cyrilzakka/clinical-trials huggingface dataset:
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).


Eligibility Criteria:
Inclusion Criteria:

PCP Group:

* Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
* Provide care to at least five patients with a diagnosis of T2D

Patient Group:

* Have a diagnosis of T2D for ≥6 months;
* Have uncontrolled T2D defined as HbA1c \>7% documented in the EHR on at least two visits in the past year;
* Fluency in English or Spanish;
* Be willing to send/receive text messages; and
* Be \> 18 years of age.

Exclusion Criteria:

Patient Group:

* Refuse or are unable to provide informed consent;
* Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR;
* Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
* Are pregnant or planning to become pregnant within 12 months;
* Currently participate in another T2D study; or
* Plan to discontinue care at the clinic within the next 12 months.
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer

This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young patients with good performance status with unresectable metastatic colorectal cancer.

The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for patients with good performance status. The estimated benefit from the combination is greater than the possible risk, especially for the patients who will become resectable after treatment. It will be extremely interesting to evaluate the resectability rate of this specific group of patient with good performance status and unresectable disease when they are treated with all active chemotherapeutic agents and cetuximab

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven metastatic adenocarcinoma of the colon or rectum
* Previous chemotherapy for metastatic disease not allowed. Patients who received prior adjuvant 5-FU-based chemotherapy are eligible if they have remained free of disease for at least 6 months after the completion of adjuvant therapy
* Patients with operable metastatic disease are excluded from the study
* Age 18-70 years
* Performance status (ECOG) 0-1
* At least one bidimensionally measurable lesion of \>= 2cm
* Life expectancy of at least 6 months
* Adequate hematologic parameters (absolute neutrophil count \>= 1.5x109/L and platelets \>=100x109/L)
* Creatinine and total bilirubin \< 1.25 times the upper limit of normal
* Aspartate and alanine aminotransferase \< 3.0 times the upper limit of normal (\<5 times in case of liver mets)

Exclusion Criteria:

* Absence of active infection or malnutrition (loss of more than 20% of the body weight)
* No history of a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma. curatively treated
* Patients treated with palliative radiotherapy had to have measurable metastatic disease outside the irradiation fields.
* Patients with severe cardiac dysfunction, liver metastases involving more than 50% of the liver parenchyma, chronic diarrhea, or prior irradiation affecting more than 30% of the active bone marrow are excluded.
* All patients will have to sign written informed consent in order to participate in the study
Human Phenotype Project Study Protocol

This is a prospective study aimed at recruiting 30,000 individuals, aged 40-70 years old, and following them longitudinally for 25 years with repeated measurements. The basic follow-up frame will include a visit to the Clinical Test Center (CTC) every two years and a phone interview every other year (on uneven years). Sample collection and biobanking will be performed every two years and online questionnaires will be filled out on an annual basis.

The primary goals are to study the variation observed across different individuals in disease susceptibility, clinical phenotypes, and therapeutic responses. The study aims at studying the complex interplay and relative contribution of different omics, physiological characteristics and lifestyle on disease pathogenesis and progression and to evaluate how these effects are mediated.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18+, males and females.

Exclusion Criteria:

* Pregnancy.
* Mentally disabled or in general legally non-competent.
* Prisoner or soldier. Soldiers: mandatory service only
* Active cancer
* Fertility Treatments (current)
* Hepatitis ( B, C), chronic or acute
* HIV
* Liver cirrhosis
* Dialysis
* Unstable medical conditions
Orthostatic Hypotension in Rehabilitation Patients

The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period.

Methods:

During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Vancouver VA Nursing Home or Rehabilitation ward

Exclusion Criteria:

* Unable to stand upon admission
* Hospice admission
* Respite admission
Clinical Research of TCM on Pelvic Inflammatory Disease Sequelae

The trial attempts to optimize, standardize and simplify the characteristic diagnosis and treatment program of the dominant diseases in our hospital-the sequelae of pelvic inflammatory disease, so as to make it suitable for clinical diagnosis and treatment in primary hospital.

Sequelae of pelvic inflammatory disease (SPID) is a common cause of chronic pelvic pain, ectopic pregnancy and infertility, which seriously affects the physical and mental health of the patients, quality of life and family happiness. Western medicine for pelvic inflammatory disease sequelae is still lack of effective treatment methods, traditional Chinese medicine treatment of this disease has a unique advantage, with broad prospects for development..Standardized diagnosis and treatment scheme of this project on the one hand, improve and optimize the sequelae of pelvic inflammatory disease, including according to the dialectical treatment of herbal medicine combined with TCM (traditional Chinese medicine enema, external application of Chinese medicine intervention treatment); on the other hand, to observe the clinical curative effect and adverse reaction of traditional Chinese medicine comprehensive treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with diagnostic criteria for the sequelae of pelvic inflammatory disease in Western medicine;
2. Patients conforming to the criteria of TCM syndrome differentiation;
3. Age 18--60 years old, married or sexual life;
4. In this study, the voluntary participation, and signed informed consent;

Exclusion Criteria:

1. Patients who do not meet the diagnostic criteria of Western medicine and traditional Chinese medicine dialectical typing standard;
2. Persons with acute pelvic inflammatory disease;
3. Related symptoms caused by diseasesGynecological tumor，specific vaginitis, acute cervicitis, pelvic congestion syndrome, endometriosis, adenomyosis, pelvic tuberculosis etc.
4. Pregnant and lactating women;
5. With severe primary disease, such as liver, kidney, heart, brain and hematopoietic system;
6. Allergic to a variety of drugs or known to be allergic to the composition of the use of traditional Chinese Medicine;
7. Patients taking part in other clinical trials;
8. Suspect or do have a history of alcohol, drug abuse or according to the judgment of the researcher,other lesions or circumstances that have reduced the likelihood of entering a group or the complexity of entering a group,such as frequent changes in the working environment, the living environment is not stable,etc.
Cancer Stem Cell Biomarkers as a Predictor of Response to Trastuzumab in Samples From Patients With Breast Cancer Previously Treated in the NSABP-B-31 Trial

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers as a predictor of response to trastuzumab in samples from patients with breast cancer previously treated in the NSABP-B-31 trial.

OBJECTIVES:

Primary

* To determine if stem cellness identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with either adjuvant doxorubicin hydrochloride \& cyclophosphamide followed by paclitaxel (the "control arm" of B31), or the same chemotherapy plus trastuzumab.

Secondary

* To conduct exploratory analyses to assess, to the extent possible, if co-localization of stem cellness, as determined by ALDH1 positivity, and HER2 identifies a group of patients previously considered to have HER2-negative cancers (using classical definitions) who benefit from adjuvant trastuzumab.

OUTLINE: Archived breast cancer stem cells samples and terminally differentiated cells from tissue samples are analyzed for HER2 and ALDH1 expression by dual-staining quantitative immunofluorescence using Automated Quantitative Analysis (AQUA) , IHC, and fluorescence in situ hybridization (FISH).

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tissue samples from patients with node-positive breast cancer whose tumors overexpress HER2
* Primary tumor samples that are negative for HER2 using classically accepted cutoffs determined in the metastatic setting
* Treated with adjuvant therapy comprising doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without trastuzumab in the NSABP-B-31 trial

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Continuous Versus 1-min Oscillometric Arterial BP Monitoring

Hypotension is common during surgery and about one-third of hypotension occur during the period from anesthesia induction to skin incision. Therefore, monitoring blood pressure during this period is crucial.

Two methods are used for measuring blood pressure during surgery: the intermittent measurement method (oscillometric method) and the continuous measurement method (arterial catheterization method). The latter is frequently used in surgical patients who require meticulous hemodynamic management, although there is no clearly defined indication for its use. Despite the benefits of arterial catheterization, it is often delayed after induction of general anesthesia, and blood pressure is monitored intermittently using the oscillometric method.

A recent study showed that continuous arterial pressure monitoring using arterial catheterization method during the induction of general anesthesia reduced hypotension significantly compared to 2.5-min interval intermittent arterial pressure monitoring using oscillometric method. The study was conducted on patients scheduled for continuous arterial pressure monitoring during surgery and the group with continuous arterial pressure monitoring showed significantly lower incidence of hypotension during the first 15 minutes of anesthesia induction.

However, measuring blood pressure using the oscillometric method at 1-min interval, rather than 2.5-min interval, may not be significantly inferior to continuous monitoring via arterial catheterization in terms of hypotension occurrence. This study aims to compare hypotension incidence between arterial catheterization method and oscillometric method with 1-min interval during induction of anesthesia in non-cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 19 or older undergoing scheduled non-cardiac surgery with general anesthesia and continuous invasive arterial blood pressure monitoring via the radial artery

Exclusion Criteria:

* Arterial access is clinically necessary before induction of anesthesia (e.g., moderate or higher degree of aortic stenosis, moderate or higher degree of heart failure, coronary artery disease requiring revascularization, intracranial aneurysm with a significant risk of rupture, etc.)
* Emergency surgery
* American Society of Anesthesiologists (ASA) physical status 5 or 6
* Arterial access is required in a different artery other than the radial artery (e.g., the femoral artery)
* Electrocardiogram other than sinus rhythm
* Refusal to participate in the study
Assessment of PET Tracers to Evaluate T Cell Change and Activation in Relation to Immunotherapy Treatment Response in Non-Small Cell Lung Cancer

The iRelate is a PET imaging trial to compare two upcoming and promising T cell PET tracers. Following chemo-immuno therapy, as part of standard care, NSCLC patients will be recruited to receive two PET scans, shortly before their surgery. Both PET scans will be compared to each other, as well as compared to the pathological analysis of the resected tumor.

This study will provide detailed information on the unique as well as additive capacities of imaging biomarkers derived from the immune cell targeting PET tracers.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed NSCLC
* T1-4N0-2, lesion size of ≥2cm, at time of the restaging FDG PET/CT
* Planned to undergo resection after chemo-IO according to routine treatment guidelines
* Willing and able to provide written informed consent for the trial
* Above 18 years of age on day of signing informed consent
* Have measurable disease based on RECIST 1.1
* Have a ECOG performance status of 0-1, and are considered operable based on pulmonary function test and/or exercise testing

Exclusion Criteria:

* Patients deemed inoperable
* Patients who have received a splenectomy
* Patients who have received any vaccination within 14 days of enrollment
* Patients with a condition requiring systemic treatment with either corticosteroids (\&gt; 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of day 0. Inhaled or topical steroids, and adrenal replacement steroid \&gt;10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial.
Pregnancy Related Inappropriate Sinus Tachycardia

A feasibility study into the exploration of possible mechanisms underlying inappropriate sinus tachycardia (IST) syndrome in pregnancy.

This is a non-interventional, physiological study which will explore the feasibility of examining autonomic function and related haemodynamic variables in pregnant women with and without inappropriate sinus tachycardia, with the aim of providing scope for future research.

Sinus tachycardia (normal heart rhythm but fast heart rate) is common and usually related to an obvious cause (e.g. exercise such a running or cycling) and doesn't cause any untoward symptoms. In rare cases however, sinus tachycardia can occur without an obvious cause (i.e. it is inappropriate to the situation) and can cause distressing symptoms such as palpitations, dizziness and breathlessness at rest or with minimal exertion. This syndrome of inappropriate sinus tachycardia is poorly understood and can be difficult to manage; especially when the affected individual is pregnant. In order to understand the condition better and improve care pathways we aim to measure various features of the cardiovascular system in pregnant women with and without IST.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-45 years of age
* Able to give written informed consent and willing to participate
* The participant falls into one of the below categories:

  i. Pregnant women with IST ii. Pregnant women without IST

Exclusion Criteria:

* Obesity (BMI \> 29.9)
* Current or recent (within last 3 months) smoker
* Known medical condition likely to affect HRV (other than IST in relevant groups)
* Previous history of hypertensive disorders in pregnancy
* Lack of written informed consent
Radial Medical - GAPS

This study will prospectively compare compliance rates between a novel FDA cleared wearable compression therapy with and without digital engagement for DVT prophylaxis in both hospital and home environments after total knee or hip arthroplasty.

This study is a single-arm, open-label, prospective, single-center study designed to evaluate compliance to CirvoTM therapy use with and without digital engagement. Historical questionnaire data with a different compression device will be compared to the same questionnaire used for the prospective cohort of up to 200 subjects. All patients prescribed compression therapy following total joint arthroscopy will be offered participation.

Subjects will receive CirvoTM compression therapy according to the standard of care protocol at NYU during or after surgery and 18 hours per day for 14 days.

1. Baseline: Following consent, participants will provide demographic, medical history and information with respect to their elective orthopedic procedure and receive training on the CirvoTM device. Participants will be randomized to either digital engagement or no digital engagement groups.
2. Post procedure: After the procedure, CirvoTM device operation will be reviewed with the participant.
3. Discharge: Any adverse events occurring during hospitalization will be reviewed, data capture on the CirvoTM app will be confirmed.
4. 14- day visit: Participants will complete a patient satisfaction questionnaire, provide information with respect to any adverse events including specific details about DVT and readmission and return the devices.
5. 30-day phone call/visit: Participants will be contacted at 30 days to answer questions about DVT's and readmissions.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 18
* Undergoing elective primary total hip/knee replacement
* Planned discharge to home
* Able to train to and operate the Cirvo device with app

Exclusion Criteria:

* History of Pulmonary Embolism
* Active cancer
* BMI \>40
* Current smoker
* History of a hyper-coaguable condition
* Actual or expected prolonged bedrest for \>3 days
* Calf geometry on which Cirvo device does not appropriately fit (prospective cohort only)
* Known sensitivity to any of the materials used in the Cirvo device (prospective cohort only)
* Currently participating or planning to participate in any other investigational clinical evaluation during study period that may, in the opinion of the investigator, affect compliance (prospective cohort only)
Comparative Effects of Plyometric Training and Theraband Resistant Exercises in Karate Players

The aim of this study is to find out the Comparative effects of Plyometric training and Theraband Resistant Exercises on Agility, Power and Dynamic balance in karate Players with Patellofemoral Syndrome. Understanding how these methods impact agility, power, and dynamic balance provides practical insights for designing rehabilitation programs.It help therapists to find which evidence-based recommendations are beneficial for maximizing the athletes agility, power, dynamic balance and overall performance or well-being of the karate players with Patellofemoral pain syndrome.

The literature gap in this study on the Comparative Effects of Plyometric Training and Theraband Resistant Exercises on Agility, Power and Dynamic Balance in Karate Players with Patellofemoral Syndrome may exist, there might be limited studies specifically addressing this unique combination of factors, further investigation is needed to explore the evidence based effect of these exercises on karate players with Patellofemoral syndrome, considering the interplay between the exercises and the sport specific demands.

Eligibility Criteria:
Inclusion Criteria:

* Males
* Age 18 to 25 years
* With playing experience of 3 to 5 years will be included
* Minimum Sports activity 1 hour 4 times a week
* Positive patella femoral compression test (Pain is in around the patella and back of knee cap)

Exclusion Criteria:

* Recreational players
* Players with recent injury in past 6 months
* Any musculoskeletal and neurological problem
* Player addicted to any drug or alcohol will be excluded
Domperidone Expanded Access Treatment Program

To allow the use of domperidone by patients with gastrointestinal disorders who have failed standard therapy.

To provide oral domperidone to patients ≥12 years of age where, according to the investigator's judgment, a prokinetic effect is needed for the relief of refractory gastroesophageal reflux disease with upper gastrointestinal (GI) symptoms, gastroparesis, and chronic constipation in patients whom the potential benefit may outweigh the risk of cardiovascular adverse reactions including QT prolongation, Torsades de Pointes, and death.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female
2. Age 12 and older
3. Symptoms or manifestations secondary to GERD (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.
4. Patients must have a comprehensive evaluation to eliminate other causes of their symptoms.
5. Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsades de Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

1. Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc \> 450 milliseconds for males, QTc\>470 milliseconds for females).
2. Hepatic dysfunction
3. Renal insufficiency
4. Clinically significant electrolyte disorders.
5. Gastrointestinal hemorrhage or obstruction
6. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
7. Pregnant or breast feeding female
8. Known allergy to domperidone