cyrilzakka/clinical-trials huggingface dataset:
Tomato Juice for Health Study

The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease

The aim of this study is to improve understanding of how diet can ameliorate the state of chronic inflammation. Short term inflammation is an important part of the body's response to injury, but long term inflammation, as happens in the state of obesity, can result in a multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. Using a novel tomato-soy juice, we aim to demonstrate the potential of tomato-soy juice for reducing inflammation in adults.

Eligibility Criteria:
Inclusion Criteria:

* Between 30 and 75 years old
* Voluntarily agree to participate and sign an informed consent document

Exclusion Criteria:

* Aged \< 30 years or \> 75 years
* Known allergy or intolerance to tomatoes or soy
* BMI \< 30 or \> 45 kg/m2
* Blood plasma glucose \> 125 mg/dL
* Blood plasma/serum triglycerides \> 250 mg/dL
* Blood plasma/serum cholesterol \> 240 mg/dL
* Diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Previous bariatric or gastrointestinal surgery affecting absorption
* Suspected or known strictures, fistulas or physiological/mechanical gastrointestinal obstruction
* Presence of gastrointestinal or malabsorptive disorders (including Crohn's, ileus or ulcerative colitis, or diverticulitis), or nutrient malabsorption disease (such as celiac disease)
* Presence of autoimmune disease, metabolic disease, liver disorders, or kidney disorders
* Diagnosis or treatment of certain cancers in the past 3 years
* Use of tobacco products or marijuana
* Daily use of anti-inflammatory drugs
* Use of antibiotics over the previous 3 months
* Colonoscopy within a month of the study start date or during the study
* Use of a carotenoid or isoflavone-containing or metabolism-altering supplement for the last 1 month
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
* Unable or unwilling to give informed consent or communicate with study staff
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Evaluation of the Effectiveness, Safety, and Cost of a Smart Home-based Hospital System for Patients With Interstitial Lung Disease: Prospective Multicenter Randomized Controlled Trial

This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with interstitial lung disease to easily access and use biosignals generated using biosignal collection medical equipment at home.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with COPD who meet the following pulmonary function test results:

1. Pre FEV1 \< 80% \*\*or\*\*
2. Pre FVC \< 80% \*\*or\*\*
3. DLCO \< 60%

Exclusion Criteria:

1. Patients who do not agree to participate in the study.
2. Patients who fail to use the medical device equipment.
3. Patients where tracking during the study period is expected to be impossible.
4. Patients who have difficulty communicating verbally.
5. Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
6. Patients receiving hospital-centered rehabilitation treatment during the study period.
Effect of Cyproheptadine on Ventilatory Support-free Days in Critically Ill Patients With COVID-19

This randomized controled open label clinical trial conducted in patients with hypoxemic respiratory failure admitted to the ICU and requiring ventilatory support (invasive or non-invasive) is to evaluate whether treatment with cyproheptadine, a serotonin receptor antagonist, compared to usual care, increases the number of ventilator-free days.

Some studies have shown increased platelet activation and reactivity in patients with COVID-19. This platelet activation is associated with serotonin release. Some characteristics observed during the evolution of COVID-19 may be associated with these increased levels of serotonin. In this scenario, the antagonism of the action of serotonin could improve the clinical course of patients affected by COVID-19. Cyprohepatdine is an anti-serotonergic antihistamine drug with a long track record of safety and tolerability.

Investigators will randomize 274 patients who have tested positive for COVID-19 and who will be admitted to the ICU requiring ventilatory support (invasive or non-invasive).

Patients will be randomized to a 1:1 ratio for receiving usual care + cyproheptadine (8mg three times a day for 10 days) or usual care.

Patients will be followed until discharge to determine length of stay in the ICU and hospital, mortality in the ICU and hospital and days free from ventilatory support during the first 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Positive PCR for SARS-Cov-2
* ICU admission \< 48 hours
* Age 18 years or older
* Need for invasive or non-invasive ventilatory support (non-invasive ventilation or high-flow nasal cannula) \< 48 hours

Exclusion Criteria:

* Pregnancy or breastfeeding
* Refusal to sign the informed consent form
* Expected death in the next 24 hours
* Patients taking routinely SSRI or monoamine oxidase inhibitor therapy
* Impossibility of using the enteral route
* History of seizure disorder
* History of adverse reaction to antihistamines or to cyproheptadine
* Readmission to the ICU
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.

However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Informed consent
* Histologically proven melanoma
* Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases

Exclusion Criteria:

* Pregnant or lactating women
* Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
* Patients with severe liver disease or severe renal disease
* Simultaneous immunosuppressive treatment (e.g. steroids)
* Simultaneous chemotherapy
* Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)
Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol

Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.

The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.

Eligibility Criteria:
Inclusion Criteria:

* All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.

Exclusion Criteria:

* Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA.
* A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria:
* CVC line insertion or exchange within 72 hours;
* any surgery, organ biopsy, obstetrical delivery within 72 hours;
* active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks;
* active pericarditis; arterial puncture within 48 hours;
* bacteremia with positive blood cultures.
A Pilot Test for Newly Developed Synoptic Operative Template for Ovarian Cancer (SOTOC): National Cancer Center - Peritoneal Carcinomatosis Index

objectives: To development of NCC-PCI-Operative Template (NPOT) for the objective description of perioperative tumor burden and surgical approaches in the management of ovarian cancer, tubal cancer, and primary peritoneal cancer

* Informed consent
* Digital photography \& Checking PCI (tumor size\& location )
* Postoperative surveillance(tumor marker, image and physical examination)
* Developing the best fitting NCC-PCI template to reflect recurrence and survival pattern

Eligibility Criteria:
Inclusion Criteria:

* Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma
* Available preoperative image study (CT and/or MRI and/or PET)
* Patients who gave a written informed consent
* Patients must be surgical candidate considering medical and psychological condition

Exclusion Criteria:

* Patients who refuse to participate or want to withdraw at anytime.
Feasibility of Radiotherapy and Concomitant Gemcitabine and Oxaliplatin in Locally Advanced Pancreatic Cancer and Distal Cholangiocarcinoma

The aim of the study is to evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose delivered, of an association ofgemcitabine, oxaliplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease
* WHO performance status of 0 or 1
* Complete recovrey from surgery in case an enteric and/or biliary tract by-pass operation has been performed
* Maximum delay after surgery: 8 weeks
* No previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervic carcinoma in situ
* Adequate bon marrow reserve
* No previous chemotherapy or radiotherapy
* Expected survival \> 6 months

Exclusion Criteria:

* Active infection
* Metastatic disease
* Inadequate liver function after derivative surgery
* Inadequate renal function
* Pregnancy, breast feeding
* Use of any other investigational agent in the month before enrollment
* Patients with grade 2 or more neuropathy
Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation

Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere.

To make intubation easier, several newly designed tubes and laryngoscopes are developed and tested every year. Their performance is evaluated subjectively by the acting anesthesiologist, and by using objective parameters such as speed of intubation, the force applied during laryngoscopy , or catecholamines secretion during intubation as a stress parameter . The studies set for testing these parameters lead to establish accepted indications for the treatment of the airway in cases of anticipated and unanticipated difficult airway.

In the present study we will compare the performance parameters of intubation using Etview Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer dimensions and material is exactly as the standard tube, the difference is only the inner fiber of the camera.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Age under 18 years
* ASA greater than 3
* Lip, oral or airway infection
* Coagulopathy
* Indication to perform Sellick's maneuver for increased risk of aspiration
Impact of NMES on Spirometry Values, Functional Capacity and Quality of Life in Patients With Pulmonary Hypertension

Pulmonary hypertension (PH) features symptoms related to a decreased cardiac autonomic response, pulmonary function and exercise capacity.

Non-pharmacological interventions are low cost and can significant enhance outcomes in these patients. Neuromuscular electrical stimulation (NMES) has been proposed as a viable therapeutic approach in patients with functional limitations, particularly those that present with difficulty to perform exercise protocols.

Objective: to evaluate the impact of NMES on exercise capacity, spirometry values and quality of life of patients with PH.

Material and methods: prospective randomized controlled study with a control group (GC, n9) and NMES goup (GE, n8). Quality of life and exercise capacity through the six-minute walk test (6MWT) were assessed before and after the NMES protocol.

Results: the GE presented with a significant improvement in distance walked in the 6MWT, cycle ergometry, spirometry and quality of life in the areas of vitality, emotional and social aspects of the questionnaire Short Form Health Survey-36.

Conclusion: NMES is a useful tool in the treatment of patients with PH, resulting in improved exercise capacity, quality of life and lung function testing.


Eligibility Criteria:
Inclusion Criteria:

Males and females greater than or equal to 18 years of age, clinically stable with optimized drug therapy in the last 3 months, previously diagnosed with a mean pulmonary arterial pressure ≥ 25 mmHg by right heart catheterization and who agreed to participate by signing an informed consent were included.

Exclusion Criteria:

Exclusion criteria included a diagnosis of Down syndrome, orthopedic disease or neurologic or diagnoses, history of acute heart attack, use of beta-blockers, any urgent or elective surgical intervention during the implementation of the protocol, those who used assistive devices to ambulate or develop an infectious process during the study protocol.
Analgesic Efficacy, Safety and Tolerability of Two Paracetamol-Containing Solutions in Post-Surgical Hip Replacement Pain

The aim of the study is to evaluate the therapeutic efficacy, safety and local tolerability of two different paracetamol-containing solutions in postoperative total hip replacement. They will be compared to placebo (a dummy treatment which contains no active ingredient).


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II or III and scheduled for elective total hip replacement, using a standard approach and a cemented implant.
* Moderate or severe pain within 4 hours after stopping the PCA in the morning of the first post-operative day.

Exclusion Criteria:

* Another acute or chronic painful physical condition
* Use of any other analgesics (within 24 hours), sedatives, or narcotic drugs as well as microsomal enzyme inducers
* Inability to use and understand Visual Analog Scale and Verbal Rating Score
Analgesic Efficacy of Ultrasound-guided Transverse-abdominal Plain Blockade in Urological Surgery

The purpose of this study is to compare pain level (according to numerical score)at 4, 8, 12 and 24 postoperative hours between patients under transverse abdominal plain blockade (TAP) and patients under conventional analgesia. Also the opioid consumption is assessed.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 yrs.
* Patients undergo laparoscopic urologic surgery
* Physical status ASA \< 3
* Surgical procedure without complications
* Signed informed consent

Exclusion Criteria:

* Allergy to bupivacaine chlorhydrate
* Patients with chronic pain treatment
* Alcoholism
* Decompensated hepatic disease
* Coagulation disorders
* BMI \> 35
* Patient involved in another clinical trial
Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds

In the present trial, the StethoMe electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population.

Multicenter, international - 2 EU sites (max. 1 in Poland) and a single US site.

Trial centers and investigators will be identified and selected based on their clinical and research experience.

The trial objective is to assess whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds in the categories of wheezes, rhonchi, fine crackles and coarse as compared to pulmonary auscultation by experienced physicians (general practitioners (GPs) and pulmonologists).

The recordings will be used to form a gold standard database of lung sounds as evaluated by an expert, independent panel according to the study protocol. The gold standard database will include approximately equal representation of wheezes, rhonchi, fine crackles and coarse crackles. Moreover, the database will also include recordings without any of the previous descripted pathological sounds. The results of these two analyses, by traditional physician listening and by the StethoMe AI software application, will be assessed for sensitivity and specificity to the gold standard database in detection of the four lung sounds and recordings without defined pathological sounds. The StethoMe AI will be considered to provide clinical benefit if it demonstrates statistically better sensitivity or specificity on any of the four lung sounds as compared to the traditional physician auscultation, together with F1 score analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward (PL and EU).
* Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward or treated in an outpatient clinic (US).
* Informed consent of parents or caregivers, according to local regulations.

Exclusion Criteria:

* Skin/soft tissue disease or local infection at the site of pulmonary auscultation or any other contraindication for the pulmonary auscultation.
* Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project.
Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug.

The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a \>20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.


Eligibility Criteria:
Inclusion Criteria:

* primary inguinal and/or umbilical hernia repair
* age \> 18 years old

Exclusion Criteria:

* history of gastrointestinal bleeding
* allergy to ibuprofen
* creatinine \> 1.5 mg/dL
Safety and Efficacy of Silk Vista and Silk Vista Baby Flow Diverter for Intracranial Aneurysm Treatment

The FIRST study is an observational, prospective, multi-center, international, single-arm, study. The aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms.

All patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study.

The patient's inclusion and follow up in the study will occur as part of their usual standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study)
2. Patients with recanalized aneurysms previously treated with coils exclusively are also eligible.
3. In case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit)
4. Patient ≥ 18 years, who signed an informed consent.

Exclusion Criteria:

1. Patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the IFU (Instruction for Use).
2. Recanalized aneurysms initially treated with stent (including stent assisted coiling)
Behavioral Approaches to Reducing Diabetes Distress and Improving Glycemic Control

This study is comparing three programs to reduce Diabetes Distress (the worries and concerns that people with diabetes may experience as they struggle to keep blood glucose levels in range) in adults with type 1 diabetes. About a third of participants will take part in the TunedIn program, about a third will take part in the FixIt program, and about a third in the StreamLine program.

Diabetes Distress (DD) is the personal, often hidden side of diabetes: it reflects the unique emotional burdens and strains that individuals with diabetes may experience as they struggle to keep blood glucose levels within range. When high, DD can have a major, negative impact on disease management and glycemic control. High DD is characterized by frustration, feeling overwhelmed, and feeling hopeless and discouraged by the unceasing demands of diabetes. DD is also linked to an individual's beliefs, expectations, current life situation, and personal and social resources.

The proposed study is a three-arm, 12-month randomized comparison trial to test the added value of a DD-targeted (TunedIn) intervention vs. a unified DD and management intervention (FixIt), relative to a traditional, educational/behavioral-management intervention (StreamLine). Each of the three programs (arms) will follow a separate, standardized protocol. All participants will receive three months of intervention with nine months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with type 1 diabetes (confirmed by clinical history and/or anti-glutamic acid decarboxylase\] antibody testing) on intensive insulin treatment;
* Diagnosis of type 1 diabetes for at least 12 months that occurred at or below age 40;
* Have a recent HbA1c of 7.5% or higher;
* Not have started to use any new (to the participant) diabetes device (such as an insulin pump or continuous glucose monitor) in the past 6 months;
* Internet access through a computer or smart phone;
* Ability to speak/read English.

Exclusion Criteria:

* No documented psychosis, blindness, dementia, active dialysis, substance abuse, amputations, or severe functional deficits, or recent major surgery or hospitalization in the past year.