cyrilzakka/clinical-trials huggingface dataset:
Immune Responses to the Flu Shot During Pregnancy

This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.


Eligibility Criteria:
Inclusion Criteria:

* less than 29 weeks pregnant
* ages 18-42
* planning to deliver at The Ohio State University Wexner Medical Center

Exclusion Criteria:

* prior serious adverse reaction to seasonal influenza vaccine
Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

This is a prospective evaluation of the clinical utility of the new cholangioscopy platform SpyGlass DS. The aims of this study are to prospectively document the clinical utility and technical aspects of ERCP with cholangioscopy and/or pancreatoscopy in the diagnosis and management of pancreatic-biliary disorders.

Cholangioscopy allows for direct visualization of the bile and pancreatic duct. In 2006, the SpyGlass Direct Visualization System for per-oral cholangiopancreatoscopy was introduced and since then has been shown to provide incremental diagnostic and therapeutic benefits. The main limitations of the original SpyGlass platform are fiber optic visualization system, limited tip angulation, square cut Spy scope tip, and complex multi-component setup. A new generation cholangioscopy platform, SpyGlass DS is currently in clinical use. The new system addresses many of the shortcomings of old platform including digital optics, improved tip angulation, tapered tip and simplified set up. It is unclear at this time whether this technical improvement will translate into better outcomes. Therefore, the investigators want to study the clinical utility of SpyGlass DS by prospectively collecting data on the clinical outcomes of patients undergoing cholangioscopy with Spyglass DS as part of their routine medical care.

Eligibility Criteria:
Inclusion Criteria:

* Participants who have been scheduled to undergo a cholangiopancreatoscopy as routine clinical care

Exclusion Criteria:

* failure to provide informed consent
* any contraindications to endoscopy
Keloid Scarring: Treatment and Pathophysiology

To clarify the mechanisms of Keloid scar formation.

Elucidate the action and therapeutic value of 5-FU in Keloid scar treatment

Identify the genetic link with Keloid scar formation.

Quantify the psychological/social impact in keloid scarring patients


Eligibility Criteria:
Inclusion Criteria:

* Adult ( \> 18 years old).
* Keloid scarring present.
* Able to understand and give informed consent.
* Patients giving informed consent to donate keloidal or non-affected skin when that is redundant after a procedure (i.e. BBR, Abdominoplasty).
* Patients with a strong familial pedigree of keloid scar formation.

Exclusion Criteria:

* Open wound at or proximity of the lesion

  * Infected lesion
  * Pregnant or planning pregnancy in the near future
  * Lactating (Breast Feeding)
  * Abnormal renal or liver function tests
  * Atrophic scars
  * Patient under 18 years of age
  * Immunocompromised
  * OR immunosuppressed
Small Bioactive Molecules in Early COPD Diseases

To study the predictors contribute to the progression of COPD by follow-up of patients with early COPD and analyze their changes in bioactive molecular, exhaled gas, CT image, lung function, patient's symptoms and life quality.

A research found that nearly 40% of patients with chronic respiratory symptoms who showed significant airway inflammation (airway wall thickening and/or lung structure destruction (emphysema) on chest CT had advanced COPD within 5 years, although their current lung function failed to meet diagnostic criteria for COPD. Current spirometry-based diagnostic methods are not the best predictors of COPD progression and death. CT indicated emphysema and airway inflammation were recognized as better predictors of disease progression and mortality. Based on a large cohort study, some scholars proposed the concept of "early COPD", focusing on people under the age of 50, smoking for more than 10 pack years, having one of the manifestations of early airflow limitation, abnormal chest CT, and rapid decline of FEV1, to study the mechanism of disease progression and early intervention methods.\[4\] In this study, we enroll participants with early COPD symptoms, to detect the progression of COPD with 3 years of follow-up. The predictors of disease progression and variants of bioactive molecular were analyzed, so as to clarify the progressive mechanism of COPD.

Eligibility Criteria:
Inclusion Criteria:

* 1. \<60 years old;

  2. Smoking ≥ 10 pack years.

  3. With any of the following anomalies: a. Post-bronchodilator FEV1/FVC\< 0.7. b. CT image abnormalities: emphysema, air trapping or bronchial wall thickening; c.Rapid decrease of FEV1 (\>60 ml/yr).

Exclusion Criteria:

* 1. With other known chronic lung diseases, including bronchiectasis, interstitial pulmonary disease, tuberculosis, and pulmonary vascular disease (CTEPH).

  2. With severe pleural disease and/or lesions of the sternum or ribs.

  3. Suffering from serious uncontrolled other systemic diseases, including chest and abdominal surgery, heart attack (angina pectoris, myocardial infarction, malignant arrhythmia, etc.) and cerebrovascular disease (stroke) within 3 months, as well as kidney disease (AKI), cirrhosis, and any malignant tumor except lung cancer.

  4. Suffering from severe cognitive impairment.

  5. With active tuberculosis or are taking anti-tuberculosis treatment.

  6. Pregnancy or lactation.

  7. Previous lung surgery.

  8. Acute upper and lower respiratory system infection within 4 weeks.
Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery

The study, "Effect of Listening to Standardized Music Sequences on Preventing Postoperative Pain in Proctologic Surgery," aims to evaluate the impact of preoperative listening to standardized music sequences on postoperative pain in patients undergoing proctologic surgery (for hemorrhoids, fistulas, or anal fissures).

This research will assess the influence of preoperative music on postoperative pain management, the use of analgesics after surgery and during the following month, and its effect on the quality of life post-surgery.

MUSICO-PROCTO is an interventional, randomized study involving two groups (patients will be randomly assigned to either the music intervention or control group). The study is monocentric, conducted at Clinique Saint Vincent in France, and includes 550 participants.

Participants will be followed for 28 days, while the overall study duration will span 28 months.

To participate, individuals must:

Be aged 18 or older. Be affiliated with a social security system. Provide signed informed consent. Undergo proctologic surgery for hemorrhoids, fistulas, or anal fissures. This study seeks to explore the potential of music as a complementary method to improve postoperative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged over 18 years.
* Patient who has signed an informed consent form.
* Patient scheduled to undergo proctological surgery (for hemorrhoids, fistula, or anal fissure) at the participating institution.
* Must be affiliated with a social security system or be a beneficiary of such a system.
* Patient must have access to the necessary technical means (smartphone, computer, tablet) to use the Music Care® application.

Exclusion Criteria:

* Refusal to consent.
* Patient unable to read, write, or understand French.
* Vulnerable patient according to Article L1121-6 of the French Public Health Code (CSP).
* Adult patient under guardianship or curatorship or under legal protection (safeguard of justice).
* Patient unable to personally give informed consent according to Article L.1121-8 of the CSP or an adult protected by law.
* Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
* Patient who has already participated in a study within the last 12 months.
A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

It is reported that the prevalence of Ankylosing Spondylitis (AS) in Japanese patients is extremely lower than that of Caucasians; therefore, a controlled, double-blind study with similar sample size in Western studies for active AS in Japan was not able to be conducted. As a result, this study was conducted with an open-label design to investigate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active AS. The inclusion criteria and primary endpoint measurement (Achieving Assessment in Ankylosing Spondylitis 20 at Week 12) were designed the same as the Western studies for active AS in consideration with the confirmation of Western data. Treatment with adalimumab was to be continued until the approval of adalimumab for AS in Japanese subjects with active AS.

Eligibility Criteria:
Inclusion Criteria:

* Subject who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs

Exclusion Criteria:

* History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
* Previously received anti-TNF therapy
* Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.


Eligibility Criteria:
Inclusion Criteria:

* Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
* Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol

Exclusion Criteria:

* Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
* Have used forbidden concomitant medications as defined by the protocol
Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention

The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:

1. Age: 18-80 years old
2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
3. National Institute of Health Stroke Scale (NIHSS) 8-22
4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
6. Signed informed consent

Exclusion Criteria:

Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

1. Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
2. Historical Modified Rankin Scale (mRS) of ≥2
3. National Institute of Health Stroke Scale (NIHSS)\<8 at the time of treatment
4. Positive pregnancy test in women at age of childbearing
5. Intracranial or intraspinal surgery within 3 months
6. Stroke or serious head injury within 3 months
7. History of intracranial hemorrhage
8. Uncontrolled hypertension at time of treatment (eg, \>185 mm Hg systolic or \>110 mm Hg diastolic)
9. Seizure at the onset of stroke
10. Active internal bleeding
11. Intracranial neoplasm
12. Arteriovenous malformation or aneurysm
13. Clinical presentation suggesting post-MI pericarditis
14. Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) \>1.7
15. Internation normalized ratio (INR) \>1.7
16. Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
17. Platelet count \<100,000/mm
18. Major surgery within 2 weeks
19. GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
20. Aggressive treatment required to lower blood pressure
21. Glucose level \<50 or \>400 mg/dL
22. Arterial puncture at a noncompressible site or lumbar puncture within 1 week
Impact of High Flow Therapy on Complications Related to Airway Stenting

The application of HFNC therapy in patients with airway stent, improving both humidification and clearance of the airway secretion, could potentially reduce the risk of mucoid impaction, respiratory infections and granulation. HFNC therapy could be superior to nebulization of normal saline (usual care) in order to keep the stent cleaned, reducing, by inference, the risk of complications, as defined above.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Central Airway obstruction, both malignant and nonmalignant, treated with airway stenting (silicone or fully covered metallic stent)

Exclusion Criteria:

* Contraindication to HFNC (recent - within 3 months - nose surgery or facial trauma)
* Lack of written informed consent
* Neuropsychiatric disorders
* Pregnancy
Ranibizumab for the Inhibition of Neovascularization in Pterygia

The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab given via subconjunctival injection in patients undergoing pterygium surgery.

As a secondary objective, this study also aims to establish the tissue concentration of ranibizumab when delivered via subconjunctival injection in patients undergoing pterygium excision and to determine the effects of ranibizumab on conjunctival healing, corneal epithelial healing, and wound dehiscence.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible if the following criteria are met:
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 18 years
* Patient related considerations: All patients of both genders will be considered for enrollment.
* Disease related considerations:

  * Patients with pterygia will be considered for enrollment if the pterygium meets standard pterygium excision criteria including encroachment into the visual axis
  * severe induced astigmatism
  * foreign body sensation unresponsive to medical therapy.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

* Pregnancy (positive pregnancy test)
* Women seeking to become pregnant
* Lactating women
* Prior enrollment in the study
* Prior glaucoma surgery in the region of the pterygium
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
Cardiopulmonary Bypass and Inflammatory Response

The purpose of this study is to determine if a difference exists in the inflammatory response which occurs related to coronary artery bypass graft (CABG)surgery performed on cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of Pittsburgh Medical Center.

Acute inflammatory response occurring in cardiopulmonary bypass (CPB) patients has been clearly associated with deleterious clinical outcomes. Increasing understanding of the pathophysiology of systemic inflammatory response syndrome (SIRS) following CPB has facilitated the development of strategies to attenuate the damaging effects of cytokine-induced inflammation. For any strategy to be tested, one needs to clearly define and understand the inflammatory response occurring with CPB. Although this has been extensively studied, there is wide variation in the reported time course and magnitude of this response. This variation is, in part, due to the heterogeneous nature of the patient population studied (variable severity of illnesses, ejection fractions, co-morbidities, etc.). Hence, in our study, we propose to study the inflammatory response occurring in patients undergoing coronary artery bypass graft (CABG) with and without the use of CPB in our institution, and to determine whether the severity of inflammatory response seen in CABG patients is associated with impairment of any specific clinical parameter in the immediate post-operative period (i.e., ventricular dysfunction, lung injury, bleeding, renal failure, etc).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing CABG and/or patients undergoing other procedures (i.e., valve surgery, myomectomy, etc.) in addition to coronary revascularization
* Age: 18 years up to and including 90 years

Exclusion Criteria:

* Patient is not scheduled to undergo CABG surgery
* Ejection Fraction £ 30%
* Chronic renal failure requiring hemodialysis
* Long-term steroid use prior to surgery
* HIV positive patients (HIV testing will not be required to rule out HIV)
* Status post organ transplantation or on immune modulating drugs
* Presence of severe sepsis in the past month prior to surgery
* Prisoners
Anal Fistula and Microdialysis - What is Yet to Learn?

Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.

Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose.

The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* to be able to understand and accept the terms of study

Exclusion Criteria:

* age under 18
* dementia, language barrier
Pharmacotherapy and Intensive Treatment of Drug Abuse - 1

The purpose of this study is to evaluate desipramine and carbamazepine in reducing cocaine craving; increase outpatient treatment capacity and evaluate their incidence of psychiatric disorders.


Eligibility Criteria:
Please contact site for information.
the Effectiveness of Intermittent Pneumatic Compression on Neuropathic Pain in Patients With Diabetic Polyneuropathy

In this study,the effectiveness of intermittent pneumatic compression therapy on neuropathic pain and quality of life in patients with neuropathic pain due to type 2 diabetes was investigated

The investigators conducted our research from 50 patients with type 2 diabetes of 5-20 years, who received pregabalin treatment with diabetic neuropathy with consent form between 40-75 years.The investigators divided the patients into two equal groups , some of the patients were given an intermittent pneumatic compression program at a pressure of 35 mmhg for 30 min to the lower extremity for 10 days of extreme alternation in our clinic and pregabalin treatment was continued,only pregabalin treatment of the other group was continued. VAS, PQAS, LANSS, SF-36 were evaluated.The evaluation was done before the treatment, at the end of the intermittent pneumatic compression treatment(approximately 2 weeks after the start of the treatment) and 3 months later.

Eligibility Criteria:
Inclusion Criteria:

* 5-20 years history of type 2 diabetes
* Between the ages of 40-75
* Body mass 25-40
* Blood pressure 100/60-140/90
* Patient diagnosed with diabetic polyneuropathy
* Use of pregabalin

Exclusion Criteria:

* Connective tissue disease
* Peripheral nerve vasculitis
* Postherpetic neuralgia
* Alcoholic neuropathy
* Autonomic neuropathy
* Chronic renal failure
* Charcot-marie tooth disease
To Document the Effectiveness of BoNT-A Injection in Adult Subjects With Upper Limb Spasticity Following Stroke

The purpose of the study is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one BoNT-A injection cycle in accordance with routine practices.


Eligibility Criteria:
Inclusion Criteria:

* Upper limb spasticity following stroke
* At least a 12-week interval between the last injection (BoNT-A or BoNT-B) and inclusion
* Decision already been agreed to inject BoNT-A
* Agreement with the subject on goal setting

Exclusion Criteria:

* Contraindications to any BoNT-A preparations