cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Akathisia Incidence of Slow Infusion Metoclopramide

Study Objective:

The purpose of this study is to compare the effects of metoclopramide administration in bolus versus slow infusion medications in ED patients complaining of nausea for the determination of the therapeutic effect and prevention of akathisia.

Methods:

This was a prospective, randomized, double-blind trial. The investigation was held between 01 March 2007 and 01 May 2008, in the Emergency Department of Pamukkale University Faculty of Medicine. The patients with moderate to severe nausea randomized and divided into two groups as for the previously planned administration type of drug. Ten mg metoclopramide was administered in one group with slow infusion (SIG) in 15 minutes, via 2 minutes bolus infusion (BIG) into the other group. Whole procedure was observed, akathisia and nausea scores and vital changes were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 through 65 years of age and 50-90 kg of weight who presented to the ED with primary or secondary complaints of moderate to severe nausea who not use of commonly accepted antiemetic within the previous 24 hours were eligible for this study.
* Their peripheral oxygen saturation level was 90% or over while respirating room air and free of any respiratory problems.

Exclusion Criteria:

* Patients with mild symptoms of nausea
* Altered mental status
* Abnormal vital signs
* Any known allergy to the metoclopramide
* Previously enrolled in the study
* Known renal failure or insufficiency
* GIS hemorrhage, ileus and/or perforation
* Women who were pregnant and lactating
* Those with a history of epilepsy
* Admitted to the ED due to acute psychiatric symptoms
* Restless legs syndrome
* Parkinson
* Organic brain disease
* Phaeochromocytoma
* Patient with alcohol
* Anticholinergic, sedative, hypnotic, trankilizan, digoxin, cimetidine, tetracycline and levo-dopa use
* Presence of severe agitation akathisia can not be evaluated and uncooperative individuals.
The Effect of "Persons With Disability Friendly Nursing Education Program"

The purpose of this research; The aim of this study is to measure the effect of the Persons With Disability Friendly Nursing Education Program developed based on the Story Theory on the empathic tendencies of senior nursing students towards persons with disability and their perceptions of competence of senior nursing students to care for persons with disability. In the research, a multi-stage evaluation design from mixed method research will be used. Focus group interviews will be conducted before and after the program in the qualitative dimension of the research, while the randomized controlled double-blind pretest-posttest control group experimental design will be used in the quantitative dimension. The data of the research will be collected in the Department of Nursing of the Faculty of Health Sciences of Ondokuz Mayis University in Samsun, Turkey.

The purpose of this research; The aim of this study is to measure the effect of the Persons With Disability Friendly Nursing Education Program developed based on the Story Theory on the empathic tendencies of senior nursing students towards persons with disability and their perceptions of competence of senior nursing students to care for persons with disability. In the research, a multi-stage evaluation design from mixed method research will be used. Focus group interviews will be conducted before and after the program in the qualitative dimension of the research, while the randomized controlled double-blind pretest-posttest control group experimental design will be used in the quantitative dimension. The data of the research will be collected in the Department of Nursing of the Faculty of Health Sciences of Ondokuz Mayis University in Samsun, Turkey. The program will be applied to nursing senior students in this department. Before the training program, focus group discussions will be held with nursing students, and the content of the training program will be created. The pre-test data of the study will be collected using an introductory information form questioning sociodemographic characteristics, Efficacy Perceptions Form for Caring for Persons with Disabilities, Empathic Tendency Scale and Achievement Test. A 2-week " Persons With Disability Friendly Nursing Education Program" will be applied to the experimental group. After the program, focus group discussions will be held with the students in the experimental group, and the program will be evaluated. Post-tests will be applied to the experimental and control groups 3 months after the program. Descriptive statistics, paired t-test, chi-square, Mann-Whitney U, Wilcoxon analysis will be used in the analysis of the data. Content analysis will be used in qualitative data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Being senior nursing student

Exclusion Criteria:

-
The Effects of An Addition of Water Enema to PEG for Colon Preparation

The purpose of this study is to compare the preparation quality by using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening

Background : Good bowel preparation improves the rate of polyp detection and the time of caecal intubation during colorectal cancer (CRC) screening.

Suboptimal bowel preparation can results in adenoma miss rate up to 42% (95% CI, 35-49) and advanced adenoma miss rate up to 27% (95% CI, 17-41) The European Society of Gastrointestinal Endoscopy (ESGE) Guideline recommends a split regimen of 4L of polyethylene glycol (PEG) solution (or a same-day regimen in the case of afternoon colonoscopy) for a routine bowel preparation and the delay between the last dose of bowel preparation and colonoscopy should be minimized and no longer than 4 hours.

The investigators hypothesize that the addition of water enema to the standard PEG bowel preparation could provide the better quality of bowel preparation and then result in improvement in the rate of adenoma detection among participants scheduled for CRC screening with preparation to procedure interval \> 8 hr.

The purpose of this study is to compare the preparation quality using Ottawa Bowel Preparation Scale between the standard PEG preparation and the addition of water enema in participants scheduled for CRC screening. The secondary aim is to compare the effect of the standard PEG bowel preparation and the addition of water enema in terms of adenoma detection rate, the completeness of the examination, total and withdrawal time, safety and adverse events among those scheduled for CRC screening.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for CRC screening
* Bowel preparation using 3 liters of PEG solution
* Colonoscopy performed at 8-16 hours after bowel preparation

Exclusion Criteria:

* History of a failed bowel preparation
* Previous colonic surgery
* Uncontrolled underlying disease
* Pregnancy
Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for IntracytoplasmicSperm Injection Outcome

This study will be conducted at the In vitro fertilization Unit at Ain Shams University Maternity Hospital.

Women will be recruited from the In vitro fertilization Unit who will fulfill the inclusion criteria. They will be counseled to be included into the study The study will assess Role of Ratio of Progesterone to Number of Follicles as a Prognostic Tool for Intracytoplasmic Sperm Injection outcome.

Blood samples were collected on the day of final oocyte maturation, and serum Progesterone levels were measured using a chemiluminescent immunoassay for quantitative determination of the hormone .

The P/F ratio was calculated according to the equation (P(ng/mL)/number of follicles) and was defined by the measurements obtained on the day of final oocyte maturation.

All ultrasounds were performed at our In vitro fertilization center, and we included the number of follicles ≥14mm on the day of final oocyte maturation in the ratio calculation Oocytes were retrieved 36 hours after injection and were subsequently fertilized by In vitro fertilization or Intra cytoplasmic sperm injection. On day 2 - 5, all embryos were evaluated for cell number and morphology.

Each embryo transferred was evaluated for blastomere size and fragmentation. Embryos were graded as follows. Those with equal blastomere size and no fragmentation were considered Grade 1; those with blastomeres of equal size with slight fragmentation (\<20 %) were Grade 2;those with blastomeres of unequal size but no fragmentation were Grade 3; those with blastomeres of equal or unequal size and moderate fragmentation (20 %-50 %) were Grade 4; and those with unrecognizable blastomeres and severe fragmentation (\>50 %) were Grade 5.

The embryos were transferred on postretrieval day (2 - 5). Pregnancy was defined by Human chorionic gonadotropin titers within 11 days following Embryo transfer. Clinical pregnancy was defined by the observation of intrauterine embryo heart motion by 7 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

1. Women with any type of subfertility undergoing IVF treatment.
2. Age between (20-40) years old
3. Body mass index between (20-40)
4. Selected embryo are of grade 1 and 2 quality.

Exclusion Criteria:

1. Age above 40 years old
2. BMI above 40
3. Bad quality embryo
4. Uterine anomalies or malformation that affect embryo transfer.
Retrospective Survey for Patients With Hypertension and Diabetes Mellitus

This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of hypertension patients having Type 2 Diabetes mellitus, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient Type II DM patients receiving hypertension medication in 2006
* Patient with Type II DM receiving hypertension medication during at least 1 year.

Exclusion Criteria:

* Secondary hypertension patients
* Patients not receiving hypertension medication
Hypofractionated Imrt (Vmat-Ra) For Elderly Patients With Newly Diagnosed High Grade Glioma

To assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG.

Investigators designed this study with the aim to assess the effect of IMRT using VMAT rapidarc approach, followed by adjuvant temozolomide on survival and quality of life in elderly, poor performance status patients with newly diagnosed HGG. The potential advantage of this approach is deliver a more selective irradiation to tumor's target with reducing the dose to normal brain and to allow the delivery of a higher dose, optimizing the therapeutic window.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 70 years
* Karnosky performance status (KPS) ≤60
* Histologically confirmed HGG after tumor biopsy

  * GBM
  * Anaplastic Astrocytoma
  * Anaplastic Oligoastrocytoma
  * Anaplastic Oligodendroglioma without IDH1 mutation and no codeletion 1p19q
* Estimated survival ≥ 3 months.
* Normal liver, Kidney and bone marrow function
* Written informed consent

Exclusion criteria:

* Prior radiation therapy
* Other primary cancer

Exclusion Criteria:

-
A Study to Evaluate Corrected QT Interval From Clinical Studies Conducted With Bevacizumab

This is a supplemental study designed to evaluate the effect of bevacizumab on QTc interval in cancer patients. Patients who have consented to participate in selected randomized controlled bevacizumab clinical trials will be invited to participate in this study.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Enrollment in one of a list of certain randomized, controlled bevacizumab trials

Exclusion Criteria:

* Implantable pacemaker or automatic implantable cardioverter defibrillator (AICD)
* Congenital long QT syndrome
* Family history of long QT syndrome
* Clinically significant bradycardia (defined as \< 50 beats/minute)
Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position.

We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

Eligibility Criteria:
Inclusion Criteria:

* Previous vitrectomy due to proliferative diabetic retinopathy
* Recurrent diabetic vitreous hemorrhage

Exclusion Criteria:

* Monocular vision
* Uncontrollable intraocular pressure
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy

This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition
* ALK positive
* Postoperative NSCLC patients who have undergone complete resection
* Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days

Exclusion Criteria:

* Patients participating in interventional study of adjuvant treatment
* Pregnant, lactating, or breastfeeding women
Epigenetic and Metabolomic Changes in Childhood Cancer Survivors

The purpose of this research study is to try and identify markers in childhood cancer survivors to help predict if they will develop late effects from their cancer treatment.

This is a pilot study to obtain preliminary data that will be used to apply for a larger grant to fund the full study with an adequate sample size for analysis.

Specific Aim 1. What are the epigenetic differences between children treated for childhood cancers and healthy controls matched for age, sex, ethnicity, geographic region, and tanner stage.

Specific Aim 2. Compare the metabolomic differences between children treated for childhood cancers and healthy controls matched for age, sex, ethnicity, geographic region, and tanner stage.

Eligibility Criteria:
Inclusion Criteria:

* Childhood cancer survivors age 1-18 years old who received intensive treatment which included anthracycline and/or alkylating agent chemotherapy.
* Diseases which will be eligible include, high risk or very high risk acute lymphoblastic leukemia, acute myeloid leukemia, Hodgkin lymphoma, non-Hodgkin lymphoma, sarcomas.

Healthy controls:

• Healthy controls are defined as children ages 1-18 years old who are free from diseases or medical conditions that might be affected by or have an impact on this research study. Healthy controls will be matched with patients for age, sex, ethnicity, geographic region, and tanner stage, since it is known that these factors can affect the epigenetic signature of an individual. Controls will already be having blood drawn as part of their routine care.

Exclusion Criteria:

Cancer survivors:

• Patients who have received a bone marrow transplant will not be eligible.

Healthy controls:

• Age, sex, ethnicity, geographic region, and tanner stage matched controls with any acute or chronic disease will be excluded.
Effects of Sulfur Water and Mud Therapy on Serotonin Activity and Biochemical Parameters in Patients' Osteoarthrosis

This study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the osteoarthritis patients, as well as water the application of exercise in water effects the results we receive.

Sulfur baths and mud packs are known to have a positive effect in patients with osteoarthritis (OA). OA is a chronic degenerative disease accompanied by a constant pain that often leads to changes in the mood of patients. Over the last few decades, numerous articles reported various beneficial effects of sulfur water and peloid therapeutic applications. Serotonin is one of the important neurotransmitters that have numerous functions such as regulation of body temperature, sleep, appetite, while its main function is reflected in controling of depression.

The aim of this study is to examine the effects of sulfur bath and mud therapy on serotonin levels and other biochemical parameters in the blood of the OA patients, as well as whether the application of exercise in water effects the results we receive.

Randomized controlled study included patients with hip and/or knee OA both sexes, randomized into two groups. The first group patients underwent sulfur balneotherapy and mud pack therapy. Patients in the second group had sulfur balneotherapy, mud pack therapy and exercise in hygienic water. The duration of spa therapy program was 12 days. Serotonin values, parameters of complete blood count, lipid status and inflammatory markers were analyzed before and after the therapy.

This study is expected to be another contribution to existing evidence and shed light on the mechanisms of beneficial effects of balneotherapy and mud therapy and whether addition underwater exercise would have extra therapeutic effects.

Eligibility Criteria:
Inclusion Criteria:

1. Ages of 50 - 65 , both sexes
2. Patients diagnosed with hip and / or knee OA without having used balneotherapy in the previous year
3. Patients who have not changed their medication in the last 2 months
4. Patients who have not received injections into the hip and / or knee joint in the last 6 months (PRP, Diprofos...)

Exclusion Criteria:

1. Secondary hip and / or knee OA
2. Patients with MOA inhibitors, selective serotonin inhibitors, morphine, lithium and methyldopa in therapy
3. Visible disruption of hip and / or knee joint structures
4. Treatment of malignancy
5. Diseases of the heart, lungs, decompensated conditions of other organs, infections, active bleeding
6. Severe hip and / or knee joint injuries, fractures, and previous surgical procedures
7. Physical therapy, balneotherapy back one year
Reducing Anticholinergic Bladder Medication Use in Spinal Cord Injury With Home Neuromodulation

The purpose of this study is to determine the efficacy of home transcutaneous tibial nerve stimulation (TTNS) in spinal cord injury(SCI) and to determine the impact on quality of life using TTNS at home


Eligibility Criteria:
Inclusion Criteria:

* Traumatic and non-traumatic SCI performing IC
* Up to 2 anticholinergic overactive bladder (OAB) medications
* No changes in OAB medications
* Neurologic level of injury above T10
* English and Spanish speaking

Exclusion Criteria:

* Past history of genitourinary diagnoses or surgeries
* History of central nervous system (CNS) disorders and/or peripheral neuropathy
* Pregnancy
* Lower motor neuron bladder
* Concern for tibial nerve pathway injury
* Absence of toe flexion or AD with electric stimulation
* Bladder chemodenervation in past 6 months
* Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Restoring High Dimensional Hand Function to Persons With Chronic High Tetraplegia

This study is for people who have a paralyzed arm and hand from a spinal cord injury, who have also received a recording electrode array in the brain as part of the BrainGate study. The study will look at the ability of these participants to control different grasping patterns of the hand, both in virtual reality and in his/her actual hand. Movement of the participant's hand is controlled by a functional electrical stimulation (FES) system, which involves small electrodes implanted in the arm, shoulder and hand that use small electrical currents to activate the appropriate muscles.

This work aims to advance Brain-Computer-Interfaces (BCls) to provide severely paralyzed persons a natural way of controlling Functional Electrical Stimulation (FES) neuroprostheses for restoring arm and dexterous hand movements. The prospect of using BCI technology for restoring arm and hand movements for reaching and grasping is based on the hypothesis that in a paralyzed human, there is a repeatable and understandable relationship between recordable brain activity and specific aspects of imagined arm movements. Many previous studies have attempted to understand the relationships between brain activity and arm and hand movements in able-bodied monkeys. Little is known about these same relationships in humans, and specifically within the context of trying to control an FES arm and complex hand system. This study will recruit persons who already have BCI and FES systems implanted to take advantage of the possibility of recording high resolution brain activity in human participants. Thus, from this study, we aim to gain a better understanding of how brain signals are related to specific aspects of arm and complex hand movements in humans with paralysis. Additionally, this study will test novel implementations of complex hand movement restoration in Veterans and other persons with chronic hand and arm paralysis.

Eligibility Criteria:
Inclusion Criteria:

* Cognitively intact (able to follow instructions)
* A spinal cord injury resulting in at least partial arm paralysis
* Participant in BrainGate2 clinical trial, having already received an intracortical array and demonstrated the ability to use the neural signals to control a cursor on a monitor.

Exclusion Criteria:

* Profound visual impairments
* Participant in BrainGate2 clinical trial with insufficient recordable neural signals (such that the researchers cannot decode a movement intention command signal)