cyrilzakka/clinical-trials huggingface dataset:
The REBUILD Trial: Closure of the Abdominal Wall

The main objective of this clinical trial is to demonstrate the safety and efficacy of REBUILD when used to support abdominal wall closure after laparotomy. The main question it aims to answer are whether the device when used to support suture in abdominal wall closure safely maintains apposition of the abdominis rectus muscles within a pre-defined distance.

Participants will undergo standard of care laparotomy and the investigational device will be used to support the suture used to close the abdominal wall. Participants will have an MRI at 1-month after surgery to measure the distance between the abdominus rectus muscles.

The REBUILD Trial (Protocol CTP-0002) is an investigational medical device study designed to demonstrate the efficacy and safety of REBUILD for abdominal wall closure (AWC). The primary evaluation period will include the first 30 days of follow up. After the 1-month endpoint evaluation period, additional follow-up at 3, 6, 12, and 24-months for post-market analysis and publication will be conducted. All adverse events will be collected and reported for the full duration of the study.

* Primary efficacy endpoint will be evaluated based on the measured distance between the rectus abdominis muscles (RAMs) by MRI at 1-month (Day 30 +14/-7 days) post-surgery (Day 0).
* Primary safety endpoint will be evaluated based on reported serious device-related adverse events through 1-month (Day 30 +14/-7 days) of follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is 22-80 years of age
2. Patient is undergoing a midline laparotomy procedure
3. Patient is able to provide written informed consent
4. Patient is able and willing to comply with all study requirements

Exclusion Criteria:

1. Patient has BMI \> 40
2. Patients with available imaging measuring abdominal wall thickness \< 5.7 mm or \> 16.5 mm
3. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
4. Patient has mesh at the site of deployment
5. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
6. Patient has a CDC wound classification of Class IV
7. Patient has devitalized tissue present at the intended surgical site
8. Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)
9. Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)
10. Patient has history of radiation therapy targeting the abdominal wall
11. Patient is participating in a concurrent investigational medical device study
12. Patient is pregnant or planning on becoming pregnant during the study period
13. Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits
Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure

The purpose of this study is to obtain observational data allowing for the preliminary assessment of the utility of a noninvasive physiologic monitor for monitoring of patients with congestive heart failure.

The study proposes to utilize the CoVa™ Monitoring System, a novel body-worn sensor that remotely monitors thoracic fluid, heart rate, heart rate variability, respiration rate, skin temperature, posture, and, using transmitted waveforms, stroke volume and cardiac output to evaluate the system's monitoring capabilities in individuals recently hospitalized for congestive heart failure. The data acquired through this study will play a critical roll in developing future interventional studies that will allow patients with HF to potentially receive better and more timely treatment in the home setting, decreasing hospitalizations and improving quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18
* Have wireless internet access within their homes.
* Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:

  1. Symptoms:

     * Onset or worsening of dyspnea within the past 2 weeks
  2. Physical exam (at least 1 present):

     * Rales/ Crackles on auscultation
     * Elevated JVP \> 8 cmH2O
     * Weight gain
     * LE edema
  3. Diagnostic imaging/ labs (at least 1 present):

     * Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
     * Elevated NT-pro-BNP (age-adjusted) (\>1000)
* Patients of particular interest will be those who already have a Medtronic Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy device with the OptiVol feature that tracks transthoracic impedance.

Exclusion Criteria:

* Allergy to ECG electrodes
* Psychological or social situation that would make the study difficult for the patient
* Inability to consent
* Pregnant women
* Pneumonia - currently, or within the past 30 days
* Non-cardiogenic pulmonary edema (e.g. ARDS)
* Interstitial lung disease
* End-stage renal disease and on hemodialysis
* For any reason unable to wear or place the CoVa™ device, e.g. pectus excavatum, fragile skin, severe arthritis.
Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
* Symptoms less than 14 days
* ID Physician determination that the patient does not need hospitalization
* O2 saturation of \>93%
* Informed consent provided by the patient or healthcare proxy
* Age ≥ 18 years
* Ambulatory Outpatient when informed consent obtained and study drug is administered

Exclusion Criteria:

* Age \< 18 y/o
* Patients currently receiving intravenous immunoglobulin
* Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
* Need to be hospitalized
* O2 sat \< 93%
* D-Dimer \> 2x normal
* Chronic oxygen therapy
* Renal insufficiency with Creatinine clearance \< 30
* Long term care or assisted living facility resident
* Ongoing usage of hydroxychloroquine for any indication
* History of blood or plasma transfusion related complications
* Enrollment into any other investigational drug or device study within the previous 30 days
* Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
* Pregnant or breast feeding
* Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
* Admitted to or expected to be admitted to a medical facility
Salvage mFOLFOX in BTC After Failure of Gemcitabine

The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.


Eligibility Criteria:
Inclusion Criteria:

1. Age : older than 18
2. Histologically confirmed adenocarcinoma of the biliary tract
3. Metastatic or unresectable biliary cancer
4. Prior exposure to gemcitabine chemotherapy for biliary cancer
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
6. A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
7. Adequate bone marrow, liver, renal function

Exclusion Criteria:

1. Pregnancy and breast-feeding.
2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
4. Symptomatic or uncontrolled brain metastasis
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes

The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women with non-insulin dependent diabetes.
* Ages 25 to 75 years.
* Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%.
* Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%.

Exclusion Criteria:

* Insulin use.
* Substance abuse.
* Any documented medical problem that would inhibit full participation in the study.
* BMI less than 25 or great than 40.
* Vegans or Vegetarians
* Individuals with food allergies.
* Individuals currently on a commercial weight loss or diet program.
Triple Therapy in Patients on Oral Anticoagulation After Drug Eluting Stent Implantation

The investigators hypothesize that reducing the duration of clopidogrel therapy from 6 months to 6 weeks after DES implantation is associated with improved clinical outcomes in patients on ASA and an oral anticoagulant.

The introduction of drug-eluting stents (DES) was associated not only with a widening of the indication for percutaneous coronary intervention (PCI) but also with longer antithrombotic therapy duration. Dual antiplatelet therapy with ASA and a thienopyridine is very efficient in preventing adverse events after coronary stenting but it is inferior to oral anticoagulation (OAC) to reduce the risk of stroke in patients with atrial fibrillation. OAC is also superior to antiplatelet therapy in patients with mechanical heart valves and the therapy of choice for the treatment of deep vein thrombosis and pulmonary embolism. OAC is also administered for left ventricular thrombi and low ejection fraction. There is an increasing number of patients undergoing coronary stenting who are in need of life-long anticoagulation therapy and would therefore require a triple therapy consisting of aspirin, clopidogrel and oral anticoagulation. As oral anticoagulation and antithrombotic therapy impair primary and secondary hemostasis there are concerns that adding warfarin to dual antiplatelet therapy might cause increased bleeding rates. Several studies have retrospectively assessed efficacy and safety in patients receiving a triple therapy with various results: major bleeding rates varied from 3,1%-14,9% with total bleeding rates up to 27,5%. Prospective randomized data on this topic are not available. Therefore the aim of this study is to compare a 6 week versus a 6 month triple therapy after DES implantation.

Eligibility Criteria:
Key Inclusion Criteria:

1. Patients with an indication for oral anticoagulation and a DES implantation.
2. Informed, written consent by the patient or her/his legally-authorized representative for participation in the study.

Key Exclusion Criteria:

1. Age ≤18 years
2. Previous stent thrombosis
3. DES in left main
Outcomes of Phacoemulsification With Torsional Ultrasound

To determine the differences in intra-operative complications, surgical duration, fluid usage, corneal thickness and endothelium cell density in eyes undergoing microcoaxial phacoemulsification (MCP) either with Torsional or longitudinal ultrasound during the surgery and at post-operative day 1, 1 month and 3 months.

Introduced in mid 2006, torsional ultrasound (OZil, Infiniti Vision System, Alcon Laboratories, Texas, USA) uses rotational oscillations at ultrasonic frequencies to emulsify cataractous lens material in a seamless cutting motion from a tip that oscillates laterally. The side-to-side movement of the phaco tip produces minimal repulsion of lens material from the phaco tip resulting in improved followability. Clinically this translates into more effective lens removal with torsional phaco in comparison to the conventional ultrasound mode.to test this in a clinical scenario we undertook this study.

Eligibility Criteria:
Inclusion Criteria:

* patients 55 years and older with a senile cataract grades 1 to 5 nuclear sclerosis based on Emery's classification,
* endothelial cell density \> 1500 cells/mm2,
* anterior chamber depth \> 2.4 mm, and
* a dilated pupil \> 7 mm.

Exclusion Criteria:

* eyes with pseudoexfoliation,
* mature, traumatic, or complicated cataracts,
* history of previous intra-ocular surgery, glaucoma, uveitis, and
* patients who were unable to comply with follow-up examinations.
Device Based Therapy in Hypertension Extension Trial

This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001)
* Have signed an approved informed consent form for participation in this study

Exclusion Criteria:

* Are unable to comply with protocol requirements.
* Are enrolled in another concurrent clinical trial.
Live Feedback to Increase Adherence in Adolescents With Patellofemoral Pain

This study investigates if live feedback during home-based exercises will improve the ability to perform the exercises with the prescribed time under tension (TUT) per repetition compared with no feedback among adolescents with patellofemoral pain. The hypothesis is that adolescents who receive live feedback from BandCizer™ will have a mean TUT that is significantly closer to the prescribed TUT compared to the group not receiving feedback during the course of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* 15 to 19 years of age
* Anterior knee pain of non-traumatic origin which is provoked by at least two of the following activities: prolonged sitting with bended knees or kneeling, squatting, running, jumping or ascending or descending stairs
* Tenderness on palpation of the peripatellar borders
* Pain of more than 6 weeks duration
* Worst pain during the previous week ≥ 30 mm on a 100 mm VAS

Exclusion Criteria:

* Concomitant pain from other structures in the knee (e.g. ligament, tendon or cartilage), the hip or the lumbar spine
* Previous knee surgery
* Patellofemoral instability
Assessment of Relationship Between Preoperative Nutritional Status and Perioperative/Postoperative Conditions in Patients With Lung Cancer Scheduled for Lobectomy

Malnutrition is common in patients with lung cancer. In patients with malnutrition risk, the risk of complications is high both in the perioperative, early and late postoperative periods. Malnutrition is an independent risk factor for length of hospital stay and cost in these patients. Patients with lung cancer may have many morbidities in postoperative period, especially problems with wound healing. Therefore, assessment of the nutritional status of patients with lung cancer should begin at the diagnosis stage.

In patients with lung cancer scheduled for lobectomy, anthropometric measurements will be measured and the results of laboratory tests(albumin, prealbumin, creatinine, total lymphocyte count, C reactive protein), Nutritional Risk Screening-2002, Nutritional Risk Index, Mini Nutritional Assessment, Glasgow Prognostic Score, Prognostic Nutritional Index and neoadjuvant chemotherapy or not will be recorded in 72 hours before surgery. In addition, demographic information of the patients (name, surname, identification number, age, comorbidity, American Society of Anesthesiologists score) will be recorded. After the information is given to the patients, their written and verbal consent will be obtained.

In the operating room, routine monitoring (electrocardiography, invasive blood pressure measurement, arterial blood gas monitoring, peripheral oxygen saturation, end-tidal carbon dioxide measurement by capnography) will be applied to the patients in accordance with the standard protocol for elective lobectomy surgery.

Hemodynamic changes (eg. dysrhythmia, hypotension, hypertension, hemorrhage), metabolic status (pH, bicarbonate, base excess), lactate, glucose level in blood gas evaluation and intraoperative complications will be recorded during the intraoperative period.

In the postoperative period, length of stay in the intensive care unit, length of hospital stay, early complications (eg. dysrhythmia, acute coronary syndrome, sepsis, mediastinitis, pneumonia, surgical site infection, prolonged air leak), time to start oral intake and transition to adequate oral intake will be recorded in the one-month postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of lung cancer
* Lung lobectomy operation will be performed
* 18 years and older patients
* Having an American Society of Anesthesiologists score of 1, 2, 3
* Having approved and signed the informed consent form

Exclusion Criteria:

* Patients who underwent lobectomy with a diagnosis other than lung cancer
* Patients younger than 18 years
* Patients with an American Society of Anesthesiologists score of 4 and above
* Patients who did not accept informed consent
* Patients who refused to participate in the study
Communication Memory of Cancer Diagnosis Within the Pediatric Triangle

Present project aims to investigate memories related to a cancer communication diagnosis in pediatric oncology. It evaluates possible common elements and specificity between family and healthcare staff.

Lots of scientific evidences have shown that autobiographical episodes' narrative has a beneficial effect on the elaboration of memories. Indeed, narrating is a way to order thoughts and moods, which are connected to particular episodes of one's life, in order to rework and relive them. Since the diagnosis, a relationship and an open and sincere dialogue between the various parts of the pediatric triangle can promote a process of adaptation to the experience of illness and an integrated biopsychosocial healing. The first aim of this study is to explore and analyze autobiographical memories of pediatric patients, parents and healthcare staff. Also, it aims to investigate possible common and discordant element between deposition.

Phases of the present study:

1. Sample recruitment and informed consent collection.
2. Diagnosis communication audio recording.
3. Communication of the autobiographical memory of the diagnosis audio recording of patients, parents, oncologist, nurse and psychologists involved, the day after the communication.
4. Questionnaire APAM administration for adult participants.
5. Audio Transcription and data coded. Data will be registered and operated by means of statistical software as SPSS (IBM) and T-Lab (Lancia, 2004).
6. Statistical processing: ANOVA and t of Student tests will be implemented in order to compare collected questionnaires. Narrative analysis will be implemented by means of textual analysis software.

Eligibility Criteria:
Inclusion criteria for pediatric patients:

* age from 12 to 17 with cancer diagnosis only taken by Meyer Children's Hospital prior consent.
* Italian speaking

Exclusion criteria for pediatric patients:

* under 12 years old and above 17;
* followed by other hospital;
* cognitive disability

Inclusion criteria for parents:

- Italian speaking and signature informed consent.

Exclusion criteria for parents:

- cognitive disability
Effectiveness of Kinesio Taping in Patients with Congenital Muscular Torticollis

The aim is to investigate the effectiveness of kinesiotaping application in addition to Congenital Muscular Torticollis exercise on neck joint range of motion, tilt degree and muscle function test. Research Group: In addition to the regular exercise program, patients diagnosed with Congenital Muscular Torticollis will be given kinesio taping for torticollis. Kinesio taping will be applied for 4 weeks, 5 days on and 2 days off. Control Group: Patients diagnosed with Congenital Muscular Torticollis will continue their regular exercise program. No intervention will be applied. Patients will be evaluated with neck joint range of motion, tilt degree and muscle function test before and 3 months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Being followed up with a diagnosis of Congenital Muscular Torticollis
* The family's willingness to participate in the study

Exclusion Criteria:

* Presence of cardiopulmonary disease and musculoskeletal deformity that will prevent exercise
* Having an open wound in the area where kinesio taping will be applied or being allergic to tape application