cyrilzakka/clinical-trials huggingface dataset:
Migraine With Aura and Patent Foramen Ovale: Identification of Biomarkers to Select Patients In Whom Intervention Would Be Beneficial (MANET)

This is a multicenter prospective observational study aimed to asses whether a specific prothrombotic platelet phenotype can discern migraine patients with PFO (patent forame ovale) - related symptoms from patients with incidental PFO. The study will also explore additional distinguishing features of causal and incidental PFO using a metabolomics approach. It involves the enrollment of well-characterized patient cohorts and an ex vivo approach using comparative cell biology models that reproduce the most critical aspects of the clinical scenario.

Patients with PFO, who meet all the inclusion and none of the exclusion criteria, will be enrolled in the study. Patients will undergo percutaneous correction of PFO and the following evaluations as clinical practice:

* thrombophilic screening (factor V and II and MTHFR gene mutation); sampling for homocysteine, Protein C (Prot C), Protein S (Prot S) and antithrombin III assay;
* anatomic evaluation of the SIA (Saccular intracranial aneurysm) by color-doppler TT echocardiogram and intracardiac ultrasound for definition of the anatomy of the fossa ovalis: tunneled appearance; absence of SIA aneurysm; bulging of the SIA; convex right/left SIA aneurysm;
* quantification of right-left intracardiac shunt by CT doppler;
* classification of migraine according to Anzola scale at baseline visit, post PFO correction, at follow-up at 6 and 12 months.

For the purpose of the study, blood sampling will be performed for evaluation of platelet reactivity; oxidative stress, aggregability, and deformability of red blood cells; and isolation of Endothelial Colony Forming Cells (ECFCs) for analysis of endothelial function. The latter in particular will be evaluated in comparison with the endothelial function of 30 subjects without known disease with age \> 18 years, enrolled as a control group.

All analyses will be performed before PFO correction and 180 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* presence of PFO with right-left shunt at baseline \> 10 MES and during Valsalva \> 20 MES
* previous Stroke or TIA
* positive MRI for ischemic outcomes
* SIA aneurysm or residual Chiari/Eustachian valve network
* thrombophilic screening positivity (MTHFR/prot C/prot S)
* cability to sign informed consent for study participation and adherence to planned clinical follow-ups

Exclusion Criteria:

* paroxysmal/refractory atrial fibrillation
* TSA vasculopathy
* left ventricular ejection fraction \<30%
* moderate/severe mitral valve regurgitation
* need for long-term anticoagulant therapy
* allergy or intolerance to antiplatelet therapy
* nickel allergy
* severe chronic kidney disease (GFR \< 30 mL/min)
Impact of Obesity on Postural Control

The goal of the present study was to objectively evaluate the postural behaviour of type II obese patients as compared to adults showing a normal body mass index (BMI) in critical postural tasks.


Eligibility Criteria:
Inclusion:

* BMI \> 35 or BMI \< 25

Exclusion:

* Muscular, neurological or cardiovascular deficits
* Competitive physical activities
Proof of Confidence Study of CCR2 Antagonist (BMS-741672) in Insulin Resistance

The purpose of the study is to determine whether a CCR2 antagonist (BMS-741672) improves glucose homeostasis in drug-naive type 2 diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Drug-naive Type 2 diabetics with a screening HbA1c of ≥ 7.5% and ≤ 10%
* Screening FPG ≥ 140 mg/dL and ≤ 220 mg/dL
* BMI ≤ 40 kg/m2

Exclusion Criteria:

* Active tuberculosis
* Symptoms of poorly controlled diabetes
* History of diabetic ketoacidosis
* Significant cardiovascular history or gastrointestinal disorders
* History of unstable or rapidly progressing renal disease
* Active liver disease and/or significant abnormal liver function
* Abnormal chest x-ray at screening indicative of tuberculosis or other infection
Effectiveness of Self-Myofascial Stretching on Carpal Tunnel Syndrome

Background and aim: Carpal tunnel syndrome (CTS) also known as median mononeuropathy occurs when the median nerve is squeezed or compressed as it travels through the carpal tunnel at the wrist. The main aim of the study was to compare the effectiveness of carpal ligament self-myofascial stretching over conventional physical therapy on reducing pain and improving function in patients with stage I and II CTS.

Methodology: Thirty-six subjects with stage I and II CTS who fulfilled the inclusion criteria were randomly assigned to experimental group and control group with 18 patients in each group. Experimental Group received carpal ligament self-myofascial stretching along with conventional physical therapy while the Control Group received conventional physical therapy alone. The duration of the treatment was 6 weeks. The outcome measures used were Boston Carpal Tunnel Questionnaire and Visual Analogue Scale.


Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with carpal tunnel syndrome.
* Age range between 30 - 60 years
* Both genders.
* Patients with stage I and II (mild) carpal tunnel syndrome, confirmed by nerve conduction study (EMG diagnosed by a medical professional)
* Unilateral and bilateral dominant hand.
* Patients who are able to read and understand English.

Exclusion criteria: Participants with:

* Presence of polyneuropathy
* Consistent use of adaptive equipment, such as wheelchair or cane.
* Patients presenting with shoulder pathologies
* Patients with other neurological or musculoskeletal conditions as Cervical radiculopathy, history of wrist and hand fractures, upper extremity joint dislocations, brachial plexus injuries, cubital tunnel syndrome, rheumatoid arthritis, De quervain's tenosynovitis, or cut injuries of hand.
* Patients who have underwent recent carpal tunnel release (within 1 year)
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population.

We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age greater than or equal to 37 weeks
* Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
* Chronologic age of 24-48 hours old at the time of study enrollment

Exclusion Criteria:

* twins and higher level multiples
* infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
* mother incarcerated
* mother's age \<18 years
* mother reports mature milk production prior to study enrollment
* mother does not speak English
* infants offered \> 1 supplemental feeding of formula or donor milk
* weight loss greater than 10%
Effects of Internet-based ERITA Added to TAU in Young People With Non-Suicidal Self-Injury (TEENS) Feasibility Trial

There has been a significant increase in non-suicidal self-injury the last decades especially among young people and treatment initiative are sparse. We aim to assess the feasibility of methods, procedures, and safety of internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as add on to treatment as usual (TAU) in 13-17-year-old patients with non-suicidal self-injury referred to psychiatric services.

Non-suicidal self-injury has disseminated almost epidemically through the last decades in young persons. There is no evidence of any experimental treatment for non-suicidal self-injury in adolescents, superior to treatment as usual. Patients with stigmatizing illness such as non-suicidal self-injury may find internet-based interventions more acceptable. The study is a feasibility trial, with a randomization procedure in a parallel group design. Patients will be recruited from Child- and Adolescent Mental Health Services (age 13 to 17 years). The experimental intervention is internet-based, and therapist guided; ERITA consists of online Emotion Regulation Individual Therapy for Adolescents (ERITA) as add-on to treatment as usual. Treatment as usual is provided by multidisciplinary teams in nine outpatient clinics within Child and Adolescent Mental Health Services in the Capital Region of Denmark. Feasibility of recruitment and trial procedures will be monitored as well as explorative clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 5 non-suicidal self-injury episodes in the past year and ≥ 1 non-suicidal self-injury episodes in the past month (DSM-5 criteria for a diagnosis of non-suicidal self-injury disorder in terms of frequency of NSSI).
* Age-appropriate literacy.
* Having at least one parent committing to participate in the parent program.
* Informed consent from parents/legal caretakers.

Exclusion Criteria:

* Imminent suicidal risk assessed by clinicians during routine screening procedure (rated as no risk, elevated risk, imminent risk) in need of admission or other life saving strategies.
Genetics, Metabolism and Weight Loss in Older, Obese Veterans

This study is designed to determine whether sequence variation in the lipoprotein lipase (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary veterans.

Veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. Exclusion criteria are: diabetes, hypertriglyceridemia (\>400 mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or hematologic disease, and medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers). Changes in total and visceral body fat are measured by dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. Glucose tolerance is assessed during a three-hour oral glucose tolerance test with measurement of glucose- and insulin levels every 30 minutes. LPL activity is measured in 3050mg pieces of subcutaneous abdominal and gluteal adipose tissue.

Eligibility Criteria:
* 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam.

Exclusion criteria:

* Diabetes,
* Hypertriglyceridemia (\>400 mg/dl),
* History of cancer or myocardial infarction,
* Clinical depression,
* Renal, liver or hematologic disease, and
* Medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers).
Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan

Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.

This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.

DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.

The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with grazoprevir/elbasvir are candidates of study subjects.

Exclusion Criteria:

* none
Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation

The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.


Eligibility Criteria:
Inclusion Criteria:

* a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation
* Eastern Cooperative Oncology Group performance status of 0 - 2.

Exclusion Criteria:

* abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis
* a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications
Impact of Placement of a Diazepam Suppository on Early Postoperative Pain Following Pelvic Reconstructive Surgery

This is a randomized double-blinded placebo controlled trial to examine the use of rectal diazepam suppositories after major vaginal pelvic organ prolapse surgery will decrease postoperative pain in the interval between 3.5 and 6 hours postoperative compared to placebo.

Hysterectomy is the most common major surgery performed in gynecology. Minimally invasive techniques for hysterectomy including vaginal and laparoscopic routes are preferred over the more invasive abdominal procedures, which are associated with more pain, longer hospital stays, and increased rates of complications.

Research has continued to provide evidence that same day discharge (SDD) after hysterectomy is safe, cost effective, and well received by patients. Pain is a common concern for patients undergoing major pelvic surgery and pain must be well controlled prior to discharge home.

Rectal administrations of medications are an attractive option postoperatively in patients desiring SDD. Rectal analgesia avoids 1st pass metabolism in the liver, leading to increased bioavailability of many medications and fewer side effects such as nausea and vomiting.

The purpose of the study is to investigate whether perioperative administration of a rectally administered diazepam suppository results in improved pain scores between 3.5 and 6 hours postoperatively in patients undergoing major vaginal pelvic reconstructive surgery.

Eligibility Criteria:
Inclusion Criteria:

* English speaking, able to understand informed consent and questionnaires
* Vaginal hysterectomy with vaginal vault suspension by one of the providers in the Division of Urogynecology and Reconstructive Pelvic Surgery at TriHealth, Inc.

  * With or without anterior and posterior repairs
  * With or without concomitant procedure for stress urinary incontinence
  * With or without removal of fallopian tubes or ovaries

Exclusion Criteria:

* Use of mesh for prolapse repair
* Robotic, laparoscopic, or open technique used for prolapse repair and/or hysterectomy
* Concomitant procedure done by an additional surgeon
* Concomitant anal sphincteroplasty or rectovaginal fistula repair
* Contraindication to use of Diazepam:

  * Allergy to Diazepam or other benzodiazepines
  * Acute narrow-angle glaucoma
  * Untreated open-angle glaucoma
  * Myasthenia gravis
  * Severe respiratory impairment
  * Severe hepatic impairment
* History of chronic pelvic pain receiving medical care
* Daily use of medication for pain: NSAID, Tylenol, opioid, gabapentin, and/or amitriptyline
* Pregnancy
Hyperbaric Oxygen and Fibromyalgia: Randomised Prospective Clinical Trial

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).

The study is a prospective, randomized, cross-over trial. Patients will be randomized into two groups (test and control) to receive the HBOT at the beginning of the trial or 2 months afterwards. The control group will receive its treatment after the elapsed two months.

This study will be a prospective, randomized cross over study. After signing a written informed consent, all patients will be invited to a 2 hour examination, including pain sensitivity examination and a series of questionnaires. In addition, prior to the beginning of the treatment all patients will have chest X-ray, neurological examination, cognitive evaluation and brain metabolism evaluation (SPECT scan). A similar evaluation will be done after the 8 weeks, test versus control time period, and another evaluation will be held after 16 weeks. The HBOT procedure will be performed in the hyperbaric chamber at Assaf Harofeh Medical Center, Israel.

The following HBOT protocol will be applied for the treated group: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. After 8 weeks the control group, that did not received HBOT, will receive the same HBOT protocols.

At baseline, after 2 months and after 4 months all patients will undergo complete neurologic and pain evaluation and brain SPECT scan (total of 3 evaluation and scan per patient).

Eligibility Criteria:
Inclusion Criteria:

* fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.

Exclusion Criteria:

* any past hyperbaric oxygen therapy
* chest x-ray pathology which does not allow the income into the hyperbaric chamber.
* middle ear problems.
* patients, who cannot "pump", equals middle ear pressure, effectively.
* patients who suffer from claustrophobia.
* inability or Refusing to sign the Informed Consent Form
24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.


Eligibility Criteria:
Inclusion Criteria:

* Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
* Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
* Study patients should have mild to moderate exfoliative glaucoma (VF loss \<12 dB; cupping 0.8 or less)
* Patient with exfoliation syndrome should fulfill the IOP criterion (IOP \> 29 mm Hg at 10:00)
* Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
* Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
* In study eye distance best corrected Snelen visual acuity greater than 1/10

Exclusion Criteria:

* Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
* History of non-adherence or previously recorded evidence of lack of response (\<10% morning IOP reduction) to any antiglaucoma medication
* Patient can not understand the instructions and adhere to medications
* Patient is a female of childbearing potential or lactating mother
* Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
* Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
* The other eye can not receive the same therapy, or remain without medical therapy
* Closed angles
Acute and Short-term Chronic Effects of Galvus (Vildagliptin) in Diabetes Type 2 Obese Women

The prevalence of obesity and type 2 diabetes mellitus (T2DM) has increased progressively in the past decades, and consequently, a higher incidence of cardiovascular diseases is observed. As this process develops, the endothelial dysfunction is present at early stages of the atherosclerotic disease. Studies conducted at BioVasc/UERJ show the occurrence of endothelial and microvascular dysfunction in obese carriers, even in the absence of dysglycemia. New concepts indicate the endothelium as a possible therapeutic target, and drugs which act not only on diabetes mellitus pathophysiology but also acting as direct cardiovascular protectors bring new therapeutic possibilities. The dipeptidyl-peptidase-4 inhibitors (DPP4), such as vildagliptin, are drugs used on the T2DM treatment. Its incretin mimetic and insulinotropic effects are already well established and several other studies show its effectiveness in reducing glycated hemoglobin, even in monotherapy.

Currently, fat rich foods are being increasingly introduced in the western way of life and recent evidence suggests that the postprandial lipemia (LPP) is related to cardiovascular risk. A better glucose control using vildagliptin can reduce the oxidative stress, and consequently promote a better microvascular and endothelial reactivity. However, vildagliptin can have an additional cardiovascular protective action, not only because of its effect on glycemia and oxidative stress reduction, but maybe because of its direct effect on intestinal peptides with postprandial lipemia reduction. To test this hypothesis, we will proceed the following exams: venous occlusion pletysmography, nailfold videocapilaroscopy and laser-Doppler flowmetry aiming to evaluate vascular reactivity on muscle and at cutaneous site. Anoter group of patients with the same clinical charactherisitics will use metformin, in order to compare its effects with those obtained from the use of Vildaglitpin. Our purpose is to determine whether vildagliptin, evaluated in obese and diabetic women, has vascular protective effects, and whether the regulatory mechanisms of these actions correlate with oxidative stress, inflammatory markers and intestinal peptides in baseline state and after a lipid overload.


Eligibility Criteria:
Inclusion Criteria:

* All patients should have BMI \> 30kg/m²
* Present untreated diabetes mellitus type 2
* Age between 19 and 50 years
* Waist Circumference \> 80 cm

Exclusion Criteria:

* Renal, coronary vascular or peripheral, hematologic or hepatic disease
* Presence of severe hypertriglyceridemia (\> 400mg/dl)
* Smokers
* Significant body mass loss (\> 5%) within the six months prior to the study