cyrilzakka/clinical-trials huggingface dataset:
Loratadine for the Prevention of G-CSF-related Bone Pain

The research question for the current study is: Is loratadine more effective than placebo in preventing G-CSF-related bone pain during autologous hematopoetic stem cell transplant in patients with lymphoma or multiple myeloma? The hypothesis is that prophylaxis with loratadine will help prevent or reduce the severity of bone pain in this setting.


Eligibility Criteria:
Inclusion Criteria:

1. A histologically or cytologically documented lymphoma or multiple myeloma
2. Next line of therapy is autologous stem cell transplant
3. Adult ≥ 18 years old.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
5. Life expectancy of at least 12 weeks.
6. The absence of any additional poorly controlled systemic disease that is directly contraindicated or places subject at significant risk, including but not limited to: congestive heart failure, diabetes mellitus, cirrhosis or liver failure, renal failure.
7. Able to adhere to study protocols and visit schedules

Exclusion Criteria:

1. Hypersensitivity or intolerance to antihistamines
2. Use of antihistamines within two days prior to the study period, excepting the use of single dose antihistamines during chemotherapy or blood transfusion protocols.
3. Recent use of G-CSF or pegfilgrastim defined as within 12 weeks of study accrual.
4. New and continued regular use of analgesics within the four days prior to the first dose of G-CSF
Role of Inflammatory Markers and Doppler Parameters in Late-Onset Fetal Growth Restriction: A Machine Learning Approach

Fetal growth restriction (FGR) is a serious complication in pregnancy that can lead to various adverse outcomes. It's classified into early-onset (before 32 weeks) and late-onset (after 32 weeks), with late-onset associated with long-term risks like hypoxemia and developmental delays. The study focuses on the role of inflammation in FGR, introducing new blood markers for better understanding and diagnosis. It also addresses the challenges of using advanced diagnostic tools in low-resource settings and explores the use of machine learning to predict FGR based on inflammatory markers, highlighting the potential of artificial intelligence in overcoming these challenges.

Fetal growth restriction (FGR), also known as intrauterine growth restriction, is a prevalent pregnancy complication with potentially negative outcomes for newborns. The condition's causes are varied, involving genetic factors, maternal inflammation, infections, and other pathologies. FGR is categorized based on its onset: early-onset FGR occurs before 32 weeks' gestation, while late-onset happens after 32 weeks. Late-onset FGR, though less risky in perinatal complications compared to early-onset, is linked to an increased risk of hypoxemia and neurodevelopmental delays. Diagnosis primarily relies on ultrasound measurements and Doppler flow analysis of specific arteries. The study highlights the complexity of diagnosing and managing late-onset FGR, emphasizing the unclear pathophysiological mechanisms. It proposes the exploration of inflammatory processes and the potential role of new markers such as the systemic immune inflammation index (SII), systemic inflammatory response index (SIRI), and neutrophil-percentage-to-albumin ratio (NPAR) for understanding FGR. These markers are easily measured through blood tests and are significant in various diseases. The text also discusses the challenges of applying advanced diagnostic methods in low-income countries due to the need for sophisticated equipment, contrasting with the accessibility of artificial intelligence and machine learning models via the internet. The study aimed to assess the impact of inflammatory processes on late-onset FGR by analyzing NPAR, along with other markers, and evaluating their predictive value using machine learning algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-45
* Completed their pregnancy follow-up in our center
* Pregnant women whose data can be accessed
* Singleton pregnancies without systemic maternal comorbidities other than FGR

Exclusion Criteria:

* Multiple pregnancies
* Having a maternal disease
* Fetal congenital and chromosomal anomalies
* Chronic drug use, alcohol and cigarette use
* Accompanying additional pregnancy complications during follow-up
* Cases whose data cannot be accessed
Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

The primary aim of this study is to assess the relationship between obstructive sleep apnoea (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D.

The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship between OSA and diabetic-related complications if such a relationship is found.

Obstructive sleep apnoea (OSA) has been reported to be very common in patient with type 2 diabetes (T2D), and this relation is expected as both conditions share obesity as a common risk factor. Despite that several articles have stated that OSA is an independent risk factor for abnormal glucose metabolism, hypertension, and cardiovascular diseases.

In contrast, patients with type 1 diabetes (T1D) are leaner and younger than patients with T2D, so it was expected that OSA might be less common in patients with T1D. However, few studies have reported the prevalence of OSA in T1D with a range between 8 and 46%. The relationship between OSA and diabetes-related vascular disease is poorly explored in patients with T1D. This suggests a mechanism other than obesity may be responsible for OSA in patients with T1D. Therefore, the investigators hypothesized that (1) OSA is related to CAN rather than obesity in patients with T1D. (2) OSA is common in patients with T1D. (3) OSA is associated with worse metabolic profile and microvascular complications in T1D. (4) Oxidative and nitrosative stress are possible mechanisms relating OSA to T1D complication.

Eligibility Criteria:
Inclusion Criteria:

* T1DM patient aged 18 and above, who was diagnosed more than 4 years ago.
* Able to give informed consent.
* Has sufficient proficiency in English to verbally answer interview questions.

Exclusion Criteria:

* Past medical history of severe respiratory disorders including treated OSA.
* Patients using oxygen supplements.
* Patients with end-stage renal disease receiving dialysis.
* Pregnancy.
* Dementia.
* End stage diseases with life expectancy below 6 months.
* Patients with implantable devices
* Patients with known atrial fibrillation
Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae

In this study, we will compare the effect and safety of lignocaine versus bupivacaine infiltration for postpartum perineal pain after vaginal delivery with episiotomy in primigravidae.

Episiotomy is the most common procedure used for dilatation of the vaginal opening for giving birth. Although episiotomy is associated with benefits for the mother, it may lead to short term and long-term disabilities, including postpartum perineal pain that is secondary to perineal tearing. The perineal pain experienced due to receiving an episiotomy is severe during the first few days after delivery, and it can lead to limitations in movement and difficulties with urination and defecation.

Bupivacaine is a long-acting local anesthetic that effectively reduces postoperative pain. In practice, bupivacaine is used for infiltration anesthesia, nerve blocks, epidural, and caudal anesthesia. It has a more selective effect on sensory nerve fibers as compared to motor nerve fibers, therefore is preferred in obstetrics.

Lignocaine infiltration, with the presence or absence of epidural anesthesia, is the most frequently employed local anesthetic in ameliorating postpartum perineal pain. It is a rapid-onset amide local anesthetic with a short duration of action lasting up to two hours.

Eligibility Criteria:
Inclusion Criteria:

* Primigravidae with the full term undergoing vaginal delivery with episiotomy.
* Pregnancies and singleton vertex cephalic fetuses.
* In the active phase of the first stage of labor.

Exclusion Criteria:

* Patients with history of drug allergies to study drugs as this will increase the risk of complications.
* Patients undergoing vaginal delivery under epidural or spinal anesthesia as they will affect post-operative pain and interfere with assessment of efficacy of local infiltration of the study drugs.
* Evidence of local infection at site of injection as this will interfere with the action of the study drug and will increase the risk of complications.
* Inability to cooperate as this will affect our assessment.
* Patient's refusal.
* Any intraoperative complications that will affect our outcome criteria (bleeding, organ injury) as they will affect patient's vital data and affect our assessment.
* Neurological comorbidities (chronic pain disorder, chronic systemic disease, neurological disorder, neuropathic pain) as they will need more analgesia.
* Drug abuse as they will be tolerant to the used analgesics.
The Effect of Pharmacological Antilipolysis on the Metabolic Effects of Ghrelin

This study will investigate the non-growth-hormone-dependent metabolic effects of the hormone Ghrelin in growth hormone deficient subjects by examining the insulin tolerance as well as signal proteins in fat and muscle biopsies.

Ghrelin is a relatively 'new' hormone that is produced in the stomach and to a lesser extend in the hypothalamus of the brain. The actions of ghrelin are diverse and includes stimulation of the appetite center of the brain and the release of growth hormone. We have for the first time shown that ghrelin also stimulates the metabolism of fatty acids and induces insulin resistance in skeletal muscle. These effects have we confirmed in growth hormone deficient subjects on a stabile substitution treatment with growth hormone and hydrocortisone. With these subjects we can investigate the effects of ghrelin that are independent of growth hormone. The present study is a continuation of these findings, as we wish to investigate whether the insulin resistance effect of ghrelin is dependent of the concomitant metabolism of fatty acids. This is possible by administration of the niacin acid antagonist Acipimox, that blocks the fatty acid metabolism reversibly. We have applied this experimental principle in other settings with success.

Knowledge of the effects of ghrelin in general can in shot-sight as well as in long-sight have great importance for the understanding of growth disorders from overweight and type 2 diabetes to malnutrition and eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* males with hypopituitarism in regard to growth hormone and ACTH in stabile treatment regime
* age 18-65
* BMI 20-35

Exclusion Criteria:

* abuse of alcohol
* malign disease
* medication other than that expected for hypopituitarism
* known disease other than hypopituitarism
* participation in isotope investigations the last 6 months
MEK Inhibitors for the Treatment of Hypertrophic Cardiomyopathy in Patients With RASopathies

The goal of this study is to evaluate the effectiveness of trametinib treatment in patients with Hyperthropic cardiomyopathy and a genetic mutation in the RAS/MAPK pathway.

Introduction RASopathies are a group of genetic diseases caused by mutations in the mitogen-activated kinase (RAS-MAPK) pathway. These mutations affect many processes and are the cause of numerous genetic syndromes (including Noonan syndrome) in the course of which severe hypertrophic cardiomyopathy (HCM) develops. MEK kinase inhibitors are used to treat cancers with mutations in the RAS-MAPK pathway in adults. So far, single cases of HCM treatment in patients with RASopathies have been described, with rapid improvement in both laboratory and echocardiographic parameters and regression of myocardial hypertrophy. Due to the described effectiveness, it is reasonable to verify these effects in a well-designed randomized study on a large group of patients.

Objective To evaluate the effectiveness of trametinib treatment in patients with HCM and a genetic mutation in the RAS/MAPK pathway.

Methodology

Randomized, open-label study. The study will include patients aged 0 to 18 with:

* mutation in the RAS/MAPK pathway confirmed by genetic tests
* HCM diagnosed by echocardiography

In the first phase of the study (3 months), patients will be randomly assigned to one of two groups:

* the intervention group will receive trametinib and standard treatment (beta-blocker and disopyramide)
* the control group will receive only standard treatment. Once this phase is complete, patients will be assessed. If higher effectiveness is demonstrated in the intervention group, in the second phase of the study, patients in the intervention group will continue their current treatment and patients in the control group will receive trametinib treatment. Each group will receive trametinib for 12 months.

Importance of the study The study results will provide grounds for routine introduction of MEK kinase inhibitors for the treatment of patients with HCM due to RASopathy. If effectiveness is demonstrated, this group will gain a simple, non-invasive and causal treatment option.

Eligibility Criteria:
Inclusion Criteria:

* patient with diagnosed RASopathy
* patient with diagnosed hypertrophic cardiomyopathy
* signed innform consent

Exclusion Criteria:

* contraindications to treatment with propranolol (drug hypersensitivity, atrioventricular block, severe bradycardia) disopyramide (drug hypersensitivity, WPW syndrome, atrioventricular block, QT prolongation) trametinib (drug hypersensitivity)
* lack of consent of the child's guardians to participate in the study
Carpal Tunnel Syndrome and Amyloid Cardiomyopathy

The investigators will prospectively evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid in the soft tissue that is removed. Patients who have tissue that stains positive for amyloid will undergo cardiac testing to look for evidence of cardiac involvement.

Since the 1970s, the connection between amyloidosis and carpal tunnel syndrome has been described, with tenosynovial tissue staining positive for amyloid fibril deposition. Up to 30% of patients in prior studies with idiopathic carpal tunnel syndrome have biopsy tissue that stains positive for amyloid deposition. However, the prevalence of cardiac involvement at the time of carpal tunnel syndrome surgery has not been established. Furthermore, the role of TTR kinetic stability in the disease progression of amyloidosis is unclear.

Diagnosing TTR amyloidosis at the time of carpal tunnel involvement could lead to an earlier identification of the disease at a stage where the cardiomyopathy may be occult or less advanced. In addition, abnormal TTR kinetics may even precede tissue deposition in the flexor tendon retinaculum. As several emerging pharmacological strategies are in development that may slow or even halt TTR amyloidosis, earlier diagnosis is advantageous. Identification and implementation of therapy for prevention or early disease treatment may alter the natural history of this progressive systemic disease.

Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 50 years of age
* Females ≥ 60 years of age
* Undergoing carpal tunnel release surgery (adequate symptoms are not responding to conservative management requiring surgery)
* Able to consent
* Underwent carpal tunnel surgery and biopsy within last 30 days, if the study was discussed prior to surgery by one of the study physicians.

Exclusion Criteria:

* Secondary CTS (Hemodialysis, rheumatoid arthritis, trauma)
* Known diagnosis of amyloidosis
Intravitreal Ranibizumab for the Prevention of Radiation Maculopathy Following Plaque Radiotherapy

Uveal Melanoma is the most common primary intraocular malignancy in adulthood. Eye preserving treatments can deliver equivalent life prognosis in the management of small and medium sized uveal melanomas, as compared to enucleation. Plaque radiotherapy has emerged as the most common eye-preserving treatment in the current management of uveal melanoma, but is complicated by visual loss in approximately 70% of patients at 10 years follow-up. Strategies for the prevention and early treatment of radiation retinopathy/maculopathy need to be developed to improve visual outcomes following plaque treatment. Ranibizumab (Lucentis) is the antigen binding fragment of a recombinant, humanized monoclonal antibody, which inhibits the activity of vascular endothelial growth factor A, a mediator in the development of choroidal neovascularization. Lucentis is commonly used in the eye for eye conditions such as age related macular degeneration. This study will investigate the possible benefit of Anti-VEGF therapy (Lucentis) in reducing the incidence of radiation complications following plaque radiation for uveal melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* new diagnosis of choroidal melanoma
* scheduled for plaque radiotherapy at Wills Eye Health System

Exclusion Criteria:

* Pre-existing retinal disorders (i.e. age-related macular degeneration, diabetic maculopathy, retinal vascular occlusion, macular hole, surface wrinkling retinopathy)
* prior retinal detachment
* media opacities precluding accurate OCT imaging
* history of glaucoma
* pregnancy
* age \<18 years.
A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices

With the number of individuals becoming overweight or obese, healthcare professionals are in need of accurate, reliable, and convenient tools to help personalize weight loss programs. Recently, a new indirect calorimeter (i.e. MedGem / BodyGem; aka "Gem") was introduced as a convenient solution to determine resting metabolic rate (RMR) for assessment of daily energy needs. Several validation and comparison studies were conducted to determine if the Gem device is accurate and reliable. The purpose of this study was to conduct a systematic review of previous studies that evaluated the accuracy and reliability of the Gem devices.


Eligibility Criteria:
Inclusion Criteria:

* Random or counterbalanced assignment of participants to eliminate measurement bias; similar subject positioning for both Gem and reference system measurement or adjustment to a measurement for positioning differences; and use of a measurement protocol that is similar to the established "best practice" guidelines for employing indirect calorimetry
Real-world Study of Anti-TNFa Treatment Regimes of Hyrimoz or Zessly in Patients With Crohn´s Disease

Hyrimoz™ was developed as a biosimilar to HumiraTM (INN: adalimumab) and Zessly™ was developed as a biosimilar to RemicadeTM (INN: infliximab). Within the Biosimilar Development Program of Hyrimoz™ and Zessly™, two clinical confirmatory efficacy and safety studies were conducted: Hyrimoz™ in plaque psoriasis and Zessly™ in rheumatoid arthritis. Both confirmatory Phase III studies demonstrated equivalent efficacy and similar safety and immunogenicity of Hyrimoz™ to HumiraTM and Zessly™ to RemicadeTM, respectively.

The current study is designed to provide a systematic and consistent overview of the real-world data in biologic-naïve patients with moderate-to-severe Crohn's disease (CD). The data collected in this observational trial will be used to increase the knowledge of the effectiveness of Hyrimoz™ and Zessly™ in clinical routine care in patients with moderate-to-severe CD.


Eligibility Criteria:
The inclusion and exclusion criteria are to ensure the enrollment of patients receiving the drug according to the label of Hyrimoz™ and the label of Zessly™. Patients observed in this study need to meet all of the following inclusion criteria and none of the exclusion criteria at enrollment:

Inclusion criteria

1. Confirmed diagnosis of CD
2. Harvey-Bradshaw Index (HBI) ≥ 5
3. Treatment failure upon steroids / topical budesonide with or without immunosuppressants
4. Males and females ≥ 18 years of age at enrollment
5. Biologic-naive patients scheduled to receive Hyrimoz™ or Zessly™ and patients already receiving Hyrimoz™ or Zessly™ according to the label and at the discretion of the investigator for up to three months prior enrollment
6. Provision of signed informed consent form

Exclusion criteria

1. Patients with CD in clinical remission (HBI \< 5)
2. Hemoglobin \< 8.5 g/dL
3. Patients at imminent risk of scheduled intestinal surgery (stenosis, strictures, internal fistula)
4. Any contraindications to Hyrimoz™ or Zessly™ according to the prescribing recommendations in each country
5. Participation in an interventional clinical trial for immune-mediated inflammatory diseases (IMIDs) or having received any investigational agent or procedure within 30 days prior to enrollment (consenting)
LSVT Big and Dual Task Training in Cognitive Impaired Patients

The goal of this study ifs to determine the comparative effects of Lee Silverman voice treatment Big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment.

Perform LSVT big four times in a week for about 4 months. Perform dual task training four times in a week for about 4 months. Complete assessments at baseline, the 4th, 8th, 12th weeks, and a follow-up at the 16th week.

Outcome measures include Mini BESTest, MoCA, stroop test and time up and go test. Statistical analyses will assess within-group and between-group effects based on data distribution.

This study, titled "Effects of of lee Silverman voice treatment big and dual task training on balance, cognition and functional mobility in older adults with cognitive impairment" aims to assess the combined effectiveness of Lee Silverman voice treatment and dual task training in older adults with cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female patients.
* Age limit for patients will be above 65.
* Patients with Mild and moderate cognitive impairment patients MoCA 13-25.
* Patients with Berge balance scale value 41-50.
* Patients who give consent to participate in study and undergo relevant test.

Exclusion Criteria:

* Patients with any musculoskeletal disorder in which these exercises are contraindicated.
* Patients using any walking aids.
* Patients with hearing impairment.
* Patients with other neurological conditions with limit the patient participation in planned exercise like stroke, Parkinson's.
* Patients with diagnosed psychiatric disorder or taking medication that affect cognitive function within 24 hours.
Rhupus Syndrome and Efficacy of Etanercept Treatment

between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

between March 2013 and March 2014, patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) \>5.1 were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

- Rhupus patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) \>5.1

Exclusion Criteria:

- those who had participated in other studies
Assessment of Circulating Fubctional Mitochondrias in Vitiligo Patients

To compare the level of circulating functional mitochondria in the serum of vitiligo patients as compared to controls


Eligibility Criteria:
Inclusion Criteria:

* Patients with non segmental vitiligo,
* atopic dermatitis, psoriais, alopecia areata,
* 1st degree relative of vitiligo patients.

Exclusion Criteria:

* segmental or mixed vitiligo,
* personnal history of other autoimmune disorders,
* oral use of antioxidant,
* pregant women