasive mean arterial pressure (MAP), Cardiac Index (CI), Heart Rate (HR), Stroke Volume (SV) and System Vascular Resistance (SVR)/ (SVRI).

A lumbal spinal anesthesia will be performed using a 25G pencil point needle. The intrathecal dose of anesthesia consists of isobar bupivacaine 5mg/ml 2,4 ml and fentanyl 50ug/ml 0,4ml. Sensory level will be monitored by "cold spray" Hypotension will be defined as a fall in MAP by \>30% or MAP \< 65 mmHg. As an surrogate factor for the aggregated time of hypotension the total amount of given vasopressor will be calculated.

Eligibility Criteria:
Inclusion Criteria:

1. \>65 years of age
2. patient with hip fracture
3. ASA \>/=2
4. scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent

Exclusion Criteria:

1. anticoagulantion medication
2. planned for general anesthesia
3. surgery delayed \> 72h
4. lack of informed consent.
5. severe aortic stenosis
A Prospective Longitudinal Mixed Study on the Change Track of Sleep Quality in Critically Ill Children

This research adopts the uniform parallel hybrid research design; The quantitative data and qualitative data were collected at the same time, and then the quantitative and qualitative data were analyzed respectively. Finally, the two data sets were combined. Comprehensive interpretation of the study issues through complementarity and mutual validation of quantitative and qualitative data.

With the progress and development of medical technology, the mortality rate of critically ill children continues to decline. To improve the long-term prognosis of children has become a new goal of modern medicine. Sleep disorders in critically ill children are caused by disease factors, the complex environment of ICU, and various treatment factors, which have seriously affected the patient's rehabilitation and long-term quality of life. Attention should be paid to the sleep disorders in critically ill children. At present, the research on sleep disorders in critically ill patients in China is mostly focused on adults, and the critically ill children are rarely involved, and there is no research related to sleep disorders and recovery tracks of critically ill children. This prospective longitudinal mixed study aims to describe the change trajectory of sleep disorder and recovery in critically ill children and provide suggestions for subsequent clinical workers to formulate reasonable intervention measures.

Eligibility Criteria:
Inclusion Criteria:

① Age 3-12 years;

* Children who are conscious during ICU,
* children with Glasgow score of 15

Exclusion Criteria:

* (1) did not meet the discharge standards, and asked to be discharged;

  * Children with sleep disorder before admission to PICU, that is, those with baseline CSHQ score \> 41;

    * The child had a history of mental illness and cognitive impairment.

      * Children with brain injury, coma, disturbance of consciousness, epilepsy and status epilepticus, obstructive sleep apnea hypopnea syndrome; ⑤ Children with hearing and hearing impairment ⑥ICU stay \> 30 days.
Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.


Eligibility Criteria:
Inclusion criteria

* Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997)
* Patients between 2 and 19 years of age
* Patients who are under 16 years of age at onset
* Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions

Exclusion criteria

* Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product
* Patients who have received the following treatments within 4 weeks before treatment with the investigational product

  1. Surgical treatment (e.g., operation)
  2. Plasma exchange therapy"
Adrenal Function in Patients With Newly Diagnosed Lung Cancer

Patients with newly diagnosed lung cancer may have hypofunction of the adrenal cortex either from tumour metastasis or other mechanisms. Since lung cancer patient may have to undergo stressful investigation and treatments, undetected hypofunction of the adrenal cortex may be hazardous. Knowledge of the size of the problem may help determine whether routine check is warranted.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary lung cancer
* Newly diagnosed
* No specific treatment given
* No active infection in the previous week
* No general anesthesia in the previous week

Exclusion Criteria:

* Known adrenal disease
* Receiving exogenous systemic corticosteroids
* Concomitant illness known to affect adrenal function. e.g. active TB
Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Aim of this study is to evaluate the effect of conducting self-management interventions on severity of lower urinary tract symptoms (LUTS) for patients with benign prostatic hyperplasia (BPH).

Research hypothesis:

To fulfill the aim of this study, the following research hypothesis was formulated:

Patients with benign prostatic hyperplasia will suffer less lower urinary tract symptoms (LUTS) after conducting self-management intervention than before conducting.

Research design: Quasi-experimental (pre-posttest) research design was utilized to conduct this study.

This study was conducted at Assiut Urology and Nephrology Hospital. A purposive sample of 60 adult male patients diagnosed with benign prostatic hyperplasia were older than 40 years old, had no other factors influencing their urination, such as prostate cancer.

Patients had been assessed at base line using the following tools:

Tool (I): A structured interview questionnaire. Tool (II): International Prostate Symptom Score (IPSS).

Each patient will be assessed before conducting self-management intervention for socio-demographic data, clinical data, and patients' knowledge regarding self-management using the tool I.

Each patient will be assessed for lower urinary tract symptoms before conducting self-management intervention using tool tool II(IPSS).

IPSS is a scoring system used to screen for and diagnose BPH as well as to monitor symptoms and guide decisions about how to manage the disease monitor lower urinary tract symptoms, It includes seven questions, about symptom of BPH.Each question had a range from 0 to 5 for its answer. Maximum score of 35 points. On the basis of total score, the symptoms were categorized into mild (0 -7), moderate (8-19), and severe (20-35).

After 3 months from conducting self-management intervention each patient was reassessed for clinical progression "severity" of lower urinary tract symptoms(LUTS)using (tools II).

Eligibility Criteria:
Inclusion:

* Adult patients.
* Men.
* Clinical diagnosis of benign prostatic hyperplasia.

Exclusion:

* Prostate cancer.
* Severe symptoms necessitating surgical treatment.
* Uncontrolled diabetes.
* End-stage cardiac disease or respiratory failure.
Safety of Cultured Autologous Adult Adipose Derived Mesenchymal Stem Cell Versus Cultured Allogeneic Adult Umbilical-cord Derived Mesenchymal Stem Cell Intrathecal Injection for SCI

This trial will study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cells for the treatment of spinal cord injury

Studies have shown that stem cell treatment is safe and efficacious for the treatment of spinal cord injury (SCI). This patient funded trial aims to study the safety and efficacy of intrathecal injection of cultured autologous adult adipose derived mesenchymal stem cells (AD-MSCs) versus cultured allogeneic adult umbilical-cord derived mesenchymal stem cell for the treatment of SCI. Patients with SCI will receive a single intrathecal injection of AD-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Spinal Cord Injury
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Anticoagulation medicine use
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Previous organ transplant
* Hypersensitivity to sulfur
* Continued drug abuse
* Pre-menopausal women not using contraception
MiProstate - Information Hub for the Prostate Cancer Care Flow

This is an observational cohort study with a non-concurrent comparison group evaluating the use of a digital decision support tool (MiProstate/ISPM) at pre-prostatectomy, multidisciplinary conferences.

In the study cohort, all clinically relevant data on patients undergoing radical prostatectomy at Karolinska University Hospital were registered on the platform and subsequently presented using the platform at the conferences in which a detailed treatment plan was devised for each patient.

Eligibility Criteria:
Inclusion Criteria:

* All patients planned for prostatectomy and discussed at pre-operative conference at Karolinska University Hospital

Exclusion Criteria:

-
Outcome Analysis of Endoscopic Resection of Pituitary Adenomas

The goal of this prospective study is to learn about the operative outcomes in patients with pituitary adenoma who receive endoscopic resection.

The main question it aims to answer is:

• What are the outcomes of patient following endoscopic resection? including visual, hormonal, survival, and functional outcomes.

Participants' data including clinical history, laboratory data, radiographic images, intraoperative videos will be evaluated and analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Pathological diagnosis of pituitary adenoma
* Underwent endoscopic endonasal resection

Exclusion Criteria:

* Age \< 18 or \> 80 years
* Non-pituitary adenoma pathologies
* Underwent non-endoscopic surgery
Donepezil Attenuate Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.


Eligibility Criteria:
Inclusion Criteria:

1. Elder than 60 years old
2. Speak Chinese Mandarin
3. Those who will undergo knee or hip replacement
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. several audition or vision disorder;
4. unwillingness to comply with the protocol or procedures.
5. Can not communicated with Chinese Mandarin
6. Existing bradycardiac arrhythmia（Heart rate \<60 bpm for any reasons）
7. Existing gastrointestinal ulcer
8. Existing urinary incontinence
9. Existing asthma or chronic obstructive pulmonary disease
10. Allegory to Donepezil
Impact of Maternal Xylitol Consumption on Mutans Sterptococci

The study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children.

Method: Study sample included 60 mother and child pairs with high salivary mutans streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. Both groups received oral hygiene instructions, dietary counseling and restorative treatment. All children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (MS) levels.

Eligibility Criteria:
Inclusion Criteria:

* mothers with high salivary counts (≥ 105)
* mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.

Exclusion Criteria:

* subjects with systemic disorders or on regular medications
Prevalence of Intestinal Parasitic Infections in Under-Five Children With Malnutrition in Sohag, Egypt

This study aims to estimate the prevalence of intestinal parasitic infections in under-five children with malnutrition.

Malnourished children are vulnerable to IPIs suffering. In contrast, IPIs can contribute considerably to the evolution of undernutrition in the pediatric population, thus creating a potentially lethal cycle/vicious cycle of worsening illness and deteriorating nutritional status so, I will examine stool specimens of those children suffering from malnutrition.

One fecal sample will be collected from each patient in a labelled clean plastic container. Specimens will be immediately transferred to the Medical Parasitology Department laboratory The obtained fecal samples will be both macroscopically and microscopically examined. For microscopic examination, specimens will be examined by direct smear and FECT.

Anthropometric indices will be used for checking the nutritional status of the recruited children.

Eligibility Criteria:
Inclusion Criteria:

- 100 children aged between 6 months and 5 years, having malnutrition symptoms (growth retardation, failure to thrive, lethargy, generalized weakness, xerophthalmia, etc.) will be randomly recruited from pediatric outpatient clinics, Faculty of medicine, Sohag University.

Exclusion Criteria:

* children who took specific anthelmintic, antiprotozoal, purgatives or anti-diarrheal drugs three weeks before the stool sampling.
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)

This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).


Eligibility Criteria:
Inclusion criteria:

1. Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
2. Female patients of childbearing potential must be practicing an acceptable method of contraception.

Exclusion criteria:

1. Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
2. History of alcohol or substance abuse within the last six months.
3. History of seizures or use of anticonvulsant medication.
4. Any psychiatric condition that requires medication or may interfere with study participation.
5. Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
6. Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
7. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
8. Diagnosis or family history of Tourette's syndrome
9. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke

Other protocol-defined inclusion/exclusion criteria may apply
Radiomics and Molecular Expression Predictive Model for Esophago-Gastric Junction and Gastric Cancer TRG

The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.

• To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.

A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.

Therefore, we hypothesize that texture analysis could let to identify the good response patients.

• To find correlation between the molecular expression of the tumor and the radiomics features.

Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.

Therefore, we hypothesize to add some others radiomics signatures to the analysis and to find an association with the molecular expression.

• To find correlation between the molecular expression of the tumor and the TRG.

MSI gastric cancer has been shown to be less responsive to preoperative chemotherapy.

Therefore, we hypothesize to confirm this result.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
* Preoperative staging: cT2-T4a, cN0-N3, M0.
* Patients \>18 years old.
* Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).

Exclusion Criteria:

* Siewert I EGJ tumor
* Patients undergoing preoperative radiotherapy.
* Absence of both pre and post-chemotherapy CT-scan.
* Patients with tumor progression during preoperative chemotherapy.
* Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
* Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis