cyrilzakka/clinical-trials huggingface dataset:
Assessment of the BodyGuardian Remote Monitoring Platform in Elderly Healthy Subjects

To adapt and refine the BodyGuardian remote health monitoring system to acquire ECG, Heart rate (HR), activity and breathing data, which will be integrated with weight, blood pressure and symptom data, in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

The elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. Congestive heart failure (CHF) is a growing health epidemic and is associated with significant morbidity, mortality and cost. Mayo Clinic and Preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. It enables on-body monitoring and integration of ECG, heart rate, breathing, and activity, with measures of weight and blood pressure. It is designed as a platform for physician directed patient self-management. This technology may be useful in monitoring CHF patients. Our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Eligibility Criteria:
Inclusion Criteria:

* Resident at independent living facility
* Adequate phone service
* Healthy with life anticipated survival \>than one year

Exclusion Criteria:

* Skin reaction/allergies to adhesives
* Have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC).

This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients \>=18 years with histologically documented inoperable, locally advanced or metastatic (stage IIIB or IV) NSCLC;
* patients must have failed at least one but no more than two standard chemotherapy regimens;
* measurable disease according to the RECIST criteria;
* Eastern Cooperative Oncology Group (ECOG) performance status;
* life expectancy \>12 weeks.

Exclusion Criteria:

* patients with active central nervous system (CNS) lesions;
* prior treatment with agents acting via insulin-like growth factor 1 receptor (IGF-1R) inhibition or epidermal growth factor receptor (EGFR) targeting;
* administration with high doses of systemic corticosteroids;
* radiotherapy in the 4 weeks prior to study start;
* surgery or significant traumatic injury with in the last 2 weeks prior to study start.
Evaluation of EverOn™ - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion

Evaluation of continuous monitoring device on patients Risk during hospitalization and nurse satisfaction level.

To assess the effects of continuous patient monitoring using a contactless monitor in a medical-surgical unit on transfers and length of stay at higher level of care units

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients

Exclusion Criteria:

* None
Outcomes of Surgery in COVID-19 Infection: International Cohort Study (CovidSurg)

CovidSurg will capture real-world international data, to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This shared international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, ultimately improving their clinical care.

There is an urgent need to understand the outcomes of COVID-19 infected patients who undergo surgery. Capturing real-world data and sharing international experience will inform the management of this complex group of patients who undergo surgery throughout the COVID-19 pandemic, improving their clinical care.

The primary aim of the study is to determine 30-day mortality in patients with COVID-19 infection who undergo surgery. In doing so, this will inform future risk stratification, decision making, and patient consent.

CovidSurg is an investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. This study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics

AND

- The patient had COVID-19 infection either at the time of surgery or within 30 days of surgery, based on

(i) positive COVID-19 lab test or computed tomography (CT) chest scan

OR

(ii) clinical diagnosis (no COVID-19 lab test or CT chest performed)

Exclusion Criteria:

* If COVID-19 infection is diagnosed \>30 days after discharge, the patient should not be included.
Sport Surgery Products Outcomes - A Post-market Follow-up

Teknimed is currently conducting a post-market clinical follow-up which will confirm performance, safety and usability for all the Teknimed range of Sports products. TEKNIMED has developed several devices currently used in orthopaedic surgery. With the increasing use of these procedures, there is a need for real-life long-term safety and efficacy data on these products.

The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

It is admitted that:

* Bioabsorbable interference screws are frequently used for graft attachment in knee cruciate ligament reconstruction,
* Bioabsorbable pins are indicated for the realignment and fixation of epiphyseal fractures, osteotomies, arthrodesis and bone grafts of toes,
* Non-absorbable suture is usually used for the repair and the reinforcement of ligaments or tendons structures during surgery procedures,
* Anchor devices are usually used for the repair of rotator cuff tendons and biceps tenodesis.

Furthermore, resorption properties of many available devices (screws, pins) that are marketed as bioabsorbable may be different and not always very well defined.

This retro-prospective study is performed to confirm the safety and performance of TEKNIMED sports surgery products in their current clinical use.

Studied products include - but are not restricted to - the following TEKNIMED products:

* EUROSCREW® NG
* ISOFIX®
* SUTUR'LINK®
* A'LINK'S®
* BIORESORBABLE PINS

And following associated TEKNIMED instrumentation:

* ACL Instrumentation
* A'LINK'S® Instrumentation
* STAINLESS STEEL PINS

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years or older.
* Be willing to sign an informed consent approved by IRB or EC (where applicable) or not being opposed to the use of their clinical data in the study (France)

For prospective inclusion:

- Be considered for a surgery with one of the TEKNIMED sports surgery product comprised in this study.

For retrospective inclusion:

* Have undergone a surgery with a TEKNIMED sports surgery product between the 1st January 2016 and the date of the site initiation visit.
* Be informed of the study and not being opposed to the use of their clinical data in the study (France) or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).

Exclusion Criteria:

* Patients presenting one of the following conditions will not be included: under trusteeship or guardianship, pregnancy
* Anyone of the contraindications mentioned in the respective IFU of each device under study
Effects of Mulligans BLR and CR on Hamstrings Flexibility in Office Workers

The aim of this research is to compare the effect of mulligan bent leg raise and contract relax technique on hamstring flexibility in office workers with sedentary life styles.

Flexibility is regarded as a crucial component of typical biomechanical operation. A tight hamstring increases the risk of frequent impairment to the associated musculature and bony structure. Hamstring muscles are associated with lumbar spine, pelvic and lower limb movement disorders and have been connected to low back discomfort and abnormal gait pattern. It has been observed that long sitting and sedentary life style is directly related to reduce the hamstrings flexibility, so the persons with tight hamstrings are more prone to develop musculoskeletal disorders if not addressed properly. Previous research has shown that contract relaxation and Mulligan's bent leg are both useful for increasing hamstring flexibility. But there hasn't been much research comparing the two methods, Mulligan bent leg lift and contract relax, for hamstring muscle stiffness in middle age office employees; instead, it was done in young people and athletes. Hence, the aim of present work is to study and compare the effectiveness of contract relax and Mulligan bent leg raise in middle age office workers with long sitting hours having hamstring tightness

Eligibility Criteria:
Inclusion Criteria:

* Middle age men and women (30 to 45 years)
* Working/ sitting hours ≥ 36 hours per week.
* Real estate and IT office workers.
* Participant with positive Active Knee Extension Test: A lag of 20degrees is considered normal from full extension, anything less than 20degrees is considered as hamstrings tightness

Exclusion Criteria:

* History of knee and hip injury
* Neurological impairment
* Other orthopedic conditions i.e., hip fracture, THR, TKR etc
* Fracture of lower limb
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin

This study is a multicenter, randomized, open-label, parallel, phase IV trial.

The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.

The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.

After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.

The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.

Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.

The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 19 and 75 years
2. Presence of atherosclerotic cardiovascular disease Coronary artery disease

   * History of acute coronary syndrome
   * Stable or unstable angina
   * History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
3. Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
4. Patients who gave informed consent

Exclusion Criteria:

1. Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
2. A serum triglyceride on fasting \>400 mg/dL
3. A history of muscular symptoms or rhabdomyolysis due to the use of statin
4. Hypersensitivity to rosuvastatin or ezetimibe
5. Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl \<30 mL/min by Cockcroft-Gault formula or estimated GFR \<30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
6. Enrollment of other clinical trials within 30 days
7. Any other issues that the treating physician assumes ineligible for participation in the trial
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.


Eligibility Criteria:
Inclusion Criteria:

* At the same time, patients voluntarily participated in the study and signed informed consent;
* Either male or female, aged 18 or older;
* Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;
* No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
* HER2 IHC 2+ and FISH-;
* ECOG scores 0-1;
* Estimated survival ≥3 months;
* Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
* Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.

Exclusion Criteria:

* Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;
* Known hypersensitivity to RC48-ADC;
* HBV DNA\>500 IU/ mL (or 2000 copies /ml), HCV RNA\>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
* History of HIV infection;
* History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment;
* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Manual Diaphragmatic Release on Ventilatory Functions in Elderly Diabetic Women

Evaluate the effect of manual diaphragmatic release on ventilatory functions and functional capacity in elderly diabetic women.

Sixty elderly type 2 diabetic women were sourced from the endocrinology outpatient clinic at Mansoura University hospitals in Egypt, with referrals from endocrinologists. Patients were randomly assigned into two groups.

The study group includes 30 women participating in manual diaphragmatic release plus aerobic training for 12 weeks, while the control group includes 30 women participating in aerobic training only for 12 weeks. At baseline and poststudy, the following outcomes are assessed:

1. Ventilatory functions (Forced vital capacity and forced expiratory volume in the first second).
2. Functional capacity using modified Bruce treadmill incremental exercise test (Maximal oxygen consumption estimation).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic for more than 5 years.
* Well controlled diabetes with glycated hemoglobin≤7%.
* Normal to mild ventilatory functions impairment.
* Their ages ranges from 65 to 70 years old.
* Their body mass index are less than 30 Kg/m2.

Exclusion Criteria:

* Other types of diabetes.
* Patients with any other chronic chest diseases .
* Cardiovascular disorders (coronary heart disease, heart failure, cardiac arrhythmia, peripheral arterial disease, uncontrolled hypertension).
* Smokers.
* Rheumatoid arthritis.
* Musculoskeletal/ neurological limitations to exercise.
The Effectiveness and Safety of 4% Sodium Citrate as a Lock Solution in Central Venous Hemodialysis Catheter

Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. This study will compare effectiveness and safety utilizing 4% sodium citrate vs. heparin as a lock solution in central venous hemodialysis catheter among hemodialysis patients.

Vascular access is necessary for hemodialysis(HD) procedure. In normal situation, vascular access for HD is created in peripheral vessels. However, vascular catheter may be considered in patients without available peripheral vessels for vascular access. The characteristic of these patients include elderly, diabetes, not tolerant to vascular surgery etc.. Commonly, the HD catheter is inserted in the central vein in these population. Considering clotting condition, anticoagulant is indicated for catheter locking after HD session. In the past years, heparin is the most common solution to be used as locking solution. Nevertheless, heparin has a few disadvantages, such as systemic anticoagulation, thrombocytopenia, and bleeding risk. An alternative for anticoagulation in HD session is 4% sodium citrate. The effectiveness and safety of sodium citrate in HD sessions have been reported in clinical studies.

Characteristics of sodium citrate and safety profile Trisodium citrate acts locally as an anticoagulant by chelating ionized calcium in blood, resulting in the blockage of calcium-dependent clotting pathways. Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. The advantageous effects of sodium citrate in HD catheter locking solution includes reducing frequency of catheter exchanges, reducing using of thrombolytic drugs, reducing hospitalization rates, and bacteremia. Regarding adverse effect of sodium citrate, hypocalcemia and other untoward outcomes are rare reported in the previous clinical studies

Eligibility Criteria:
Inclusion Criteria:

1. Age \>=20 years
2. End-stage renal disease patients who received regular HD weekly via central venous catheter for at least 3 months in outpatient clinic in Kaohsiung Chang Gung Memorial Hospital, Taiwan

Exclusion Criteria:

1. bleeding tendency
2. on radiotherapy or chemotherapy for malignancy
3. pregnancy
4. drug allergy history to citrate
5. undefined reasons for refuted participation.
Evaluating the Efficacy of the ENav Toolkit to Improve Colorectal Cancer Screening

The purpose of this research study is to evaluate the efficacy of a digital navigation tool, called the eNav to improve colorectal cancer screening uptake among patients treated at federally qualified health centers (FQHC)s. The digital navigation tool includes a website and text messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

This is a multi-site randomized clinical trial to evaluate the efficacy of the eNav Toolkit. A total of 400 participants will be from four FQHC clinics within the Institute for Family Health FQHC network. Participants will be randomly assigned to one of two groups:

1. eNav group (N=200) or
2. usual care group (N=200)

Participants will consent and complete a baseline questionnaire (demographics, medical information) 1-4 weeks before their primary care appointment.

Those in the intervention group will receive a link to the eNav website. The digital navigation tool includes a website and text-messaging support. The website includes information, motivational support, decisional support and cues to action (e.g., ability to request a CRC screening test). The eNav tool also includes text-messaging based navigation (e.g., reminders, instructions to complete the screening test).

The control group will receive standard clinical care.

Then 3-6 weeks after that primary care appointment, the research team will reach out to participants to complete a follow-up questionnaire. The follow up questionnaire will assess constructs guided by the health belief model (e.g., self-efficacy, benefits/barriers for CRC screening).

The impact of the eNav Toolkit on CRC screening completion at 6 months will be evaluated by checking their medical records. If a patient does not have a CRC screening recorded in their medical record, the research team will call the patient to inquire whether they have completed the CRC screening.

Eligibility Criteria:
Inclusion Criteria:

* Patient treated at the Institute for Family Health (IFH)
* Patient 45 to 75 years old
* English or Spanish speaking
* Able to provide consent within the study time frame (within a month of the primary care appointment
* Patients have access to a computer, tablet or mobile device to access the eNav Toolkit OR willing to use a clinic provided device, in person at either IFH OR Mount Sinai
* Patient scheduled for a primary care appointment at IFH
* Patients are due for colorectal cancer screening (as determined by the health maintenance alert in the medical chart)

Exclusion Criteria:

* Unable to provide informed consent
Perianal Versus Endoanal Application of Glyceryl Trinitrate 0.4% Ointment for Chronic Anal Fissure

Perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. However, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. Recent studies (Dis Colon Rectum. 2007 Apr;50(4):509-16) have demonstrated that nitroglycerin ointment products compounded by pharmacies did not meet the USP specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. These results raise significant issues as to whether the patient is put at undue risk relative to the relief of their anal fissure pain. In addition, one study (Dis Colon Rectum. 2006 Jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose of ointment.

Topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials and is effective in healing chronic anal fissures. It assures exactly dose and concentration of nitroglycerin.

Hypothesis: The endoanal application of exactly dose and concentration of nitroglycerin must reduced headache and the final recurrence.

The purpose of this study is:

1. Principal end-point: to compare perianal vs endoanal application of Rectogesic and evaluate the different morbidity of the two presentation

inclusion criteria: chronic anal fissure. Outcome measures: recurrence and headache.

Eligibility Criteria:
Inclusion Criteria:

* Before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). Chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres.

Exclusion Criteria:

* Associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids)
* Patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression)
* Cardiopathy
* Headache and pregnancy.