cyrilzakka/clinical-trials huggingface dataset:
Angiotensin II Stress Test. Renin Kinetics During Treatment of Vasoplegic Shock With Angiotensin II.

Shock is a life-threatening condition which can cause multiple organ failure and even death. One characteristic of shock is low blood pressure which is managed with drugs called vasopressors. Most frequently used vasopressors are noradrenaline, vasopressin and recently also angiotensin II. Angiotensin II is present in the body and has a physiological role in maintaining blood pressure in healthy persons. Renin is an enzyme and a key factor in angiotensin II production in the body. In patients with shock, there is a lack of angiotensin II and an excess of renin in the body. Due to the literature renin has the potential to be a marker of severity of shock. Synthetic angiotensin II is used in patients with shock in whom we cannot normalize the blood pressure with noradrenaline and vasopressin. Regarding scientific data, the use of synthetic angiotensin II reduces the dose of noradrenaline and vasopressin and the incidence of acute kidney injury. The aim of our study is to find out what is the relation between the concentration of renin before and 6 hours after the start of using angiotensin II in patients with shock and their clinical outcome. Since not all patients with shock are responding to angiotensin II, the aim of our study is also to find out which patients could benefit most from synthetic angiotensin II.

In patients with distributive shock (≥18 years) with noradrenaline \>0,3 mcg/kg/min and vasopressin \>0,03 IE/min not achieving an appropriate mean arterial pressure (65-85 mmHg) an angiotensin II infusion will be started at 20 ng/kg/min and after that adjusted to a max dose of 40 ng/kg/min if needed. Before the infusion and 6 hours after the start of angiotensin II infusion a blood sample will be drawn to determine the renin concentration. The primary outcome will be organ failure free days and ICU free days. Secondary outcome will be the need for vasopressors, dialysis, mechanical ventilation, trend of renin concentration.

Eligibility Criteria:
Inclusion Criteria:

* patients with distributive shock lasting \< 72 hours
* a goal mean arterial pressure (65-85 mmHg) not achieved despite an infusion of at least noradrenaline 0.3 mcg/kg/min and vasopressin 0.03 IE/min
* the patient did not get angiotensin II before
* predicted survival is \>24h
* no limitations for active treatment

Exclusion Criteria:

* burns \>20% body area
* acute coronary syndrome
* bronchospasm
* liver disease (MELD ≥30)
* severe acute bleeding (need for 4 or more units of concentrated erythrocyte)
* acute mesenteric ischemia
* aortic dissection
* leucopenia \<1000/mm3
* pregnancy
* Raynaud disease, systemic sclerosis, vasospastic disease
* the need for daily dose of hydrocortisone 500 mg or more
* ECMO
Core Stabilization Exercises in Forward Head Posture

Based on the reviewed literature, Core Stabilization Exercises (CSEs) have been shown to have positive effects on patients with low back pain. To our knowledge, very few studies have examined the impact of CSEs on neck pain, particularly in patients with forward head posture (FHP), despite that several authors suggested that FHP may be caused by lumbopelvic malalignment.

Therefore, the purpose of the study is to assess how CSEs may affect the cervical sagittal balance parameters (CSB) in patient with FHP.

After the patient fills the consent form, the Craniovertebral angle will be measured by taking a photograph, then this photograph will be analysed by the KINOVEA software.

If the CVA is less than 50 degrees, he/she will have a lateral x-ray on the cervical spine to measure the radiographic variables of the CSB parameters. These variables will be assessed and quantified by Image J software.

The patients will be classified randomly into 2 groups, the intervention and control groups. The intervention will receive CSEs program and Postural Correction Exercises (PCEs) program, but control group will receive only PCEs program.

Both programs will be implemented for 6 weeks 3 times/ week and after 6 weeks, patients will be reassessed again to determine the difference.

Eligibility Criteria:
Inclusion Criteria:

* CVA less than 50 degrees/ neck pain for about 4 weeks

Exclusion Criteria:

* Vertebrobasilar insufficiency/ cervical surgery/ cervical or TMJ fracture
Prevalence and Risk Factors of Uterine Niche Following Different Caesarean Section Techniques:a Hospital Based Study

The primary objective of this study is to institute clically relevant and objective sonographic criteria for the diagnosis of ceasearan section scar defect(CSSD) once the appropriate diagnostic criteria are established the natural history of CSSD could be elucidated through exploration of the prevelance ,risk factors, and associated symptomes of the disease


Eligibility Criteria:
Inclusion Criteria:

* all women underwent c-section

Exclusion Criteria:

* known uterine anomaly
* prior uterine surgery -prior uterine rupture
* chronic medical disease like diabetes -use of steroid over last year regularly
* obstetrical complications like multifetal pregnancy
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Eligibility Criteria:
Inclusion Criteria:

* Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria:

* Prior treatment of current cSSSI with an antimicrobial.
* Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Studying Phosphorus Metabolism

Phosphorus and phosphate irons play critical roles in bone structure and essential cellular functions.

The purpose of this study is to learn more about the factors and hormones that regulate phosphorus in the body by collecting blood and urine samples from patients with disorders of phosphate control.

Both children and adults will be enrolled in this study. Researchers will collect blood and urine samples from participants on multiple occasions (2 to 6 times). Some blood specimens will be taken after an overnight fast and participants may be asked to collect all their urine during a 24-hour period. Researchers will analyze these blood and urine samples to better understanding how the body handles phosphorus.

Phosphorus and phosphate ions play an important role in cellular metabolism as well as bone structure. Scientific evidence suggests that, in addition to Vitamin D and PTH systems, novel factors, such as Fibroblast Growth Factor 23 (FGF-23) and Matrix extracellular phosphoglycoprotein (MEPE), may play an important role in phosphorus regulation. These factors have been best studied in rare genetic and acquired phosphate wasting disorders such as tumor induced osteomalacia (TIO), X linked hypophosphatemia (XLH) and autosomal dominant hypophosphatemic rickets (ADHR). Patients with other abnormal phosphate regulating states such as hyperparathyroidism and hypoparathyroidism, pseudohypoparathyroidism etc. undergoing phosphorus-altering interventions may provide important insight into the role of these hormones.

We are proposing an observational study with collection of blood and urine samples to study both established (e.g. mineral ions, bone markers, PTH-Vit D system, TMP-GFR) and novel (e.g. FGF-23 and MEPE) constituents of the phosphorus metabolism pathway. Patients with abnormal phosphorus regulating states will be enrolled and we will study the natural history of their disease and the effects of specific interventions that are likely to change phosphorus balance.

The outcome will potentially aid understanding of this new field of mineral regulating hormones and generate both interest and research in phosphorus metabolism. It is hoped that this will also encourage clinical trials in treatment of phosphate wasting disorders.

Eligibility Criteria:
INCLUSION CRITERIA:

Patients of any age, gender or ethnicity who will help fulfill the objectives laid out in Section II.

We propose to study patients primarily enrolled in other clinical center protocol(s). They will continue to receive treatment/ interventions per the original protocols.

EXCLUSION CRITERIA:

Patients with significant cognitive impairment who are unable to give informed consent or patients having other significant mineral disturbances that could confound the parameters being studied will be excluded.
Azithromycin in the Treatment of Cryptosporidiosis in Patients With Acquired Immune Deficiency Syndrome (AIDS): A Randomized, Multi-Center, Placebo-Controlled, Double-Blind Study

To evaluate the safety and efficacy of azithromycin in the treatment of intestinal cryptosporidial infection in AIDS patients.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine.
* Antidiarrheal medication with imodium or paregoric only.

Patients must have:

* HIV infection.
* Intestinal cryptosporidiosis proven by stool microscopy on at least two occasions prior to study enrollment.
* Life expectancy of at least 2 weeks by clinical assessment. In states where the legal age of consent for medical procedures is 21 years, patients below the age of 21 must have consent of parent or guardian.

Prior Medication:

Allowed:

* Zidovudine.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Known hypersensitivity or significant intolerance to macrolide antibiotics.
* Marked abnormalities of liver or renal function.
* Causes for diarrhea other than, or in addition to, cryptosporidiosis.
* Inability to receive oral medication.

Concurrent Medication:

Excluded:

* Cancer chemotherapy (including therapy for Kaposi's sarcoma).
* Any drug or biologic preparation (e.g., bovine colostrum, paromomycin, spiramycin, somatostatin) with possible anticryptosporidial activity.
* Immunostimulant or lymphocyte replacement therapy.

Prior Medication:

Excluded:

* Another investigational drug within 7 days prior to study enrollment (investigational medications available through a treatment IND will be allowed with the approval of the sponsor, the treatment IND sponsor, and the Pfizer clinical monitor).
* Immunostimulant or lymphocyte replacement therapy.
* Cancer chemotherapy (including therapy for Kaposi's sarcoma).

Not expected to comply with the requirements of the protocol, in the opinion of the investigator.
The Outreach and Prevention at ALcohol Venues in East Africa Study (OPAL-East Africa- Aim 1)

This study will test innovative interventions to increase uptake and use of biomedical HIV prevention options by engaging women and men at drinking venues in rural Kenya and Uganda in care, while gaining insights into the facilitators, barriers, and cost-effectiveness of these approaches.

\[BACKGROUND\] Alcohol use is a common risk factor for both HIV prevention uptake and retention in sub-Saharan Africa (SSA). Interventions that promote biomedical HIV prevention (PrEP and PEP) among persons with heavy alcohol use and their sexual partners are urgently needed. Alcohol-serving drinking venues play an important role as sites of HIV transmission in SSA and are ideal sites to engage women and men at increased risk of HIV in biomedical prevention services.

\[OVERVIEW\] The investigators have developed a mobilization strategy of integrating HIV testing within multi-disease screening to recruit \>2,000 people from drinking venues in Kenya and Uganda. The investigators now need to determine whether multi-disease mobilization can promote uptake of HIV prevention for adults at drinking venues in the context of new biomedical prevention options.

The project will rigorously test innovative interventions in Kenya and Uganda to increase uptake of biomedical HIV prevention, and assess facilitators, barriers, and cost-effectiveness of these approaches.

Specific Aims:

* Compare the effectiveness of two mobilization strategies to increase uptake of biomedical HIV prevention among adults at drinking venues.
* Determine the cost-effectiveness of interventions that increase biomedical HIV prevention uptake among adults at high-risk for HIV who attend drinking venues.

The proposed research will address the critical intersection of alcohol use and HIV risk in SSA, by promoting reach and uptake of biomedical HIV prevention and exploring associated facilitators and barriers.

Eligibility Criteria:
Participant Inclusion Criteria:

* adult (≥18 years)
* patron or worker at a drinking venue within the study community

Exclusion Criteria:

* age \<18 years
* previous participation in the study (may only participate once)
* inability to consent (including gross inebriation)
ReSure Sealant Post Approval Study

This is a prospective multicenter observational post-approval registry study that will collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with the FDA-approved ReSure Sealant when used by a broad group of physicians under commercial use conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a cataract and is expected to undergo clear corneal cataract surgery with intraocular lens placement

Exclusion Criteria:

* ReSure Sealant is not applied to the operative eye
SARS-CoV-2 Nucleic Acid Detection Kit Clinical Performance Study

SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for RNA detection of SARS-CoV-2 in human specimens using multiplex real-time polymerase chain reaction (RT-PCR) technology. The conserved regions of ORF1ab and N genes are used as target sites of the primers and probes according to the indications provided in the Instructions for Use (IFU).

The SARS-CoV-2 Nucleic Acid Detection Kit is an In Vitro Diagnostic (IVD) medical device intended for Qualitative RNA detection of SARS-CoV-2 using multiplex real time RT-PCR technology for professional use. The kit is available in two different formats (48 tests/kit or 200tests/kit), and it can be stored at -20±5ºC away from light for 12 months. This kit includes a PCR Reaction Mix, PCR Enzyme Mix, SARS-CoV-2 PCR Primer/Probe Mix and a negative/positive control.

TransGen SARS-CoV-2 Nucleic Acid Detection Kit is intended for in vitro qualitative detection of ORF1ab and N genes from the SARS-CoV-2 virus in nasopharyngeal swab specimens collected from COVID-19 suspected cases, suspected clusters of cases or other individuals who need SARS-CoV-2 infection diagnosis or differentiation diagnosis. The definitions of COVID-19-related groups, such as "suspected cases" or "suspected clusters of cases", are detailed in the Diagnosis and Treatment Protocol for Novel Corona virus Pneumonia, Surveillance Protocol for Novel Corona virus Pneumonia or other COVID-19 documents from the Centers for Disease Control and Prevention (CDC). The TransGen SARS-CoV-2 Nucleic Acid Detection Kit should comply with the requirements of Diagnosis and Treatment Protocol for Novel Corona virus Pneumonia, Protocol for Prevention and Control of COVID-19 and other COVID-19 documents from the CDC. The biosafety requirements should be strictly followed as well.

Specimens used for this clinical performance study will be remnants of specimens taken for purposes of standard of care (leftover or archived) through a nasal swab from male and female subjects. Specimens may come from persons suspected of SARS-CoV-2 infection but also from those who need a diagnostic test due to other reasons such as medical intervention, blood donors, or travel for which a negative test is requested.

Eligibility Criteria:
Inclusion Criteria:

* Specimen collected with a nasal swab.
* Negative samples from specimens confirmed SARS-CoV-2 negative by the gold standard, or positive samples from specimens confirmed SARS-CoV-2 positive by the gold standard.

Exclusion Criteria:

* Specimens that have been stored at 4ºC for more than 24h
* Specimens stored at -70ºC that have been under more than 2 freeze/thaw cycles
* Specimens that have been stored at -20 for more than 10 days
* Contamination and/or deterioration of the specimen that, in the investigator's opinion, may impact its handling and/or analysis
Vaginal Estrogen and Pelvic Floor Physical Therapy in Women With Symptomatic Mild Prolapse

This is a randomized controlled trial in which women with symptomatic mild pelvic organ prolapse undergoing Pelvic Floor Physical Therapy (PFPT) receive vaginal estrogen versus placebo to see if a combined approach to treatment leads to improvement in clinical outcomes. The investigators predict that PFPT in combination with vaginal estrogen will lead to decreased pelvic floor symptoms and improved anatomical support corroborated by biomarker data.

The pathogenesis of pelvic organ prolapse (POP) is unknown. Few studies have correlated patient symptoms and amount of prolapse with biomarkers. POP has traditionally been managed with a pessary or surgery. Recent studies suggest a reduction in POP symptoms following Pelvic Floor Physical Therapy (PFPT). Vaginally delivered hormones are also commonly used to treat prolapse symptoms, with little evidence supporting a clinical benefit. The investigators hypothesize that the optimal approach to improving prolapse symptoms in the patient with mild prolapse requires re-alignment and strengthening of levator muscles via PFPT, and optimization of tissue integrity via local estrogen therapy. The investigators propose to test this hypothesis in a randomized controlled trial in which women with symptomatic mild prolapse opting for PFPT, receive treatment with PFPT in combination with vaginal estrogen versus placebo. The investigators predict that the combined approach will lead to decreased symptoms and improved anatomical support corroborated by biomarker data.

Eligibility Criteria:
Inclusion Criteria:

* Women in good health aged 40-80
* Has symptoms of pelvic organ prolapse; answers yes to at least 1 of the following questions:

Do you feel or see a vaginal bulge? Do you feel pressure in the vagina?

* Meets POP-Q criteria on exam for stage I, II, or III prolapse
* Interested in PFPT for management of POP
* Normal mammogram within 1 year of enrollment

Exclusion Criteria:

* Prior surgery for prolapse or incontinence
* Other prior interventions for prolapse (e.g. pessary, PFPT)
* Previous bilateral salpingo-oophorectomy (women with 1 ovary will be eligible)
* Known liver dysfunction
* Connective tissue diseases known to affect collagen or elastin remodeling (including: Lupus, Rheumatoid Arthritis, Scleroderma, Sjogrens syndrome, Marfan syndrome, and Ehlers-Danlos syndrome)
* Unevaluated abnormal vaginal bleeding or abnormal pap smear in the previous year
* BMI \> 35 kg/m2
* Estrogen therapy (including birth control) in the previous year
* Current or prior breast or pelvic malignancy (ovarian, tubal, uterine, cervical or vaginal)
* Contraindication to hormone use (i.e. thromboembolic disorder, use of anti-coagulants, coronary artery disease, history of stroke)
Comparing the Use of a Mobile App for Surveillance of Adverse Events Following Influenza Immunization to a Web-Based Platform

Methods Study Procedures A two-centred randomized control trial (RCT) was conducted to evaluate the use of safety reporting via a mobile app compared to safety reporting via web-based CANVAS notifications amongst individuals receiving the influenza vaccine from October 6 to November 29, 2020 during the seasonal influenza vaccine campaign in Ottawa and Vancouver, Canada.

Individuals were recruited at the time of receiving their influenza vaccine. Eligibility criteria included the ability to speak English or French, having an active email address and telephone number, and being immunized with the seasonal influenza vaccine.

Randomization After study enrollment, participants were randomized to receive the online safety survey either through the mobile app or emailed a link to the online survey using a four-block randomization design.

Web-based notification arm All participants randomized to the web-based notification arm received the following web-based CANVAS notifications. Briefly, participants received an email notifying them of their registration in the study. Eight days following their influenza vaccine, participants received an email with the survey link asking them to complete their online influenza vaccine safety survey. Participants received a reminder email on day 11 if they did not complete their survey. Further details on CANVAS surveillance and description of the questionnaire can be found here.

Mobile app arm Participants randomized to the mobile app arm, received an email asking them to download the app and activate their account. Users who did not activate their account after 48 hours received a reminder email. Participants who activated their accounts, could spontaneously report an adverse event through the app, and were also notified of the day 8 survey through the app.

Eight days following their vaccination mobile app participants who activated their account received a push notification on their phone to complete their survey. A reminder push notice was sent out on day 11 to participants that had not yet competed the day 8 survey. On November 16, 2020 (mid-way through the recruitment period), additional email reminders in the mobile app arm were implemented on days 2, 4 and 6 to remind participants to register for the app. All participants received a day 8 email directing them to use their CANImmunize account to complete their influenza vaccine survey. Access to the survey link also was available in the email reminder.


Eligibility Criteria:
Inclusion Criteria:

* Speak English or French,
* Have an active email address and telephone • Immunized with the seasonal influenza vaccine
* Parents of children are eligible to participate after the first or second dose of vaccine

Exclusion Criteria:

* Those who do not meet the inclusion criteria