cyrilzakka/clinical-trials huggingface dataset:
Comparison of Enteral Versus Parenteral Feeding in Healthy Human Subjects

Literature suggests that route of feeding and/or certain nutrients may cause alterations in the body's immune cells. Immune cells help protect the body and fight infection/disease. Tube feeding (TF) is a method of delivering nutrition directly to the stomach/intestines via a small tube. The immune system may respond differently when receiving continuous TF as compared to receiving intermittent TF. Heart rate variability (HRV, the intervals between heartbeats) is a measurement of the nervous system's response to a stress/illness. The differences in immune cells and/or HRV may influence how the body reacts to complications such as infection.


Eligibility Criteria:
Inclusion Criteria:

* General good health as demonstrated by medical history, physical\& laboratory tests
* Age between 18 and 40 years
* Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Any medication taken in past 48 hrs (except birth control)
* Recent history of alcohol or drug abuse
* Unable to provide written informed consent
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnant or breast-feeding
A Safety and Efficacy Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration

Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of "wet" age-related macular degeneration

Exclusion Criteria:

* Prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months
Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management

Electro fetal monitor monitoring in the antepartum and intrapartum periods is one of the most important responsibilities of midwives, who have important roles and responsibilities in maintaining and managing the health of women and newborns before, during and after delivery. Although midwives receive training on EFM monitoring with classical methods before graduation, they may experience problems in EFM monitoring in the clinical field after graduation. For this reason, midwife students should have the knowledge, skills and self-efficacy about a good level of EFM monitoring during their undergraduate education. In recent years, simulation-based education in the field of health has increased rapidly. This method creates an opportunity for health professionals, students, patient assessment, interaction and holistic care without compromising patient safety, and develops participants' critical thinking, clinical decision making and problem solving skills.

In this context, it is very important to evaluate the EFM trace in the antepartum and intrapartum periods, to determine the possible risks, to plan, implement and evaluate the interventions, to provide the emergency crisis management in a short time without affecting the fetal health, and to increase the self-confidence of the midwives.

The research was planned quantitatively in the form of randomized control-intervention of the scenario-based realistic simulation method, to increase the satisfaction and self-confidence levels of midwifery students in learning, to evaluate the simulation design and educational effectiveness, in EFM management. The research will facilitate midwifery students to intervene with the patient in a shorter time, with confidence and with sufficient clinical skills, and patient safety will be increased. It will also allow for the reduction of erroneous clinical practices and malpractices.

This research aims to evaluate the effect of high-fidelity simulation teaching method on knowledge, satisfaction and self-efficacy of midwifery students in EFM follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the research,
* Being a midwifery second year student and taking the "Risky pregnancy" course,
* Attending training with simulation for the first time

Exclusion Criteria:

* Incomplete filling of data collection forms,
* Not participating in all applications of simulation teaching,
* Desire to leave the research.
Supplementation of L-arginine in Patients With Non-resectable Brain Metastases

This study evaluates the nutritional supplement arginine as supportive measure for patients with unresectable metastatic brain tumors that receive radiation therapy with palliative intent

Brain metastasis, the most common intracranial tumor, is associated with neurological disability and short survival time. For selected patients this outcome can be improved by achieving greater local control. Virtually all cancer patients with brain metastases receive radiotherapy; a majority as part of their primary treatment while others in connection with surgery or palliation. Agents that increase the sensitivity of cancer cells to radiation may improve the control of the disease. Previous data indicates that arginine supplementation can modify the metabolism of cancer and immune cells making tumors more susceptible to standard treatments liked radiation. In this phase 1/2 comparative study the investigators will investigate whether 10 mg of arginine oral supplementation (compared to placebo administration) administered twice a day prior to the radiation therapy can modify tumor metabolism, immune response and effect of radiation. The primary end-points are safety and toxicity of arginine, quality-of-life and clinical response. The secondary end-points are imaging response and neurological progression-free survival. Additional exploratory end-points include intensity of radiation administered, effects on tumor metabolism by magnetic resonance spectroscopy, immune response by cytokine pattern in serum, body composition and nutritional parameters , overall survival and progression free survival

Eligibility Criteria:
Patients with pathology-confirmed diagnostic of solid cancer and measurable brain metastases by CT scan and/or MRI

Inclusion Criteria:

* Unresectable criteria by neurosurgeon
* Recursive partitioning analysis (RPA) -Radiation Therapy Oncology Group (RTOG) class II (Karnofsky's performance score ≥ 70 and extracranial metastases and/or non-controlled primary tumor)
* Measurable brain lesion/s by contrast-enhanced CT or MRI
* Absolute granulocyte count more or equal than 2000/mm3
* Hemoglobin more or equal than 9 g/L (patients with lower levels were transfused before the randomization)
* Normal renal laboratory (serum creatinine \<1.5 mg/dL and 24-h creatinine clearance \>60 mL/min)
* Normal hepatic function (aspartate aminotransferase and alanine aminotransferase \<2.5 times the upper limit of normal)
* Stable body weight and composition for at least one month prior enrollment

Exclusion Criteria:

* Prior treatment for brain metastases and/or brain tumor.
* Primary brain tumor
* Hematologic malignancies
* Solid tumors of germinal origin
* Contraindication for external radiation therapy.
* Allergy to L-arginine.
A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

The objective of this study is to explore the safety and efficacy of SHJ002 Sterile Ophthalmic Solution relative to atropine in myopia control

SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.


Eligibility Criteria:
Inclusion Criteria:

1. Be male or female, age 3-12 years (inclusive).
2. Cycloplegic sphere of -1.00 D or worse in both eyes
3. Able to complete all study assessments and comply with the protocol
4. Literate or able to orally communicate.
5. Parent or guardian able and willing to provide written informed consent
6. Parent or guardian able and willing to assure subject compliance with the protocol, follow study instructions, and attend study visits
7. Able to tolerate eye drops in both eyes.
8. Be able and willing to avoid all disallowed medications and refractive correction
9. For female subjects of childbearing potential (those who have experienced menarche and who are not surgically sterilized \[bilateral tubal ligation, hysterectomy, or bilateral oophorectomy\]), a negative urinary test.
10. Women of childbearing potential must agree to use two reliable methods of contraception
11. Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception

Exclusion Criteria:

1. Axial length \> 26 mm
2. Anisometropia
3. Astigmatism \> 2.00 D
4. Intraocular pressure \> 21 mm Hg or \< 6 mm Hg
5. Active or recent history of severe ocular infection or inflammation
6. Previous incisional or laser surgery
7. Any clinically significant finding on slit lamp biomicroscopy or ophthalmoscopy
Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (\>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* BMI≤45 kg/m2
* A1c ≥7.5% and ≤10.5%

Exclusion Criteria:

* type 1 diabetes
* symptoms of poorly controlled diabetes
* eGFR \<50 ml/min/1.73m2
Efficacy and Safety of Lertal® as an add-on to Standard Therapy for Allergic Rhinoconjunctivitis in Pediatrics

The purpose of this study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Allergic rhinoconjunctivitis (AR) is a common chronic disorder in children, especially in developed countries. It is not characterized by nasal symptoms only (such as congestion and sneezing), but may also cause general complaints such as fatigue and cough. AR can also have detrimental effects on mood, sleep, social activities and scholastic performance.

Lertal® is a novel nutraceutical containing seed extracts from Perilla Frutescens, Quercetin extracted from Sophora japonica and Vitamin D3, all compounds that have demonstrated their ability to reduce allergy symptoms and the use of anti-allergy drugs in adults.

The aim of this randomized, double-blinded, parallel-group, placebo-controlled study is to evaluate the efficacy and safety of Lertal® as an add-on treatment for children affected by allergic rhinoconjunctivitis.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 12 years
* Male or female
* Diagnosis of allergic rhinoconjunctivitis
* Hypersensitivity to dust mites or pollen confirmed with skin-prick test (wheal and redness, ≥ 3 mm more extended than control) performed in the previous 12 months
* Total Symptoms Score (TSS) ≥ 15 and at least 1 for nasal congestion
* Written informed consent of patient and of parent or legal guardian

Exclusion Criteria:

* Uncontrolled asthma
* Secondary rhinitis to other causes
* Documented evidence of acute or chronic sinusitis
* Nasal polyps
* Chronic or intermittent use of inhaled, oral, intramuscular, intravenous or topical corticosteroids
* Use of leukotriene antagonists
* Continuous use of antihistamines
* Inadequate washout of drugs:

  * Systemic or intranasal corticosteroids: 1 month
  * Leukotriene antagonists: 1 month
  * Sodium cromoglycate: 2 weeks
  * Systemic or intranasal decongestants: 3 days
  * Cetirizine, fexofenadine, loratadine, desloratadine, hydroxyzine: 5-10 days
* Malformations of the nose, ear or throat
* Upper or lower respiratory tract infection in the last 2 weeks
* Participation in other clinical studies in the last month
* Documented hypersensitivity to the study product or its excipients
* Trip planned outside of the study area
Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs

Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation

* Apply the speckle myocardial tracking technology to early diagnose dysfunction in patients with idiopathic frequent monomorphic PVCs
* Assessment of cardiac function before and after ablation and comparison before and after ablation and between sites of origin of the PVCs as diagnosed by the electrophysiologic and 3d mapping techniques that may be more confirmed by successful ablation whenever achieved

Eligibility Criteria:
Inclusion Criteria:

* All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs

Exclusion Criteria:

* Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.
Sustained Effect of Urticaria Remission With Relatively High Dose Vitamin D Supplementation After Omalizumab Discontinuation

The proposed research is intended to determine if supplementation of relatively high dose vitamin D in chronic urticaria patients receiving omalizumab will result in continued symptomatic control of hives after the discontinuation of omalizumab.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosed chronic urticaria
* Currently be receiving omalizumab therapy for the treatment of chronic idiopathic urticaria and be well controlled with a USS \<25

Exclusion Criteria:

* Not capable of informed consent.
* Not capable of answering the questionnaire.
* Subjects with a pure physical urticaria.
* Pregnant or lactating women.
* Subjects with hypercalcemia (calcium \> 10.3 mg/dl) or renal insufficiency (GFR \<50 ml/min).
* Subjects with prior anaphylaxis to omalizumab.
* Currently taking high dose vitamin D supplementation.
* Prior high dose vitamin D supplementation for urticaria with failure.
* Baseline 25(OH)D \>80 ng/ml
* Subjects with sarcoidosis, hyperparathyroidism, histoplasmosis, lymphoma or tuberculosis
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients

The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.

KP-1461 is a prodrug of KP-1212 triphosphate, a unique nucleoside that is incorporated into the HIV viral genome resulting in an accumulation of nucleic substitutions that interfere with viral replication. The study is designed to investigate the safety and antiviral activity for 124 days in antiretroviral-experienced HIV-1-infected subjects. By inducing additional mutagenic events in the viral genome, viral decay accelerators such as KP-1212 may force the virus to exceed the threshold of nonviability.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic HIV-1-infected individuals who are treatment-experienced and who have not been on ART for at least 16 weeks.
* Have documented prior non-suppressive ART including at least 1 NRTI, 1 NNRTI and 2 PIs; or have documented prior ART resistance to at least 1 NRTI, 1 NNRTI and 1 PI; AND in the opinion of the investigator, have few, if any, effective treatment options available.
* Have \>2,500 copies/mL of HIV-1 RNA at screening.
* Have a stable CD4 cell count while off ART and \>250 cells/mL at screening.
* Have no clinically significant findings on screening evaluations.

Exclusion Criteria:

* Have a current or recent opportunistic infection that, in the opinion of the investigator, is not being controlled by medication.
* Have any condition that, in the opinion of the investigator, could compromise subject safety or adherence to the protocol.
* Have a documented positive test for hepatitis B surface antigen, or have received any antiviral therapy for hepatitis C \<6 weeks prior to study drug administration.
Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)

The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
* 2 of 3 pretreatment platelet counts that were less than 30 x 10\^9/L (if not currently on ITP therapy) or less than 50 x 10\^9/L (if currently receiving corticosteroids for ITP therapy)
* Ability to give informed consent

Exclusion Criteria:

* Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
Safety and Efficacy of TSHA-102 in Pediatric Females with Rett Syndrome (REVEAL Pediatric Study)

The REVEAL Pediatric Study is a multi-center, Phase 1/2 open-label, dose-escalation and dose-expansion study of TSHA-102, an investigational gene therapy, in pediatric females with Rett Syndrome.

The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated. The study duration is up to 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a confirmed diagnosis of classical/typical Rett Syndrome with a documented mutation of the MECP2 gene that results in loss of function.
* Participant is between ≥5 to ≤8 years of age at the time of consent.
* Participant must be up to date with all relevant local vaccination requirements, with last vaccination dose received at least 42 days prior to the start of the immunosuppression regimen.
* Participant's parent/caregiver must be willing to allow participant to receive blood or blood products for the treatment of an AE if medically needed.

Exclusion Criteria:

* Participant has another neurodevelopmental disorder independent of the MECP2 gene loss of function mutation, or any other genetic syndrome with a progressive course.
* Participant has a history of brain injury that causes neurological problems.
* Participant had grossly abnormal psychomotor development in the first 6 months of life.
* Participant has a diagnosis of atypical Rett syndrome.
* Participant has an MECP2 mutation that does not cause Rett syndrome.
* Participant requires non-invasive and invasive ventilatory support.
* Participant has contraindications for IT administration of TSHA-102 or lumbar puncture procedure, other medical conditions, or contraindications to any medications required for IT administration.
* Participant has acute or chronic hepatitis B or C infections.
Vitamin D Supplementation and and Glycemic Indexes

Age affect insulin sensitivity and the metabolism, and vitamin D status was shown to have a correlation with markers of insulin resistance. That's why, we aimed in our trial to study the effect of vitamin D supplementation on glycemic markers and index of insulin resistance.

A low serum 25-hydroxyvitamin D \[(25(OH) D)\] concentration was shown to correlate with higher fasting blood glucose (FBG) and insulin levels. Since age affect insulin sensitivity and the metabolism, we aimed in this randomized controlled trial to investigate the effect of vitamin D supplementation on glucose homeostasis and index of insulin resistance in elderly subjects living in Beirut, Lebanon.

Participants (n= 115) deficient in vitamin D were randomly divided into two groups, a group receiving 30,000 IU cholecalciferol/week for a period of 6 months, and a placebo group. The index of insulin resistance HOMA (homeostasis model assessment) was the primary outcome. Glucose homeostasis and metabolic markers were also measured at start of treatment and at 6 months.

Eligibility Criteria:
Inclusion Criteria:

-Deficiency in vitamin D and having no medical history of type 2 diabetes mellitus

Exclusion Criteria:

patients with a history of type-2-diabetes, congestive heart failure, liver failure, renal failure, cancer, or taking oral hypoglycemic drugs or statin therapy, or patients having metabolic bone disease.
A Study of Yoga for Treating Geriatric Insomnia

Insomnia is common in the elderly population and is associated with increased health problems, reduced quality of life and greater use of sleep inducing drugs. This research aims to examine the effectiveness of Yoga practice to treat insomnia in elderly people, determine the ability to enhance their quality of life and determine if it is suitable to western culture and conditions.

Introduction: Geriatric insomnia is prevalent, reducing life quality, diminishing cognition and increasing risk of accidents and mortality. Treatment with sedative-hypnotic drugs has limited effectiveness and further increases the risk of accidents and falls. Yoga has been shown to increase well-being in the elderly.

Hypotheses

1. Integrated yoga style practice can improve sleep quality/quantity
2. Integrated yoga style practice can improve quality of life.

Objectives:

1. Examine effectiveness of yoga for insomnia and reduction in use of hypnotics/relaxants in the elderly;
2. Determine whether yoga enhances quality of life in the elderly; and 3. Determine whether yoga is suitable for elderly in western culture(s).

Methods:

A mixed design crossover controlled trial (n =74, age range 60-87, M = 74.4, SD = 7.1) with 2 weekly classes incorporating physical and meditative yoga, and daily home practice of meditative yoga for 12 weeks. Measures included self-reported assessment of sleep quality (Sleep Logs, KSS, ESS, PSQI, MAPS), mood states (DASS, POMS), general health (SF-36) and mobile objective home sleep studies.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Independent, self mobile
* Suffering from light to severe primary insomnia

Exclusion Criteria:

* Age less than 60 years
* Currently or in the past engaged in regular yoga practice
* Suffering from any physical or mental health condition or disability which may affect sleep, or for which Yoga practice is counter indicated or may lead to health risks or complications.
* Suffering from co-morbid insomnia in conjunction with another condition clearly salient to sleep disturbance.
Combined Effects of Blow Bottle Device and Postural Drainage in Moderate to Severe Elderly COPD Patients

It will be a randomized clinical trial. Age of selected subjects will be between 40 to 70 years. Data will be collected from Wazirabad institute of cardiology. There will be 2 groups i.e. group A will receive combination of blow bottle technique and postural drainage and group B will receive postural drainage. Spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (BCSS) will be used to evaluate the improvement in sputum diary of patients. Interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. After data collection, data will be analyzed using SPSS version 25.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed moderate to severe GOLD (2017) COPD
* 40-60 years old
* Both male and female
* Patients hemodynamically stable
* PFT showing irreversible airflow limitation.

Exclusion Criteria:

* Type II diabetic mellitus
* Systemic illness
* Thoracic deformation or rib fracture.
* Pulmonale decompensation and signs of an unstable heart condition.