cyrilzakka/clinical-trials huggingface dataset:
The African Critical Illness Outcomes Study

In Africa, the prevalence of critical illness is likely to be higher due to a greater burden of disease, and the associated mortality higher due to limited resources. This is a prospective, observational study to rapidly establish the prevalence of critical illness in in-hospital adult patients in Africa, and the resources available to provide essential critical care (care that should be available to every patient in the world) and factors associated with mortality. Rapid dissemination of these findings may help mitigate mortality from critical illness in Africa. These points provide the rationale for the African Critical Illness Outcomes Study.

STUDY OBJECTIVES

The objectives of this study are to determine:

1. The proportion of hospital patients who are critically ill,
2. The mortality associated with critical illness,
3. The proportion of critically ill patients who receive essential emergency and critical care,
4. The relationship between essential emergency and critical care provision, and mortality, and
5. The availability of resources necessary to provide essential emergency and critical care.

STUDY DESIGN

An African multi-centre prospective observational cohort study of adult (≥18 years) in-hospital patients. Patient follow up will be for a maximum of 7 days in-hospital.

The primary outcome is in-hospital mortality in adult hospital patients with and without critical illness in Africa.

The intention is to provide a representative sample of the mortality, the risk factors associated with mortality in adult patients with critical illness, and the resources available and interventions provided to treat critical illness in Africa. This study will run between September and November 2023.

PREPARATORY WORK

This study will be run by the African Perioperative Research Group (APORG), with a network of over 600 hospitals in more than 40 African countries which has successfully conducted the African Surgical Outcomes Study (ASOS), the ASOS-2 Trial, the African COVID-19 Critical Care Outcomes Study (ACCCOS) and the African Pediatric Surgical Outcomes Study (ASOS-PEDS).

IMPORTANCE OF THIS STUDY

To decrease the mortality associated with critical illness in Africa, it is important to rapidly establish the potential risk factors for mortality, and resources available to manage these patients. The APORG network has the capacity to provide these data timeously.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aged 18 years or over who have been admitted for inpatient care in any department or ward in participating hospitals.

Exclusion Criteria:

* None
A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18 to 65 years of age inclusive
* Chronic hepatitis C, genotype 1 or 4
* Cohort 1: Treatment-naïve for hepatitis C
* Cohort 2: Prior null responder to treatment with approved doses of pegylated interferon plus ribavirin
* Liver biopsy confirming cirrhosis
* Compensated cirrhosis (Child-Pugh A)

Exclusion Criteria:

* Pregnant or lactating women or male partners of women who are pregnant
* History or presence of decompensated liver disease (ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices)
* Cohort 2: Patients who discontinued previous pegylated interferon plus ribavirin treatment due to reasons other than null response
* History of clinically significant cardiovascular or cerebrovascular disease
Impact of Sterilization Technique on Incidence of Urinary Tract Infection After Cystoscopy

The purpose of this study is to verify that the incidence rate of urinary tract infections after a routine outpatient cystoscopy is the same for non-sterile (clean) and sterile procedural techniques.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Patients undergoing routine outpatient flexible cystoscopy

Exclusion Criteria:

* Patients who have had a urinary tract infection within 3 months prior to flexible cystoscopy
* Patients with an indwelling catheter
A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.

To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
* Patients having received at least 1 Macugen injection
* Treatment naive patients, or patients having received conventional therapy
* Patients having signed and dated informed consent.

Exclusion Criteria:

* Patients participating in another clinical study with Macugen.
US vs MRI for Stress Injuries

The primary purpose of this study is to determine whether or not there is a correlation between MRI and ultrasound for the diagnosis of lower limb stress injuries. Patients that are seen at the University of Iowa Sports Medicine Center with a suspected diagnosis of a lower limb stress injury will be recruited. These patients will undergo a diagnostic ultrasound of the affected region prior to undergoing an MRI of that region. Then, the ultrasound findings will be compared to the MRI findings to determine if a correlation exists.


Eligibility Criteria:
Inclusion criteria:

* Age 18-50
* MRI confirmed tibial or metatarsal stress injury

Exclusion criteria:

-Prior history of stress fracture or fracture in the affected limb at the region of concern.
Evaluation of Retinal Structure With High Resolution Optical Coherence Tomography (OCT)

Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Comparison of different OCT instruments to assess retinal thickness, correlation to fluorescein angiography, and visual outcome after therapy with anti-VEGF therapy

Eligibility Criteria:
Inclusion Criteria:

* Macular disease
* Healthy subjects
Improving Posthospital Medication Management of Older Adults Through Health IT

The incidence of drug-induced injury is high in the ambulatory geriatric population and is increased for elders upon transition from the hospital to the ambulatory setting. In this application, we describe an effort to build on our extensive experience in medication safety and HIT-based medication management to respond to the AHRQ RFA entitled Ambulatory Safety and Quality Program: Improving Quality through Clinician Use of Health IT (RFA-HS-07-006). In this study, we propose to develop and evaluate the value of an enhanced, HIT-based transitional care intervention superimposed on the ambulatory electronic medical record (EMR) to improve the quality and safety of medication management, focusing particularly on the transition from the inpatient to the ambulatory setting for older adults with multiple comorbid conditions who are prescribed high risk medications. We propose a randomized controlled trial of a HIT-based transitional care intervention with enhanced medication and therapeutic monitoring alerts to improve the quality and safety of patient monitoring and medication management. We postulate that the efficient and coordinated delivery of actionable health information to the clinician via use of HIT in the ambulatory setting can improve medication safety for the growing geriatric population. The specific aims for this study are to evaluate, among a population of older adults discharged from the hospital, the impact of an enhanced discharge information system initiated upon transition to the ambulatory setting: (1) on the rate of follow-up by an outpatient provider within 14 days of hospital discharge; (2) on the prevalence of appropriate monitoring for selected high risk medications at 30 days from the time of hospital discharge; (3) on the incidence of adverse drug events (ADEs) 30 days after discharge; and (4) on the rate of emergency department visits and hospital readmission within 30 days of discharge. A secondary aim for this study is to determine costs directly related to the development and installation of the HIT-based transitional care intervention. This research allows for the examination of an integrated HIT intervention on the quality of follow-up, outpatient clinician workflow, occurrence of ADEs, and health care utilization to gain insights into the effective use of clinical alerts and coordinated delivery of actionable information to outpatient clinicians in the management of ambulatory elderly patients subsequent to hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* 65+ years old, member of the study site health plan, hospitalized at the study site hospital, discharged to an outpatient provider at the study site health plan clinic

Exclusion Criteria:

* does not meet inclusion criteria
A Prospective, Observational Study in Patients With Late-Onset Pompe Disease

Pompe disease (also known as glycogen storage disease type II, "GSD-II") is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA). Normally, GAA is used by the body's cells to break down glycogen (a stored form of sugar) within specialized structures called lysosomes. In patients with Pompe disease, an excessive amount of glycogen accumulates and is stored in various tissues, especially heart and skeletal muscle, which prevents their normal function.

This study is being conducted to collect prospective, observational data on patients with late-onset Pompe disease. Approximately 60 subjects with late-onset Pompe disease will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* The patient must provide signed, informed consent prior to performing any study-related procedures.
* The patient must have a diagnosis of Pompe disease based upon: a) documented marked deficiency of GAA activity by muscle biopsy, skin fibroblasts, or leukocytes OR b) documented GAA gene mutation by deoxyribonucleic acid (DNA) analysis
* The patient must be greater than 8 years of age if enrolled at a site in the U.S. and greater than 18 years of age if enrolled at a site in Europe
* The patient must have documented onset of symptoms of Pompe disease after 12 months of age
* The patient must have at least 3 testable muscle groups in the arms and 3 testable muscle groups in the legs using quantitative muscle testing
* The patient must be able to perform pulmonary and muscle function testing in the supine position
* The patient must be able to provide reproducible muscle and pulmonary function test results within 10% of each other performed on Day 1 and Day 2 of the Screening/Baseline visit and forced vital capacity measurements within 10% of each other performed in the upright position on Day 1 and Day 2 of the Screening/Baseline visit
* The patient must have the ability to comply with the clinical protocol

Exclusion Criteria:

* The patient is unable to ambulate (use of assistive devices, such as walker, cane, crutches, is permitted);
* The patient requires the use of invasive ventilatory support.
* The patient requires the use of noninvasive ventilatory support during waking hours.
* The patient has received enzyme replacement therapy with acid alpha-glucosidase from any source
* The patient has received an investigational drug within 30 days prior to study enrollment, or is currently enrolled in another study which involves clinical evaluations
* The patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance including all prescribed evaluations and follow-up activities
* The patient has a major congenital abnormality
* For female patients only, the patient is pregnant or lactating, or is unwilling to practice birth control methods during the course of the study
Clinical Outcomes and Patient Satisfaction With Use of the Amma System

The primary goal is to conduct a pilot evaluation of the Amma device, to determine whether it is feasible to offer as an option for patients within oncology suites within the PH\&S system.

A novel cold capping device, named Amma™, is now commercially available for use and FDA approved. The Amma system has the potential to be as effective as the Penguin Cold Cap system, but with key innovations that make it more efficient and feasible in the clinic. Innovations include:

* Portable and battery powered unit, not requiring dry ice
* Form-fitting scalp cap that eliminates the need for frequent cap exchanges The Amma system has not been evaluated for efficacy, and no clinical trials are published.

Because of the ease of use and the self-directed administration of the Amma scalp cooling device, we wish to explore this as an option for patients treated within the PH\&S system. To do this, we propose an observational study that evaluates clinical outcomes and patient-reported satisfaction amongst a cohort of patients who undergo self-directed scalp cooling using the Amma system.

Eligibility Criteria:
Inclusion Criteria:

- Women with stage I-III breast cancer are eligible to participate if:

* They consent to conduct baseline (week 0) and follow-up (week 4 post-chemo) surveys/interviews
* They consent to be photographed at baseline (week 0) and follow-up (week 4 post-chemo), to document hair retention outcomes
* Curative-intent chemotherapy is planned with a taxane-based, anthracycline-sparing chemotherapy regimen (which includes but may not be limited to: TC x 4, T x 12, TCHP x6)
Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study

Pregnancy rates for women over 35 years old are significantly lower when compared to younger women. One of the causes for this decrease is believed to be chromosomal aneuploidy. Chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been implicated in spontaneous miscarriages, and preimplantation embryo wastage (Hassold and Hunt, 2001).

As maternal age increases, so too does the incidence of chromosomal aneuploidy. Embryo quality from older patients undergoing IVF tends to be reduced and associated with higher rates of chromosomal abnormalities when compared to good quality embryos (Munne et al., 1995).

Chromosomal aneuploidy derives from the improper segregation of chromosomes during preimplantation development. The process of segregation, or mitosis, includes synthesis of the complete genome, equal division of chromosomes to opposite poles by the spindle apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally identical cells. The entire process of cellular and genetic replication requires energy in the form of adenosine tri phosphate (ATP). ATP is mainly produced in mitochondria in the process known as the electron transport chain (ETC). There are many important molecules required for ATP production, CoQ10 can act as the appropriate carrier of electrons through the ETC. When a deficiency in CoQ10 is present, ATP production is decreased resulting in aneuploidy (Bentov et al., 2013). Similarly, research has shown that chromosome alignment and spindle formation are affected by mtDNA copy number (Ge et al., 2012). It has also been shown that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women with repeated embryonic failure has result in children with subsequent mitochondrial heteroplasmy (Cohen et al., 1998).

CoQ10 concentrations have been shown to decrease as age increases (Bentov et al., 2011). Consequently, the decrease in CoQ10 concentrations seen in older women may cause an increase in chromosomal aneuploidy in subsequent embryos (Bentov et al., 2013). In this pilot study, we test the hypothesis that the supplementation of CoQ10 prior to an IVF cycle can increase mitochondrial DNA activity and possibly decrease chromosomal aneuploidy in AMA patients.

Brief Summary

Eligibility Criteria:
Inclusion Criteria:

1. 36-42 years old
2. Must present with an AMH level ≤2.0 ng/mL
3. 1st cycle of IVF treatment
4. Antral follicle count \>5 and \<20

Exclusion Criteria:

1. BMI \>39
2. Active smoker
3. Blood serum baseline level of CoQ10 ≥2.20 µg/mL
4. Prior use of CoQ10
5. Type II diabetes mellitus
A LAparoscopic and TransAnal Total Mesorectal Excision (TME) for Rectal Cancer Trial

All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.

Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.

The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.

It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.

Eligibility Criteria:
Inclusion Criteria:

* presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
* possible to operate with laparoscopic technique
* possible to operate in regard to concomitant disease
* giving informed consent to participate

Exclusion Criteria:

-Participation in other trials in conflict with the protocol and end-points the LATA-trial
Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen

This study will test the effects of pemetrexed on mesothelioma and non-small cell lung cancer patients with fluid around their lungs or abdomen.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) or mesothelioma
* Presence of third-space fluid (fluid around the lungs or abdomen).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the sharp toxic effects the anticancer treatment.
* Estimated life expectancy of at least 8 weeks.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that was not a marketed product.
* Active infection that, in the opinion of the investigator, would not allow the patient to tolerate therapy.
* Pregnancy.
* Breast-feeding.
* Significant weight loss (that is, greater than or equal to 10% of body weight) over the 6 weeks before study entry.
* Brain metastases.
Home Exercises Protocol for Neck Pain

Delphi study about home exercise protocol development for neck pain.

Introduction: Neck pain is rising globally as a musculoskeletal disorder, as a result of several factors. Currently, there are several types of treatments for cervicalgia, applied according to the therapist's choice and patient's conditions and preferences, however, there are no reports of an effective self-performing treatment aiming to stabilizing the cervical, giving musculoskeletal balance, and focus on reducing pain.

It is important the promotion of a self-performing treatment, resulting in a high cost benefit because patient does not have to move to perform the treatment outside his or her home, does not need financial resources and demands little time to perform it. In addition to decreasing the frequency and intensity of hospitalizations and government costs incurred in this musculoskeletal disorder. Therefore, the study aims to construct, validate and adapt a self-performing exercise protocol in reducing cervical pain.

Methods: The first phase was the development of the first version of the protocol, through literature search; in the second phase, the content was validated, through evaluation by a committee of nine physiotherapists judges using the Delphi technique; and the last phase of the protocol, the cultural adequacy, is being performed through evaluation by fifteen participants of the target population to assemble the final version of the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Judges: physical therapists with at least 2 years of experience in cervical area.
* Target population: chronic neck pain.

Exclusion Criteria:

* Vestibular system problems, balance impairment, nervous system-related disorders, inability to perform exercises, history of cervical trauma or surgery in the region, history of cervical radiculopathy, history of cervical spine injury, temporomandibular dysfunction.
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.

This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 or over
2. Active UC defined as a Mayo score (7) \>3
3. A Mayo endoscopic score (7) \>0
4. Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion Criteria:

1. Participating in another intervention study for UC
2. Unable to give informed consent
3. Severe comorbid medical illness
4. Severe UC requiring hospitalization.
5. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted.
6. Antibiotic therapy in the last 30 days.
7. Pregnant women.
8. Patients with clinically significant hepatic dysfunction at the time of screening: ALT \> 5 times the upper normal range.
9. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/L
10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.