cyrilzakka/clinical-trials huggingface dataset:
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis.

The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.

Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine.

Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks.

Exclusion criteria: Pregnancy \& fulminant course

Eligibility Criteria:
Inclusion Criteria:

* chronic active ulcerative pancolitis
* course more than 4 months
* clinical index rachmilewitz 7 or more
* endoskopic index 7 or more

Exclusion Criteria:

* steroids in the last 4 weeks
* immunosuppressants in the last 4 weeks
* use of topical klymsa
* pregnancy
* fulminant course
* infectious colitis
A Study of Fycompa (Perampanel) in Korean Participants

The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with approved indication for Fycompa (Perampanel) in Korea as follows:

   * Monotherapy (film-coated tablets)

     o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
   * Adjunctive therapy (film-coated tablets \& oral suspension)

     * 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
     * 7 years and older Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in participants with idiopathic generalized epilepsy
2. Participants who have written consent for use of personal and medical information for the study purpose

Exclusion Criteria:

1. Hypersensitivity to the active substance or to any of the excipients of this medicine
2. In case of Fycompa film-coated tablets, Fycompa tablets contains lactose; therefore, participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa suspension contains sorbitol; therefore, participants with rare hereditary problems of fructose intolerance should not take this medicine.
3. Other participants judged to be inadequate to participate in the study by doctor
Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response.

The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing donor hepatectomy
* American Society of Anesthesiologists class 1 to 2
* Ability to consent

Exclusion Criteria:

* American Society of Anesthesiologists greater than 2
* Documented or known sensitivity to any drug to be used in the study.
* Patient with immunosuppressant/ cytotoxic/ steroid therapy.
* not understand the aim and objectives of the study
Resolution of Thrombi in Left Atrial Appendage With Edoxaban

Non-valvular (NV) atrial fibrillation (AF) increases the risk of stroke by approximately fivefold. The atrial thrombi associated with AF are seen within the left atrial appendage (LAA) in most cases (\> 90%). Anticoagulation with a vitamin-K antagonist (VKA) is recommended to prevent thromboembolic complications and to resolve thrombi. Non-VKA oral anticoagulants (NOACs) have replaced the VKA for the thromboprophylaxis in patients with NVAF since 2010. Therefore, NOAC can be the excellent alternative to VKA concerning resolving preexisting LAA thrombi because of its rapid onset of action and no need of bridging with heparin. However, there is still lack of data regarding the optimal treatment for patients with AF and thrombi in LAA with NOAC. There are only several case reports of the efficacy of NOACs in resolving LAA thrombi available.

Edoxaban, which has data showing efficacy and safety in thromboprophylaxis, can be the new option for treatment of patients with AF and LAA thrombi. The purpose of this study is to evaluate the efficacy of Edoxaban in resolving the LAA thrombi, which is related with nonvalvular AF.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 20 years
* Hemodynamically stable nonvalvular AF or atrial flutter
* LAA thrombus documented by TEE up to 72 hours prior to start of study medication
* VKA or NOAC-naïve or untreated within 1 month prior to sign the informed consent
* VKA pretreated but under the therapeutic International Normalized ratio levels (\<2.0; documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
* Women of childbearing potential and men must agree to use adequate contraception when sexually active

Exclusion Criteria:

* Transient Ischemic Attack within 3 days prior to study inclusion
* Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
* Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
* Acute myocardial infarction within the last 14 days prior to study inclusion
* Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus
* Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19

This study is being done to see if hydroxychloroquine is an effective treatment for COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Subjects must have a documented positive test for the SARS-CoV-2 infection within 7 days of randomization
* Subject must be hospitalized within 72 hours of randomization
* Subjects must be receiving standard of care for SARS-CoV-2
* Subject/Legally Authorized Representative (LAR) must have the ability to understand and give informed consent
* Subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator

Exclusion Criteria:

* Prior receipt of hydroxychloroquine for treatment or prophylaxis of SARS-CoV-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis)
* No documented SARS-CoV-2 infection
* Mechanical ventilation
* Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives Preexisting retinopathy documented in medical history
* Pregnancy or Breastfeeding
* Concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin)
* Antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide)
* History of glucose-6-phosphate dehydrogenase deficiency
* Pre-treatment corrected QT interval (QTc) \>500 milliseconds
* Pressor requirement to maintain blood pressure
* Alanine aminotransferase (ALT) and/or asparate aminotransferase (AST) level \> 5X upper limit of normal
* Creatinine clearance \<30 mL/min or requirement of dialysis or continuous venovenous hemofiltration
* Concomitant participation in a therapeutic trial for SARS-CoV-2 or receiving any experimental treatment for SARS-CoV-2 within 7 days of randomization
* Any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints
Quality Control of CE-Labelled Phonak Hearing Systems (Study Part: Sonova2015-00)

The purpose of this study, which contains a series of successive study parts, is to methodically evaluate Phonak Hearing Systems on hard of hearing participants to grant quality control prior to each product launch.


Eligibility Criteria:
Inclusion Criteria:

* Hearing impaired persons with and without (experience with) hearing aids
* Good written and spoken (Swiss) German language skills
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the medical device in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend weekly appointments
* Limited ability to describe listening impressions/experiences and the use of the hearing aid
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Central hearing disorders
Dexamethasone for PENG Block in Total Hip Arthroplasty

Effect of adding Dexamethasone to Periarticular Nerve Group Block in Patients undergoing Total Hip Arthroplasty

Hip arthroplasty is one of the most common orthopaedic procedures, especially in elderly patients, due to the deformation of joints. Patients may complain of severe pain due to surgical trauma and prostheses. Regional anaesthesia methods may be performed to reduce the inflammatory response, opioid consumption, and opioid-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total hip arthroplasty
* patients aged \>65 and \<100 years
* patients able to provide informed consent
* patients able to reliably report symptoms to the research team

Exclusion Criteria:

* inability to provide first-party consent due to cognitive impairment or a language barrier
The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients

The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.

The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .

Eligibility Criteria:
Inclusion Criteria:

* geriatric patients requiring intensive care treatment

Exclusion Criteria:

-
Pivotal Study of the CapsoCam Colon (CV-3) in Detecting Colonic Polyps, Using Colonoscopy as the Reference

This study will evaluate the safety and effectiveness of the CapsoCam Colon (CV-3) endoscope system for the detection of colonic polyps.


Eligibility Criteria:
Inclusion Criteria:

1. At least 45-75 years of age
2. Committed to undergo a colonoscopy, independent of this study
3. Choose to participate and must have signed the IRB-approved informed consent document and agreed to release colonoscopy images and results report to Sponsor

Exclusion Criteria:

1. Colonoscopy or CT-colonography within the past 5 years that demonstrated no polyps
2. Has contraindication for capsule endoscopy or colonoscopy
3. Subject is suspected or diagnosed with familial adenomatous polyposis, hereditary non polyposis colon cancer, or any high-risk genetic syndrome
4. Subject is suspected or diagnosed with inflammatory bowel disease such as ulcerative colitis or Crohn's disease
5. History of incomplete colonoscopy
6. Type I or uncontrolled II Diabetes (Uncontrolled defined as HbA1C\>6.4 within the past 3 months and/or with history of constipation or gastroparesis.)
7. Impaired cardiac function assessed as greater than NYHA Class II
8. History of small- or large-bowel obstructive condition
9. Known history of swallowing disorder, and/or ischemic bowel disease neuropathies and/or radiation enteritis
10. Known history of NSAID enteropathy and stricture resulting from taking NSAIDs on a regular basis that, in the opinion of the Investigator, would put the subject at greater risk for capsule endoscope retention
11. Known allergy to ingredients used in bowel preparation and boosters
12. Daily and/or regular narcotic use
13. Decompensated cirrhosis
14. Prior abdominal radiation therapy
15. Diagnosis of anorexia or bulimia
16. History of or suspicion of any of the following: strictures, volvulus or intestinal obstruction, or internal hernias or abdominal surgeries that the Investigator believes should exclude the patient from study participation
17. Known or suspected megacolon
18. Scheduled to undergo MRI examination within 7 days after ingestion of the capsule
19. Has known slow gastric-emptying time or confirmed diagnosis of gastroparesis
20. Pregnant or nursing or is of child-bearing potential and does not practice medically acceptable methods of contraception. WOCBP must have a negative urine pregnancy test at screening.
21. Unable to follow or tolerate fasting, bowel preparation, and other study procedures
22. Any documented medical or psychological condition or significant concurrent illness which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study or would affect the validity of the study results
23. Are currently enrolled in an interventional clinical study or currently enrolled in or within the last 30 days, a pharmaceutical clinical study
24. Chronic constipation as defined by \<3 bowel movements per week, or the use of routine laxatives (other than fiber) to attain regular bowel movements
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use

This study aims to evaluate the influence of genetic polymorphisms of OCTN1 and OCT2 and other possible covariates on the kinetic disposition of GAB in patients undergoing GAB chronic treatment. Thus, patients treated with GAB, for at least one week, are being investigated.

Gabapentin (GAB), an anticonvulsant used for the treatment of epilepsy and chronic pain, has nonlinear kinetics, it is not metabolized and it is mainly eliminated by renal excretion. Studies suggest that the renal excretion of GAB is dependent on active secretion by organic cation transporter 2 (OCT2) and organic cation/ergothioneine transporter 1 (OCTN1). These transporters are expressed at the membrane of the renal proximal tubules and they are involved in the elimination of endogenous compounds and many drugs. The genetic polymorphism of drug transporters has been studied to explain the kinetic disposition variability of their substrates. The objective of this study is to investigate the influence of genetic polymorphisms of OCTN1 and OCT2 and other possible covariates (e.g., sex, age, creatinine clearance, body mass index) on the kinetic disposition of GAB in patients undergoing GAB chronic treatment. Patients treated with GAB, for at least one week, are being investigated. Blood and urine samples are being collected to GAB pharmacokinetic analysis, serum creatinine analysis and for genotyping. The plasma concentration of GAB will be assessed using liquid chromatography with UV detection (LC-UV).

Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years old or older, both gender.
* Patients undergoing chronic use of gabapentin (at least one week).

Exclusion Criteria:

* Pregnant and lactating patients.
* Patients who were in use of OCT2 and OCTN1 inhibitors.
* Patients who disagree to continue the study.
Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction

Aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and myofascial release techniques on performance in healthy individuals with sacroiliac joint dysfunction.

Aim: aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and myofascial release techniques on performance in healthy individuals with sacroiliac joint dysfunction. Design: Randomized control trial. Setting: University physiotherapy clinic. Participiants: Participants aged 18-45 years with confirmed Dysfunction by six clinical Sacroiliac Joint diagnostic tests. Intervention: The groups determined as randomly into the four groups. Group I (n=14) received HVLA spinal manipulation, Group II (n=14) underwent foam roller stretching, Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching, and Group IV (n=14) underwent sham manipulation as the control group. Measures were measured before the acute intervention and right after the intervention. Outcomes: Prior to the interventions, participants were evaluated using the Visual Analog Scale (VAS) for pain assessment, the Baseline Sit and Reach test for flexibility assessment, the Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance and multiple jump tests, and the MicroFet2 digital hand dynamometer (United States, Utah) for muscle strength measurement. Results: The study groups showed statistically significant improvements in performance parameters compared to the control group (p\<0.05). Pre-treatment and post-treatment performance parameters and pain values were statistically significant in both groups (p\<0.05). While performance improvements were observed in all four groups, the highest changes were generally observed in the HVLA + Myofascial release group. Conclusion: Considering the overall results, the combined use of HVLA and Myofascial release in the treatment protocol is recommended.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer
2. Being between the ages of 18-45,
3. Not to have any psychological, neurological, orthopedic and rheumatic disorders,
4. Not having any other musculoskeletal pathology affecting the lower extremities,
5. Not having undergone spine and/or lower extremity surgery,
6. Those with mechanical sacroiliac joint pain,
7. Patients in whom at least 3 out of 6 provocation tests showing sacroiliac joint dysfunction and validity-reliability studies were positive: 1. Distraction, 2. Compression, 3. Gaenslen, 4. Posterior friction test, 5. Sacral thrust, 6. Faber (8) Individuals with sacroiliac pain at least 3 points on the VAS in the last 1 month 11

Exclusion Criteria:

1. Being under the age of 18 and over the age of 45,
2. Having any psychological, neurological, orthopedic and rheumatic disorders,
3. Pregnancy and suspicion of pregnancy,
4. Having active malignancies,
5. Having an active infection,
6. Injection and operation of the sacroiliac joint in the last 3 months,
7. Having drug or substance addiction,
8. Central vascular/neurological conditions
Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD

This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women

This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.

Eligibility Criteria:
Inclusion Criteria:

* Perimenopausal women who did not undergo HRT

Exclusion Criteria:

* (1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.

  (2) Have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.Use of topical medicines other than eye lubricants in the past 3 months.Use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.Occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received HRT treatment.

  ④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.
Efficacy and Safety of Pulsed Radiofrequency Combined With Platelet Rich Plasma to Treat Idiopathic Glossopharyngeal Neuralgia (GPN)

To investigate the efficacy and safety of the application of PRF combined PRP to the for the treatment of GPN.


Eligibility Criteria:
Inclusion Criteria:

1. age \>18 years;
2. diagnosed with idiopathic GPN according to the third International Classification of Headache Disorders (ICHD) classification;
3. patients who failed pharmacotherapy or intolerable side effects of medication;
4. undergoing PRF for GPN;
5. at least 1 month of follow-up recordings.

Exclusion Criteria:

1. Patients with bilateral GPN;
2. Abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography;
3. Infection at the puncture site;
4. Previous mental illness;
5. Previous history of narcotic drug abuse;
6. Prior anticoagulant or antiplatelet therapy;
7. An implantable pulse generator;
8. Current pregnancy or breast feeding.
9. Patients with incomplete medical records (lack of baseline data or postoperative follow-up data).