cyrilzakka/clinical-trials huggingface dataset:
Remote Monitoring System for Patients, Who Had Myocardial Infarction

one-centered, open, prospective, non-randomized, controlled clinical study will be aimed at creating remote monitoring system for patients' condition and the development of methodological approaches and its usage for conducting patients, who had myocardial infraction and who has a very high risk of developing an unfavorable outcome.

The research will involve patients, who had myocardial infraction and who has the high level of potential adherence to treatment, which will be determined by the usage of Russian generic questionnaire for evaluation of compliance to drug therapy. At the end of a 12 month observation with the registration of unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries) based on the analysis of non-genetic and genetic factors (polymorphism of genes Thr174Met and Met235Thr in gene angiotensinogen, Arg389Gly and Ser49Gly in gene adrenoceptor beta 1, Ser447Ter in gene lipoprotein lipase and Leu28Pro in gene apolipoprotein E, Trp212Ter and G681A in gene cytochrome P450 family 2 subfamily C member 19) factors of unfavorable prognosis will be identified and considering which group of patients requires the use of remote monitoring system will be formed. From one group of patients we will form two comparable groups, one group will use this remote monitoring system and another will not. The effectiveness of the remote monitoring system will be evaluated after 6-month's observation based on the registration of the unfavorable cardiovascular occasions (death from cardiovascular reasons, nonfatal myocardial infraction, cerebral stroke, necessity for repeated revascularization of the coronary arteries, frequency of hospitalizations).

Eligibility Criteria:
Inclusion Criteria:

1. A significant diagnosis of myocardial infraction, confirmed by the level of biomarkers of myocardial necrosis in blood examination (troponin, creatine kinase-MV), electrocardiographic criteria, typical clinical presentation.
2. The high level of adherence to treatment
3. Signed informed agreement

Exclusion Criteria:

1. Active cancer or remission period less than 5 years;
2. Absolute contradictions to the prescription of beta-adrenergic blocking agents, angiotensin converting enzyme inhibitors, statins, antiaggregants.
3. Mental illnesses.
4. Alcohol and drug abuse
5. Patient's noncompliance, according to the researchers
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed PAR.
* Has a positive skin prick test (SPT) with indoor allergens and/or positive antigen-specific serum immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
* A dermatographic participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum IgE test.
* Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion Criteria:

* Have received a dose of lebrikizumab.
* Is currently on allergen immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy (SCIT/SLIT) for ≥3 years prior to randomization are eligible, if they were not on a maintenance allergen immunotherapy (AIT) regimen.
* Have received treatment with any rescue medication during the screening and/or run-in period.
* Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:

  1. B cell-depleting biologics, including rituximab, within 6 months.
  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  3. Systemic immunosuppressants within 4 weeks prior to baseline.
* Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 4 weeks of the maintenance period.
* Anticipates significant changes in their daily environmental exposure
* Has a known history of recurrent acute or chronic sinusitis,
* Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
Renal and Hormonal Effects of Pioglitazone

This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Aim: Glitazones are powerful insulin sensitizers prescribed for the treatment of type 2 diabetes. Their use is however associated with fluid retention and an increased risk of congestive heart failure. We previously demonstrated that pioglitazone increases proximal sodium reabsorption in healthy volunteers. This study examines the effects of pioglitazone on renal sodium handling in subjects prone to insulin resistance, i.e. diabetic and/or hypertensive subjects.

Methods: In this double-blind, randomized, placebo-controlled, four-way, cross-over study, we examined the effects of pioglitazone (45mg daily during 6 weeks) or placebo on renal, systemic and hormonal responses to changes in sodium intake in 16 individuals, 8 with type 2 diabetic and 8 with hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Type II Diabetes
* Hypertension

Exclusion Criteria:

* Cardiac or renal diseases
* Anaemia
* Drugs like aspirin, non steroidal anti-inflammatory drugs and hormonal replacement therapy.
Clinical Impact of Rapid Identification of Positive Blood Cultures vs. Internal Laboratory Standard

In this before-after study, different new methods for bacterial species identification from positive blood cultures will be compared towards historic controls. All samples are analyzed within the routine workflow for bacterial species identification and antibiotic resistance profiling. Patients with positive blood cultures from 2016 to 2018 receiving a conventional identification methods (controls) will be compared to patients from 2018 and 2019 with a new identification method (cases). The conventional identification method consisted in general of an over-night subculture and subsequent identification of the bacterial pathogen using either biochemical profiling or Matrix-assisted Laser-Desorption/Ionization Time-of-Flight (MALDI-TOF MS). The new identification of positive blood cultures methods include (i) either the newly introduced Biofire FilmArray© Blood Culture Identification (BCID) panel or (ii) in a subset of patients whole genome sequencing (WGS) approaches.


Eligibility Criteria:
Inclusion Criteria:

* patients with positive blood cultures hospitalized between August 2016 and October 2019
* documented refusal of the general consent

Exclusion Criteria:

* outpatients
* patients hospitalized in other hospitals
* patients with known bacteremia diagnosed in another hospital
Muscle Malonyl Coa Biomarker Assay Development

Biopsies of the outer thigh muscle and serum samples will be collected from untreated healthy subjects. These biological samples will be provided to the Diabetes Research Unit Translational Biomarker Laboratory for use in developing and validating human muscle malonyl CoA and serum malonate biomarker assays.

This non-drug method study was terminated on November 19, 2009. The decision to terminate was based on safety concerns (biopsy-related pain) observed in the first set of subjects. Four subjects were give a sample and did not tolerate it well. No data was collected to report.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests). Female subjects will be of non-childbearing potential.
* An informed consent document signed and dated by the subject or a legally acceptable representative.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic, (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing), muscle disease, diabetes, or severe uncontrolled hypertension.
* Any significant bleeding diathesis which could preclude recovery from the biopsy procedure. ASA, ibuprofen, and any other oral anti platelet agent should be discontinued at least 7 days prior to procedure.
* Prothrombin time (PT)/INR and/or activated partial thromboplastin time (aPTT) above the respective local laboratory normal ranges.
* Abnormal CK as per CRU laboratory ranges.
* Subjects with either a medical history of or physical evidence of keloid scar formation upon physical examination.
* 12 lead ECG demonstrating a clinically significant abnormality.
* Females of child bearing potential, pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection.
* Known hypersensitivity to lidocaine or any component of the study procedure.
* Participation in non-routine rigorous exercise (eg, road races, heavy lifting, etc.) within one week prior to the muscle biopsy procedures.
* Professional athletes.
Non-OpeRative MANagement of Rectal Cancer Patients

This study is a single-center, open, prospective, single-treatment trial (pilot study). This study aims to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer and to investigate the feasibility of non-surgical treatment.

Indication:

1. mid-to-lower rectal cancer was diagnosed histologically as adenocarcinoma in preoperative examination,
2. the tumor was located at the lower boundary of the tumor spans the anorectal junction, and the clinical stage is stage 2 or 3, and
3. clinical complete remission was confirmed after the treatment response evaluation at 8 weeks after completion of preoperative chemoradiotherapy according to MR/SFS and biopsy.

Aim:

1. to analyze the treatment results after receiving capecitabine adjuvant chemotherapy for 4 months after non-surgical treatment in patients who had completed and could have clinical complete remission with capecitabine preoperative chemoradiotherapy with capecitabine for mid-to-lower rectal cancer
2. to investigate the feasibility of non-surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical CR after pre-operative CRT for Rectal cancer

Exclusion Criteria:

-
Prevalence and Associated Factors of Sarcopenia Among Elderly Patients in Osteoporosis Clinic

This was a cross-sectional study. Patients who attended the osteoporosis clinic of Kowloon Hospital from June to December 2022 were recruited.

Grip strength and appendicular skeletal muscle mass index were measured with a Jamar dynamometer and a bioimpedance analyser. Since most patients in our clinic are of Chinese ethnicity, the diagnostic criteria in the Consensus Update on Sarcopenia Diagnosis and Treatment by the Asian Working Group for Sarcopenia in 2019 was utilised. The diagnosis of sarcopenia was established by the presence of both low grip strength (Male: \< 28 kg, Female \< 18 kg) and low appendicular skeletal mass (Male: \< 7.0 kg/m2, Female: \< 5.7 kg/m2)


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years old or above
* Diagnosed with osteoporosis by: Fragility fracture or T-score ≤-2.5 SDs at any site on DXA scan and;
* Able to read and write Chinese

Exclusion Criteria:

* Unable to maintain standing posture for bioimpedance analysis
* Modified Functional Ambulation Classification (MFAC) ≤ IV
* Incompetent in giving consent
* Unable to follow instructions
* Implanted with metal in any of four limbs
* Implanted with pacemaker, implantable cardioverter defibrillator or any other types of electrical device
Multicomponent Exercise on Executive Function and Balance

The present study is to examine the effects of a multicomponent exercise on executive function and balance in pre-frail older adults.


Eligibility Criteria:
Inclusion Criteria:

* Age≥ 65
* Pre-frail according to the Fried Physical Frailty Phenotype
* Community-dwelling and able to walk independently\>6m

Exclusion Criteria:

* Unstable medical condition (ACSM Health Facility Pre-participation Screening Questionnaire)
* Neurological conditions(eg, Parkinson's disease, stroke, multiple sclerosis)
* MMSE\<24
* Visual or color discrimination impairment
A Prospective Study to Evaluate the Effect of Systemic Adjuvant Therapy on the Cognitive Function of Breast Cancer Patients

The primary objective of this prospective pilot study is to examine the variation of cognitive function at various time-points in stage I-III breast cancer patients who have undergone or are undergoing adjuvant systemic therapy (chemotherapy and/or anti-hormonal therapy) and compare this to a group of healthy controls to evaluate if there is a difference. All randomized patients and their respective controls would be required to complete the computerized neuropsychological assessment CANTAB at certain time-points.These patients and controls would also be given on the same day as CANTAB testing, a set of questionnaires to evaluate subjective factors such as anxiety, depression, fatigue or menopausal symptoms which may also have an effect on cognition. Subjective assessment of cognitive function will rely on self-reporting by study participants using a validated questionnaire.The potential risks to subjects are minimal, as this is a study without any intervention regarding the medical management of patients. By participating in this study, subjects will be helping in the aim of determining if there is cognitive impairment post-therapy, and if so, how prevalent is this phenomenon, when it arises and how it changes with time. This will consequentially play an important role with regard to patient knowledge. Furthermore, if chemotherapy is shown to be associated with cognitive impairment, further studies can be carried out to determine the exact pathophysiology behind this phenomenon. This will allow for sensitive and timely detection of cognitive dysfunction in patients who have received chemotherapy and/or anti-hormonal therapy, and subsequently open the avenue for research in preventing or alleviating this phenomenon. This is crucial in improving patients' quality of life, social and occupational performance.

The investigators hypothesis is that systemic adjuvant therapy in the form of chemotherapy and/or anti-hormonal therapy given to primary breast cancer patients can cause cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed stage I-III breast carcinoma
2. \< 65 years old
3. Female

Exclusion Criteria:

1. Previous exposure to chemotherapy/anti-hormonal therapy for any other malignancy
2. Previous neoadjuvant therapy for breast cancer
3. Concomitant second primary in-situ or invasive carcinoma or previous history of carcinoma/carcinoma-in-situ
4. Known disease or injury to the central nervous system (including neurodegenerative diseases, epilepsy), severe visual or auditory disorders
5. Motor weakness due to any cause which makes using a touchscreen computer difficult
6. Known background of depression, anxiety disorders or other neurobehavioural conditions
7. Ongoing use of tranquilisers or anti-depressants
8. Previous neuropsychological testing
9. Current or previous history of alcohol or drug dependent
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* healthy men or women, 18 to 55 years of age
* weight within +/- 25% for height and weight for body frame
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* history of allergic response to mesalamine
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 28 days prior to study dosing
Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (between 18-75 years of age) scheduled for extradural spine surgery with instrumentation (greater than or equal to two levels and including minimally invasive) of expected duration ≥ 2 hours
* Postoperative hospital stay expected to be ≥ 2 nights at the time of consent

Exclusion Criteria:

* Use of methadone currently or within the previous 6 weeks
* Drug misuse history (e.g., ketamine, cocaine, heroin, amphetamine, methamphetamine, MDMA, phencyclidine, lysergic acid, mescaline, psilocybin).
* Current use of opioid antagonist/partial antagonist (i.e. buprenorphine).
* Current or past diagnosis of a Major Psychiatric disorder (such as Schizophrenia, dementia, delirium).
* Patients with a BMI ≥ 36 kg/m2
* 2nd or 3rd degree heart block as assessed by preoperative EKG.
* QTc \> 450 msec on preoperative EKG.
* Documentation of congestive heart failure and/or ejection fraction \< 30% if recorded in the Pre-Operative Record.
* Contraindication to use of any analgesic medications listed in the ERAS pathways (acetaminophen, gabapentin, celecoxib, IV opioids).
* Any known hypersensitivity to methadone.
* Pregnant or breastfeeding.
* Abnormal liver function tests as related to the MSK guidelines for use of IV acetaminophen: ALT greater than 2 x Upper Limit of Normal (\> 75 U/L)
* Serum Creatinine \> 1.5 mg/dl
* Instrumented spine cases of less than 2 levels
* All non-instrumented spine cases
* All intradural tumor resections
* All "take backs" that occur within 72 hours of surgery (wound revisions, hematomas, etc.)
Outpatient Total Joint Arthroplasty in Dedicated Daycare Facility vs Standard Patient Ward

The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.

Introduction of fast-track total hip arthroplasty (THA) and total knee arthroplasty (TKA) has led to a decrease in length of stay without compromising patient safety and clinical outcome . In recent years outpatient THA and TKA has gained popularity, especially as major focus is placed on reducing cost and increasing efficiency in all medical treatments . Studies have shown outpatient arthroplasty to be feasible both for THA and TKA patients , with up to 70% of unselected patients being potentially eligible for outpatient surgery. Various results are published on success rate of discharged patients on the day of surgery, ranging from 25% to 99% , depending on patient selection and logistic setup. While the majority of published studies utilizes a modern fast-track setup with early mobilization and multimodal pain treatment, the optimal logistic setup remains unknown.

The purpose of this single center randomized controlled trial (RCT) is to investigate whether outpatient arthroplasty surgery in a dedicated daycare facility will improve discharge on day of surgery, as opposed to surgery followed by subsequent stay in the ward and also same day discharge, without compromizing safety and outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and radiological osteoarthritis of the hip suitable for primary cementless THA and patients with clinical and radiological osteoarthritis of the knee suitable for primary Cruciate Retaining (CR) TKA
* Age 18-80
* American Society of Anesthesiologists (ASA) Score (1-2)
* BMI \<35
* Interested in and motivated for same day discharge
* Family or relatives to be present for \>24 hours after discharge
* Able to understand and give consent to the study

Exclusion Criteria:

* Unable to provide care at own home on day of surgery for \>24 hours after discharge
Using an Electronic Personal Health Record to Empower Patients With Hypertension

Project Summary:

An electronic personal health record (ePHR) could maximize patient/clinician collaboration and consequently improve patient self-management and related health outcomes. The purpose of the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that has been modified using a patient- and family-centered approach and incorporates the experiences, perspectives, and insights of patients and family members actually using the system. Comparison of patients with the ePHR intervention to a group of "care as usual" patients will be performed. The investigators Specific Aims are: (1) To improve the application of patient- and family-centered care elements in an existing ePHR, based on feedback from a pilot study of patients and their families. The modified ePHR will be tested in a pilot group of patients with hypertension and their families. (2) To implement and test the effectiveness of the modified ePHR with patients being treated for hypertension by a team of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory settings. Outcome measures will include patient activation and perception of care, quantifiable biological markers, patient-physician communication, and congruence of treatment with guidelines, particularly medication management; (3) To monitor the shift in provider and support staff awareness and incorporation of patient- and family-centered care as a result of implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR could be implemented in additional locations in the Southeast.


Eligibility Criteria:
Inclusion Criteria:

* age 21
* hypertension
* referral by physician

Exclusion Criteria:

* age over 80
* no hypertension
* too ill to participate