cyrilzakka/clinical-trials huggingface dataset:
Soybean Based Diets and CVD Risk Factors

To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.

Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

Eligibility Criteria:
Inclusion Criteria:

Plasma LDL-C \>120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.

Exclusion Criteria:

Soy allergy, Smokers, Consuming \>2 alcoholic drinks per day, Pre-menopausal women.
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily \[QD\] vs twice daily \[BID\] application) for the future clinical development of topical PF-06700841.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Atopic Dermatitis for at least 3 months
* Investigator's Global Assessment (IGA) Score of 2 or 3
* Eczema Area Severity Index (EASI) score of 3-21
* Body Surface Area (BSA) of 2-20%
* Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

* Other forms of dermatological diseases (other than atopic dermatitis)
* Fitzpatrick skin type score greater than 5
* Clinically significant abnormal ECG, vital signs, and laboratory values
* Infection with HBV, HCV, herpes zoster or tuberculosis
Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent inject devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Phakic study eye
* IOP ≥ 21 mmHg and ≤ 40 mmHg at the screening visit (subjects with OHT require a second screening IOP measurement

Exclusion Criteria:

* Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs)
* Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma
Volume Deficit Prior to Surgery

It is the purpose of the researchers to identify the variation in intravascular deficits which can have relevance in high risk patients for minor and medium sized surgery.

The investigators will also estimate fluid deficit in healthy, non-fasting subjects for comparison.

Intravascular volume optimization has shown to improve outcome after surgery. In minor and medium surgery , however, the preoperative volume deficit has not been estimated with functional parameters. Patient scheduled for minor surgery are included. After the patient is anesthetized the intravascular volume is optimized by stroke volume maximization by colloid boluses. Stroke volume is obtained by esophageal Doppler technique which is a minimally invasive method.

The volume estimated for optimization is considered as the functional volume deficit.

In the healthy subjects the probe will be placed in the awake subject. A standardized meal and fluid intake secures that the subjects are in a non-fasting state.

Eligibility Criteria:
Inclusion Criteria:

* Planned minor or medium sized surgery

Exclusion Criteria:

* Oesophageal pathology
* Age \>90 yr or \< 18 yr
* Alcohol abuse,
* Insulin dependent DM
Integrated Pulmonary Index as a Predictor of Respiratory Compromise in Critically Ill Patients

The integrated pulmonary index (IPI) is a newly developed index for respiratory monitoring. However, there is limited evidence on its effectiveness and usefulness in critically ill patients. The purpose of this study is to evaluate the clinical relevance of the IPI as a predictor of respiratory compromise in critically ill patients.

Recent developments aim to use multiple parameters to detect AREs. Application of smart algorithms that combine individual physiological variables into one index may increase the ability to detect a true adverse respiratory event while avoiding false alarms and limiting alarm fatigue.

An example of such a multiparameter index is the Integrated Pulmonary Index or IPI™, which integrates oxygen saturation (SpO2), respiratory rate (RR), end-tidal PCO2 (PETCO2) and heart rate (HR) into a single integer value of 1-10 that represents adequacy of respiratory condition of the patient using a fuzzy logic inference mathematical model; scores ≥ 8 points are within normal range and those ≤ 4 points suggest requirement of interventions.

The IPI algorithm summarizes the state of ventilation and oxygenation at the point in time. Previous studies reported that IPI correlated with respiratory physiological parameters of patients undergoing sedation for surgeries or for colonoscopy.

Up to our knowledge, the clinical relevance of the IPI as a predictor of respiratory compromise in critically ill patients has not been discussed before.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients aged 18 years or older of both genders admitted to the intensive care unit

Exclusion Criteria:

* Age \< 18 years' old
* Morbid obesity
* Mechanical ventilation
* Hemodynamic instability.
* Thoracotomy and cardiac surgery
Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD

The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of Yi-Qi-Qing-Jie formula (YQF) combined therapy compared with immunosuppression monotherapy in high-risk IgAN.

The investigators plan to randomize 60 participants with biopsy-proven IgAN to a YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-YQF combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter a 48-week in-trial treatment phase and receive post-trial follow-up until 50% (30/60) have a composite endpoint or have been followed for 3 years (study completion). All patients will receive optimal supportive care.

Eligibility Criteria:
Inclusion Criteria:

1. patients who maintain regular follow-ups at Guang'anmen Hospital, agree to participate, and provide informed consent;
2. biopsy-proven IgA nephropathy, with recent progression to high-risk IgAN\*;
3. eGFR 15 to 60 ml/min/1.73 m2, calculated with the use of CKD-EPI Creatinine Equation 2009.

   * High-risk IgAN: persistent proteinuria ≥ 1 g/d despite at least 8 weeks of optimal supportive care \[maximally tolerated RAS blocker which refers to no symptomatic hypotension, no hyperkalemia, and serum creatinine increased by not more than 30% of baseline, blood pressure control meeting targets (135/85 mmHg or lower), and dietary management (sodium intake less than 6 g/d, protein intake of 0.6-0.8 g/kg/day, and low-fat diet)\], the mean annual eGFR decline rate (eGFR-slope) \>10 ml/min per 1.73 m2 per year, while needing to restart immunosuppressive therapy; or eGFR\<60 ml/min/1.73 m2 at the first diagnosis.

Exclusion Criteria:

1. secondary IgAN;
2. comorbidity of other primary or secondary glomerular diseases;
3. comorbidity of severe primary diseases such as cardiovascular, hepatic, cerebral, and hematopoietic system diseases or mental disorders;
4. allergy or intolerance to the experimental medication (e.g., RAS blockers, prednisolone, cyclophosphamide, YQF compound and its placebo compound);
5. contraindications to immunosuppression therapy-acute and chronic infectious diseases, malignancies, leukopenia, thrombocytopenia, gastrointestinal hemorrhage, ulcers of stomach or duodenum, post-transplantation;
6. pregnant or lactating women;
7. unwilling to participate in this study, failure to accept or tolerate Chinese medicine compound;
8. history of alcohol or drug abuse;
9. poor compliance, loss to follow-up;
10. participation in another clinical investigation.
The Effect of Sponge Versus No-Sponge Placement of Mitomycin-C on the Outcomes of Trabeculectomy With Ex-PRESS Glaucoma Filtration Device

The primary focus of this study is to assess intraocular pressure and complication rates between patients who receive mitomycin-C using a sponge versus no-sponge.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women aged 18 years and older at screening.
2. Diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma.
3. Suitable candidate for trabeculectomy with Ex-PRESS glaucoma filtration device with MMC in the superonasal quadrant in the study eye which the physician deems as medically necessary.
4. Capable and willing to provide consent

Exclusion Criteria:

1. Unable or unwilling to provide consent
2. Any previous ocular surgeries in the study eye preventing placement of the trabeculectomy with Ex-PRESS glaucoma filtration device with mitomycin-C in the superonasal quadrant
3. Any previous glaucoma drainage devices in the study eye
4. Any abnormality other than glaucoma in the study eye that could affect applanation tonometry.
5. Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
6. Presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1.
7. Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
8. Known Pregnancy or Breastfeeding

   Physical and Laboratory Findings
9. Conjunctival scarring precluding a superonasal implantation location.
10. Vitreous in the anterior chamber.
11. Abnormality preventing reliable applanation tonometry in the study eye.
Overlaying a Visual Wound Trace Onto Its Thermal Image in a Wound Clinic

The purpose of this study is to test and evaluate how well a medical imaging device that takes both visual and thermal pictures of wounds or body surface areas of interest can help collect added information about the wounds or body surface areas of interest in a wound clinic.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or greater, of either gender and of any ethnic background
* Able to tolerate position change(s) and turns for up to 10 minutes comfortably
* Have an existing external wound or body surface area of interest:

  * External wound or body surface area of interest must be in separate body locations (ex: one on the right heel, one on the left heel, and the other on the sacrum)
* Have qualifying external wound or body surface area of interest:

  * External wound or body surface area of interest that fits entirely within the field of view and does not wrap around a body edge
  * No device or treatment will obscure the external wound or body surface area of interest

Exclusion Criteria:

* Neonatal and pediatric patients
* Pregnant women
* Cannot tolerate position changes for up to 10 minutes comfortably (per external wound site imaged)
* On therapies or treatments which cannot be safely suspended long enough to conduct an imaging session as determined by facility policy
* Have a wound dressing or medical device which cannot or should not be removed as determined by site investigator
* Have an external wound with excessive or heavy exudate that cannot be controlled during the imaging session. Excessive drainage can obscure external wound features.
* If the patient has a complex external wound:

  * The external wound wraps around a body edge or otherwise cannot be imaged entirely within the visual field of view.
  * From visual assessment, the external wound edges are not definable and/or cannot be clearly distinguished from other conditions near external wound (E.g. breakdown or the deterioration of the surrounding body surfaces due to other conditions such as cancer or other types of ulcers makes determining the edge of the external wound impossible).
* Have not provided signed informed consent
* Non-English speaking
* Subjects in isolation
Effect of Early Prosthetic Fitting in Patients With Below Knee Amputation

A randomized control trial of 50 patients to identify the effect of early prosthetic fitting and physical rehabilitation. Previous studies show a significant impact of early induction of prosthetic rehabilitation of amputation.

Delayed rehabilitation may cause severe physical complications like joint contracture, muscle strength loss. Along with physical complications delayed in rehabilitation may also significantly affect psychological, economical and quality of daily life. Pakistan is a low income under developed country and major cause of amputation in here is traumatic amputation, that will effect mostly the younger age people. After missing a precious body part if the amputee comes along with such kind of physical and Psychological complications, his/her whole daily life will be effected. There is a keen need of implementation of global rules for physical rehabilitation of amputees and disables including the duration of induction of prosthetic as well as overall physical rehabilitation after surgical and traumatic removal of limbs.

Eligibility Criteria:
Inclusion Criteria:

* Male and female below-knee amputees due to trauma and diabetes

Exclusion Criteria:

* patients with comorbidities
* old user of prosthesis
Minimal Optimal Dose of Sugammadex in Elective Surgery

Time of appearance of TOF Ratio \>0,9 with different doses of Sugammadex

Design: monocentric, prospective, controlled, randomized, double-blind study Inclusion criteria: women and men\> 18 years old, elective surgery, BMI \<30, patients giving consent to free and informed participation in writing;

Exclusion criteria:

* minor patients;
* Patients refusing to sign the consent;
* Patients included in another protocol within 3 months;
* Pregnant or lactating patients;
* Patients with a history of allergy to Sugammadex;
* Patients with known neuromuscular disease;
* Patients with renal or hepatic impairment.

Course of the study :

* 40 patients will be recruited at the time of the anesthesia consultation and randomized to double blind in 8 groups (the day before surgery)
* All patients will benefit from general anesthesia. Anesthetic management

  (1- 3mg / kg / IV propofol, 0.2 μg / IV sufentanil, 0.6 mg / kg rocuronium and maintenance anesthesia with sevoflurane) will be standardized for all patients.
* Upon administration of rocuronium the acceleromyography transducer will be attached to the distal phalanx of the thumb, and repeated TOF stimulation will be applied to the ulnar nerve wrist at intervals of 15 seconds. Neuromuscular monitoring is continued until the end of the anesthesia.
* Once the first answer (1st twitch) appeared a dose of sugammadex will be administered according to the group whose patient was randomized: Test Groups Control Groups Group 1: Placebo + TOF 1 Group 1bis: Placebo + TOF2 Group 2: 0.5 mg / kg + TOF1 Group 2bis: 0.5 mg / kg + TOF2 Group 3: 1mg / kg + TOF1 Group 3bis: 1mg / kg + TOF2 Group 4: 2mg / kg + TOF 1 Group 4bis: 2mg / kg + TOF 2
* Then a standard dose of 4mg / kg will be administered at the end of the procedure before awakening to all patients who have signs of residual curarization (TOF ratio \<0.9). The pharmacy will be responsible for preparing the different doses of sugammadex, the syringe will be carefully covered and packaged, will contain an equal volume so that the anesthetists do not know which group the patient belongs to. Data collection: In real time during the intervention by the anesthesiologist in charge of patient Method of Analysis: Analysis of intent-to-treat data

Eligibility Criteria:
Inclusion Criteria:

women and men\> 18 years of age Elective Surgery BMI \<30, patients who gave consent to free and informed participation in writing

Exclusion Criteria:

* minor patients;
* patients refusing to sign consent;
* patients included in another protocol within 3 months;
* pregnant or nursing patients;
* patients with a history of allergy to Sugammadex;
* patients with known neuromuscular disease
* patients with renal or hepatic impairment.
Prognostic Factors for Acute Pulmonary Embolism in Critically Ill Patients

Acute pulmonary embolism (PE) is an important cause of in-hospital mortality and may be rapidly fatal if not diagnosed and treated. Despite recent advances in diagnostic and therapeutic modalities, it is still one of the important causes of hospital mortality. Previous several reports have described the variable outcome of patients with PE with reported mortality rate ranging from 8.1% (stable patients) to 25% (with cardiogenic shock) and 65% (post cardiopulmonary resuscitation). Nevertheless, there are no published studies from Korean hospitals that assessed the outcome of acute PE treated in the hospital with IV unfractionated heparin. We conducted this study to determine the outcome, risk factors, clinical characteristics and demographics of patients with acute PE and to identify possible demographic and clinical factors associated with prognosis.


Eligibility Criteria:
Inclusion Criteria:

patients admitted to the Severance Hospital, Yonsei University Health System with primary diagnosis of PE between January 2008 and December 2012. (diagnosed by CT and treated in the hospital with IV unfractionated heparin)

Exclusion Criteria:

1. diagnosis was prior to arrivalor
2. anticoagulation was contraindicated
3. diagnosis was not confirmed by CT
CYP2C19 Genotype Predictor of Gastric Acid Suppression

If CYP2C19 genotype can predict the efficacy of healing erosive esophagitis and gastric acid secretion in patients taking once a day omeprazole.

Proton pump inhibitors are metabolized through the CYP2C19 hepatic enzyme system. Several variant genotypes of this enzyme exist which may lead to decreased, normal or increased metabolism of the proton pump inhibitor. With alteration of metabolism, the degree of gastric acid suppression achieved and efficacy in treating reflux could be affected. For example, Asian populations who have low activity of CYP2C19, commonly need lower doses of proton pump inhibitors to manage gastroesophageal reflux because of more sustained blood levels and availability of the drug. Theoretically, those patients who are rapid metabolizers would receive less effective treatment with proton pump inhibitors

Eligibility Criteria:
Inclusion criteria:

* Age 18 or older
* Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
* Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.

Exclusion criteria:

* Neoplasm of the esophagus or stomach
* Use of drugs that interfere with CYP2C19 metabolism Diazepam, phenytoin, amitriptyline, clomipramine, clopidogrel Cyclophosphamide, progesterone, fluoxetine, fluvoxamine, ketoconazole Lansoprazole, omeprazole, ticlopidine
* Evidence of active H. pylori infection
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Predictors of Future Type 2 Diabetes Mellitus in Circassians Minority in Israel

The aim

The aim of the present study is:

1. The metabolic risk factors that can predict diabetes after 10 years in a Circassians population-based sample of people who were aged 35 years or older and living in Israel.
2. To define the incidence of type 2 diabetes mellitus in Circassians minority in Israel.

The hypothesis of the study:

High fasting glucose has the most powerful predictive value for type 2 diabetes mellitus in the future.

The claimed importance of the study:

Finding a powerful risk factor for future diabetes mellitus can contribute to intensifying the preventive measures in a small part of the population, by that to reduce the incidence of new diabetes without increasing the health cost.

Research design and methods The present study is a 10 year, nested prospective cohort, population-based survey of the metabolic syndrome risk factors including type 2 diabetes mellitus. The original cross-sectional survey was conducted in two small Circassian villages in north Israel with 4000 inhabitants. The baseline evaluation was performed between 1996 and - 1997. Among the 739 randomly selected men (n=289) and women (n=450 of the 4000 individuals who were aged 35 years or older. Mean age of men was 53.2±11.8 years and of women was 52± years. Mean BMI for men and women was 27.5± and 29.4± Kg/m2, respectively. Plasma glucose level for men and women was mg/dL(22).

The investigators will recruit the same cohort in the proposed study and individuals who were free of diabetes at base line will be included. The number of deceased changed their residence and those who will decline to participate in the follow-up study will be reported.

The protocol was approved by the Ethics Committee of the Ziv hospital and all participants will give an informed consent.

Clinical data. Body mass index (BMI), fasting blood glucose, blood total cholesterol, triglycerides, low density cholesterol (LDL), high density cholesterol (HDL) and blood pressure measurements were done 10 years ago. In the present study, after 8 hours of caloric fast, blood glucose levels will be tested and patients will be asked about known recent diabetes mellitus in the last 10 years or treatment by dietary, hypoglycemic drugs or insulin.

Laboratory data. In the morning, after an overnight caloric fast, venous blood will be sampled for the measurement of plasma concentrations of glucose. The blood levels of glucose will be done by Olympus 640 at ZIV hospital. Diagnosis of diabetes. At baseline and at the 10-year follow-up, the presence of diabetes will be established according to World Health Organization (WHO) criteria (84), i.e., when fasting glucose will be ≥126 mg/dl or when the participants will have a clinical diagnosis of the disease and treatment was ongoing (diet, drugs).

The presence of the disease will be confirmed by reviewing the medical records of their general practitioners. No case of diabetes will be accepted without a validated confirmation.

Eligibility Criteria:
Inclusion Criteria:

Previous participation in similar study which was occured 10 years ago

Exclusion Criteria:

none