cyrilzakka/clinical-trials huggingface dataset:
Altering Activation Patterns Post-stroke

This study evaluates a new rehabilitation approach for stroke survivors in the chronic phase of recovery in which the combination of drug therapy (cyproheptadine) and active movement practice (AMP) is used to encourage increased voluntary muscle control and strength.

In this four arm parallel design you will be randomly assigned to one of 4 groups:

Group 1) cyproheptadine and active movement therapy, Group 2) placebo and active movement therapy, Group 3) cyproheptadine and passive stretching, or Group 4) placebo and passive stretching.

The groups will be blinded so neither you nor the research staff (or even the study doctor) will know which drug (Cyproheptadine or placebo) you receive. Only the RIC pharmacist will have access to this information until all participants complete the entire study. Although you and the research staff administering the training sessions will know if you have been assigned to the active movement practice (AMP) or passive cyclical stretching group, it is important not to discuss this information with the rater (evaluator) or the study doctor.

Cyproheptadine is an anti-serotonergic and anti spastic agent. It is expected to reduce the unwanted muscle hyper excitability (one measure of spasticity) common after stroke.

During the course of the treatment you will be required to make several visits per week to RIC to either be evaluated or participate in the treatment sessions. Evaluations last approximately 2 hours and will be performed at the beginning of weeks 1, 2, 3 and 4, during the middle of treatment (beginning of week 7), at the end of training (beginning of week 10) as well as a final follow-up visit one month after the end of treatment (beginning of week 14). The training sessions will occur from weeks 4 through week 9 and will involve 1.5-hr. sessions (1 hr training plus setup time) 3 times per week.

The investigators hypothesize that the group receiving the combined cyproheptadine and active movement therapy will have better outcomes than the groups receiving cyproheptadine or active movement therapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Chronic, severe hand hemiparesis resulting from a single stroke (Chedoke- McMaster Stroke Assessment: Stage of Hand 2 or 3)
* Single stroke occurring at least 6 months prior to enrollment
* Spasticity
* Capacity to provide informed consent

Exclusion Criteria:

* Excessive pain in paretic upper limb
* Hemispatial neglect (as assessed by the Behavioral Inattention Test)
* Apraxia (as assessed by the FABERS battery)
* Botulinum toxin injection in the upper extremity within the past 6 months
* Introduction of new anti-spasticity medication within the past 6 months
* Orthopaedic impairments
* History of seizure disorder
* Other major health impairment
Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT

The purpose of this study is to demonstrate the safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute deep vein thrombosis (DVT). Secondarily, the study team hope to illuminate the financial implications of single session catheter directed therapy versus a potential 48 hour lysis procedure (Lysis is an approach in which vascular specialists deliver clot-dissolving drugs directly to the site of the clot through a catheter).


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Onset of acute DVT occurred \<14 days
* Ability to undergo thrombolysis in combination with Indigo endhole aspiration device

Exclusion Criteria:

* Under 18 years of age
* Presence of subacute (14-28 days) or chronic DVT (\>28 days)
* Contraindication to mechanical thrombectomy
Effect of Low Power Laser in Tooth Pain Modulation Caused by Irreversible Inflammation

Anxiety, pain and discomfort are common stressful situations that occur during the dentistry practice, especially in the urgency endodontic practice. Studies have concluded that low intensity laser therapy is effective in treating pain. However, most studies have reported the low intensity laser therapy in chronic pain, few studies have shown its application on acute pain and none have evaluated the low intensity laser´s analgesic effect in acute pain of the pulp inflammation. Since the pulp tissue has the peculiar characteristic to be surrounded by dentin, in acute pulpits, the inflammatory reaction is more complicated than usual. Furthermore, during the inflammatory process, sometimes anesthesia is not always completely effective. Thus, this present study aims to evaluate whether previous therapy with low intensity laser could, by its analgesic effect, promote greater comfort especially to this type of patient. 60 patients with acute pulpits pain will be selected to this study (randomized and double-blinded) and they will be divided in 4 groups:

Group 1 ( n=15) - Control Group; Group 2 (n=15) - Laser 1: 780 nanometers (nm); 40 milliwatts (mW); 4 seconds per point; 0.16 Joules/point; total irradiated points: 02; Group 3 (n=15) - Laser 2: 780nm; 40 mW; 40 seconds per point; 1.6 Joules/point, total irradiated points: 02; Group 4 (n=15) - Placebo group - Sham Laser Irradiation.

The pain will be evaluated by a visual analogue scale (VAS) in 3 different times: initial pain, pain immediately after and 15 minutes after interventions (laser irradiation, or sham laser irradiation). After that, patients with acute pulp irreversible inflammation will be submitted to conventional endodontic urgency treatment. Data concerning the need of complimentary local anesthesia will be also taken into account. Data of different groups and times will be statistically compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pain due to irreversible inflammation of the a vital pulp tooth

Exclusion Criteria:

* Non-Intact Pulp chamber
* Necrotic pulp
Clinical Translation of 18F-Labeled Hydroxyphenethylguanidines

The purpose of this study is to perform first-in-human PET imaging studies of two new cardiac sympathetic nerve imaging agents, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG).

In this study, PET imaging studies of two structurally related 18F-hydroxyphenethylguanidines, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) will be performed. All studies will be performed in normal healthy volunteers.

PET stands for Positron Emission Tomography which is a type of imaging that uses a radioactive tracer. This is also called a radiotracer which is a compound linked to a radioactive element. Most compounds are short-lived, meaning that the radioactivity breaks down quickly or is excreted from the body.

In the first stage of the study, dynamic PET imaging for 90 min will be done with \[18F\]4F-MHPG (n = 4) and \[18F\]3F-PHPG (n = 4).

Data from these studies will assess each radiotracer's imaging properties, pharmacokinetics and metabolic breakdown in plasma. Application of tracer kinetic analysis methods to the kinetics of each tracer in heart and plasma will be studied to see if these methods can provide accurate measurements of regional nerve sympathetic nerve density in the hearts of human subjects. Results from these initial studies will be used to select the lead compound for further studies in patient populations.

In the second stage of the study, whole-body PET imaging studies (n = 4) with the selected lead radiotracer will be performed to acquire data necessary for generating more accurate human radiation absorbed dose estimates.

Eligibility Criteria:
Inclusion Criteria:

* Non-obese (BMI \< 30)
* Normal blood pressure
* Normal blood lipid profile
* No history of prior cardiovascular disease
* Not susceptible to claustrophobia
* Ability to lay flat for 90 min

Exclusion Criteria:

* Obesity (BMI \> 30)
* Risk factors for heart disease (age \> 55y, hypertension, smoking, high blood pressure, high cholesterol levels, diabetes, etc.)
* History of heart disease (heart attack, atrial fibrillation, ventricular tachycardia, exertional angina)
* Currently using certain medications that may interact with cardiac nerves (antidepressants, cold medications, nasal decongestants, monoamine oxidase inhibitors, etc.)
* Claustrophobia
* Inability to lie flat for 90 min
* Pregnant or breast feeding
Observational Study on GEP-and Pulm-NET Treated at FPG

Observational ambispective monocentric study on the clinical, laboratory, pathological and molecular characteristics of patients suffering from gastroenteropancreatic tract and pulmonary neuroendocrine tumors and their prognostic and predictive value.

Neuroendocrine tumors (NETs) are a heterogeneous group of rare epithelial neoplasms arising from cells of the diffuse neuroendocrine system. In recent years their incidence has been constantly increasing and up to 80% of cases already begin in an advanced stage. The most frequent site of primary localization is the gastroenteropancreatic tract (GEP-NET) in 60% of cases, followed, in 25%, by the lung (L-NET). Clinically, NETs are classified as functioning (F) or non-functioning (NF) based on the presence of symptoms caused by hormonal secretion produced by tumor cells. NETs are characterized by great clinical and biological, inter- and intra-tumoral heterogeneity. The WHO classification identifies four categories: well-differentiated NETs, G1, G2 and G3, and poorly differentiated neuroendocrine carcinomas (NECs), which represent 10%-20% of all neuroendocrine neoplasms. This classification, together with the TNM stage according to the American Joint Committee on Cancer (AJCC 8th edition) takes on an important prognostic value. However, these two criteria are not exhaustive in predicting the aggressiveness of the pathology nor the response to oncological therapies. There is therefore a clear clinical need, to date unsatisfied, for new prognostic and predictive biomarkers, which can better define the heterogeneity of NETs by implementing classification and staging, to guide prognosis and support therapeutic decisions.

The main feature of all well-differentiated NETs is the overexpression of the somatostatin receptor, measured by PCR-based or immunohistochemistry (IHC)-based methods or by imaging. Among these receptors, the SSTR2A subtype is the most commonly expressed. Diagnostic and therapeutic approaches aimed at SSTR have shown advantages but it is not clear how much the degree of expression of SSTR in positive patients influences the response to treatment and whether it has a correlation with survival, regardless of the oncological treatments used. Furthermore, since the expression of this receptor appears inversely proportional to the degree of differentiation and can be different within the same disease between primary tumor and metastatic disease, this receptor could have a further role as a measure of tumor heterogeneity and disease progression.

Eligibility Criteria:
Inclusion Criteria:

* histological diagnosis of gastroenteropancreatic or pulmonary NET
* age ≥ 18 years;
* radiological evidence of resectable/locally advanced/metastatic disease;
* signing of informed consent;
* at least one visit following the first oncological visit.

Exclusion Criteria:

* absence of clinical data that allow adequate definition of survival (primary endpoint of the study);
* absence of histological diagnosis;
* failure to sign the informed consent.
High Protein Breakfast on Appetite, Postprandial Glycemia and Weight Loss in T2D

The investigators hypothesis is that eating whey protein in the breakfast versus other proteins will results in higher satiety, reduced overall postprandial glycemia and more weight loss in obese diabetic individuals

Recently we have shown that compared to low carbohydrate diet, an isocaloric diet with addition of high calorie and protein breakfast promoted sustained weight loss and prevented weight regain by reducing diet-induced compensatory changes in hunger, cravings and ghrelin suppression.

However the effect of isocaloric and isoproteic breakfast with different source of proteins, (whey vs other proteins or vs low protein in breakfast) on weight loss, appetite and on glycemic fluctuations after breakfast lunch and dinner was not explored in obese diabetic individuals.

To search whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast will lead to reduced hunger and overall postprandial glycemia and will enhance weight loss in obese diabetic individuals

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥30 and ≤70 years of age
2. BMI: 26 to 34 kg/m2)
3. Diabetes criteria
4. HbA1C: 7-9 % or
5. Habitually eat breakfast
6. Only naïve or treated with metformin.
7. Those with anti-hypertensive and lipid-lowering medication will be included.
8. . Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 6 months

10.Those who provide signed informed consent 11.Stable physical activity pattern during the three months immediately preceding study initiation.

12. Normal liver, kidney and thyroid function. 13. Negative urinary microalbumin test (urMA) and estimated glomerular filtration rate (GFR) \> 60 mL/min/1.73 m2.

Exclusion Criteria:

1. Type 1 Diabetes
2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
3. Anemia (Hg \> 10 g/dL)
4. Serum creatinine level \< 1.5 mg/dl
5. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
6. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
7. Infectious disease
8. Malignancy
9. Pregnant women or lactating
10. Known hypersensitivity to milk components

10. Participating in dietary program or using of weight-loss medications 11. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.

12. Use of psychotropic, anorectic or steroid medication during the month immediately prior to study onset

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Phase I Study to Investigate the Alcohol Interaction of SK3530

This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.

This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.

Eligibility Criteria:
Inclusion Criteria:

* ages 20 to 50
* body weight of IBM ± 20%

Exclusion Criteria:

* cardiovascular disease
* color-blindness or weakness
* no availability to intake 0.5 g/Kg alcohol
* abnormal supine blood preesure
FASHION Fabry Disease Hypertrophic Cardiomyopathy and Infammation

In Fabry disease (FD) and hypertrophic cardiomyopathy (HCM) systemic inflammation recently gained attention as a possible key pathophysiologic process involved in the development of cardiac hypertrophy and progression of the disease. Differences in inflammatory profile between FD and HCM have never been investigated so far.

This study investigate whether partecipants with FD and HCM have a different inflammatory phenotype defined by plasma biomarkers, serum proteomic profile and transcriptomic analysis in peripheral blood mononuclear cells. Moreover, the investigators sought to explore if a correlation exists between the inflammatory phenotype and the severity of cardiac phenotype cardiovascular events during 24 months of follow up.

This will be a prospective, multicenter, observational study. Adult partecipants with a genetically-proven diagnosis of FD and age-matched patients with a diagnosis of sarcomeric HCM will be enrolled, according to the following exclusion criteria:

1. Diagnosis Autoinflammatory disorders;
2. history of recurrent infections;
3. HIV infection;
4. Active cancer;
5. History of organ transplantation needing chronic immunosuppressor treatment. For each patient, at the time of enrollment, a blood sample will be collected and plasma levels of markers of inflammation, oxidative stress and cardiac remodeling will be determined (C-reactive protein, interleukin \[IL\]-6, IL-1β, IL-2, soluble vascular cell adhesion molecule, tumor necrosis factor \[TNF\], TNF receptor 1 and 2, Myeloperoxidase, calprotectin, uric acid, asymmetric dimethyl arginine, symmetric dimethyl arginine, matrix metalloprotease \[MMP\]-2, MMP-8 and MMP-9, galectin-1, galectin-3, B-type natriuretic peptide, midregional pro-atrial natriuretic peptide, monocyte chemoattractant protein.

Serum proteomic analysis and transcriptomic analysis on peripheral blood mononuclear cells, investigating molecular mediators involved in inflammatory pathways will be also performed. Partecipants enrolled will also undergo a comprehensive 2D-echocardiography with Doppler, Tissue Doppler (TD) and speckle tracking analysis and 12-leads electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years;
* Patients with confirmed genetic diagnosis of FD19;
* Patients with a known diagnosis of sarcomeric HCM adult (with pathogenic mutation in sarcomeric genes identified);
* Signed informed consent.

Exclusion Criteria:

* Age \<18 years;
* Diagnosis of Autoinflammatory disorders;
* History of recurrent infections;
* HIV infection;
* Active cancer;
* History of organ transplantation needing chronic immunosuppressor treatment;
* Pregnancy
* Refusal to sign informed consent to study participation.
Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis

This trial is designed to evaluate olanzapine compared to the metoclopramide in the treatment of break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy. Efficacy will be assessed using a modified MASCC questionaire with a visual analog scale.


Eligibility Criteria:
Inclusion Criteria:

* break through emesis after prophylaxis with dexamethasone, 5-HT 3 receptor antagonists and aprepitant in patients receiving chemotherapy defined as vomitus or nausea\>25mm on VAS
* signed IC

Exclusion Criteria:

* psychiatric disorders
* drug abuse
* pregnancy
* high dose chemotherapy
* treatment with other antiemetic drugs
Complex Spine Enhanced Recovery After Surgery (ERAS)

In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.

Purpose : In the field of Adult Spinal Deformity (ASD), there are currently no standardized protocols for preoperative, intraoperative or post-operative care. New standards are being created for minimally invasive spine surgery within orthopedics and some neurosurgical centers. This study will evaluate the efficacy of an Enhanced Recovery After Surgery protocol for complex spine surgery performed for the treatment of ASD.

Participants : Patients undergoing surgery aimed at treating adult spinal deformity are the subject of this research. This population was chosen as these procedures are often associated with prolonged length of stay (LOS), high post-operative narcotic use, and often require complex post-operative discharge planning.

Procedures : Patients undergoing surgery to address the complications of ASD present a unique challenge in that this patient population is diverse, and there are multiple operative procedures available to treat the same condition. Given that there are currently no accepted or recommended Enhanced Recovery After Surgery protocols for complex spine procedures, the investigators have developed an ERAS protocol at the University of North Carolina (UNC) in collaboration with the anesthesia department for the support of complex surgical patients.

Hypothesis: Implementing a multi-modal enhanced recovery after complex spine surgery protocol will improve patient measured outcomes and patient functional outcomes leading to a statistically significant reduction in LOS, post-operative pain, complication rate, cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) Scoliosis (M41.9) category.
* Patients undergoing a \> 5 level arthrodesis using one of the following Current Procedural Terminology (CPT) coded procedures 22534, 22585, 22614, 22632, 22634 with either 22842, 22853
* Cobb angle \> 10 degrees
* Failure of 3 months of conservative management

Exclusion Criteria:

* Prior scoliosis surgery not performed at UNC Chapel Hill Hospital Facilities
* Deformity correction due to trauma
* History of neoplastic spine disease
* Patients with active osteomyelitis
* Patients with prior cement augmentation.