cyrilzakka/clinical-trials huggingface dataset:
Phase I, Pharmacokinetic, Pharmacodynamic Trial of PTK787 and Paclitaxel in Combination for Advanced Solid Tumors

This study will evaluate PTK787, a new oral drug that stops blood vessel development, in combination with Paclitaxel in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with histologically confirmed malignancy that is unresponsive to curative therapy and for which no conventional therapy exists
* ECOG Performance Status 0-2
* Measurable or evaluable disease
* Laboratory values within protocol limits within 2 weeks prior to registration
* Life expectancy ≥ 12 weeks
* Patient or guardian must have written informed consent obtained according to local guidelines
* Women of child-bearing potential (non-sterile) must use appropriate barrier contraception for duration of study (negative pregnancy test required at baseline). Oral contraceptives will not be an acceptable form of contraception
* Patients may have received prior standard taxane therapy, but have never progressed on taxane-based therapy.

Exclusion Criteria:

* History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
* Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior biologic or immunotherapy ≤ 2 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
* Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization.
* Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization. Minor surgery ≤ 2 weeks prior to randomization.
* Patients who have received investigational drugs ≤ 4 weeks prior to registration
* Prior therapy with anti-VEGF agents
* Peripheral neuropathy with functional impairment ≥ CTC grade 2 neuropathy, regardless of causality
* Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control.
* Patient agrees to avoid grapefruit (juice and fruit)

Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:

* Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
* Unstable angina pectoris
* Congestive heart failure greater than NYHA classification ≥ Grade 1 (can be controlled with medication)
* Myocardial infarction ≤ 6 months prior to registration and/or randomization
* Serious uncontrolled cardiac arrhythmia
* Uncontrolled diabetes at discretion of investigator
* Active or uncontrolled infection requiring intravenous antibiotics
* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long QTc at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
Effect Of Ophiochepalus Striatus Extract On Serum IGF-1 And IL-6 Levels In Elderly Patients With Sarcopenia

The goal of this Clinical Trial is to analyze effect of Ophiochepalus striatus extract on serum IGF-1 and IL-6 levels in elderly patients with sarcopenia. The main questions it aims to answer are:

1. Can giving Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase IGF-1 levels in elderly people with sarcopenia?
2. Can administration of 2x5 grams dose of Ophiocephalus striatus extract for 2 weeks reduce IL-6 levels in elderly with sarcopenia?
3. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks reduce the SARC-F score in elderly people with sarcopenia?
4. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle mass in elderly people with sarcopenia?
5. Can the administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks increase muscle strength in elderly people with sarcopenia?
6. Can administration of Ophiocephalus striatus extract at a dose of 2x5 grams for 2 weeks improve physical performance in elderly with sarcopenia?

Participants will:

1. Consume Ophiochepalus striatus extract 2x5 grams a day.
2. Checked blood before and after the intervention.
3. Measured muscle mass, muscle strength, and physical performance before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with sarcopenia diagnosed using AWGS criteria consist of low muscle mass: using the BIA examination tool where men: \<7.0kg/m2, women: \<5.7kg/m2 plus low muscle strength using a handgrip dynamometer, men: \<28kg , female : \<18kg or low physical performance using the 6 meter walk test; \<1 meter/second.

Exclusion Criteria:

* Chronic liver disease (cirrhosis of the liver) or severe liver dysfunction or increased SGPT\> 3 times the upper limit of normal value
* Impaired kidney function with a glomerular filtration rate \<30 ml/minute without hemodialysis
* Acute phase of illness (eg infection, acute arthritis, acute stroke, trauma)
* Malignancy
* Depression according to the geriatric depression scale (Geriatric Depression Scale score\> 10)
* History of hypersensitivity to Ophiocephalus striatus
* Refuse to participate in research
Pilocarpine After Combined Cataract/Trabectome Surgery

Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (MIGS) have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce IOP and help reduce the medication burden on patients.There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the Trabectome, which is usually performed in combination with cataract surgery.

Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels\[2\].

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork\[3\]. Due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (POAG), except in patients for whom few other alternatives exist. However, pilocarpine is often used after trabectome surgery.

The rationale for its use after Trabectome procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. Formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven.

In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine

Eligibility Criteria:
Inclusion Criteria:

* Age Range: 30 to 100 years old
* Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center

Exclusion Criteria:

* Patients with previous history of eye surgeries (including laser procedures).
Comparison of Ferrisat vs Placebo in Anemia Associated to Inflammatory Bowel Disease During Anti-TNF Therapy

Anemia is the the most frequently extradigestive symptom for Inflammatory Bowel Disease. This is due to iron deficiency and inflammation.

Most of treatments aim to control inflammation using anti-TNF alpha therapy which should theorically reduce anemia.

The aim of the study is to show that perfusion of iron associated to anti-TNF therapy should reduce anemia and improve quality of life of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Crohn's disease or Ulcerative Colitis defined according to the usual endoscopic, histological, and radiological criteria
* Under anti-TNF therapy or indication for starting an anti-TNF therapy
* Anemia defined according to World Health Organization (Hemoglobin under 13g/dl for man and Hemoglobin under 12g/dl for woman)
* Iron deficiency anemia defined as:
* Ferritinemia under 100 if C-Reactive Protein under normal value OR - Ferritinemia between 30 and 100 if C-Reactive Protein above normal value

Exclusion Criteria:

-
Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).


Eligibility Criteria:
Inclusion Criteria:

* In good general health
* Susceptible to human rhinovirus type 16 (HRV-16)
* Male or non-pregnant and non-breast feeding female
* If female of reproductive potential, agrees to use 1 form of acceptable birth control

Exclusion Criteria:

* Donated blood within 56 days or donated plasma within 7 days prior to dosing
* History of significant multiple and/or severe allergies
* Recent history of respiratory tract infection
* History of cancer
* Body mass index \<18 kg/m\^2 or ≥40 kg/m\^2
* History of major surgery or loss of 1 unit of blood
* History of allergic reaction to sulfonamides
* Received medications within 14 days prior to randomization
* Significantly abnormal laboratory tests at Screening
* Current smoker, smoked within 5 years of Screening, or significant past smoking history
* History of alcohol or drug abuse
Non-operative vs. Operative Management of Acute Appendicitis in Vulnerable Patient Populations

The overall project goal is to conduct a pilot randomized clinical trial of operative (laparoscopic appendectomy) vs nonoperative (antibiotic) management of uncomplicated acute appendicitis for vulnerable populations. Specifically, the elderly, non-English speakers, and those with economic vulnerability (low socioeconomic status and/or manual labor jobs without a non-weight lifting aspect), are three vulnerable population subsets identified. This pilot trial will provide critical preliminary data for planning and conducting a larger multi-site randomized trial.

The study would involve consented subjects, once confirmed eligible to proceed after screening, will be randomly assigned to two arms:

* Group 1 - Operative Group - Operation will be performed to remove appendix.
* Group 2 - Non-operative group - No operation will be performed, and instead the subject will receive intra-venous (IV) antibiotics, transitioned to by mouth (oral) antibiotics, for treatment of appendicitis.

Aside from the routine hospital care, participants will be asked to fill out a survey for cognitive function (CAM Assessment Form), pain (Visual Analog Scale), and quality of life at the start and end of participant's hospital stay, 1-2 weeks after discharge, and again at 6 weeks after discharge from the initial hospital visit.

Participants will also be asked to participate in a qualitative interview, either by virtual visit, site visit, or phone call, at 1-2 weeks and again at about 6 weeks after discharge from the hospital. Each interview will be approximately 20-30 minutes of the participant's time.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able to consent for the study
* Diagnosis of acute appendicitis confirmed by CT imaging

Exclusion Criteria:

* Appendicolith/fecalith on imaging
* Chronic or recurrent appendicitis
* Having received prior antibiotic treatment for other reasons within 5 days prior to study enrollment
* Hemodynamically abnormal (SBP\<90 mmHg, Heart Rate (HR) \>120, mmHg, Partial Pressure of Oxygen in Arterial Blood (PaO2\<60), or potential of Hydrogen (pH\<7.3)).
* Inability to tolerate general anesthesia (determined by surgery and anesthesiology teams)
Cost-Effectiveness of a Specialized Ultrasound Instrument to Diagnose Carotid Stenosis as a Way to Reduce the Risk of Stroke

Carotid stenosis, a condition in which plaque builds up inside the arteries of the neck and blocks blood flow to the brain, is one common cause of stroke. This study will evaluate the cost-effectiveness of using a new, specialized ultrasound device to screen individuals who are at risk for carotid stenosis.

Stroke is the third leading cause of death, and the leading cause of long-term disability in the United States. At least half of all strokes are caused by carotid stenosis, a condition in which the arteries in the neck become blocked with plaque and harden. Plaque that breaks off the carotid artery wall and travels to the brain can block critical blood vessels, possibly resulting in a stroke. Carotid endarterectomy, a procedure that removes plaque buildup, can greatly reduce an individual's risk for stroke. Currently, the conventional duplex Doppler ultrasound examination that is used to screen for carotid stenosis requires a skilled sonographer or physician, and is therefore expensive. Study researchers have developed a more cost-effective option: a specialized ultrasound instrument specifically designed to perform carotid stenosis screenings and meant to be used by non-specialist nurses. Previous research has shown that this instrument is inexpensive, easy to use, and effective at diagnosing carotid stenosis. The purpose of this study is to evaluate the cost-effectiveness of the alternative ultrasound instrument at screening older adults who are at risk for carotid stenosis. If the instrument is shown to be cost-effective, it may eventually lead to widespread screening and a reduced incidence of stroke.

In this study, nurses in selected physician's offices will be trained to use the carotid ultrasound screening instrument. Patients over 65 years of age with at least one risk factor for carotid stenosis but with no symptoms will be screened with the device. Screening will take place in the doctors' offices or, when more convenient, at a central screening location; however, in all cases the nurses will use the instrument rather than specialized ultrasound technologists. Individuals found to have carotid stenosis will be referred to undergo a conventional duplex Doppler ultrasound examination for a definitive diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* At least one risk factor for carotid stenosis (e.g., cardiac disease, elevated cholesterol, smoking, hypertension)

Exclusion Criteria:

* Any symptoms or indications of carotid stenosis or stroke
The Cranio-cervical Flexion Test Using the NOD Device

to measure strength of the deep anterior neck muscles with a new measurement protocol and by using the NOD device, a dynamometer, in subjects with and without bruxism, and compared to EMG on the superficial muscles of the anterior neck and the masseter muscle.


Eligibility Criteria:
Inclusion Criteria:

* with or without bruxism
* German fluent
* informend consent

Exclusion Criteria:

* primary headache
* cranio-mandibulary disorders (CMD) in \>3 months within the last 12 months
* current neck pain intensity \> 2 out of 10 on Numeric rating scale
* known:
* neurological pathologies
* mental impairments or diseases
* pregnancy
* rheumatic disorders
A New Tool to Promote Patient's Engagement in Their Healthcare Process

Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.

Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.

Women with any type of early breast cancer (0-2A stages) will be recruited at Istituto Europeo di Oncologia (IEO). 170 patients with early breast cancer and 30 clinicians involved in the present project will directly benefit from better-provided care, an increase in patients' knowledge and management of their oncological symptoms, an improved patient-and-doctor relationship, and a reduction of hospital economic costs.

Our interdisciplinary team will include breast cancer patients, oncologists, surgeons, psychologists, radiologists, , and nurses. All members of our team will play an active role in the most important phases of our data-driven project development cycle. A patient-centered approach will allow us to ensure their active participation from the design phase to the dissemination phase of the project.

This present research project will be based on two different prospective studies: a first study based on patients already treated for breast cancer and a second study with patients newly diagnosed with early breast cancer.

Semi structured interviews will be used in the first study, while newly diagnosed women in the second study will be asked to fill in an online battery of questionnaires in three different times (T0: one week after the first consultation; T1: a month later the first medical consultation; T2: three months later the first medical consultation) to assess the possible impact of using the Patient Decision Aids (PDA) on the doctor-patient communication and shared decision-making (SDM) process.

This project will follow a multi-step approach and will be therefore divided into different developmental phases, within which specific objectives will need to be reached in order to move forward.

Eligibility Criteria:
Inclusion Criteria:

* be 18 or older;
* have received/receive diagnosis of resectable breast cancer in the early stage;
* women treated or who will undergo oncological treatment for early breast cancer;
* demonstrate the absence of psychopathological features.
* be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria:

* breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;
* neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.
* Distant metastases from breast cancer or locally advanced/unresectable disease
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Preoperative Auricular Acupuncture in Elective Cesarean Section.

Preoperative anxiety before cesarean section is common and may be severe. Stress consequences are often deleterious for the mother and for the upcoming newborn. Means to reduce anxiety before cesarean section are limited. Anxiolytic drugs are avoided in the context of the birth of a newborn. Auricular acupuncture has been shown to relieve anxiety disorders. The aim of this study is to evaluate the anxiolytic effect of auricular acupuncture administered before an elective cesarean section. Anxiety will be measured at T0: inclusion (approximately 1-2 hours before cesarean section) and T1: departure to surgical unit (approximately 30 minutes to 1 hour after T0). Patches (needle or needle-free) will be set up at T0 just after the initial anxiety assessment (anxiety Visual Analog Scale aVAS).


Eligibility Criteria:
Inclusion Criteria:

* All patients American Society of Anaesthesiologists 1or 2 targeted for elective cesarean section under spinal anesthesia
* Aged over 18 years
* Affiliation to social security
* Participation Consent signed after oral and written information

Exclusion Criteria:

* Guardianship
* Psychological disorders preventing informed consent
* Long-term antidepressant or anxiolytic
* Previous history of auricular acupuncture
* Refusal of participation in the study
* Cesarean section for placenta accreta
* Presence of a pacemaker
Effects Of Chlorhexidine Mouthrinse On Peridontopathogens: A Randomized, Placebo-Controlled Study

The aim of this study is to evaluate the therapeutic effectiveness of chlorhexidine mouthrinse on gingival inflammation and subgingival microbiota in addition to daily mechanical plaque control in a population with established gingivitis.

Failure to perform oral hygiene adequately at the gingival margin results in the formation of a pathogenic plaque that has the potential to initiate gingivitis and in some individuals to progress to periodontitis. However, factors, such as dexterity and motivation, can limit the effectiveness of daily self-performed oral hygiene. The use of a chemical plaque-inhibitory mouthrinse as an adjunct to toothbrushing may improve the oral health of individuals who are inadequate in mechanical plaque control in maintaining gingival health.

Chlorhexidine (CHX) has been effectively used in the treatment of gingival inflammation and can be considered as the gold standard for oral antiseptics.

The effectiveness of CHX in reducing the formation of dental plaque and preventing gingivitis in addition to professional mechanical debridement were studied in several clinical studies, but there is limited number of studies investigating the effects of CHX on untreated gingivitis and subgingival microbiota.

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old male or female with gingivitis associated with dental plaque, no clinical signs of destructive periodontal disease, clinical attachment loss \< 3mm, a minimum of 20 teeth (teeth that have gross caries, were fully crowned or extensively restored, orthodontic banded, abutments, or third molars were not included in the tooth count).

Exclusion Criteria:

* use of tobacco products, history or current manifestation of systemic disease which could impair immune response such as diabetes mellitus, immunological disorders, hepatitis and HIV infections, use of antibiotic or anti-inflammatory or immunosuppressive drugs during 3 months period prior to the start of the trial, periodontal therapy during the last 3 month, pregnancy or lactation and oral contraceptives usage.