cyrilzakka/clinical-trials huggingface dataset:
Efficacy of KOVIR Capsule in the Combination Regimen With Background Treatment in COVID-19 Patients

The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms vary from fever or chills, cough, shortness of breath, to muscle aches, headaches, loss of taste or smell.

The capsule KOVIR is a product based on the traditional medicine named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.

The acute pneumonia pandemic caused by a new strain of corona virus 2019, namely as COVID-19 by the World Health Organization (WHO), is a pandemic caused by SARS-CoV-2 virus. The reported symptoms have included, but are not limited to fever or chills, cough, shortness of breath, muscle aches, headaches, loss of taste or smell, diarrhea, dizziness, sore throat, abdominal pain, anorexia, and vomiting.

The capsule KOVIR is a product based on the traditional prescription named "Ren shen bai du san" which is used to treat the cold conditions, also known as the initial plague according to the theory of traditional medicine.

The study compares between standard dose regimen of KOVIR combined with background treatment in COVID-19 patients and only background treatment in COVID-19 patients. The study will enroll 700 participants to KOVIR group and 300 participant to Non-KOVIR group.

All participants will be treated and followed up in 14-day period. In case the participant meets the discharge criteria before 14 days, discontinuing the study drug will be done at the discretion of the investigators.

Screening procedures occur at Day 1. Periodic assessments are conducted daily from Day 2-14. Finally, End of study visit is conducted.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged from 18-65, Vietnamese nationality
* Participants diagnosed with Positive result of SARS-CoV-2 using real time RT-PCR test, Ct value \<30 (equivalent to viral load \> 3log)
* Voluntary participation in the study by signing an informed consent
* Ability to adhere to treatment according to the investigator's assessment

Exclusion Criteria:

* Symptoms of severe upper and lower respiratory tract infections such as dyspnea, SpO2\<93%.
* Acute reduction of ventilation function of respiratory apparatus and/or respiration function of the lung in any of the following three groups:

  * Respiratory distress due to hypoxemia with PaO2 less than 60mmHg when breathing room air.
  * Respiratory distress due to hypercapnia with PaCO2 above 50mmHg
  * Mixed respiratory distress accompanied by both a decrease in PaO2 and an increase in PaCO2
* Allergy/intolerance to any component of the study drug.
* Inability to administer medicine.
* Severe pneumonia as assessed by the investigator.
* Inability to comply with study procedures or to ensure compliance with study drug administration as assessed by investigators.
Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery

The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.


Eligibility Criteria:
Inclusion Criteria:

* ASA I and II female or male patients undergoing wisdom teeth extraction
* Aged 18-70 years
* Scheduled for ambulatory surgery requiring postoperative pain medication

Exclusion Criteria:

* Weight less than 70% or more than 130% of ideal body weight
* Neurological disorder
* Recent use of psycho-active medication, including alcohol
* Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
* Use of chronic anti-emetic medication
* Use of chronic corticoid therapy
Effects of Aquatic Exercise on Post-exercise Hypotension

This is a randomized controlled trial. The present study involves an acute and chronic intervention, which is a water-based exercise (one session: to acute intervention; 12-weeks of aquatic exercise program: to chronic intervention). The sample will be composed by elderly enrolled in university extension program titled "Hidroginastica na Terceira Idade" (Hydrogymnastics in aging). It will be evaluated the effects of water-based exercise on hemodynamics, self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity. The investigators hypothesized that an acute water-based exercise under different intensities promotes hemodynamics changes in elderly. In addition, the investigators hypothesized that 12-weeks of aquatic exercise may lead improvements in self-reported sleep quality, depressive symptoms, quality of life, body composition, level of physical activity and functional capacity in elderly.


Eligibility Criteria:
Inclusion Criteria:

* Elderly (60 years and over)
* Able to practice physical exercise in water
* Able to answer all questionnaires
* Non-smoker

Exclusion Criteria:

* Morbid obese
* Those who not complete all data collection procedures
New Mechanisms of Obesity

Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.

Pediatric obesity is a major health burden affecting millions of children and adolescents as it predisposes to the development of cardio-metabolic diseases early in life, such as insulin resistance, fatty liver disease and type 2 diabetes. Investigators have recently completed a series of studies to understand the relationship between the intestinal microbial activity and human metabolism in youth. It was observed that intestinal fermentation, a process through which fermentable carbohydrates are processed by intestinal bacteria, results in a variety of biological responses aimed at protecting the human body from developing obesity and some of its metabolic complications, such as insulin resistance and ectopic fat accumulation. In particular, investigators observed that intestinal fermentation causes 1- a reduction of plasma free fatty acids (FFA), due to the inhibition of adipose tissue lipolysis (ATL); 2- a marked entero-endocrine response to reduce appetite, characterized by an increase in the production of peptide YY (PYY) and glucagon-like peptide1 (GLP-1) and a reduced production of ghrelin. In addition, investigators observed that some intestinal fermentation responses are impaired in youth with obesity and insulin resistance (OIR). In light of this evidence, the current proposal will address: 1- how adipose tissue lipolysis response to intestinal fermentation is affected by insulin resistance; 2- whether changes in ATL, observed when fermentation occurs, are also associated with a reduction of glycerol derived neo-gluconeogenesis; 3- if physical activity may restore the entero-endocrine and adipose tissue response to intestinal fermentation in youth with insulin resistance. This is the first study to test the effect of insulin resistance on the relationship between intestinal microbial metabolic activity and human metabolism (namely adipose tissue lipolysis, gluconeogenesis and entero-endocrine response). The results obtained will provide fundamental insight into how insulin resistance occurring in youth with obesity affects the metabolic response to fermentable carbohydrates. In fact, despite the large body of literature showing an association between intestinal microbial fermentation and human metabolism, how and whether insulin resistance may modulate this association remains unknown.

Eligibility Criteria:
Inclusion Criteria:

* Age 15 to 22 years
* In puberty (girls and boys: Tanner stage III-V);
* BMI \>85th

Exclusion Criteria:

* Pregnancy;
* endocrinopathies (e.g., Cushing syndrome);
* substance abuse;
* medications affecting insulin resistance such as metformin, GLP-1 analogues; -
* high fibers intake (\> 30g/day) as assessed by a 3-day food record.
Renal Manifestations of IBD

To detect whether patients with inflammarory bowel disease (IBD) have some degree of renal involvement and also to determine if associated with disease activity or not.

Inflammatory bowel diseases (IBD) comprise two types of chronic intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). CD involves the ileum and colon, but it can affect any region of the intestine, often discontinuously. UC involves the rectum and may affect part of the colon or the entire colon (pancolitis) in an un interrupted pattern. In Crohn's, the inflammation is often transmural, whereas in Ulcerative colitis the inflammation is typically confined to the mucosa . The extraintestinal manifestations of IBD are common and may occur in 25%-40% of patients. Inflammatory manifestations in the skin, eyes, liver and joints are considered primary manifestations. Development of primary extra intestinal manifestation appears to increase the risk of developing a second extra intestinal manifestation. Most IBD patients with extra intestinal manifestations have colonic inflammation, although some patients develop them prior to the onset of colonic symptoms. Extra intestinal manifestations are usually present at the time of active phase of IBD . In recent years, there have been reports on renal and urologic complications of IBD. They were mostly found to be related to ureteral obstruction by oxalate stones, cystitis, acute tubular necrosis due to volume depletion and AA amyloidosis. Nephrolithiasis and obstructive uropathy are especially seen with small bowel dysfunction. In a great proportion of IBD patients, ureteral obstruction is not caused by stones. This non calculus obstruction can occur in 50%-73% of CD patients and 50% of UC patients, and is usually caused by retroperitoneal local inflammation or by surgical complication (sutures) or colon cancer . There have also been reports of interstitial nephritis, mainly due to applied anti-inflammatory therapy, such as 5-aminosalicylic acid (5-ASA). Serious renal impairment is reported to occur in 1 of 500 patients treated with 5-ASA derivative. On the other hand, there are some reports that renal tubular damage is an extra intestinal manifestation of IBD and not a toxic side effect of anti-inflammatory therapy using 5-ASA or sulfasalazine. Furthermore, renal failure due to glomerulonephritis (GN) caused by the immune complex has been reported in several cases as an extraintestinal manifestation of IBD.

Eligibility Criteria:
Inclusion Criteria:

- A ny patients with IBD

Exclusion Criteria:

Pregnant kidney disease
Simulation of Facial Soft Tissue in Orthognathic Surgery

Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect.

The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 ;
* Patients who have been informed of the study and who have freely given their informed consent to participate in the study;
* Patient undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.);
* Patient covered by a French social security scheme

Exclusion Criteria:

* Patient with maxillary disjunction ;
* Patients with facial malformations;
* Pregnant or breast-feeding patient;
* Patient under guardianship;
* Patients who do not understand French;
* Patients under court protection
* No pre- or postoperative CT scan or CT scan that cannot be used
* Surgery, trauma, progressive infection or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation

The objective of the present study is to investigate the effect dexamethasone and hyaluronic acid have on hearing preservation

Many efforts have been made to prevent residual hearing loss after cochlear implantation, such as the development of soft surgical techniques and pharmacological protection.

In this study we investigate whether the topical application of dexamethasone and hyaluronic acid prevents residual hearing loss.

Eligibility Criteria:
Inclusion Criteria:

* Adults (greater than 18 years old) with severe/profound, bilateral sensorineural hearing loss with indication of cochlear implantation.
* Hearing thresholds better than 80 dB in 125 Hz, 90 dB in 250Hz and 100 dB in 500, 1000, 2000, 3000 and 4000 Hz in at least 3 of these frequencies

Exclusion Criteria:

* Malformation or cochlear ossification
* Developmental Disabilities
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

We have developed novel Brillouin microscopy and we are testing its potential for keratoconus and ectasia diagnostics. We plan to perform axial scans of the cornea in human volunteers in order to compare biomechanical properties of Keratoconus vs. Normal corneas and compare biomechanical properties of post-LASIK ectasia vs. normal corneas.


Eligibility Criteria:
Inclusion Criteria:

Group I includes healthy subjects with normal appearing corneas, normal topography and pachymetry. Group II includes patients diagnosed as having mild, moderate or advanced keratoconus by our ophthalmology expert on the basis of topography and pachymetry. Group III includes healthy subjects who have undergone LASIK surgery in the past 12 months without complications. Inclusion criteria include normal post-operative topography and pachymetry. Group IV includes patients (age 20 - 60) who have undergone LASIK surgery at least 12 months before the study imaging and have been diagnosed with post-LASIK ectasia based on topography, pachymetry and clinical evaluation.Patients diagnosed with keratoconus. Group V- Volunteers to receive PRK surgery This group includes patients who have been diagnosed with myopia and have been scheduled to undergo PRK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen or artificial tears will be excluded. Group VI-Volunteers to receive LASIK Surgery This group includes myopic patients who are scheduled to receive LASIK surgery. Patients with high astigmatism \> 2 diopter, prior ocular surgeries, and those patients taking any ocular medications except seasonal allergy medicine such as ketotifen and artificial tears will be excluded. Group VII- Patients with Fuch's Endothelial Corneal Dystrophy. This group includes subjects who are diagnosed with Fuch's corneal dystrophy, at early, mild and advanced stages. The inclusion also extends to subjects with, and without keratoconus. But this exclude patients with any other corneal disorders other than keratoconus, and/or history of ophthalmological surgeries that may affect endothelium cell status, e.g. cataract surgeries.

Overall Exclusion Criteria for all groups: Volunteers who

* Have occludable narrow angles (without a patent peripheral iridotomy)
* Monocular subjects
* Do not or cannot understand the instructions for the imaging
Investigation of Performance and Compatibility of the Baxter Dialyzer Xenium XPH 210 During On-line Hemodiafiltration

The proposed study seeks to determine the appropriate balance between the removal of undesirable small molecular substances (urea, creatinine, phosphate) and large molecular substances (ß2-m) and the retention of important substances (e.g.albumin) for the Baxter Xenium XPH dialyzer type under defined therapeutic conditions of olHDF primarily concerning filtration flow rates in relation to blood flow/plasma water flow rates. Furthermore the possibility of the removal of certain protein-bound substances shall be investigated together with the impact of increasing ultrafiltration on the parameters of the micro-inflammation.

The new high flux dialyser membrane Xenium XPH 210 from Baxter will show an considerably increased removal of ß2-Microglobulin with olHDF in post dilution mode together with a markedly increased removal of small molecules (urea, creatinine, phosphate). The loss of albumin will depend on the treatment modalities. However, the albumin permeability is tolerable over the whole range of total filtration rate selected and applied to the patients.

Together with the albumin loss into the filtrate/dialysate a small amount of albuminbound substances is detectable.

Parameters of micro-inflammation can be influenced by an increasing convective part of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed an informed consent form.
* Patients between 18 and 75 years.
* Patients who have been treated with hemodialysis for more than three months.
* Patients who are treated three times a week for 4-5 hours.
* Patients who are usually treated with high-flux dialyzers.
* Patients who are on a stable anticoagulation and erythropoetin regimen.
* Patients whose hematocrit is over 28 %.
* Patients having no vascular access related problems.

Exclusion Criteria:

* Patients not meeting the inclusion criteria.
* Patients who are in a poor nutritional status as judged by the investigator.
* Patients in a gravid state.
* Patients with an unstable clinical condition (e.g. cardiac or vascular instability).
* Patients whose life expectancy is less than 12 months.
* Patients with a positive anamnesis for the first use syndrome.
* Patients with known coagulation problems.
* Patients who receive hemodialysis via a single dialysis needle or central venous catheter.
* Patients participating in another study that may interfere with the outcome of the present study.
Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.

Interim analysis will be carried out for every 50 subjects enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Patient must be willing to sign a a patient informed consent form.
* Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
* Target vessel reference diameter 2.5 to 8 mm.

Exclusion Criteria:

* Subjects pregnant or planning to become pregnant during the course of the study.
* Life expectancy of less than 1 year.
* Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.
Streaming Web-based Exercise At Home: A Pilot Study

This is a single-arm pilot study to evaluate the use of web-based video conferencing as a method of exercise training delivery. This study will include 10 female breast cancer survivors and 10 male prostate cancer survivors. For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist (EP) for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.


Eligibility Criteria:
Inclusion Criteria:

* Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer.
* For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable.
* For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment.
* Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across.
* Physically able to complete modified Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment.
* Physician clearance to participate in this study. Can be done through review of patients' medical records.
* Ability to read, write, and understand English.
* Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair).
* Ambulatory without assistance.
* Has a clear 5 x 6-foot space at home in which to exercise.
* Age \>18 years.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer.
* Known metastatic disease.
* Grade 3 or higher peripheral neuropathy.
* Major surgery within 3 months of baseline visit.
* Positive pregnancy test for women of child-bearing potential.
* Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician.
* Known allergy to Fitbit device.
* Currently meeting physical activity guidelines (score of \>23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).