cyrilzakka/clinical-trials huggingface dataset:
A Multi-center, Randomized, Double-blind, Double-dummy Clinical Study to Evaluate the Safety and Efficacy of Prulifloxacin Film-coated Tablet for the Treatment of Acute Exacerbations of Chronic Bronchitis With Levofloxacin Hydrochloride Tablet as Active Control

The purpose of this study is to use oral prulifloxacin to treat patient with Acute Exacerbations of Chronic Bronchitis and compare the effect with Levofloxacin.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is willing to participate in the study and gives the signature of informed consent;
2. In and out-patients (aged 18-70 years old), male or female;
3. Patient receives no effective antibacterial therapy or the therapy has no remarkable efficacy, or positive bacterial test result in the past 72 hours;
4. Diagnosed as mild to moderate acute exacerbation of chronic bronchitis patients (see \<Severity Evaluation Criteria Table\>)
5. Within 48 hours prior to the study, women of child-bearing age have a negative urine pregnancy test and is willing to use efficient measures of contraception to avoid pregnancy during the study.

Exclusion Criteria:

1. Patient hypersensitive to quinolones or with allergic constitution;
2. Patient with severe condition which need combination with other antibacterial agents;
3. Concurrent infections in other organs or system;
4. Patient with severe heart, liver or kidney disease, or Q-T prolongation of over 450 ms, serum AST or ALT more than twice as high as the upper limit of normal or Cr over the upper limit of normal;
5. With any of the following diseases: active tuberculosis, bronchiectasis, lung abscess, aspiration pneumonia, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary addicted acidic granulocyte infiltration and pulmonary vasculitis syndrome;
6. Patient with severe hematologic disease or central nervous system disease or convulsion history, with mental status unable to coordinate;
7. Patient with malignant tumor or other severe background disease;
8. Patient with severe immunodeficiency;
9. A history of tendon;
10. Known pregnancy or lactation;
11. Prulifloxacin contains lactose, therefore, patients with a rare genetic disease such as galactose intolerance, Lapp lactase deficiency or glucose - galactose malabsorption cannot be enrolled;
12. Participation in other clinical trials within 3 months before screening or currently on any investigational therapy.
ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES

The aim of this randomized study is to compare the safety and performance of EndoVascular Aneurysm Repair with ESAR using Endurant + Heli-FX™ EndoAnchor™ system and FEVAR using customizable grafts from Cook (Zenith Fenestrated Graft) and Terumo (Fenestrated Anaconda Graft) for the treatment of aortic aneurysms with short aortic neck (4 to 15mm).


Eligibility Criteria:
Inclusion Criteria:

* Subject is \>18 years old
* Subject is scheduled for primary treatment of the abdominal aortic aneurysm with a non-aneurysmal infrarenal aortic sealing zone proximal to the aneurysm that is sufficiently healthy for a proximal neck length that is at least 4mm and not more than15 mm and has a circumferential minimum sealing zone length of 8 mm
* Subject is not a candidate for safe, effective and durable standard EVAR due to challenging anatomical criteria as confirmed by the Core Lab screening
* Subject is able and willing to comply with the protocol and to adhere to the follow-up requirements.
* Subject has provided written informed consent

CT Angiographic Inclusion Criteria

* Subject meets the other anatomical requirements according to the locally applicable Endurant II/IIs stent graft system, Heli-FX EndoAnchor system, Terumo Fenestrated Anaconda (available in EU only) and/or Cook Zenith Fenestrated Graft Instructions for Use
* Proximal neck length of the aorta within 4-15mm and a minimum circumferential sealing zone of 8mm
* Aortic neck diameter from 19 to 31mm
* Infrarenal neck angulation ≤45°

Exclusion Criteria:

* Subject is participating in a concurrent study which may confound study results
* Subject has a life expectancy \<2 year
* Subject is female of childbearing potential in whom pregnancy cannot be excluded
* Subject with eGFR \<30 mL/min/m2 (KDOQI classification - exclude class IV and above) and or on dialysis
* Subject with a MI or CVA within 3 months prior to index procedure
* Subject with known Connective Tissue Disease
* Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to post-treatment
* Subject who has undergone prior endovascular or open surgical treatment for abdominal aortic aneurysm
* Subject requires emergent aneurysm treatment, for example, trauma or rupture
* Subject has a known hypersensitivity or allergies to study device implant material
* Subject has an aneurysm that is:

  * Suprarenal, pararenal, or thoracoabdominal
  * Mycotic
  * Inflammatory
  * Pseudoaneurysm
* Subject is presenting with thrombus or calcification of the proximal aneurysm neck: circumferential \>50%
* Pre-op stenosis of the renal arteries \> 50%
* Subject has active infection or history of COVID-19. History of COVID-19 is defined as availability of positive COVID-19 test with sequelae or hospitalization for treatment of COVID-19.
Investigation of the Effects of Pilates Training in Patients with Drug-Resistant Epilepsy

This study was planned to examine the effects of Pilates training in patients with drug-resistant epilepsy. It was planned to include 40 epilepsy patients in the study. The control group was planned to continue routine drug treatment for 8 weeks. The Pilates group was planned to receive Pilates training 3 days a week for 8 weeks in addition to routine drug treatment. It was aimed to examine the effects of Pilates training performed 3 times a week for 8 weeks on seizure frequency, core stability, balance, functional exercise capacity, cognitive functions, dual task, fatigue, kinesiophobia, sleep quality, depression and quality of life in patients with drug-resistant epilepsy.

This study was planned to investigate the effects of Pilates training, a "core" stability-based exercise method that improves body alignment, postural control, and balance in patients with drug-resistant epilepsy, on seizure frequency, core stability, balance, functional exercise capacity, cognitive functions, dual task, fatigue, kinesiophobia, sleep quality, depression, and quality of life. It was planned to include 40 epilepsy patients in the study. The patients were planned to be randomly divided into two groups as Pilates (n: 20) and control (n: 20). The control group was planned to continue routine drug treatment for 8 weeks. The Pilates group was planned to receive Pilates training 3 days a week for 8 weeks in addition to routine drug treatment. Seizure frequency with the seizure diary; the "core" power with the "sit-ups" and the modified "push-ups" tests; the "core" endurans with the lateral bridge, the trunk flexor endurance, the prone bridge and the modified "Biering-Sorensen" tests; balance with the Balance Error Scoring System (BESS) and the Four-Step Square Test (FSTT); functional exercise capacity with the 6-Minute Walk Test (6-MWT); functional mobility and dual task with the Timed Up and Go Test (TUG); cognitive functions with the BILNOT battery; fatigue with the Fatigue Severity Scale (FSS); kinesiophobia with the Tampa Kinesiophobia Scale; sleep quality with the Pittsburgh Sleep Quality Index (PSQI); depression with the Neurological Disorders Depression Inventory in Epilepsy (NDDI); and health-related quality of life with the Quality of Life in Epilepsy Scale (QOLIE-31) were evaluated before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being diagnosed with idiopathic refractory epilepsy by a specialist neurologist
* Not having had status epilepticus for 1 year before the study
* Being able to walk independently
* Not having participated in a regular exercise program
* Having a Standardized Mini Mental Test score greater than 24
* Antiepileptic drug doses being stable during the study

Exclusion Criteria:

* History of any diagnosed neurological or neuropsychiatric disease other than epilepsy
* Presence of any cardiovascular, pulmonary, orthopedic or other medical conditions that would limit participation in the study
* Pregnancy and breastfeeding
AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis

The purpose of this study was to provide long term clinical data for the compound for the treatment of the indication of moderate to severe chronic plaque-type psoriasis.

In the Proof-of-Concept study (CAIN457A2102/ NCT00669916), AIN457 was proven to be efficacious in the treatment of moderate to severe chronic plaque-type psoriasis. As a result, a phase IIb regimen finding study had been started (CAIN457A2211/NCT00941031).

The data gathered in this extension study of the core study (CAIN457A2211)was used to expand the safety database of the compound for the treatment of moderate to severe chronic plaque-type psoriasis. The participants in the extension study continued to stay on the exact same treatment regimen they were taking when completing the core study. The extension trial was first designed to provide long-term safety data of up to 100 weeks of treatment (32 weeks in the core study plus 68 weeks in the extension study (part 1)), and an additional 12 weeks of treatment-free follow-up for participants who did not continue in the extension study. Amendment 2 provided an additional 156 weeks of treatment (32 weeks in the core study plus 224 weeks in the extension study, equaling 256 weeks of total treatment (part 2)), before participants entered the 12 weeks of treatment-free follow-up. Protocol Amendment 3 extended the prolongation part of the study by up to 104 additional weeks of treatment (part 3) or until the drug was commercially available in the market of the country of participation, whichever occurred first.

Eligibility Criteria:
Key Inclusion Criteria:

* Patients who completed the core study CAIN457A2211. A patient is defined as having completed the core study if he/she completed the study up to and including visit 13 (F4) of the core study
* Patients must be able to understand and communicate with the investigator and comply with the requirement of the study and must given written, signed and dated informed consent before any study assessment is performed.
* Patients must be expected to benefit from the ongoing treatment with AIN457, as assessed by the patient and investigator
* Male patients must consent to practice reliable contraception during the study and for 16 weeks after the last dose of study drug administration Note: Due to new data available from the toxicology studies, the need for male contraception was removed.

Key Exclusion Criteria:

* Patients who experience a second consecutive full relapse at visit 13 ( week F4) of the core study CAIN457A2211
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG laboratory test (\> 5mlU/mL)
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.
Comparison of Contact Lens Maintenance Systems for Silicone Hydrogel Lenses

The primary purpose of this study is to investigate the performance of contact lens maintenance systems when used with silicone hydrogel contact lenses during daily wear over a period of 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Is correctable to at least 20/40 distance visual acuity in each eye with spherical contact lenses.
* Is an experienced soft contact lens wearer for at least 1 month.
* Has no clinically significant anterior eye findings.
* Has no other active ocular disease.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye surgery or injury within 12 weeks prior to enrolment.
* Has any systemic disease or ocular abnormality that might interfere with contact lens wear
* Has any pre-existing ocular irritation that would preclude contact lens fitting.
* PMMA lens wear previous 6 months.
* EW or CW in previous 1 month.
* Hydrogen peroxide users
* Latex sensitivity
Emergency Surgery During Covid Compared to Emergency Surgery During Pre-covid Period

The aim of this study is to analyze the trend of hospitalizations and how emergency operations have qualitatively and quantitatively changed in our Department of Medical and Surgical Sciences of the Foggia Hospital from 2019 (pre-covid era) to date.


Eligibility Criteria:
Inclusion Criteria:

* Patients underwent emergency surgery from March 2019 to May 2022

Exclusion Criteria:

* Patients underwent elective surgery
Glucose Variability

A retrospective data review of 243 pregnant women (≤32 wks gestational age), dtat collected prior to 5/18/2014, with GDM, or T2DM, and their infants (until discharge from the hospital, typically up to 1 week after deliver) will be conducted. These women are of any age and all ethnic backgrounds delivering at St. Mary's Health Center.

Maternal glucose control is considered to be a major determinant of neonatal outcome in pregnancies complicated by diabetes. Studies have examined the link between neonatal mortality and morbidity using specific mean preprandial or postprandial plasma glucose levels, however, have not taken into account the daily wide excursions that occur in maternal glucose levels. Limited data are available on glucose variability (GV) in pregnancy and affect on maternal or neonatal outcomes. A recent study amongst diabetics showed that glucose variability between two data points, a morning fasting blood glucose and an afternoon blood glucose, increased the rate of adverse neonatal outcomes1. Glycosylated hemoglobin (A1c), which has been considered the "gold standard" for diabetes control since the Diabetes Control and Complication Trial (DCCT)2, lacks the specificity to predict pregnancy outcomes. Through review of data, we propose to examine other methods of evaluating daily maternal glucose variations to determine the correlation to maternal and neonatal outcomes.

The objective of this study is to determine the effect of glucose variability and/ or other elements on maternal and neonatal outcomes in the obese diabetic patient. We hypothesize that glucose variability will be a stronger indicator of neonatal outcome than A1c or any single given blood glucose value. Glucose variability, including the magnitude of hyperglycemia or the incidence of acute maternal hypo- or hyperglycemic events, will be explored. We hypothesise that obese pregnant women with higher magnitude of glucose fluctuations have more maternal and fetal co morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Women with diabetes in pregnancy of any age, any ethnic background who deliver at St. Mary's Health Center, 1/1/2000 to 5/18/2014.

Exclusion Criteria:

* Data collected ager 5/18/2014
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of LG00034053 in Patients With Knee OA

This study is a multi-center, randomized, placebo-controlled, double-blind clinical study, consisting of Part 1 (Phase 1b) in a sequential, dose-escalating design and Part 2 (Phase 2) in a parallel design.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary osteoarthritis of the knee according to the ACR clinical criteria, with Kellgren-Lawrence grade 2 to 3 in the corresponding knee as determined in the X-ray test
* Patients with pain in the index knee requiring NSAIDs or analgesics which sustained for at least 6 months
* Patients with a score of ≥ 4 and ≤ 9 in response to question 1 (walking pain) on the WOMAC pain subscale (11-point NRS)
* Patients with the subtotal score of ≥ 20 and ≤ 45 on the WOMAC pain subscale (11- point NRS)
* Patients with BMI at or below 40 kg/m2

Exclusion Criteria:

* Patients with chronic pain requiring continuous treatment
* Patients with rheumatoid arthritis or other inflammatory arthritis
* Patients with skin disorders at the administration site
* Patients with clinically significant renal or cardiovascular disease or those with suspected SARS-CoV-2 infection
* Patients in a medical condition which may affect the efficacy and/or safety assessment
* Patients with Kellgren-Lawrence grade 4 in the contralateral knee
* Patients with tense effusion
* Patients having administered an opioid analgesic/ other analgesic/health functional foods, single dose of IA injection within a certain period prior to drug administration
* Patients having undergone knee replacement
Gut Flora and Lipid Metabolism

It is well known that metabolic responses to diet and drugs are affected by genetic and environmental factors. Still, a large part of differences in responses between individuals remains unexplained. To increase our understanding of individual differences, more and more attention is paid to the role of intestinal microbiota. Not only energy and glucose may be related to the microbiota, but also lipid metabolism. This is not surprising as lipid metabolism, glucose metabolism, and obesity are closely linked.

There is substantial evidence from in particular animal studies that the gut microbiota is related to lipid and lipoprotein metabolism. However, there is less evidence to what extent modulation of the gut microbiota changes lipid and lipoprotein metabolism in humans.


Eligibility Criteria:
Inclusion Criteria:

* aged between 18-70 years
* serum total cholesterol: 5-8mmol/L

Exclusion Criteria:

* serum triacylglycerol \> 3.0mmol/L
* use of oral anticonceptives
* pregnant or breastfeeding women
* kidney insufficiencies
* unstable body weight
* allergy to antibiotics
* treatment with cholesterol-lowering drugs
* use of medication or a medically prescribed diet
* active cardiovascular disease
* abuse of drugs
* more than 21 alcohol consumptions per week for men and 14 consumptions for women
* use of an investigational product within the previous 30 days
* not willing to stop the consumption of products rich in plant stanol or sterol esters 3 weeks before start of the study
* use of gastric acid inhibitors, laxantia, prebiotica, probiotica and antibiotica for at least one month before the start of the study and during the study
Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function

Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* negative sensation of digestive well-being (score ≤ 1 on at least 2 of the 6 evaluation days, scored on a - 5 / +5 scale.
* poor tolerance of a gas challenge test (abdominal perception score ≥ 3, on a 0-6 scale, for at least three 15-min time points over the last 90 minutes of the 180-minute-long intestinal gas infusion test).

Exclusion Criteria:

* antibiotic intake,
* exceptional diets,
* changes in dietary habits or intake of Ca supplements over the preceding month.
Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Laparoscopic Bariatric Surgery

The purpose of this study is to compare volume controlled-ventilation (VCV) and pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric surgery.

Today, morbid obesity has become a global problem. It is not clear which mechanical ventilation mode will be used in bariatric surgery, which is one of the treatment options of these patients. VCV is the most commonly used mode to ventilate anesthetized patients. However, especially in obese patients, high airway pressures and hypoxia may occur due to increased intrapulmonary shunts. Therefore, we aimed to investigate the potential of PCV strategy to improve pulmonary gas exchange, respiratory mechanics and arterial blood gas values according to VCV in patients undergoing bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or above,
* ASA II patients
* BMI \> 40 kg / m2
* No serious comorbidity.

Exclusion Criteria:

* Unstable patients during the operation
* The requirement for mechanical ventilation in the postoperative period.
Effect and Utilization of Protected Time Among Interns on Extended Duty-Hour Call Shifts

This study will test the feasibility and effectiveness of protected time for physicians in training during 30 hour shifts in a medical intensive care unit. The primary outcome will be fatigue. Secondary outcomes include the amount slept while on call, depression, and burnout.

Background: The Institute of Medicine has proposed 5 hour naps for residents on extended overnight call-duty shifts citing resident and patient safety. Concerns raised about this recommendation include increased handoffs, truncated continuity, and if residents would be able to effectively use the protected time for sleep.

Objectives: The purpose of this study is to test if protected time for sleep during extended duty overnight shifts improves resident fatigue and if they actually utilize the time for sleep.

Methods: All interns rotating through the medical intensive care unit from October 2009 through October 2010 will work extended shifts every 3rd night. On Sunday through Thursday nights they will have a 5 hour protected period from 2 AM to 7 AM. During this time they will relinquish their pager and cell phone to the Night Float PGY2 or PGY3 who is already responsible for the ICU patients. The four hours between 2 and 6 am are entirely protected. From 6 AM to 7 AM, interns will be expected to start computer rounding on the ICU patients and to begin progress notes for the remaining members of the ICU team but still have no pager, cell phone, or cross coverage duties. On Friday and Saturday nights there will be no protected time but these interns will have 42 consecutive hours off following their extended shift.

Results from the October 2009 to October 2010 protected time cohort of interns will be compared with two comparison groups from the same institution and the same medical intensive care unit during the academic year June 2008 to June 2009. The first comparison group is interns working 30 hour shifts every 3rd night without any protected time and an average of 80 hours per week. The second comparison group is interns working a maximum shift length of 16 hours and an average of 60 hours per week.

The primary outcome will be measurement of fatigue (daytime multiple sleep latency tests). Secondary outcomes include the amount slept as measured by actigraphy, assessment of burnout (Maslach Burnout Inventory) and depression (Beck Depression Inventory-II).

Eligibility Criteria:
Inclusion Criteria:

* Interns in the Providence St. Vincent Medical Center Internal Medicine Residency Program who are rotating through the medical intensive care unit.

Exclusion Criteria:

* Refusal to consent to participate