cyrilzakka/clinical-trials huggingface dataset:
Initiating Early Control of Migraine Pain and Associated Symptoms

AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo.

This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.


Eligibility Criteria:
Key Inclusion Criteria:

• Has an established diagnosis of migraine with or without aura.

Key Exclusion Criteria:

* Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
A Clinical Study on the Analysis of Risk Factors for the Occurrence of PD-1/PD-L1 Inhibitor-associated Liver Injury in Lung Cancer Patients

The goal of this observational study is to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury. The main questions it aims to answer are:

* Exploring risk factors for liver injury.
* Constructing a Predictive Model for the Occurrence of Liver Injury in PD-1/PD-L1 Inhibitor-Related Liver Injury.
* Improving immunotherapy protocols for lung cancer patients.

PD-1/PD-L1 inhibitors have achieved surprising results in lung cancer treatment and have been approved by the FDA for the treatment of different types of lung cancer. Their overall toxicity is lower than that of standard chemotherapy, but a number of immune-related adverse events have been reported clinically. Liver injury is one of the leading causes of death from adverse events due to PD-1/PD-L1 inhibitors. The occurrence of immune-related liver damage has an important impact on the tumor treatment and prognosis of patients. Most of the current domestic and international studies focus on the overall description and study of PD-1/PD-L1 antibody-related adverse events, and there is no definitive description of the risk factors for the development of immune-related liver injury in lung cancer patients. The aim of this project is to review the clinical data of lung cancer patients treated with PD-1/PD-L1 inhibitors from 2020.01 to 2024.06, to investigate the risk factors of PD-1/PD-L1 inhibitor-associated liver injury, to construct a prediction model for the occurrence of liver injury, and to take measures to prevent the occurrence of fatal immune liver injury, which is of great significance to the immunotherapy of clinical tumor patients. It is of great significance to the immunotherapy of clinical tumor patients.

Eligibility Criteria:
Inclusion Criteria:

1. Lung cancer patients who have received at least one and more PD-1/PD-L1 inhibitor treatments;
2. Gender is not limited, age 18-80 years old

Exclusion Criteria:

1. Severe liver injury prior to immunotherapy (elevation of transaminases, alkaline phosphatase, and glutamyl aminotransferase more than 5 times the upper limit of normal).
2. Patients who, in the opinion of the investigator, are not suitable for participation in the study.
Detection of G-quadruplex DNA Methylation in Cancer

This study aims to evaluate the early diagnosis value of G-quadruplex DNA methylation in patients with cancer.

Global DNA hypomethylation is a hallmark of most cancers that occurs early during oncogenesis. We would like to investigate whether cancer-specific transcription factor binding to DNA G-quadruplex drives DNA hypomethylation in cancer. In this observational study, we would like to clarify whether DNA hypomethylation around G-quadruplex loci in cell-free DNA could be detected in early-stage cancer patients from healthy donors with high sensitivity and specificity.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers identified as asymptomatic during medical examination;
* Age≥42 years old;
* Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

* History of malignancy or having achieved complete remission following tumor surgery;
* Certain autoimmune diseases (e.g., systemic lupus erythematosus, Sjögren's syndrome, antiphospholipid syndrome, rheumatoid arthritis, Crohn's disease, IgA nephropathy, myasthenia gravis, dermatomyositis, immune thrombocytopenic purpura, etc.);
* Pregnancy;
* Acute trauma (including surgical procedures), sudden onset organ failure (e.g., resulting from a car accident, fulminant hepatic failure, acute pancreatitis, severe pneumonia due to influenza virus), or diagnosis of sepsis;
* Previous receipt of allogeneic blood transfusion, transplant surgery, or allogeneic cell therapy;
* Volunteers who cannot provide informed consent.
Dancing Against Fall Fractures in Osteoporosis Patients and Healthy Elderly

This study evaluates physiological measurements and their role in among falls in healthy elderly (65yr or older) or elderly suffering from osteoporosis. The study further seeks to evaluate if dancing can be used as training for preventing falls.

This study seeks to examine the relationship between strength, postural control and bone mineral density on the risk of falling among elderly (65 yr or older). The study will carried out on osteoporosis patients and healthy, matched controls. The study further seeks to examine whether a dancing intervention may improve any of these parameters, resulting in a decreased risk of falling.

Eligibility Criteria:
Patient groups

Inclusion Criteria:

* Verified osteoporosis (T-score -2.5 to -3.5) from previous Dual-energy X-ray absorptiometry scanning (DXA)
* Receiving medical treatment for osteoporosis

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs.
* Use of medical cannabis.
* Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
* Lack of ability to cooperate.
* Osteoporosis grade higher than moderate or severe (T-score \< -3.5)

Healthy elderly groups

Inclusion Criteria:

• T-score higher than -2.5 from previous Dual-energy X-ray absorptiometry scanning (DXA)

Exclusion Criteria:

* Drug addiction defined as the use of cannabis, opioids or other drugs.
* Use of medical cannabis.
* Previous neurologic, musculoskeletal (besides osteoporosis) or mental illnesses
* Lack of ability to cooperate.
* Osteoporosis grade higher than mild, moderate or severe (T-score \< -2.5)
* Receiving medical treatment for osteoporosis
Effect of Manual Therapy on Jaw Movement and Function in Patients With Bruxism

Hypothesis

1. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on pain level in patients with bruxism.
2. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Range of Motion in patients with bruxism.
3. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Sleep Quality Index in patients with bruxism.
4. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on proprioception awareness in patients with bruxism.
5. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Stress in patients with bruxism.
6. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Anxiety in patients with bruxism.
7. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Temporomandibular (TMJ) function in patients with bruxism.
8. There will be no significant statistical effect of Trigger Point Pressure release and Deep striking massage on Oral Health Impact Profile in patients with bruxism.


Eligibility Criteria:
Inclusion Criteria:

1. The volunteers diagnosed with bruxism based on the criteria of the American Academy of Sleep Medicine
2. Positive self-report of awake bruxism.
3. Self-report of muscle fatigue or tenderness on awakening.
4. Sleeping partner reports of grinding sounds during the night in the last 6 months, or awake clenching.

Exclusion Criteria:

1. Severe psychological disorder and/or the use of antipsychotic psychotropic drugs(with the exception of anxiety and depression).
2. Using medications that influence sleep or motor behavior.
3. Direct trauma or past surgery in the orofacial region.
4. On physical, speech, dental, or psychological therapy at the time of study entry.
5. Currently undergoing physical therapy for TMD.
6. Neurological or central nervous system and/or peripheral nervous system disorders or history of neuromuscular disease.
7. The presence of prosthesis or extensive prosthetic restorations and the presence of gross malocclusion.
8. More than two missing teeth, except third molars;
9. Systemic and/or degenerative diseases.
Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section

The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

* Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
* Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
* A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
* A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
* Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
* Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
* A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
* Inclusion criteria:

  • Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
* Exclusion criteria

  * Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
  * women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
  * Hypertension with pregnancy.
  * Cardiac and coronary diseases with pregnancy
* Women included in the study were divided into 2 groups:

.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.

.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.

Eligibility Criteria:
Inclusion Criteria:

* • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

Exclusion Criteria:

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy
Exercise-induced Improvements of Inflammatory Status in Patients With Rheumatoid Arthritis

The primary aim of the study is to investigate if 10 weeks of high intensity interval training improve inflammatory status in patients with rheumatoid arthritis.

Rheumatoid arthritis (RA) is a chronic, systemic inflammatory disorder that may affect many tissues and organs, but principally attacks synovial joints. Although the cause of rheumatoid arthritis is unknown, autoimmunity plays a role in both the chronicity and progression, and RA is considered as a systemic autoimmune disease.

Due to chronic inflammatory status, RA-patients are at higher risk of developing cardiovascular disease (CVD) compared to the general population. Accumulating evidence indicates that regular physical activity has beneficial effects on RA. The mechanisms behind exercise-induce improvements are none the less unclear and more research is needed to better understand the beneficial effects of exercise training in this patient group.

Recently, promising results from gene expression studies of blood cells have revealed unexplored fields of biomarker discovery and gene expression profiling of disease. Due to easy accessible and minimally invasive sample collection, gene expression profiling of whole blood might turn out to be a promising tool in molecular diagnostics and clinical medicine. To our knowledge, whole-genome transcriptional changes have not previously been studied in RA-patients undergoing a high-intensity exercise program.

Hypothesis: Ten weeks of high intensity interval training improves the inflammatory status, quality of life, and known risk factors for cardiovascular diseases.

In addition to measure traditionally inflammatory markers in the blood, whole genome analysis will be made.

Eligibility Criteria:
Inclusion Criteria:

* Ability to exercise
* written consent

Exclusion Criteria:

* Inability to exercise
* Known ischemic cardiovascular disease
* Severe pulmonary disease
* High activity level
* Pregnancy
* drug/alcohol abuse
* Unstable RA
* diagnosis before 2000
The Cirrhosis Outpatient Optimization, Readmission & Safety Study

A prospective series comparing care incorporating home monitoring and liver care coordination to conventional care for patients with cirrhosis.

Telemonitoring has been suggested to have potential benefits in patients with cirrhosis. However, to date, no prospective studies exist to support this idea. Hence, the investigators study would like to explore the use of home telemonitoring devices with vital sign capturing capabilities in recently-discharged patients with cirrhosis to decrease 30-day readmissions, mortality and costs.

This is prospective, randomized controlled trial comparing two strategies of post-discharged care in patients with cirrhosis-related hospitalizations.

First treatment arm will incorporate the Vivify home monitoring device into post hospital care.Home monitoring kits include a tablet with wireless internet and vital sign monitoring capabilities (temperature, blood pressure, heart rate, weight and pulse oximetry if needed) and the device has the ability to trigger an alert to the "liver care coordinator."

Second treatment arm will continue the standard of care therapy that all post- hospitalized patients receive upon discharge, i.e. return to clinic appointments, education regarding any signs or worsening symptoms to watch for, as well as contact numbers to connect with their doctor or nurse.

Eligibility Criteria:
Inclusion Criteria:

1. Ascites requiring paracentesis during the hospitalization
2. Hepatic encephalopathy defined as altered mental status that improves after treatment with lactulose
3. Variceal hemorrhage, defined as clinically significant gastrointestinal bleed (tachycardia, hypotension, requirement for blood transfusion, or \>2g drop in hemoglobin) and varices seen on endoscopy
4. Spontaneous bacterial peritonitis defined as \>250 polymorphonuclear cells per high-power field and/or monomicrobial culture in the ascetic fluid
5. Renal failure in the presence of ascites, defined as a rise in the serum creatinine by 0.5mg/dl (to \>1.5mg/dl), with ascites documented on physical exam or ultrasound, or admitted on diuretics for the treatment of ascites
6. Hyponatremia, defined by serum sodium \<130 on admission labs
7. Hepatocellular carcinoma as seen on arterial phase MRI or liver biopsy, if tumor is treated and fits within Milan criteria

Exclusion Criteria:

* Admissions for scheduled or elective procedures
* Patients with a comorbid conditions with a life expectancy of less than 12 months or ones that may confound a patient's clinical course

  * Hepatocellular carcinoma
  * Hepatorenal syndrome
  * Hepatopulmonary syndrome
  * Metastatic cancer
  * Chronic kidney disease (pre-dialysis, dialysis)
  * Congestive heart failure
  * Diagnosed dementia
  * HIV/AIDS
  * Pregnancy or planned pregnancy during the study
  * Those managed by palliative care
  * Patients with liver transplants prior to or during the index hospitalization
  * Patients unable to understand study procedures/instructions/use of the home monitoring device
  * Patients unable to stand for \<1 minute
  * Patients living in nursing homes or similar institutions
Safety of Heparin in Patients With Septic Shock

Sepsis is a syndrome comprised of a systemic inflammatory response, signs of tissue hypoperfusion, and organ in the setting of presumed infection. Heparin, in addition to being an anticoagulant, is also a well-known antiinflammatory. The investigators believe that unfractionated heparin has the potential to save the lives of septic patients at a drastically reduced cost. This is a dose escalation study to determine the safety of increasing levels of heparin in this patient population; compare markers of anticoagulation and inflammation between treatment groups; and compare clinical outcomes between groups.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-90 in the medical or surgical intensive care unit
2. Within 24 hours of diagnosis with sepsis as defined by the Bone criteria (see Appendix A);
3. Acute Physiology and Chronic Health Evaluation (APACHE II) score of \> 25;
4. Signed consent

Exclusion Criteria:

1. Currently therapeutically anticoagulated for known thrombotic diagnosis (myocardial infarction, venous thromboembolism) known molecular hypercoagulable state (Factor V Leiden, lupus anticoagulant, antiphospholipid antibody syndrome); or use of cardiopulmonary support machines (left-ventricular assist device, intra-aortic balloon pump, veno-venous ultrafiltration, or extracorporeal membrane oxygenation.
2. History of gastrointestinal or cerebral hemorrhage within past 3 months;
3. Active bleeding;
4. Known allergy or sensitivity to heparin;
5. History of heparin-induced thrombocytopenia
6. Organ transplantation recipient -
Insulin Resistance and Cognitive Dysfunction in Obese Adolescents: Pilot Study

Obese Adolescents will be evaluated for insulin resistance and cognitive dysfunction.

The short-term goal of this project is to conduct a feasibility study at Winthrop University Hospital to determine how well extremely obese (BMI \> 99%tile corrected for age) children and adolescents can be recruited into an exercise program and evaluated in an efficient fashion, and to identify particular strategies (e.g., medical examination feedback) that can serve as potential benefits to research subjects and their families. In addition investigators will evaluate the effect of the exercise program on physical fitness, insulin resistance, and neurocognitive functioning as well as the relationship between insulin sensitivity and neurocognitive function among adolescents who participate in the exercise program.

The long-term goal of this project is to evaluate a large, multi-ethnic sample of adolescents, 14 to 19 years of age, to systematically assess cognitive function and school performance, fitness and examine the relationship between performance on those outcome variables and a variety of biomedical and psychosocial factors that may directly or indirectly influence brain function and test-taking performance.

High body mass index (BMI) among children and adolescents continues to be a public health concern in the United States. The most recent figures from the National Health and Nutrition Examination Survey (NHANES) for 2007-2008 report that 18.1% (95% CI, 14.5%-21.7%) of 12- through 19-year-old adolescents were at or above the 95th percentile of BMI for age. Children with high BMI often become obese adults, and obese adults are at risk for many chronic conditions. High BMI in children may also have immediate consequences, such as elevated lipid concentrations and blood pressure.

It now appears that neurocognitive dysfunction is also more common in obese children and adolescents. In a large population study of 2,519 children, 8 to 16 years of age, a brief neuropsychological assessment showed a statistically significant, albeit modest relationship between cognitive test scores and BMI that persisted after adjusting for confounding variables. Obesity is also associated with several conditions which known to affect brain function, including sleep apnea, insulin resistance, hypertension, and chronic inflammatory factors (e.g., by these variables cannot be determined, unfortunately, because those variables were not measured.

It is important to note, however, that there is not complete agreement on linkages between obesity and cognition.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subject's ages 14 to 19 years old, extremely obese (BMI ≥ 99th percentile).
* Clearance by pediatric cardiologist, including evaluation of V02Max.

Exclusion Criteria:

* Male and female less than 14years of age or more than 19 years of age.
* Patients with type 1 or type 2 diabetes
* Patients with serious medical conditions.
* Anyone who is deemed inappropriate by pediatric cardiologist during clearance evaluation.