cyrilzakka/clinical-trials huggingface dataset:
Coagulopathy of Immunodermatologic Diseases

This study will examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. Blood samples will be collected from participants with active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy will also be collected to serve as control. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

The purpose of this study is to examine the coagulation and fibrinolysis profiles of those with autoimmune skin diseases. This will be accomplished by collecting blood samples from participants with both active/poorly controlled immune-mediated skin diseases and mild/latent/well-controlled immune-mediated skin diseases. A one-time sample will be collected from 15 general dermatology outpatients who do not have a known or suspected diagnosis of bullous diseases, immune-mediated dermatologic condition, or cutaneous malignancy to serve as the control population. Blood samples from both participant populations will be analyzed for coagulation and inflammatory markers and compared. The results of this study may help inform future studies on the utility of analyzing coagulation and fibrinolysis profiles of patients with autoimmune skin diseases.

Eligibility Criteria:
Inclusion Criteria:

1. For the study group: diagnosis of immune-mediated skin disease including but not limited to bullous pemphigoid, pemphigus vulgaris, mucous membrane pemphigoid, cutaneous lupus erythematosus, dermatomyositis
2. For control group: no diagnosis of immune-mediated skin
3. For study group: receiving care from one or more of the Principal or Secondary Investigators

Exclusion Criteria:

1. Unfit to provide consent
2. P2Y12 inhibitor use in the past 4 weeks
3. History of internal malignancy prior to enrolling in the study or suspected internal/systemic malignancy during time of the study (i.e. will not exclude pre-malignant or local, early stage cutaneous malignancies)
4. Major surgery within 4 weeks of the study or trauma (e.g., accident-causing bone fracture) within 4 weeks of the study
5. Other autoimmune diseases not in remission defined as flare in the last 12 weeks
6. If patient is unable to provide detailed history and if we do not have sufficient history on record.
7. Less than 19 years of age
Food Response Training for Binge Eating

This study will examine the effectiveness of food response training interventions in reducing binge eating among adults engaged in binge eating.

Binge eating disorder is the most prevalent eating disorder and affects both men and women at comparable rates unlike anorexia nervosa and bulimia nervosa. Given that binge eating and obesity are strongly associated, binge eating treatments should aim to reduce binge eating as well as weight. However, most binge eating interventions do not produce lasting weight loss. Recent research has shown computer-based response inhibition training with high-calorie foods reduces reward region response to and attentional bias for the training foods, decreases training food intake, increases inhibitory control, and produces weight loss in overweight adults. There is evidence that the weight loss effects from such response training persist through 6-month follow-up. Further, binge eating has been associated with increased food-related impulsivity and increased activation in a reward-processing brain region to high-calorie foods. Prior research suggests that food response training may be an effective intervention for binge eating that teaches automatic self-control in response to high-calorie foods which in turn, reduces binge eating and produces weight loss. This study will examine the effectiveness of food response training interventions in reducing binge eating and weight among adults engaged in binge eating.

The goals of this study are to: (1) test the hypothesis that adults who complete the food response trainings will show significantly greater reductions in binge eating frequency and in body mass index (BMI) compared to generic response training from pretest to posttest and at 3-month follow up, (2) to determine whether one of the food response trainings is more effective in binge eating frequency and reducing BMI from pretest to posttest and at 3-month follow up, and (3) test whether a reduction in valuation of the high-calorie versus low-calorie foods (willingness to pay for the pictured foods) and/or behavioral improvement of inhibitory control during the training tasks mediate the effects of the various trainings on reductions in binge frequency and body mass index.

Eligibility Criteria:
Inclusion Criteria:

* Engages in objective binge episodes as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and meets one of the following frequency and duration criteria: 1) at least two objective binge episodes per month for at least 3 months; or 3) at least six objective binge episodes over a shorter period

Exclusion Criteria:

* Illicit drug use and excessive alcohol use
e-Cigarettes Versus NRT Gum for Smoking Cessation

This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Smokes at least five cigarettes per day
* No current or previous regular use of e-cigarettes
* Ready to quit smoking

Exclusion Criteria:

* Use of smokeless or pipe tobacco
* Smoke more than 40 cigarettes per day
* Pregnant or breastfeeding
* Unable to chew gum due to dental or jaw problems
* Myocardial infarction (heart attack) within the previous 12 months
* Hypersensitivity to propylene glycol or nicotine gum
Effect of Lidocaine on Postoperative Pain in Elderlypatients Undergoing Colorectal Cancer Surgery

Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group.

Patients who meet the enrollment criteria will be randomized 1:1 to the lidocaine group or placebo group. In the lidocaine groups, lidocaine 1.5mg/kg/h was continuously infused (using ideal body weight) during the whole procedure, postoperative analgesia pump with lidocaine (lidocaine 50mg/kg, sufentanil 2ug/kg, glassetron 12mg), diluted to 200ml with saline until 72h after surgery. Blood samples will be collected from some patients in the lidocaine group for the measurement of lidocaine plasma concentration.In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 mL.

Eligibility Criteria:
Inclusion Criteria:

1. Participants were at least 60 years old;
2. American Society of Anesthesiologists (ASA) physical status I to III;
3. Body-mass index of 18-30 kg/m2;
4. Scheduled for elective colorectal surgery.

Exclusion Criteria:

1. Metastases occurring in other distant organs;
2. Severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin \>2.5 times the upper limit of normal);
3. Renal impairment (creatinine clearance \<60 mL/min);
4. Cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction \<50%);
5. Allergies to any of the trial drugs; chronic opioid use;
6. Inability to comprehend numeric rating scale.
Relation of Blood-boron Levels With Body Mass Index

According to our experimental experiences w hypothesized that blood boron levels may be corralated to body mass index.

In the results of our experimental study on mices we revealed that low dose oral boric acid intake cause seriously body mas reducing. Although blood and urine analyses support high glucose, lipid and middle protein catabolisms, but the mechanism was unclear. There are some diseases according to blood elementary deficiencies, like hypothyroidi in hypoiyodinemia, hiperparathyroidi in hypocalcemia, etc. We hypothesised that hypoboronemia may be corralated to body mass index level.

Eligibility Criteria:
Inclusion Criteria:

* body mas index levels in over 19 peoples

Exclusion Criteria:

* known chronic, morbid and malign diseases
Thailand Transgender Women Stigma Study

This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai, young transgender women (18-29 years).


Eligibility Criteria:
Aim 1 (Formative Research and Beta-Testing) Transgender women

Inclusion Criteria:

* Ages between 18 and 29 years
* Male sex at birth
* Self-identifies as women, transgender women or culturally identifies with the female spectrum
* Laboratory-confirmed HIV-negative status
* Self-reported recent history of condomless sex
* Able to understand, read and speak Thai
* Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion Criteria:

* Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
* Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
* Currently enrolled in another HIV intervention study.

Healthcare providers Inclusion criteria

* Age 18 or above
* Has provided HIV prevention or treatment services for TGW for at least one year Exclusion criteria
* None

Aim 2 (Pilot RCT) Transgender women Inclusion criteria

* Ages between 18 and 29 years
* Male sex at birth
* Self-identifies as women, transgender women or culturally identifies with the female spectrum
* Laboratory-confirmed HIV-negative status
* Self-reported recent history of condomless sex
* Able to understand, read and speak Thai
* Either not started PrEP or currently on PrEP but not adherent (taking ≤3 pills/week) in the past month.

Exclusion criteria

* Have a serious cognitive or psychiatric problem compromising ability to provide informed consent
* Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)
* Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)
* Currently enrolled in another HIV intervention study.
Combined Approach to Resection of Glioblastoma (GBM) by 5-Aminolevulinic Acid (5-ALA) and Intraoperative Magnetic Resonance Imaging (MRI)

In the treatment of glioblastoma (GBM) neurosurgical resection of the tumor is usually considered a a first step of effective therapy. Radical resection of the tumor is highly beneficial to the patient as measured in progression-free survival and overall survival. At the same time eloquent areas of the brain have to remain intact to preserve quality of life.

Both 5-ALA fluorescence and intraoperative MRI are used for intraoperative marking of tumor tissue and thereby to improve precision of GBM-Resection.

We now study whether the combination of 5-ALA fluorescence and intraoperative MRI increases the number of sites where tumor tissue can be detected.

- Trial with surgical intervention

Precision of GBM-Resection Intraoperative marking of tumor tissue Combination of 5-ALA fluorescence and intraoperative MRI

Eligibility Criteria:
Inclusion criteria:

* patients with Glioblastoma multiforme (GBM)
* no other tumor types or metastases

Exclusion criteria:

* Allergy against 5-ALA or Porphyrin
* Porphyria
* Pregnancy
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C infection for at least 6 months duration
* Hepatitis C genotype 1a or 1b
* Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
* Participants showed a previous null response to therapy as defined by \< 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

* Hepatitis C infection with a genotype other than genotype 1a or 1b
* Body mass index \< 18 or \>= 36 kilograms per square meters (kg/m\^2)
* Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
* Herbal remedies \<=1 month prior to the first dose of study drug
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.


Eligibility Criteria:
Inclusion Criteria:

* Sign an informed consent form that has been approved by the Institutional Review Board.
* Adults at least 18 years of age.
* Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
* Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.

Exclusion Criteria:

* Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
* Be in need of a left ventricular assist device.
* Have an active pre-operative infectious process.
* Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).
Effect of Paricalcitol Over Vessel Wall

To provide evidence based prospectives of the potential benefit effects of paricalcitol, an analog of vitamin D, over the prevention / retardation of the progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin D in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 50 and 75 years.
* Chronic kidney disease stage 5 D or 4-5 No D as calculated glomerular filtration rate (MDRD).
* Concentration of intact parathyroid hormone (iPTH): 150-400 pg/ml.
* Plasma concentrations of 25 (OH) vitamin D \<30 ng/ml.
* Without vitamin D supplementation for 3 months before the study.
* Serum P\> 3.8 mg / dl.
* Serum Ca\> 9.8 mg / dl.
* No history of cardiovascular events (angina or myocardial infarction, stroke, peripheral arterial disease).
* No exclusion criteria for the use of contrast.

Exclusion Criteria:

* Allergic reaction to sulfur hexafluoride.
* Recent unstable cardiac symptoms.
* Patients with recent coronary intervention (\<7 days)
* Patients with class III and IV heart failure or severe arrhythmias.
* Severe pulmonary hypertension.
Effect of Commiphora Myrrh Solution as a Root Canal Irrigant on Post Operative Pain and Bacterial Load Reduction in Necrotic Tooth

Clinically compare the post-operative pain , incidences post-operative swelling , post-operative number of analgesic tablets taken by patient and amount of bacterial load reduction after using 50% Commiphora Myrrh Chemomechanical preparation , versus 2.5% NaOCl,in asymptomatic necrotic mandibular premolar treated in single visit.

The patients will be randomly divided into 2 groups. Intervention group (50% Commiphora Myrrh solution root canal irrigant) and control group (2.5% sodium hypochlorite root canal irrigant)

Post-operative pain will be measured at 6,12,24,48 hours post-operatively The pain will be recorded using numerical rating scale

Post-operative swelling will be measured at 6,12,24,48 hours post-operatively The swelling will be receded using visual swelling rating scale

Number of analgesic tablets taken by the patient post-operatively. Up to 48 hours

Amount of bacteria load reduction The intracanal bacterial load reduction will be determined using agar culture technique by counting the colony forming units per milliliter (CFI /ml) before and after root canal preparation.

Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy patient (ASA I, II).
2. Age between 20 and 40 years.
3. Male or female.
4. Patient who is able to sign and comprehend the pain scale (committed patient).
5. Mandibular single rooted premolars having the following criteria:

   * With single root canal.
   * Diagnosed clinically with pulp necrosis.
   * Absence of spontaneous pulpal pain.
   * Positive pain on percussion denoting apical periodontitis.
   * Slight widening of periodontal space or peri-apical radiolucency smaller than 3 mm (0-2mm)

Exclusion Criteria:

1. Medically compromised patients (ASA III or IV).
2. Teeth with:
3. Patients who could not interpret the NRS.

   * Immature roots.
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated.
   * Deep periodontal pockets more than 4 mm.
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women will be also excluded.
5. History of intolerance to NSAIDs.
Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain

Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Patients with low back pain for more than 6 months
* Healthy volunteers

Exclusion Criteria:

* Previous low back or back surgery
* Uncontrolled Diabetes Mellitus
* Mental retardation
* Metabolic disorders
Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program

In this study the investigators hypothesize that the presence of a Mayo Clinic certified therapy dog will provide additional benefits above typical therapy for patients suffering from fibromyalgia currently enrolled in the Mayo Clinic Fibromyalgia Program.

The human animal bond refers an emotional relationship between animals and people. The purpose of this study is to evaluate whether the presence of a dog provide additional benefits above typical therapy for patients suffering from fibromyalgia and also to assess the emotional wellbeing state of the therapy dog.

Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with Fibromyalgia at our Fibromyalgia Clinic
* Patients actively being seen at the Fibromyalgia Clinic
* Able and willing to give informed consent
* Able to speak English
* Able to complete questionnaires
* No fear or allergy of dogs

Exclusion Criteria

* Diagnoses of bipolar disorder, schizophrenia, or dementia
* Individuals who decline to participate in the study
* Individuals that are severely allergic to or fearful of dogs
Methylation Pattern and Pain Sensation in Children With Intellectual Disability

Previous literature data indicate that children with intellectual disability (ID) experience more severe pain and more frequently than their cognitively healthy peers, during their daily life. Repeated and chronic pain exposure triggers a vicious circle of hyperalgesia and reduction of the impaired cognitive and adaptive function. Furthermore, these children are unable to rationalize any intervention targeted to contain potentially painful actions.

Epigenetics studies mechanisms responsible for a set of modifications that regulate gene expression without altering the DNA sequence itself. DNA methylation and posttranslational modification of histones are the main epigenetic mechanisms. It is widely accepted that these mechanisms can be engaged by environmental experience, such as early life trauma, pain or addiction leading to the idea of epigenetics as 'a bridge' between genes and environment.

Several epigenetic studies evaluated genes coding proteins involved in recycling of neurotransmitters (SCL6A4), in transmission of painful stimuli (TRPA1) and in response to analgesics (OPRM1). In particular, some studies assessed TRPA1 gene, coding for a cationic channel responsible for the transmission of thermal-painful sensations, and SCL6A4, a serotonin-recycling transmembrane protein presents at inter-synaptic level, have highlighted the importance of methylation in a pathological experience of chronic pain and anxiety disorder in the adult population. Opioid receptor OPRM1 is involved in the endogenous and exogenous opioid-mediated analgesia and a recent work in a group of adolescents treated for idiopathic scoliosis highlights a link between greater pain post-surgery and methylation of this gene. In this context, children with ID are at greater risk of undertreatment both for the difficulty in pain recognition and for the fear of medication-adverse reactions.

The epigenetic study of the aforementioned genes in children with ID associated with an evaluation of painful experiences and clinical history, could help understanding a scenario that it is still complex nowadays before the eyes of parents and caregivers and healthcare workers.The finding of a different methylation pattern in children with ID could in part explain the different pain experience.


Eligibility Criteria:
Inclusion Criteria:

- Children with scheduled venipuncture or venous cannulation for diagnostic or therapeutic reasons, with and without severe intellectual disability.

Exclusion Criteria:

- Presence of Autism spectrum disorder (ASD) according to DSM-V criteria.