cyrilzakka/clinical-trials huggingface dataset:
A Safety and Effectiveness Prospective Blinded Clinical Study to Validate xBar System as Monitoring Tool for Anastomotic Leaks Detection

Purpose: To validate the safety and effectiveness of xBar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis.

The clinical team is blinded to the leak detection of the xBar system.

Study design: Pivotal, Prospective, Blinded, multi-center study. Study Population: This study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion.

xBar is an investigational device intended for post-op monitoring of patients undergoing GI surgery. The device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. The collected data is processed for early detection of complications.

Study description: The study is intended to validate the performance of the xBar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. During the index surgery the xBar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. Safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xBar results, and the system.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 22 years
2. Indication for sigmoid or rectal resection surgery.
3. Usage of drain during the surgery (to be confirmed during the surgery)
4. Willing and able to comply with the study follow up.
5. Able and agree to provide an informed consent.

Exclusion Criteria:

1. Contraindication for surgery and/or general anesthesia.
2. Pregnancy or lactation.
3. Planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery)
4. Known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator).
5. Major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule.
6. Known allergic reactions to materials used in the components of the xBar system, i.e., silicone, rubber and stainless-steel.
7. Participation in another interventional study during the xBar system usage.
Pain, Muscle Strength, Motor Imagery, Body Awareness on Function and Individuals With Chronic Lateral Epicondylitis

The aim of this study was to examine the effect of muscle strength, pain, motor imagery and body awareness on function in individuals with lateral epicondylitis. The main question it aims to answer is: Do pain, motor imagery, muscle strength and body awareness have an impact on function in individuals with lateral epicondylitis?


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of chronic LET by a physician and
* a pain score \> 3 on a visual analog scale (VAS).

Exclusion Criteria:

* concomitant disorders of the wrist and forearm, such as elbow fracture or dislocation, and treatment with corticosteroid injections within the previous 6 months
Pre-Visit Prioritization for Complex Patients With Diabetes

Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. The investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (EHR) that will enable complex patients to easily define care priorities for their upcoming visit.

Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. We hypothesize that among complex patients not meeting diabetes management goals, a web-based health IT tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (EHR) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. To test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the EHR that will enable complex patients to easily define care priorities for their upcoming visit.

Eligibility Criteria:
Primary care physicians (PCPs) at Kaiser Permanente Northern California with potentially eligible patients (type 2 diabetes and HbA1c \> 8.0%) wil be recruited and consented to participate in this study. PCPs will review lists of potentially eligible patients of theirs (defined below). Patients approved by PCP's allocated to the intervention arm will be sent a secure message on the PCPs behalf asking them to review the Pre-Visit Prioritization Questionnaire to identify top priorities for discussion at the next scheduled visit.

Patient Inclusion Criteria:

* Current adult member (\> 21 years old)
* Diagnosis of type 2 diabetes with most recent HbA1c \> 8.0%
* English as primary language
* Registered on kp.org.

Patient Exclusion Criteria:

* Excluded by PCP, and/or: terminal illness, in hospice care or reside in a long-term care facility, severe mental illness (e.g. schizophrenia or personality disorder), currently or recently pregnant, and/or significant dementia
Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

The purpose of this study is to assess the clinical impact of a rapid multiplex PCR blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in Guatemala City.

A retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in Guatemala City. These will serve as retrospective controls. The prospective portion of this study will implement the BioFire FilmArray blood culture identification panel (BCID2). Laboratory technicians will perform BCID2 simultaneously with standard culture after it flags positive on the automated blood culture system. BCID2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. Those specimens that become positive overnight will not have the BCID2 performed and will serve as concurrent controls. Physicians will be notified of panel results for the BCID2 intervention group and standard culture results per current laboratory protocol. This study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups.

Eligibility Criteria:
Inclusion Criteria:

* Age \<18 years of age
* First positive blood culture during the hospitalization

Exclusion Criteria:

* Non-blood specimens
* Repeat positive blood cultures from the same admission
* Patients who expire prior to positive culture
* Outpatient blood cultures
Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation

Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.


Eligibility Criteria:
Inclusion Criteria:

-Normal kidney function

Exclusion Criteria:

* anormal kidney function
* cadaveric transplantation
* emergency operation
* patients less than 18 years old
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies

This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.

This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies.

The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging

Exclusion Criteria:

* Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG)
* Tumor locations the surgeon deems unfeasible to image intraoperatively
* Excessive and/or generalized disease deemed inoperable by the surgeon
* Life expectancy less than 12 weeks
Comparison of the Effects of Dapagliflozin and Gemigliptin on Ketone Metabolism and Cardiac Remodeling in Type 2 Diabetes

Sodium-glucose cotransporter 2 (SGLT2) inhibitors have demonstrated cardiovascular and renal protection in patients with type 2 diabetes (T2D); however, the underlying mechanism remains unclear. We hypothesized that SGLT2 inhibitor will improve the ketone metabolism compared to dipeptidyl Peptidase-4 (DPP4) inhibitor. And we will also evaluate the association between ketone metabolism and cardiac remodeling evaluated by echocardiography. We will randomly assign 122 people with T2DM to receive dapagliflozin 10mg or gemigliptin 50mg. The primary endpoint are changes in acetoacetate, total ketone, beta-hydroxybutyric acid, left ventricular (LV) mass index, and LV global longitudinal strain during 6 months follow-up. This study may provide robust evidence of the thrifty substrate hypothesis for cardiovascular protection of SGLT2 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with T2D on stable antidiabetic medication
* No recent use of SGLT2 inhibitor within 3 months

Exclusion Criteria:

* HbA1c \> 10%
* Pregnancy or breast feeding
* estimated GFR \<45 30 mL/min/1.73㎡
* insulin user
The Effect of Walking on Cardiovascular Risk

The purpose of this study was to investigate the effects of an 8 week program of walking for 45 minutes, twice a week, on fitness, body composition , blood pressure and blood markers of cardiovascular risk. We hypothesised that this 90 minutes of walking per week would result in measurable increases in fitness and reductions in body fat, resting blood pressure and improved blood lipid profiles.

Current physical activity guidelines suggest that every adult should accumulate 30 minutes or more of moderate intensity physical activity on most days of the week. However, compliance with these guidelines requires considerable commitment in terms of time spent exercising per week (\> 150 minutes) and this may deter individuals from starting an exercise programme. Accordingly, randomised controlled trials are needed to evaluate the effects of smaller volumes of exercise on health.

37 civil servants (24 women) aged 41.5 + 9.3 years, were randomly assigned to either two 45 minute walks per week (walking group) or no training (control group). Aerobic fitness, body composition, blood pressure (BP), CRP and lipoprotein variables were measured at baseline and following 8 weeks. Steps counts were measured at baseline and during weeks 4 and 8 of the intervention

Eligibility Criteria:
Inclusion Criteria:

Member of staff at the Northern Ireland Civil Service

Exclusion Criteria:

Physically active (defined as compliance with current physical activity guidelines (Pate, 1995), age \> 65 years, resting BP \> 159/99 mm Hg, total cholesterol \> 6.2 mmol•L-1, fasting blood glucose \> 7.0 mmol•L-1, body mass index (BMI) \> 34.9 kg•m-2, current cigarette smokers, individuals with cardiovascular, pulmonary or metabolic disease, pain or discomfort in the chest, dizziness or heart murmur.

individuals taking medication known to interfere with lipid metabolism, females who were pregnant or planning to become pregnant in the following five months
Apitox, Honeybee Venom Treatment for Osteoarthritis Pain and Inflammation

The study will evaluate Apitox, pure honeybee venom as a treatment for pain and inflammation of osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis of one or both knees
* on stable NSAID or none due to intolerance
* women either post menopausal or on stable birth control
* no clinically significant disease or or abnormal laboratory values
* signed informed consent, communicate effectively, understand and comply with all study requirements

Exclusion Criteria:

* serious or unstable medical or psychological condition
* known sensitivity to honeybee venom, histamine or lidocaine
* history of asthma
* any clinically significant ECG abnormalities
* any clinically significant laboratory values OOR
* history of drug or alcohol abuse
* history of joint injury and forms of inflammatory arthritis
Determining Optimal Halo Pin Management Practises to Decrease Pin Complications

The purpose of this study is to evaluate the effects of regular pin re-tensioning on pain, pin loosening and pin replacement.

Halo Thoracic Orthoses (Halos) are used to immobilise unstable cervical fractures. The halo grips the skull via 4 pins. Pin loosening is a major complication of halo wear. Pin loosening is painful and can result in loss of control of the fractures. Treatment is required urgently and involves re-siting the pin.

Comparisons: This study will compare two pin management practises with the aim to determine which is optimal to reduce the incidence of complications including pin loosening. Patients will be randomly allocated into 2 groups. The control group will receive treatment in accordance with current practise at The Alfred, the pins will not be re-tensioned throughout the treatment period. The alternative treatment group will have their pins re-tensioned fortnightly.

Eligibility Criteria:
Inclusion Criteria:

* Must be fitted with a Halo Thoracic Orthosis at The Alfred Hospital

Exclusion Criteria:

* Patients who can not have their halo pins tensioned to at least 8lb/inch pressure.
Effects of Salsalate on Prandial-Induced Vascular Inflammation After Spinal Cord Injury (SCI)

The overall study objectives are to examine whether:

1. Persons with spinal cord injury (SCI) having elevated body mass are at greater cardiovascular disease (CVD) risk for fasting and postprandial lipidemia, glycemia, and vascular inflammation than persons with SCI having 'normal' body mass, and
2. An inexpensive, low-risk, widely-available pharmacotherapy safely reduces CVD risks associated with fasting and postprandial lipidemia, glycemia, and vascular inflammation.

To test Study Objective 1, 'overweight' and 'non-overweight' persons with SCI will be compared at baseline for fasting and postprandial responses. For Study Objective 2, all persons tested for Study Objective 1 will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. The last month will test effects of drug-placebo not examined in month 2. Fasting and postprandial responses will be tested at each time point. Intention-to-treat clinical standards ("...as randomized, so analyzed...") and 'last observation carried forward' clinical methods will be adopted.

Participants with tetraplegia are sought, as they have fewer exercise options than those with paraplegia and are at greater risk for sedentary lifestyle resulting in CVD, CVD risks, and obesity.

Eligibility Criteria:
Inclusion Criteria:

* SCI resulting in tetraplegia at C3-C7
* injury for more than one year

Exclusion Criteria:

* 1. any recent dietary or other lifestyle changes;
* 2. diabetes or inflammatory medical conditions;
* 3. a pressure ulcer;
* 4. lung or bladder infection;
* 5. undiagnosed illness or fever;
* 6. recent surgery;
* 7. stomach ulcer or a history of stomach upset when taking aspirin or medicines like aspirin, or ,
* 8. currently taking medicines used for pain or inflammation (aspirin and non-steroidal anti-inflammatory drugs, corticosteroids), blood vessel diseases (statins or fibric acid derivatives), blood clotting disorders (Coumadin, Plavix), infections (antibiotics), diabetes (Metformin), and burning 'central' pain (voltage regulators).
The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary

The study included 100 female diagnosed with polycystic ovary syndrome. They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003): oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and polycystic ovaries (by pelvic ultrasound "vaginal route").They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Eligibility Criteria:
Inclusion Criteria:

1- BMI: more than 25.0 kg/m2

2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)

1. oligoovulation and/or an ovulation
2. excess androgen activity (clinical or biochemical)
3. polycystic ovaries (by pelvic ultrasound "vaginal route")

3- Anovulatory patient resistant to induction with clomiphene citrate alone

Exclusion Criteria:

-1) BMI: more than 35.0 kg/m2

2) Infertile women due to any factor other than PCO
Efficacy of Dietary Supplement in Subjects With Acid Reflux and/or Abdominal Bloating/Distention and GI Symptoms

This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.

Study Primary Objective:

• To assess improvement in bloating symptoms

Study Secondary Objectives:

* To assess safety and tolerability of the formulation
* To compare the time taken for perceptual improvement in bloating/distention
* Enzyme blood assays
* To assess quality of life indices


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent to participate in the study.
* Willingness to actively participate in the study and to come to the scheduled visits.
* Female and/or male
* From 18 to 85 years of age
* Patients with self-reported abdominal bloating, abdominal distention, flatulence, and abdominal discomfort either after meals or not at least 3x a week for a minimum of the past 2 weeks

Exclusion Criteria:

* Drug addicts, alcoholics.
* AIDS, HIV-positive or infectious hepatitis
* Diabetes mellitus
* Disorders known to affect GI motility such as gastroparesis or amyloidosis.
* Disorders with GI symptoms such as irritable bowel syndrome, inflammatory bowel disease and celiac disease
* History of surgery known to alter the normal function of the GI tract.
* Conditions which exclude participation or might influence the test reaction/evaluation.
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area.
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years.
* Documented allergies to cosmetic products and/or ingredients
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) within the last 6 weeks prior to the start of the study and/or throughout the entire course of the study.
* Oral steroids within the last 4 weeks prior to the start of the study and/or throughout the entire course of the study
* Oral or systemic therapy with antibiotics within the last 3 months prior to the start of the study and/or throughout the entire course of the study
* Subjects who were treated with biologics within the last 6 months prior to the start of the study and/or throughout the entire course of the study.
* One of the following illnesses if not medicated: cardiovascular diseases, thyroid hyperfunction, asthma, hypertension.