cyrilzakka/clinical-trials huggingface dataset:
VNS for Long-COVID-19

The goal of this proposed clinical case series is to evaluate the effect of a non-invasive vagus nerve stimulation paradigm on: 1) Symptom reporting via validated patient reported outcomes, and 2) objective clinical biomarkers of autonomic nervous system function.

This will be a placebo controlled, randomized controlled trial with a crossover design built in. This study will aim to recruit 40 people with Long COVID to be a part of this research.

Participants will be randomized into one of two arms. Those in the "active VNS" arm will be sent home with a portable VNS device and asked to perform a daily VNS protocol designed to down regulate sympathetic nervous system activity for six weeks.

Those in the "sham VNS" arm will be asked to use the VNS device daily on a sham setting for six weeks. Those randomized to the sham group will be given the opportunity to "crossover" into the active VNS arm once they have completed the sham arm (Week 12). The participant and assessor will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* At least 18 years of age
* Clinical diagnosis of dysautonomia following an acute COVID-19 infection at least 3 months prior. See below for criteria:

  * clinical diagnosis of autonomic dysfunction as evaluated by a qualified healthcare provider
* 2 or more if the following clinical assessment findings
* symptomatic exacerbation during active stand test
* tachycardia on active stand test
* tachycardia on orthostatic vitals assessment
* hypotension on orthostatic vitals assessment
* hypertension in orthostatic vitals assessment
* symptom exacerbation on orthostatic vitals assessment
* English speaking

Exclusion Criteria:

• Pregnancy or lactation:

* Pregnant persons will not be included in this study for the following reasons:

  * There is not sufficient data surrounding the hormone cycle changes during pregnancy and its effects on the condition being studied (PCD). The results could be skewed due to pregnancy.
  * Of note, there are no risks for pregnant persons to participate.

According to the device manufacturer, the following contraindications will be followed during the screening process:

* Patients with an active implantable medical device, such as a cardiac pacemaker, heading aid implant, or any implanted metallic or electronic device
* Patients with a history of baseline cardiac disease or atherosclerotic cardiovascular disease, including congestive heath failure (CHF), known severe coronary artery disease or recent myocardial infarction (within 5 years)
* Patients with diagnosed bradycardia
* Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
* Patients whose pain syndromes are undiagnosed
* Pediatric patients
* Pregnant women
Study Evaluation LXR-623 in Healthy Adults

To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy adults.
* Liver function tests, triglycerideres, and creatinine must be below upper limit of normal at screening.

Exclusion Criteria:

* A history or active presence of clinically important medical disease.
* Any metal implants or devices.
* Claustrophobia.
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)

To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.

Individuals with gestational diabetes (GDM) during pregnancy have up to a 10-fold increased risk of developing of T2DM. Postpartum screening facilitates detection of impaired glucose tolerance and diabetes mellitus with the possibility for subsequent preventive and treatment interventions. The American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) recommend screening individuals with GDM postpartum with a 75-g, 2-hour oral glucose tolerance test (OGTT) that includes a fasting blood glu-cose.4,6 This is historically performed at 4-12 weeks so that it will coincide with the timing of the typical postpartum visit. However, the rate of postpartum screening with the recommended method are low, as many individuals do not seek timely postpartum care-only a quarter to one half of individuals undergo diabetes screening in the first year postpartum. Multiple structural barriers exist for patients and healthcare providers to effectively complete postpartum diabetes screening via the current recommended method. An immediate postpartum OGTT has been proposed as an alternative to the current standard practice which is generally performed between 4-12 week postpartum OGTT at the routine postpartum visit. An immediate OGTT has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum OGTT.

Eligibility Criteria:
Inclusion Criteria:

* Immediately postpartum individuals during their delivery hospital admission
* ≥ 18 years old with the ability to give informed consent.
* Diagnosed with GDM during pregnancy by:

  * Elevated one-hour 50-gram glucose challenge test any time during pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis OR
  * Two elevated values on a 3-hour 100-gram glucose tolerance test any time in pregnancy AND provider documentation of gestational diabetes (NOT pregestational diabetes) diagnosis
* English or Spanish speaking
* Receiving prenatal and postpartum care at OSU

Exclusion Criteria:

* Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass)
* Not English or Spanish speaking
Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)

The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.

This is a prospective and retrospective study of a population of patients with mutated non-small cell lung cancer in the Nord Pas de Calais. Retrospective cohort will involve patients with main molecular abnormalities, identifiable from molecular biology platform CRRC, except EGFR and KRAS treated from September 2011 to February 2013.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Patient with non-small cell lung cancer
* Detected in the Nord Pas de Calais
* Monitored in the Nord Pas de Calais
* Patient must have signed a non-opposition form to the use of medical data

Exclusion Criteria:

- No identified mutation
A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies

RSC-101 is a Phase 1a/1b clinical trial of RSC-1255 in adult study participants with advanced solid tumor malignancies who are intolerant of existing therapies known to provide clinical benefit, have disease that has progressed after standard therapy, or have previously failed other therapies. The study has two phases. The purpose of Phase 1a (Dose Escalation) is to confirm the appropriate treatment dose and Phase 1b (Dose Expansion) is to characterize the safety and efficacy of RSC-1255.

RSC-1255 is an orally bioavailable, small-molecule direct pan-mutant and wild-type RAS inhibitor. RSC-101 is a Phase 1a/1b, open-label, multi-center, non-randomized, Dose Escalation and Dose Expansion study in participants with advanced solid tumor malignancies. Study enrollment is approximately 134 participants. All participants receive oral RSC-1255, twice daily as monotherapy. Following Phase 1a (Dose Escalation) to identify the Maximum Tolerated Dose and Recommended Dose for use in Phase 1b, additional participants are enrolled in the Phase 1b (Dose Expansion) to further characterize the safety, pharmacology, and the clinical efficacy of RSC-1255.

Eligibility Criteria:
Inclusion Criteria (Key Factors):

1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:

   * Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
   * Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
   * Malignancy has progressed on standard therapy
2. Has evaluable or measurable tumor(s) in dose-escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
3. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG).
4. Is age ≥ 18 years.

Exclusion Criteria (Key Factors):

1. Participants receiving cancer therapy at the time of enrollment.
2. Any clinically significant disease or condition affecting a major organ system.
3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities.
4. Known Gilbert's disease.
5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer.
Balance Eyesight and Muscle Tension in the Cervical Spine in Cerebral Amyloid Angiopathy

Cerebral Amyloid Angiopathy (CAA) is one form of disease of the small vessels of the brain and can cause frequent cerebral hemorrhages as well as other types of stroke. The aim of the research was to examine the balance of the body in patients after a stroke and to determine how the tension of selected muscles of the cervical spine changes under the conditions of statics and dynamics, depending on the visual control or its absence.

This is an observational study. The tests were performed with the use of tools and devices such as the Unterberger test, Biodex SD balance platform, and Luna EMG. The static equilibrium was assessed on a balance platform (stability test). The dynamic equilibrium was tested in the Unterberger test and on the balance platform (the fall risk test). All examinations were performed twice with eyes open and then closed. Additionally, during the tests, the tension of selected muscles of the cervical spine was recorded (the sternocleidomastoid muscle and the long neck muscle) (independent variables). It was examined how the intervention, static position, and dynamic displacement of the center of body mass, as well as the control and lack of eye control, influence the tension of selected muscles, and how the eyesight influences the body's balance in statics and dynamics (dependent variables). A group of healthy people was examined to assess whether neurological deficits in people after stroke could affect the results of static and dynamic balance and changes in muscle tone and whether the organ of vision plays a large role in controlling the center of body mass.

Eligibility Criteria:
Patients Inclusion Criteria:1) stroke in the course of CAA; 2) the functional state of the patients, which allows independent walking in a place and at a distance; 3) no severe deficits in communication, memory, or understanding what can impede proper measurement performance;

Patients Exclusion Criteria: 1) cause of stroke other than CAA; 2) stroke up to seven weeks after the episode; 3) epilepsy; 4) lack of trunk stability; 5) lack of independent walking; 6) high or very low blood pressure, dizziness, malaise.

Healthy Inclusion Criteria: 1) the control group consisted of healthy subjects with a stable trunk; 2) with independent walking.

Healthy Exclusion Criteria: 1) a history of neurologic or musculoskeletal disorders such as stroke or brain injury or other conditions that could affect their ability to active movement the trunk and the legs; 2) pain, dizziness; 3) permanent use of orthopedic supplies; 4) severe deficits in communication, memory, or understanding what can impede proper measurement performance; 5) high or very low blood pressure, dizziness, malaise.
Assessment of Handwriting Skills in a Sample of Egyptian Children with Attention-Deficit Hyperactivity Disorder

PURPOSE: To assess handwriting difficulties in ADHD children. BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders that affects 7.6% of children worldwide. In addition to the core symptoms defining Attention-Deficit/Hyperactivity Disorder (ADHD), ADHD children often experience motor problems, including graphomotor movements, leading to handwriting difficulties. Studies have confirmed that handwriting skills are adversely impacted by the presence of ADHD, and this is associated with lower academic achievement and self-esteem. Children with ADHD have been found to display greater difficulties in the development of motor coordination, especially in the planning and execution of complex, lengthy, and novel chains of goal-directed behavior. Also, handwriting problems in ADHD may signal underlying executive function deficits such as inhibition, emotional dysregulation, working memory problems, and difficulty with self-monitoring, all of which are required for various daily functions beyond handwriting per se. With a slower motor response and perceptual speed, these deficits may decrease the likelihood that a child with ADHD can work efficiently and stay on-task during school and home activities.

Written informed consents will be obtained from the parents of participants. All participants will undergo the following:

1. Thorough history taking and medical examination.
2. Anthropometric measurements: weight, height
3. Diagnosis by DSM 5
4. Conners' Parent Rating Scales-Revised (CPRS-R) to assess the severity of ADHD symptoms.
5. Intelligence quotient (IQ) test: Stanford Binet intelligence scale, fifth edition to assess the mental ages of the children and measure their intelligence quotients.
6. Assessment of handwriting using (Handwriting Legibility Scale (HLS) to evaluate the handwriting skills of the participants including ......
7. Assessment of neuropsychological abilities related to executive functioning and learning Using the Learning, Executive, and Attention Functioning (Leaf) scale.
8. Language assessment to identify any underlying language deficits that might contribute to handwriting difficulties.
9. A Baseline mechanical gauge was used to measure palmer pinch strength in kilograms
10. A Baseline mechanical gauge was used to measure hand grip strength in kilograms
11. Statistical analysis using the SPSS version 22.

Eligibility Criteria:
Inclusion Criteria:

* ADHD children can read and write
* both sexes.

Exclusion Criteria:

* low IQ children
Effect of 3D Typing on Surgical Treatment of Hepatolithiasis

According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis.

According to a large amount of case affected with hepatolithiasis, we developed a typing system of Hepatolithiasis based on 3D digital conformation. And we hypothesized that it could predict a more precise construction of this disease, hence, typing by 3D conformation will improve the outcome of surgical treatment.The investigators will use a multicenter ambispective cohort study to test this hypothesis. In this cohort study, two group will be enrolled to compare the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 65 years old
* Without gender restriction
* With a favorable liver function of Child-Pugh A to B
* No contraindications to surgery and anesthesia
* Diagnosed with Hepatolithiasis and Signed informed consent.

Exclusion Criteria:

* Diffused type of Hepatolithiasis
* Impairment in liver function
* Severe disorders in vital organ
* Accompanied with tumors.
A Study of Olaratumab (IMC-3G3) in Previously Treated Participants With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors

The purpose of this study is to evaluate the tumor response of stable disease (SD), partial response (PR), or complete response (CR) \[according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1 criteria)\] at 12 weeks in participants with Gastrointestinal Stromal Tumors (GIST) harboring platelet-derived growth factor receptor alpha (PDGFRα) mutations and patients with GIST not harboring PDGFRα mutations.


Eligibility Criteria:
Inclusion Criteria:

* Participant has histologically or cytologically confirmed, unresectable and/or metastatic GIST
* Participant has measurable disease
* Participant has documented objective progression following, or intolerance to, treatment with both imatinib and sunitinib
* Participant's Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2
* Participant has either:

  1. prior results from growth factor receptor associated with tyrosine kinase activity (KIT) and PDGFRα mutation analysis that meet analytical criteria as defined for the on-study analysis of these mutations and tumor tissue (from either primary or metastatic tumor) that can be submitted for analysis within 30 days after the first dose of study therapy; or
  2. if prior results from KIT and PDGFRα mutation analysis are not available or do not meet analytical criteria as above, then tumor tissue (from either primary or metastatic tumor) must be submitted for genotype testing at the latest 28 days prior to the first dose of study therapy
* Participant has adequate hematologic, hepatic, renal and coagulation function
* Women of childbearing potential and sexually active males must agree to use adequate contraception prior to study and for at least 12 weeks after the last dose of IMC-3G3
* Participant has a life expectancy of ≥ 3 months

Exclusion Criteria:

* Participant has untreated central nervous system metastases, and as a result, is clinically unstable with regard to neurologic function
* Participant has a history of another primary cancer
* Participant has received any investigational therapy within 14 days prior to registration, or is currently enrolled in any other type of medical research
* Participant is receiving concurrent treatment with other anticancer therapy
* Participant has known human immunodeficiency virus (HIV) infection
* Participant has undergone major surgery within 28 days prior to registration
* If female, participant is pregnant or breastfeeding
The Effect of Postoperative Abdominal Binder to Improve Outcomes After Incisional Hernia Repair

Postoperative seroma formation is one of the most common complications after ventral hernia repair with mesh. Although some seromas may not have clinical impact postoperative seroma formation often causes pain and discomfort and may even compromise wound healing. Abdominal binders (also called trusses, girdle, ostomy belt, longuette or abdominal belt) (AB) are commonly used in abdominal and plastic surgery to prevent seroma formation and diminish pain and discomfort after operation. The primary aim of the present study is to investigate the effect of postoperative abdominal binders after laparoscopic incisional hernia repair on postoperative pain, discomfort and quality of life. Secondary, we register seroma formation. A randomized, controlled, investigator-blinded study supplemented with blinded statistical analysis. We include 60 (2x30) incisional hernia repairs. Patients are randomized either to abdominal binder or no abdominal binder (controls). The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. All patients have a standardized operation with standardized intra- and postoperative medication regimen. Endpoints measurements are clinically detectable seroma formation scored with seroma classification system buý S. Morales-Conde, pain scored with self-registrations with VAS, and quality of life scored with EQ-5D, recurrence and other complications are also registered. Patients are followed until 90 days after the operation.


Eligibility Criteria:
Inclusion Criteria:

* elective, primary and recurrent laparoscopic and open incisional hernia repair hernia with mesh reinforcement
* fascia defects 6-20 cm measured preoperatively by the surgeon at the out-patient clinic
* patients between 18-80 years

Exclusion Criteria:

* expected low compliance (language problems, dementia and abuse etc.)
* fascia defects \>20 cm measured at the preoperative clinical examination.
* acute operation
* decompensated liver cirrhosis (Child-Pugh 3-4)
* patients with a stoma
* if a secondary operation is performed during the hernia repair procedure.
* if a patient withdraws his inclusion consent
Predictors of Coronary Artery Calcium Progression in Adults With a Prior Zero Coronary Artery Calcium Score

This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior coronary artery calcium (CAC) score of 0 given prior CAC zero \> 5 years previous. Ancillary testing of serum, whole blood, and endothelial dysfunction will be performed to investigate any detectable systemic processes that predict CAC development.

This study is a non-randomized prospective cohort study that will define the rate of index atherosclerotic plaque development in adults with a prior CAC score of 0 given prior CAC zero \> 5 years previous. Study personnel will abstract CAC and coronary computed tomography angiography (CCTA) results on or prior to 31 December 2010 in a single, high-volume military medical center. All patients with CAC scores of zero, irrespective of whether or not this zero CAC was calculated in the presence of a CCTA with non-calcified plaque, will be offered inclusion in the study cohort. Patients will be contacted via telephone and offered study participation. Patients who sign written informed consent will be interviewed to abstract current medical history, medications, exercise practices, and social history. Cardiovascular risk factors of interest will be hypertension, hyperlipidemia, diabetes mellitus, and family history. Patients will then undergo blood draw (complete metabolic panel, complete blood count, lipid panel, serum insulin, high-sensitivity C-reactive protein (CRP), hemoglobin A1c, and thyroid function testing) to screen for undergoing cardiovascular risk factors and to be used as potential risk markers. Additionally, whole blood and serum will be obtained for future investigation to determine new markers of coronary artery disease (CAD) progression and genetic polymorphisms that may predict CAD progression. Patients will also undergo EndoPat testing utilizing an EndoPAT 2000® (digital pulse amplitude tonometry) to assess for endothelial dysfunction. Finally, patients will undergo repeat coronary artery calcium scoring based on standard laboratory protocols based on heart rate and body mass index.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Coronary Artery Calcium scoring test graded as 0 Agatston units

Exclusion Criteria:

* Interval development of symptomatic coronary artery disease (defined as prior PCI, CABG, or myocardial infarction) in the time between initial CAC scan and current data review. (These patients will not be enrolled in the trial to undergo repeat CAC testing, but any major cardiovascular events (MACE) will be documented in order to report the 5 year MACE rates amongst CAC zero patients in our population.)
* Pregnant females
* Implantable cardiac pacemaker or defibrillator
* Prior cardiac surgery for valvular heart disease
* Patients with CAC scores ≥ 1
* Patients in atrial fibrillation at the time of CAC acquisition