cyrilzakka/clinical-trials huggingface dataset:
Axis™ Allograft Dermis for Female Pelvic Floor Repair: a Prospective Post Market Study

This study is a prospective, single arm, multi-center, post-market study to evaluate the efficacy of Axis™ Allograft Dermis used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.

The study population will be adult female patients with pelvic organ prolapse, POP-Q Stage ≥ 2 that are clinically indicated for surgical intervention with Axis Allograft Dermis in the anterior, posterior or combined (anterior and posterior) compartments.

Eligibility Criteria:
Inclusion Criteria:

* Adult female at least 18 years of age.
* Willing and able to provide written informed consent.
* Confirmed pelvic organ prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading requiring surgical intervention in the anterior, posterior or combined (anterior and posterior) compartment.
* Willing and able to complete all follow-up visits and procedures indicated in this protocol.

Exclusion Criteria:

* Concurrent surgical treatment of pelvic organ prolapse using anything other than the Axis Dermis.\[Note: concurrent mid-urethral sling placement for treatment of stress urinary incontinence is allowed\].
* Confirmed Stage 2 or higher prolapse as determined by POP-Q prolapse grading for a compartment that is not being repaired in the same procedure. (Concurrent POP-Q Stage 1 repair is at the physician's discretion.)
* Previous pelvic organ prolapse repair using biologic, or synthetic grafts. \[Note: previous mid-urethral sling for treatment of stress urinary incontinence is allowed\]
* Pregnant or a desire to become pregnant in the future.
* Previous radiation or other treatments for cancer in the pelvic area.
* Severe urogenital atrophy.
* Immunosuppression and/or current systemic steroid user.
* Any contraindication to the surgical procedure.
Zinc Supplementation Effect on Immune Recovery in HIV Patients

INTRODUCTION:

An adequate zinc supplementation is essential for a good immunological function. However, zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.

HYPOTHESIS

Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV patients after three months of daily consumption.

Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV patients after three months of daily consumption

GOAL:

To assess the effect of zinc supplementation in the natural history of HIV, emphasizing on the immunological recovery of patients in a health care provider program in Medellín in 2012.

METHODS:

A prospective, randomized, double-blind, controlled clinical trial will be conducted. The selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an HIV/AIDS program of a health care provider in Medellín. They will receive zinc supplements for 3 months. A comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. The CD4 lymphocytes value will be taken as an independent variable.

Eligibility Criteria:
Inclusion Criteria:

* Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy.
* Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count.
* Patients with body mass index over 18.5 kg/m2.
* Patients without opportunistic diseases.

Exclusion Criteria:

* Pregnant women.
* Hospitalized patients with cognitive disability evaluated by a doctor.
* Patients who are unwilling to participate.
* Patients taking zinc supplements.
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A

The purpose of this study is to compare the safety and pharmacokinetics of CKD-330 (fixed-dose combination of Candesartan 16 mg and Amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteer in the age between 19 and 45 years old.
2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
3. Subjects without a hereditary problems and chronic disease.
4. Subjects whose clinical laboratory test values are inside the accepted normal range.
5. Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria:

1. Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
2. History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
4. Subjects with galactose intolerance.
5. SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
6. AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
7. Serum Creatinine \> ULN
8. Previous history or present of drug abuse.
9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
11. Subjects treated IP within 2 months prior to the first dosing.
12. Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
13. Alcohol \> 21 units/week or cannot stop drinking.
14. Cigarette \> 10 cigarettes/day.
15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
16. Not eligible to participate for the study at the discretion of investigator.
TDM-optimized Teicoplanin Dosing Versus Standard of Care

Value of TDM for teicoplanin is not well defined. In this single-center low-interventional randomized trial the investigators aim to investigate the superiority of teicoplanin TDM-optimized using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment.

Teicoplanin is a glycopeptide antibiotic that is frequently used in the treatment of gram-positive bacterial infections.

The glycopeptide antibiotic vancomycin is currently the first choice of treatment against methicillin-resistant Staphylococcus aureus (MRSA), but teicoplanin is found to have a similar efficacy while showing less nephrotoxicity (4.8% vs 10.7%). Vancomycin dosing is based on therapeutic drug monitoring (TDM). In contrast to vancomycin, value of TDM for teicoplanin is not as well defined. In this study the superiority of teicoplanin TDM-optimized dosing using Model-Informed-Precision-Dosing (MIPD) of unbound concentrations versus the standard of care (dosing based on antibiotic guidelines) in target attainment will be investigated. The overall aim of this research is to improve antibiotic treatment with teicoplanin to allow safe and optimal treatment of glycopeptide susceptible strains and to prevent de novo development of resistance.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is admitted to the ICU, haematology, gastroenterology or orthopaedics department.
2. The patient is at least 18 years old on the day of inclusion.
3. The patient is treated with teicoplanin as part of standard care.
4. The patient or a representative is willing to sign the Informed Consent Form

Exclusion Criteria:

1. The patient has previously participated in this study.
2. The patient receives any form of renal replacement criteria (RRT) other than CVVHD / CVVHDF.
3. Expected duration of teicoplanin therapy is less than 5 days.
4. The patient is pregnant
Intestinal Microbiome and Extremes of Atherosclerosis

Patients attending stroke prevention clinics and a premature atherosclerosis clinic at University Hospital in London, ON, Canada were recruited to the study. They completed a dietary questionnaire, provided stool samples and had blood drawn to measure plasma levels of metabolites produced by the intestinal bacteria.

Patients were phenotyped by their residual score in linear multiple regression with measured carotid plaque burden as the dependent variable and coronary risk factors were predictors. The residual score essentially represents the distance off the regression line of predicted plaque. They were grouped into three categories: Unexplained atherosclerosis (with more plaque than predicted by risk factors; residual score \>2); Explained (the amount of plaque predicted by risk factors, residual score \>-2 and \<2); and Protected (less plaque than predicted by risk factors, residual score \<-2).

DNA was extracted from stool samples in the lab of Dr. Allen-Vercoe at University of Guelph. RNA makeup of the intestinal microbiome was assessed in the lab of Dr. Gregory Gloor at Western. Plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate were measured by ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry in the lab of Dr. Bradley Urquhart at Western.

Nutrient intake over the past year was calculated at the Harvard School of Public Health from the 131 item self-reported and semi-quantitative Harvard Food Frequency Questionnaire (FFQ).

Estimated glomerular filtration rate was calculated from the Chronic Kidney Disease Epidemiological (CKD-EPI) equations.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending stroke prevention clinics and a Premature Atherosclerosis Clinic at University Hospital, London, ON, Canada,
* with measurements of carotid plaque burden and the risk factors used in the linear regression model.
* Willing to consent to the protocol approved by the Ethics board

Exclusion Criteria:

* Missing data on variables used in the regression model,
A Study of LY3023703 Testing Pain Relief After Wisdom Teeth Removal

The main purpose of this study is to test if a single dose of LY3023703 relieves pain after wisdom teeth removal. The study will last about one week for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have at least 2 third molars which are clinically indicated for extraction. At least 1 molar should be a mandibular third molar with partial or complete bony impaction
* Are overtly healthy as determined by medical history and limited physical examination

Exclusion Criteria:

* Have chronic pain \[for example (e.g.), fibromyalgia\] or are experiencing episodic pain not related to the wisdom teeth (e.g., migraine pain) that could affect pain measurements as judged by the investigator
* Have temporomandibular joint disease or other condition which could affect pain processing or sensation, affect recovery from dental surgery, or otherwise affect ability to assess pain signal, in the opinion of the investigator
* Have substantial anxiety regarding dental or medical procedures as measured by the Corah Dental Anxiety Scale
* Are currently using or have recently used drugs that may confound assessment of the inflammatory response or pain including, but not limited to, nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin and other analgesics, antihistamines, steroids, antidepressants, attention-enhancing drugs, or herbal supplements
Epidemiological Study on Community Acquired Pneumonia

Long-term objectives of the basic research part are improvement of CAP-management with respect to therapy, diagnosis and prevention to contribute to a better care of patients with pneumonia.

Long-term objectives of the basic research part are improvement of CAP-management with respect to therapy, diagnosis and prevention to contribute to a better care of patients with pneumonia. The aim of the study CAPNETZ is to improve diagnosis, treatment and patient care.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* infiltrate on chest X-ray
* further Inclusion criteria: cough or production of purulent sputum or pathologic lung auscultation (crackles) or fever

Exclusion Criteria:

* hospital inpatient treatment within the last 28 days
* Immune suppressed patients
Nitrocamptothecin in Treating Patients With Soft Tissue Sarcomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic soft tissue sarcomas.

OBJECTIVES: I. Assess the efficacy and toxicity of nitrocamptothecin in patients with locally advanced or metastatic gastrointestinal leiomyosarcomas or other soft tissue sarcomas.

OUTLINE: Patients are stratified by disease (gastrointestinal leiomyosarcomas vs other soft tissue sarcomas). Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Responding patients who undergo surgery then receive an additional 4-6 courses (4 weeks/course).

PROJECTED ACCRUAL: A total of 34-78 patients (17-39 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed locally advanced or metastatic inoperable soft tissue sarcoma Measurable or evaluable disease that has not been irradiated Must have received, refused, or be not eligible for doxorubicin/ifosfamide treatment Previously untreated gastrointestinal leiomyosarcoma allowed

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No active coronary disease requiring therapy Pulmonary: No severe pulmonary insufficiency Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other prior malignancy in past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No concurrent active infections No psychosis or mental disability that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 7 days since prior biological therapy and recovered No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: At least 7 days since prior hormonal therapy and recovered Radiotherapy: See Disease Characteristics Surgery: Not specified
Comparison of Intraabdominal Pressure

Increased intra-abdominal pressure(IAP) might influence on perioperative morbidity related to increased CVP, PVWP, SVR, PAP and decreased venous return and cardiac output. Prone position has been known to increase IAP. In clinical field, various apparatuses has developed to minimize IAP elevation during prone position operation.

In this study, we would compare the changes of IAP and respiratory system compliance according to positional apparatus in prone position.

In clinical field, Wison frame, chest rolls and Jackson table have been widely used for prone position surgery. Among those apparatus, Jackson table has padded supports under the chest and pelvis, so that the abdomen can hang freely and prevent the abdominal compression. By reducing abdominal and thoracic pressure, Jackson table would reduce blood loss, and less effects on pulmonary mechanics. But few studies has known to compare IAP with other positioning apparatus such as Wilson frame or chest roll.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for prone positioned spinal surgery
* ASA Physical Status Classification System class I or II

Exclusion Criteria:

* Patients who did not agree
* BMI \> 30kg/m2
* Patients who did not insert urinary foley catheter
* Patients who have COPD or emphysema
* Patients who have severe spine deformities such as scoliosis
National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study)

Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy of the procedure has been sufficiently demonstrated and the Spanish Agency of Medication approved its application a few months ago. Being aware about the difficulties to a proper application and management of the stem cells the Spanish Stem Cell therapy group devised, in a joint activity with the Spanish Group GERM (Grupo Español de Rehabilitacion Multimodal) dedicated to expand the best surgical clinical practices, a national project for the application of the therapy. The objective is to get a homogeneous implementation in all hospitals in Spain that have being baked to use this biological therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older who have complex perianal Crohn ﬁstula
* non-active or mildly active luminal Crohn's disease for at least 6 months.
* The ﬁstula had to have been draining for at least 6 weeks before inclusion.

Exclusion Criteria:

• Patient with recto-vaginal ﬁstula; rectal or anal stenosis; or active severe proctitis.
Brain MRI in Stroke Patients With Intracardiac Thrombus

Acute infarction patterns have been described in cardioembolic stroke, mainly with atrial fibrillation (AF) or patent foramen ovale. We aimed to analyse acute infarction MRI characteristics in stroke patients with intracardiac thrombus (ICT) compared with stroke patients with AF.


Eligibility Criteria:
Inclusion Criteria:

* consecutive patients presenting with acute symptomatic cardioembolic infarction associated with ICT, recruited and registered in the stroke database between June 2018 and November 2019 of our centre (Nîmes University Hospital, France). These patients were compared with consecutive cardioembolic stroke patients with known or newly discovered AF (in the absence of ICT on echocardiography), recruited during the same time period.
* Brain MRI (including diffusion-weighted imaging \[DWI\]) performed within one week of symptom onset; complete etiological work-up including intracranial (time-of-flight \[TOF\], gadolinium-enhanced magnetic resonance angiography \[MRA\], or computed tomographic angiography \[CTA\]) and extracranial (gadolinium-enhanced MRA, CTA, or duplex ultrasound) vessel imaging; transthoracic or transoesophageal echocardiography; and ≥24h ECG monitoring (acute stroke unit monitoring and/or Holter ECG monitoring).

Exclusion Criteria:

* opt-out patient
Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)

More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular disease than direct pulmonary complications. Inflammation and oxidative stress, characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO) bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet to be determined. Thus, the overall objective of this proposal is to identify the role of NO bioavailability in contributing to vascular endothelial dysfunction in patients with COPD and to provide insight into the molecular mechanisms involved. Our central hypothesis is that inflammation and oxidative stress, both independently, contribute to the reduction in NO bioavailability and vascular endothelial dysfunction in patients with COPD.

Flow-Mediated Dilation (FMD) - Subjects will lie in the supine position for 20 minutes to obtain hemodynamic steady state. A blood pressure cuff (Hokanson) will be placed around the forearm (distal to the Doppler transducer) and rapidly inflated to 250 mmHg for 5 minutes (circulatory arrest). Simultaneous ultrasound images of the vessel (B-mode) and Doppler waveforms will be collected 10 seconds prior to and for 2 minutes following deflation of the cuff. All B-mode images will be analyzed using automated edge detection software (Medical Imaging Applications), while intensity weighted velocity spectra segments will be saved to the GE Logiq 7 hard drive for off-line blood velocity waveform analysis. P.I. has utilized the traditional method of brachial artery flow-mediated dilation (FMD) induced by reactive hyperemia to assess vascular endothelial function in populations ranging from young healthy adults to older adults with pathological conditions.

Spygmocor - Pulse Wave Velocity (PWV) - A Spygmocor® device will be used at baseline and following each protocol to assess PWV. PWV analysis provides a non-invasive assessment of arterial stiffness. Increased arterial stiffness is known to be associated with cardiovascular disease. The participant is required to lie in a resting position for approximately 30-45 minutes. The research assistant will place ECG electrode sensors at the carotid, femoral, radial and distal artery locations. A highly sensitive pen-like device, called a tonometer, is then gently applied to record the velocity of the blood flow between each of the points.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD (GOLD stages II-IV) and matched healthy controls
* Caucasian or African American
* Both men and women
* Current and former smokers

Exclusion Criteria:

* GOLD Stage I
* Clinical diagnosis of heart disease, hypertension, or metabolic disease
* Vasoactive medications (i.e. nitrates, beta-blockers, ACE inhibitors, Viagra, etc.)
* Pulmonary hypertension
* Hypothyroidism
* Hyper-homocysteinemia
* Interstitial lung disease
* Phenylketonuria
* Pregnancy
* Sleep apnea
* Anemia
* Raynod's phenomenon
* Gangrene of the digits
* History of low platelets or coagulopathies
* Aspirin sensitivity or allergy