cyrilzakka/clinical-trials huggingface dataset:
Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients

This pilot study will study the impact of critical illness and ICU processes of care on the trajectory and development of frailty. It is hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in ICU and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on ICU admission.

This pilot study will be conducted in a tertiary medical surgical ICU at Kingston General Hospital- Kingston, Ontario. It will inform the feasibility, timelines and sample size for the multi-center study and will allow for the refinement of study procedures and data collection methods. This study will be published separately as a stand-alone pilot.

Single Center Observational pilot study to inform on the conduct of a multi-center observational study.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 55 years
2. Admission to ICU for over 24 hours
3. Receipt of at least one therapeutic life support intervention that can only be delivered in the ICU such as mechanical ventilation (both invasive and non-invasive), vasoactive medications (vasopressors or inotropes) or acute renal replacement therapy.

Exclusion Criteria:

1. Lack of consent for study inclusion or lack of consent to be contacted for long term follow-up.
2. Expected to survive for less than 72 hours after ICU admission.
3. Inability to obtain baseline blood work less than 48 hours after ICU admission (i.e. study enrollment must occur within 48 hours of ICU admission allowing for the blood work to be done in the time allowed).
4. No family or caregivers available to collect collateral history.
5. Not able to speak English with lack of available medical translators.
6. Admission to ICU with acute structural neurological disease:

   1. Massive stroke requiring ICU care
   2. Spinal cord injury with neurological deficit
Preventive and Reversional Effect of Vitamin D on Parenteral Nutrition Associated Liver Disease

Patients who accept long-term parenteral nutrition tend to suffer from liver injury. The mechanism for this injury has two possible explanations. The first possible reason is intrinsic toxic effects of parenteral nutrition. The second is the basic pathological condition of intestinal failure which includes infection, bacterial translocation, etc. Cholestasis is the lethal presentation of this kind of liver disease. Farnesoid X receptor (FXR) is a member of ligand-activated nuclear receptor superfamily. FXR serves as a sensor for bile acids and promotes enterohepatic clearance of bile acids by controlling the expression of genes involved in their transport and metabolism. Considering the activation of vitamin D receptor (VDR) by vitamin D can induce FXR-related genes in the liver.The hypothesis of this study is that vitamin D plays a key role in the prevention and reversion of the liver via VDR and/or FXR signaling pathway. Using a mouse cholestasis model based on short bowel syndrome and parenteral nutrition, the researchers will investigate the dynamic change of plasma vitamin D level. Afterward, intravenous supplement of vitamin D was added to this model to demonstrate vitamin D can ameliorate cholestasis. An in vitro system was developed to investigate the importance of FXR signaling pathway in this effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients with short bowel syndrome supported by total parenteral nutrition.
* Patients have intestine more than 50cm.
* Requirements of informed consent and assent of participant, parent or legal guardian as applicable consciousness and ability cooperate.

Exclusion Criteria:

* Patients have obstruction of biliary tract, infection, autoimmune disease, cancer.
* Patients have intestine less than 50cm.
* A clinically significant laboratory abnormality or a history of significant cardiac, pulmonary, hepatic, or renal disease.
* Female with positive pregnancy.
* Allergy to ursodeoxycholic acid.
Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy

The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.

The two methods of nasal inferior turbinectomy are well popularized and in use for long periods of time. Endoscopic submucosal inferior turbinectomy is performed in our hospital and blunt turbinectomy is performed usually in privat clinics outside the hospital where there is no endoscopic equipment. We will examine both subjective (QOL questionaire) and objective parameters(rhinomanometry- a non invasive method to evaluate nasal airflow, saccharine test, nasal endoscopy) in our comparison of the outcome of these two methods.

Eligibility Criteria:
Inclusion Criteria:

* all patients above 18 years

Exclusion Criteria:

* can not answer a written questionaire
A Study of the Biodistribution and Safety of [18F]GTP1 in Healthy Japanese Participants

The purpose of this study is to evaluate the biodistribution, safety and tolerability of a single dose of \[18F\]GTP1 as a tau targeted radiopharmaceutical in healthy Japanese participants.


Eligibility Criteria:
Key inclusion criteria:

* Healthy with no clinically relevant finding on physical examination at screening and prior to radiopharmaceutical administration
* Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 30 days after the final dose
* Male participants with partners of childbearing potential must commit to the use of two methods of contraception for the study duration and 90 days after the last dose
* Male participants must not donate sperm for the duration of the study and 90 days after the last dose
* Participants must have both Japanese parents and all Japanese grandparents

Key exclusion criteria:

* Participants with any significant medical disorder or disease expected to interfere with the study
* Current or prior history (within a six-month period) of exposure to nicotine products
* History of drug or alcohol abuse within 12 months prior to screening
* Prior participation in other research protocols or clinical care in the last year, such that radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSv), the allowable annual limit for research participants as established by the US Federal Guidelines
* Use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing
* Use of over the counter (OTC) medication, dietary supplements, or vitamins, within 2 weeks prior to initial dosing
* Known hypersensitivity to any component of the formulation of \[18F\]GTP1 or related compounds
* Major surgery, or donation or loss of 400 mL or more of blood within 4 weeks prior to initial dosing
* History of immunodeficiency diseases, including positive human immunodeficiency virus (HIV) test
* Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody
* Women who are pregnant, lactating or breastfeeding
* Unsuitable veins for repeated venipuncture
Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture

This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. The analysis results of the clinical efficacy of the method can serve as a reference for clinical and surgical decision-making and prognosis assessment.

Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon suture. Conventional surgical approach is open surgery in order to clean the wound, which requires multiple dressing changes and involves a longer recovery period. We recently developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This therapy may be an alternative approach to open surgery.

Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed wound healing after Achilles tendon suture.

Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60 years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The postoperative outcome was evaluated on the basis of Victorian Institute of Sport Assessment-Achilles score and Achilles tendon total rupture score (ATRS).

Eligibility Criteria:
Inclusion Criteria:

* The diagnostic criteria for delayed wound healing after Achilles tendon suture are met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing.

Exclusion Criteria:

* The expected healing time of wounds with regular dressing changes is \<2 weeks.
The Effects of Energy Imbalance on Food Intake Behaviors

This study will determine whether changes in energy balance alter regional neuronal activation of brain regions associated with food intake in individuals screened to be either resistant or prone to obesity. Specifically, it will determine whether foods of "hedonic" value elicit changes in regional neuronal activity in the fasted and fed state in "obese-resistant" and "obese-prone" men and women in varying states of energy balance.


Eligibility Criteria:
Inclusion Criteria:

In the obese-prone group:

* BMI between 20-30
* Report at least one obese first-degree relative
* Self-describe as "struggling" with weight
* Weight-stable for at least 3 months prior to study participation

In the obese-resistant group:

* BMI between 17-25
* Report no obese first-degree relatives
* Self-describe as "naturally thin" and have never been overweight
* Overall weight stability

Exclusion Criteria:

* Significant medical or psychiatric disease
* History of eating disorder
* Left handed
* Unable to complete an MRI scan (e.g., metal in body, claustrophobic)
Study of Treatment With the Combination of Drospirenone Plus Ethinyl Estradiol Plus Levomefolate Calcium in Mexican Women Seeking Contraception

The objective of this study is to compare the red blood cell (RBC) and plasma concentrations of folate in subjects treated with drospirenone (DRSP)/ethinyl estradiol (EE) plus levomefolate calcium (L-5-MTHF) at 24 weeks with respect to basal determination.

Increased intake of folic acid (synthetic form of the naturally occurring B-vitamin) before and in the first few weeks of pregnancy has been shown to reduce certain types of birth defects. This is important for women who may become pregnant following discontinuation of oral contraception. Information about any side effects that may occur will also be collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, Mexican female subjects requesting contraception
* Age \>/=18 to \</=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent
* Normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has to be taken at the screening visit, or a normal result has to be documented within the previous 6 months. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains.

Exclusion Criteria:

* Pregnancy or lactation (less than 6 months since delivery, abortion, or lactation before start of treatment)
* Body mass index (BMI) \>30 kg/m2
* Hypersensitivity to any ingredient in the study drug
* Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
* Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
* Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator.
* Undiagnosed abnormal genital bleeding
* Abuse of alcohol, drugs or medicine (eg, laxatives)
* Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug
Sit-to-stand Training With Interactive Feedback in Chronic Stroke

The major problems of people with chronic stroke include muscle weakness, sensory alteration, and inter-muscular coordination impairment. Inter-muscular coordination impairment caused altered muscle contraction sequences and weight-bearing asymmetry during functional activities. Sit-to-stand (STS) training is often used to improve functional activities among post-stroke subjects. However, the improvement may come from compensatory movements. Using compensatory movement may cause muscle weakness in the affected side and increase fall risk. This study will develop a novel STS training system with interactive visual and audio feedback emphasizing weight transferring and weight bearing. The present study aims to investigate the effects of sit-to-stand training with interactive visual and audio feedback on muscle contraction sequences and weight bearing symmetry in individuals with chronic stroke.

This is a prospective randomized single-blinded controlled trial with pre- and post-measurements. 20 individuals will be recruited, and randomly assigned to experimental or control group. Statistical data analysis will be done by SPSS 24.0. Baseline characteristics will be analyzed using independent t-test or Chi-square test. Repeated measures two-way analysis of variance (ANOVA) with Tukey's post-hoc analysis will be used for time-by-group comparisons. The significant level is set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of stroke ≥ 6 months
* Mini-mental state examination (MMSE) ≥ 24 points
* Brunnstrom lower limb recovery stage: ≥ stage 3
* Be able to independently perform STS for at least 10 times
* Single STS \>1.7 seconds
* Be able to walk ≥10 meters independently

Exclusion Criteria:

* Any other musculoskeletal, neurological and cardiovascular diseases
* Have visual or language impairments
The Effect of Supraglottic Airway Insertion on the Accuracy of Cricothyroid Membrane Identification in Females

Prospective, observational, study that will examine if a sited supraglottic airway (the igel) will increase the accuracy of identifying the cricothyroid membrane in female patients.

Consented patients that meet inclusion criteria are assessed by clinicians under general anaesthesia with and without a supraglottic airway in situ. The accuracy of CTM identification by palpation will be evaluated using ultrasound.

Palpation of the airway structures results in misidentification of the cricothyroid membrane (CTM) in a high proportion of women. Female front of neck anatomy is less distinct compared to males with reduced angulation of the laryngeal cartilages making it harder to distinguish the relevant landmarks. In obese patients, overlying subcutaneous tissue compounds this problem and several studies have demonstrated poor success identifying the CTM by palpation in this population. Supraglottic airway device (SAD) insertion precedes emergency front of neck access attempts in the stepwise progression from failed intubation to cricothyroidotomy. The nature and clinical implication of SAD insertion on cricothyroidotomy remain unstudied.

Sixty four patients will undergo front of neck airway assessment by volunteer clinicians with and without a SAD in situ (control and SAD assessments, within-subjects design). The patients are fasting women presenting for routine gynaecological surgery. Eight anaesthetists, at different levels of training, will perform eight individual CTM assessments with and without the SAD in situ.

Ultrasound images will be captured in the sagittal plane immediately before and after supraglottic airway insertion. Images are then downloaded, anonymised and randomised for blinded digital analysis.

Eligibility Criteria:
Inclusion Criteria:

* Women attending for routine surgery

Exclusion Criteria:

* unable to give informed consent
* abnormal neck anatomy
* history of gastroesophageal reflux
* history of neck surgery or radiotherapy
* contraindication to supraglottic airway device insertion
Evolocumab in Patients with Multivessel Coronary Disease After Acute Myocardial Infarction: a Target Trial Emulation

The goal of this Target Trial Emulation (TTE) study is to evaluate the effect of evolocumab on clinical prognosis in patients with multivessel disease (MVD) following acute myocardial infarction (AMI) who have deferred non-culprit vessel. The main question it aims to answer is:

Does evolocumab lower risks of major adverse cardiovascular events (MACE) in patients with deferred non-culprit vessel after AMI?

This study aims to investigate the potential prognostic benefits of evolocumab in patients with MVD after AMI at 2-year follow-up. The primary endpoint is MACE, defined as a composite of cardiac death, myocardial infarction, stroke, angina-driven coronary revascularization, and rehospitalization for heart failure. This is a multicentre, cohort-based TTE study and the target RCT is the FOURIER trial.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Acute myocardial infarction diagnosed at hospital admission;
* Multivessel coronary artery disease diagnosed at primary invasive coronary angiography;
* Culprit vessel successfully revascularized;
* At lease 1 non-culprit vessel with ≥50% stenosis and deferred at the opinion of the operator, and no staged revascularization within 6 months.

Exclusion Criteria:

* Cardiac shock, hemodynamically unstable, or severe heart failure (Killip IV)
* Any cardiac surgery within 6 weeks prior to screening;
* Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m\^2 at screening;
* Contraindication or allergy to iodinated contrast agent;
* Malignancy except non-melanoma skin cancers, cervical, or breast ductal carcinoma in situ within the last 5 years;
* Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed in short term.
FLT-PET Imaging for MDS

The main purpose of this study is to see if this tracer can be used to determine how well chemotherapy is working in patients with certain types of leukemia.

Primary objectives

1. To evaluate if FLT-PET uptake shows variation during the treatment course in subjects with MDS being treated with 5-azacitidine therapy

   Secondary objectives
2. To assess FLT-PET uptake heterogeneity within given subjects being treated with 5-azacitidine therapy
3. To generate preliminary data regarding correlation between FLT-PET imaging parameters and clinical responses based on bone marrow aspirate/biopsy

Eligibility Criteria:
Inclusion Criteria:

* All subjects with previously untreated, Intermediate-2 or High risk myelodysplastic syndrome are eligible. These patients have an international prognostic scoring system (IPSS) score of 1.5 to 3.5 based on bone marrow blast percentage, karyotype, and the number of cytopenias 26.
* Subjects will receive the standard FDA-approved dose and schedule of 5-azacitidine. This dose is 75mg/m2 SQ or IV daily for seven days with cycles repeated every 28 days
* The subject's treating physician must have an initial intent of treating with at least four cycles of therapy
* Subjects must have an ECOG performance status of 0, 1, or 2
* Subjects must not have been treated with chemotherapy or radiation for another malignancy within the preceding 6 months
* Subjects must be \> 18 years of age
* Subjects must have a serum creatinine \< 2.0 mg/dL and/or calculated GHF 50 ml/min/1.73m (MRDR formula) or greater
* Subjects must have a serum direct bilirubin \< 2.0 mg/dL unless related to Gilbert's syndrome of hemolysis. Alkaline phosphatase, SGOT (AST), and SGPT (ALT) must be less than 4 x upper limit of normal
* Women must not be pregnant nor breastfeeding
* Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception

Exclusion Criteria:

* Subjects who are pregnant or breast feeding
* Subjects for whom a therapy other than 5-azacitidine is recommended as first line treatment.

  * Allogeneic stem cell transplantation in patients with a suitable donor, lack of comorbidities, and good performance status
Pemetrexed and Gemcitabine Every 14 Days Versus Every 21 Days in Advanced Non Small Cell Lung Cancer

This study is designed to evaluate Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8 every 21 days (Arm A) and Pemetrexed and Gemcitabine Day 1 every 14 days (Arm B) in patients with NSCLC. Each agent and sequence has well demonstrated antitumor activity respectively in patients with locally advanced or metastatic NSCLC. Therefore, it is reasonable to investigate the most optimal schedule for this combination, and which combination is associated with the most anti-tumor activity in the phase II arena.


Eligibility Criteria:
Inclusion Criteria:

* histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
* no prior systemic chemotherapy for advanced Non-Small Cell Lung Cancer
* Prior radiotherapy must be completed at least 4 weeks before study enrollment.

Exclusion Criteria:

* estimated life expectancy of 12 weeks
* a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease
* documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 2 weeks before enrollment
* significant weight loss (that is, \> 10%) over the previous 6 weeks before study entry.