cyrilzakka/clinical-trials huggingface dataset:
Prognostic Implication of Angiography-Derived IMR in STEMI Patients

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

Coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of STEMI patients. Previous study presented that index of microcirculatory resistance (IMR) in culprit vessel of STEMI patients showed significant association with the risk of cardiac death or heart failure admission. Recent technical development enabled angiographic derivation of IMR without pressure wire, hyperemic agents, or theromdilution method. In this regard, the current study will evaluate prognostic implication of angiography-derived IMR in STEMI patients who were successfully revascularized.

The study cohorts consist with 2 separate cohort: first, diagnostic accuracy cohort, which will evaluate diagnostic accuracy of angiography-derived IMR for invasive IMR. For this, 31 patients with culprit vessel IMR measurement at the time of primary PCI will be evaluated. The patients cohort is the subgroup of previous registry (NCT02186093). Second, prognosis cohort, in which angiography-derived IMR will be measured in the culprit vessel after successful revascularization. Those patients have follow-up data after 10 years from index procedure. This cohort is STEMI subgroup derived from Institutional registry of Samsung Medical Center, whose results were previously published (JACC Cardiovascular Intervention. 2019 Apr 8;12(7):607-620.) Among 490 STEMI patients from the overall study cohorts, 309 patients with available angiograms and who were suitable for angiographic FFR and IMR measurement will be analyzed. Primary clinical outcome will be cardiac death at 10 years from index procedure. Secondary outcome will be any myocardial infarction, ischemia-driven revascularization, definite or probable stent thrombosis, congestive heart failure admission at 10 years from index procedure.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients who were successfully revascularized for culprit vessel
* analyzable angiograms at the index procedure

Exclusion Criteria:

* Previous coronary artery bypass grafting
* Coronary bypass graft as culprit vessel
* Patients with unclear culprit vessel
* limited image quality of coronary angiography
* Insufficient angiographic project for TIMI frame count
* Severe tortuosity of culprit vessel
* No optimal projection for reconstruction
Ketotifen in Non-Alcoholic Fatty Liver Disease Patients

The aim of this study is to investigate the safety and efficacy of using ketotifen in patients with NAFLD patients without cirrhosis

Nonalcoholic fatty liver disease (NAFLD) is characterized by the accumulation and deposition of fats in the hepatocytes which affect the liver structure and function. Causes of NAFLD vary but mainly attributed to dyslipidemia and obesity. Prevalence of NAFLD has been raised over years from 25% in 2005 to over 37% in 2016 and continues to increase to become one of the most common chronic liver disease (Li J et al., 2019).

The disease progress from steatosis and inflammatory infiltration that is known as nonalcoholic steatohepatitis (NASH) to liver fibrosis, cirrhosis, and ultimately hepatocellular carcinoma. Despite these serious outcomes, no definitive known approved medication for NASH has been developed. NAFLD management is mainly dependent on diet control, physical activity, and some supportive treatments mainly to prevent the disease complications (Mundi et al., 2020).

Mast cells (MCs) are responsible releasing mediators, including preformed bioactive metabolites (histamine and tryptase,), newly synthesized cytokines \[transforming growth factor beta (TGF-β), tumor necrosis factor alpha (TNF-α) (Pham et al., 2022). MCs can lead to microvesicular steatosis, ductal reaction (DR), biliary senescence, inflammation, angiogenesis, and liver fibrosis during NAFLD/NASH (Huang et al., 2022). Consequently, MC stabilizer such as ketotifen has emerged as promising approach to improve patients with NASH through its antioxidant and anti-inflammatory effects (Kim et al., 2014; Abdelzaher et al., 2020).

Eligibility Criteria:
-Inclusion criteria: Adult males or females aged ≥18 years.

* All patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with Hepatic steatosis index \> 36 to be considered as a NAFLD patient.
* Confirmed diagnosis of NASH
* Exclusion Criteria:
* Current or history of significant alcohol consumption.
* Use of drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).
* Prior or planned bariatric surgery.
* Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.
* Evidence of other forms of chronic liver disease as Hepatitis B, Hepatitis C, Wilson's disease, Alpha-1-antitrypsin (A1AT) deficiency, Hemochromatosis, drug-induced liver disease.
* Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding.
* Use of other drugs known to have possible positive effects on steatosis.
* Other anti-histaminic, sedating agents (CNS depressants) and anticholinergic medications.
Comparative Effectiveness of Psoriasis Treatments on Systemic Inflammation

This is a prospective longitudinal observational pilot study of psoriasis patients on continuous standard-of-care systemic therapeutics to determine the level of change in established (plasma/serum) and investigative (cellular) biomarkers that are associated with increased risk of CVD events.

The final endpoint of the proposed study will be a ranking of the examined biomarkers based upon an integrated assessment of biomarker behavior over time.

Secondary outcomes will assess changes in coronary artery calcification scoring, PET-MRI, skin biopsies, and clinical improvement.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ages 18-65 years old
* Diagnosis of moderate-to-severe plaque psoriasis
* Plaque affects ≥ 10% of subject's body surface area (BSA)
* Subjects prescribed one of the following standard-of-care treatments for their psoriasis: Ustekinumab, Methotrexate, Etanercept, Adalimumab, Narrow Band UVB (311nm), Excimer Laser Treatment (308nm), or Acitretin
* Subjects willing to complete a Washout Period prior to Visit 1 (only for subjects currently on a psoriasis treatment):

  * Discontinue systemic therapies for at least 4 weeks
  * Discontinue topical therapies for at least 2 weeks
  * Discontinue phototherapies for at least 2 weeks

Exclusion Criteria:

* Subjects who are currently on a psoriasis treatment and unwilling to go through the washout-period
* Subjects with a critical illness or who are immunocompromised
* Weight is 400lbs or greater
* Subjects who are currently pregnant or breastfeeding
* Subjects who have metal implants
* Subjects who have a pacemaker, stent, or artificial heart valve
* History of clinically significant hematological, renal or liver disease
* Patients with known co-morbidities that raise biomarkers such as:

  * History of myocardial infarction (MI)
  * History of cerebrovascular accident (CVA)
  * Significant atherosclerosis (defined as the presence of any carotid plaque; or carotid intimal media thickness (cIMT) \>75th percentile for age; or the presence of coronary artery calcium score\>100)
  * Poorly controlled diabetes (elevated HbA1c \> 8.5)
Database of Pelvic Inflammatory Disease

The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital.

The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Eligibility Criteria:
Inclusion Criteria:

* All in-patient with PID who diagnosed at Kangbuk Samsung Hospital

Exclusion Criteria:

* Secondary PID caused by other surgical problem or disease
* An inability to fill-up the informed consent
A Dose-Ranging Study of JNJ-40411813 in Healthy Male Volunteers

The purpose of this study is to characterize the 5-HT2A binding over the maximum feasible dose range of JNJ-40411813, to estimate the plasma concentration associated with 50% 5-HT2A binding, and to investigate the safety and tolerability of JNJ-40411813 in healthy male volunteers.

This will be an open-label (volunteers and study staff will know the identity of assigned treatment), dose-ranging study to determine 5-HT2A receptor engagement by JNJ-40411813 as a function of dose and time in healthy male volunteers. The study will consist of an eligibility screening examination, an open-label treatment period and a follow-up examination (approximately 10 days after dose administration, a follow-up examination will be performed). Initially, 4 volunteers (Cohort 1) will be included to determine 5-HT2A receptor occupancy following single dose administration of JNJ-40411813. Dependent on the results, doses for the remaining 8 volunteers (Cohort 2 and 3) will be selected to further characterize 5-HT2A receptor occupancy within the feasible dose range up to maximally 700 mg JNJ-40411813.The maximal study duration for a volunteer will be 6 weeks. In this study, \[11C\]-MDL 100,907 will be used as positron emission tomography (PET) ligand to investigate the concentration-related binding of 40411813 to the 5-HT2A receptor in the brain. JNJ-40411813 (200 mg to 700 mg) will be taken orally (by mouth). If multiple capsules have to be taken, the actual intake may be spread over a 15-minute period. Study drug will be administered to each volunteer just after completion of a meal and within 30 minutes after the start of the meal.

Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 30 kg/m2, inclusive
* Willing to adhere to the prohibitions and restrictions specified in this protocol
* Volunteers must sign an informed consent to document that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* Have abnormal values for clinical laboratory tests, clinically significant abnormal physical examination findings, vital signs, or 12-lead Electrocardiograms (ECGs) performed at screening considered to be of clinical significance to the Investigator
* Have Significant history of or current significant medical illness that the Investigator considers should exclude the volunteer
* Have known allergies, hypersensitivity, or intolerance to JNJ-40411813, its excipients, or to the PET ligand used in the study
* Have significant history of psychiatric or neurological illness in first-degree relatives
* Been exposed to ionizing radiation as a volunteer (including diagnostic procedures)
* Presence of other exclusion criteria as specified in the protocol
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia

The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).


Eligibility Criteria:
Inclusion Criteria:

* The subject is an out-patient.
* The subject presents with a diagnosis of idiopathic Parkinson's disease.
* Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria:

* (For female subjects) The subject is pregnant or lactating.
* The subject is participating in another clinical study or has done so within the past 30 days.
* The subject has received neurosurgical intervention related to PD.
* The subject has relevant renal impairment.
* The subject has relevant hepatic impairment.
* The subject is suffering from any dementia or psychiatric illness.
* The subject has a history of allergic asthma.
Clinical Activity During Night-shift: an Ecological Study

A convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. The impact of nightshift work on sleep, stress, quality of life, regrets, and general well being of the residents observed will be measured through completion of validated questionnaires. Quality of handoff sessions will also be assessed.

Various medical problems of patients admitted to an internal medicine ward can worsen during the stay. Furthermore, new, unidentified problems can develop (complications, medication errors, delirium, acute anxiety or pain, etc). During evenings, nights and week-ends, emergent needs of hospitalized patients are usually cared for by physicians in-training, who are in charge of a large number of patients. Hence, physicians should have a wide range of medical knowledge and procedural skills and know how acute problems are dealt with in the unique environment of the healthcare institution. Training physicians should also be able to obtain information and counseling efficiently, either from clinical guidelines, senior supervisors, or specialists.

These requirements may represent a significant stress for training physicians and may have a major impact on their health, quality of life, and finally on the quality of inpatient care. Nightshift work may lead later to a high burden of regrets among caregivers.

Better knowledge of training needs, organization features, coping strategies, and regrets associated with nightshift duty are important to prepare training physicians to that demanding and necessary task. Understanding of the epidemiology of night-shift ward emergencies could provide guidance concerning the required level of staffing and training of the responding medical team.

Furthermore, efficient transmission of information between day and night staff (so-called handoffs) is a difficult yet important part of care. Systematic observation of handoff sessions between physicians before and after nightshifts may enhance previous knowledge on key components of these topics.

The investigators will evaluate the incidence causes, and prognosis of night-shift emergencies in internal medicine wards by direct observation of the nightshift work of a convenient sample of internal medicine residents. By the means of before-and-after shift completion of various validated questionnaires, the investigators will explore quantitatively and qualitatively the physiological and psychological impact on nightshift work for physicians in training.

The planned study will also provide qualitative and quantitative data concerning handoffs session, and the repercussions on night shift emergencies management.

Eligibility Criteria:
Inclusion Criteria:

* resident in training in the internal medicine department, involved in one or more nightshift during the study

Exclusion Criteria:

* unwilling to participate
Sensor Validation Study - Quality Assurance

The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold standard for measuring this vital sign is the capnograph. For the patient, this involves wearing a tube in their nose and around their ears while trying to minimise their movement and talking so that the measurements can be taken.

A new respiratory rate monitor, RespiraSense, is non-invasive and measures the respiratory rate by measuring the displacement between the ribs and abdomen. This research study is intended to validate that this technology is effective and accurate on people with a bigger body mass.

Subjects with a BMI \> 35 will be invited to participate should they meet all of the eligibility criteria. If patients agree to participate, following informed consent, subjects will be monitored for one hour with both the capnograph and RespiraSense measuring at the same time so their results can be compared


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 Years
* Have a BMI ≥35

  * For the sub-group analysis at least 5 subjects with a BMI 35-49 and at least 5 BMI \> 50 will be needed
* Are willing to voluntarily sign a statement of informed consent to participate in this investigation

Exclusion Criteria:

* Allergic to medical grade skin adhesive
* Continuous oral long term steroid use. To be free from oral steroid use this is defined as not using oral steroids in the 4 weeks previous to enrolment
* Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
* Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent
Five-year Changes in Patients With Chronic Stroke

Objective of the study:

* To determine changes in physical and cognitive function in patients with chronic stroke over 5 years
* To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity


Eligibility Criteria:
Inclusion Criteria:

- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)

Exclusion Criteria:

- None
Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage in the Treatment of Trigger Points

The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.

The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage in the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life. "Visual Analog Scale (VAS)" was used for pain assessment of individuals who accepted to participate in the study; universal goniometer was used to measure active neck active range of motions (AROM) for functionality; and "Short Form-36 (SF-36)" was used for quality of life. Then, the participants were randomly divided into two groups \[Group 1: classical massage group; Group 2: classical massage + ischemic compression group\]. Classical massage was applied to both groups three times a week for two weeks, and ischemic compression was applied to Group 2 in addition to classical massage. At the end of the treatment period, the participants were re-evaluated in terms of VAS, neck AROM and SF-36 scores.Statistical analysis will be performed with SPSS 24.0 program. If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation. If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 20-50
* Having a myofascial trigger point detected in the upper trapezius muscle for at least two weeks
* Being a student or staff of Halic University
* Being literate

Exclusion Criteria:

* Having a history of cervical surgery
* Having a malignant disease
* Pregnancy
* Menopause
* Having cooperation problems
Established Status Epilepticus Treatment Trial

The primary objective is to determine the most effective and/or the least effective treatment of benzodiazepine-refractory status epilepticus (SE) among patients older than 2 years. There are three active treatment arms being compared: fosphenytoin (FOS),levetiracetam (LEV), and valproic acid (VPA).

The second objective is comparison of three drugs with respect to secondary outcomes.

The final objective is to ensure that the trial is informative for treatment of established SE in children by describing the effectiveness, safety, and rate of adverse reactions of these drugs in children.


Eligibility Criteria:
Inclusion Criteria: Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug; Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. The doses may be divided.; continued or recurring seizure in the Emergency Department; Age 2 years or older

Exclusion Criteria:Known pregnancy; Prisoner; Opt-out identification; Treatment with a second line anticonvulsant (FOS, PHT, VPA, LEV, phenobarbital or other agents defined in the MoP) for this episode of SE; Treatment with sedatives with anticonvulsant properties other than benzodiazepines (propofol, etomidate, ketamine or other agents defined in the MoP); Endotracheal intubation; Acute traumatic brain injury; Known metabolic disorder; Known liver disease; Known severe renal impairment; Known allergy or other known contraindication to FOS, PHT, LEV, or VPA; Hypoglycemia \< 50 mg/dL; Hyperglycemia \> 400 mg/dL; Cardiac arrest and post-anoxic seizures
Identification and Impact of Vaginal Flora Anomalies Among Pregnant Woman

This is a prospective multicentric study including six clinical units of Gynecology and Obstetrics (5 public health hospital and one private team), one research team in clinical microbiology and one Center of Clinical investigation (CIC).

There is a correlation between premature delivery and bacterial vaginosis. So, the anomalies of vaginal flora are a potential target for the campaign against prematurity.

The main objective of this study is to achieve an objective and reproducible technique of identification and quantification by molecular biology of lactobacilla and all the other micro-organisms involved in vaginal flora anomalies.

The secondary objectives are the exhaustive culture of bacteria, the characterisation of intermediate vaginal flora and bacterial vaginosis among pregnant woman by PCR targeting the ribosomic ADN 16S coupled with clonage techniques.

The number of patient to include is 1000 (time of inclusions: 24 months). The vaginal smears will be realized until 32 weeks of gestation (Max: 3 taking of vaginal smears by patient).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients aged more than 18 years and more than 14 weeks of gestation but less than 28 weeks.
* Multiple pregnancy won't be included.
* Patient with a risk of premature delivery with a short cervix or a cervix measured at less than 25 mm (measure done by vaginal ultrasound of the cervix).
* Or patient with a past of premature delivery and/or of late abortion.
* Symptomatic or asymptomatic patient.
* Patients consulting for pregnancy follow up or hospitalized in a unit of Gynecology and Obstetrics involved in the study.
* social security cover
* written informed consent

Exclusion Criteria:

* antecedents : treated hypertension, Foetal malformation, APLS known, diabetes, renal disease, SLE
* treated with antibiotics the inclusion's day
* dropping consent.