cyrilzakka/clinical-trials huggingface dataset:
Influence of Adiposity on IGF-1 and Fitness Response to Exercise in Cancer Survivors

This is a pilot feasibility study of an investigation of the influence of excess adiposity on cardiorespiratory fitness (CRF), insulin-like growth factor-1 (IGF-1), and metabolic responses to a standardized aerobic exercise program in cancer survivors. This investigation attempts to isolate the influence of adiposity on these responses. We will enroll overweight, obese, and normal weight cancer survivors with a primary diagnosis of breast, prostate, or colorectal cancer who have completed all cancer-related treatment. Participants will engage in a 15-week aerobic exercise intervention with pre- and post-intervention assessments.


Eligibility Criteria:
Inclusion Criteria:

* Primary cancer diagnosis of breast, prostate, or colorectal cancer
* Completion of all cancer-related treatment \> than 6 months prior and \< 5 years prior to enrollment
* Ability and willingness to participate in a supervised exercise program

  * All participants will be required to obtain a signed physician clearance to participate in exercise form prior to enrollment

Exclusion Criteria:

* Presence of a secondary active cancer diagnosis or metastatic disease
* Any current cancer treatment (including hormonal treatment) or planned cancer treatment in the next 5 months
* Greater than 100 min of self-reported regular exercise per week
* BMI \< 18.5 (underweight)
* Any significant metabolic condition, such as diabetes. Individuals with pre-diabetes or metabolic syndrome will not be excluded, but this information will be recorded.
* Any medical condition that would impact the safety of, or participation in, an exercise program or exercise testing, including:

  * Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
  * Advanced rheumatoid arthritis or chronic widespread pain conditions such as fibromyalgia
  * Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, or interstitial lung disease
  * Known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months
SmART Heart: Study of mHealth Apps to Reduce Cancer-Treatment Effects on the Heart

This pilot trial studies how well education and mobile health applications work in reducing the effects of cancer treatment on the heart in participants with blood cancers that are in remission. Education and mobile health applications may be effective ways to manage heart health and to reduce future heart disease risk in participants with blood cancers.

PRIMARY OBJECTIVES:

I. Determine the feasibility of recruiting and retaining hematologic malignancy and hematopoietic cell transplantation (HCT) survivors in a randomized cardiovascular (CV) risk reduction mobile health (mHealth) counseling intervention.

II. Develop and refine a protocol to engage participants using an existing social medial platform and commercially available mHealth tools to reinforce lifestyle goals.

OUTLINE: Participants are randomized to 1 of 2 groups.

INTERVENTION GROUP: Participants receive individualized goal-setting and coaching in relation to physical activity and diet, supplemented with peer support through the study's social media platform, over 4 months. They also have access to mHealth apps including Fitbit and Healthwatch that provide feedback on physical activity and diet.

CONTROL GROUP: Participants receive general information about physical activity and diet, and access to Fitbit and Healthwatch.

After completion of study treatment, participants are followed up at 2 months and at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
* At time of approach, \>= 5 years from initial cancer diagnosis or \>= 5 years from first HCT, whichever is later.
* Currently in remission and not on any active anti-cancer therapies (survivors receiving maintenance tyrosine kinase inhibitors are NOT eligible).
* Able to read, write, and speak English.
* Access to smart phone or computer with internet access.
* Presence of at least 1 CV risk factor:

  * Currently on medication for hypertension, or
  * Currently on medication for cholesterol or triglyceride, or
  * Currently on medication for diabetes, or
  * Currently not physically active (self-reported average \< 30 minutes/day), or
  * Currently smoking.
* Ability to understand and the willingness to provide informed consent.

Exclusion Criteria:

* Pre-existing ischemic heart disease (includes angina if documented in electronic medical record \[EMR\]) or ongoing symptomatic cardiomyopathy (those with asymptomatic cardiomyopathy may be allowed to participate if they do not have any current activity restrictions, but we will seek physician clearance for any submaximal exercise testing).
* Active systemic treatment for graft versus host disease.
* Currently pregnant. However, participants enrolled who become pregnant after randomization can remain on the study.
Assessment of Rapid Osseointegration of Dental Implants with Different Coatings

The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability

Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.

marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year

Eligibility Criteria:
Inclusion Criteria:

1. Patients with missing at least one maxillary posterior tooth
2. Patients free from any systemic disease
3. Patients who approve to be included in the trial and sign the informed consent
4. Patients with no intra-bony defect.
5. Adults aged 18 years old and above

Exclusion Criteria:

1. Patients who are allergic to titanium
2. Heavy smoker patient
3. Patients receiving chemotherapy or radiotherapy
4. Patients who refused to be included in the trial
Mortality Causes in Rib Surgery Patients

This study retrospectively investigates the causes of mortality and morbidity in patients undergoing rib fracture surgery due to blunt trauma. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes. Data collected includes patient demographics, trauma mechanisms, associated injuries, surgical timing, and clinical outcomes. The study aims to provide insights into improving management strategies for trauma patients and reducing complication rates through early identification and tailored interventions.

This retrospective study investigates the underlying causes of morbidity and mortality in patients who underwent rib stabilization surgery due to blunt trauma-induced rib fractures. The primary objective is to determine whether pulmonary contusion or associated extrathoracic trauma plays a more significant role in adverse outcomes such as pneumonia, prolonged air leaks, tracheostomy, wound infections, and mortality.

The study includes patients diagnosed with flail chest who underwent rib stabilization surgery between January 1, 2014, and January 1, 2024, at a single tertiary care center. Collected data encompasses patient demographics, trauma mechanisms, associated injuries (thoracic and extrathoracic), surgery timing (early vs. late stabilization), ventilator settings, extubation duration, intensive care unit (ICU) and hospital length of stay, laboratory parameters, and clinical outcomes.

Key outcomes include the incidence of morbidity (e.g., pneumonia, prolonged air leak, wound infections) and mortality. Statistical analyses will evaluate the relationship between these outcomes and factors such as the severity and timing of injuries, surgery timing, trauma mechanisms, and associated injuries.

The study aims to provide valuable insights into optimizing the management of flail chest patients, emphasizing the importance of early rib stabilization and a multidisciplinary approach. These findings are expected to contribute to the development of standardized protocols for patient selection and intervention timing, potentially improving patient outcomes in multitrauma settings.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years diagnosed with flail chest following blunt trauma who underwent rib stabilization surgery
* Those with complete clinical and laboratory data
* Those with at least 30 days of follow-up after surgery.

Exclusion Criteria:

* Patients under 18 years of age
* Flail chest patients who did not require rib stabilization surgery
* Patients with incomplete clinical or laboratory data
* Those with penetrating thoracic trauma.
Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

Eligibility Criteria:
Inclusion Criteria:

* Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
* Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
* History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
* Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
* Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
* Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
* Presence of an ocular condition that may affect the study outcomes.
* History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
* Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
* History of anaphylactic reaction to any allergens used in this study.
* Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
* Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
* Other protocol-defined exclusion criteria may apply.
A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma

Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease. Recently anti-Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 responses and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treating ABPA.

Allergic bronchopulmonary aspergillosis (ABPA) is a immunological pulmonary disorder caused by hypersensitive reaction to spores of Aspergillus fumigatus. The prevalence of disease is about 1-2% in asthmatics and 2-15% in patients with cystic fibrosis. The interest in ABPA stems from the fact that the disease is glucocorticoid-sensitive and early treatment can prevent progression to end-stage lung disease.

Systemic steroids remain the mainstay of treatment in ABPA. Antifungal agents are also useful as they reduce fungal load. Newer therapies like omalizumab (anti immunoglobulin E \[IgE\] antibody), inhalational amphotericin and Anti Th2 therapies are being studied.

In pathogenesis of ABPA, there is heightened Th2 activity as a result of type 1 hypersensitive reaction to Aspergillus fumigatus and levels of Th2 cytokines like IL-3, IL-5 and IL-13 and IgE levels are increased in patients with ABPA compared with asthma patients without ABPA.

Recently anti Th2 therapies have been suggested as treatment for ABPA. Vitamin D has been shown to suppress the Th2 immunity and decrease the levels of Th2 interleukins. Hence, the investigators propose to assess the role of vitamin D in treatment of ABPA.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ABPA as per the International Society for Human and Animal Mycology Working group criteria
* Treatment naïve

Exclusion Criteria:

* Failure to provide informed consent
* Enrollment in another trial of ABPA
* Pregnancy
* Creatinine more than or equal to 1.5 mg/dL
* Immunosuppressive states like chronic liver disease, chronic renal failure, cytotoxic therapy, uncontrolled diabetes mellitus and others
Effect of Hamstring Muscle Length on Lunge Distance in Fencing Athletes

The aim of this study was to determine the effect of hamstring muscle length on lunge distance in fencing sword athletes.

The aim of this study was to determine the effect of hamstring muscle length on lunge distance in fencing sword athletes. A goniometer was used to assess hamstring muscle length and a tape measure was used to assess lunge distance in 20 athletes who agreed to participate in the study and signed the consent form. We believe that the results of our study will provide new perspectives on increasing the success of fencing sword athletes and reducing their injuries. SPSS 24.0 program will be used for statistical analysis. Pearson correlation test will be applied to evaluate the relationship between hamstring muscle length and lunge distance.

Eligibility Criteria:
Inclusion Criteria:

* Being an active licensed fencing athlete in the Anatolian Archery and Fencing Club
* Being an athlete in the sword branch.
* Being a volunteer to participate in the study
* Being between the ages of 18-30

Exclusion Criteria:

* Having done a strenuous exercise that would affect muscle groups the day before the measurements
* Having used alcohol and/or any medication the day before the measurements
Validation of TearLab Osmometer - Human Factor Usability Report

The objective of this study is to validate the performance of the OcuSense TearLab™ osmolarity test when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects and contrived tear samples.

To validate the performance and usability of the TearLab osmometer, specifically human factor usability, when used in the hands of intended users, i.e. ophthalmology and optometry clinics. This testing is required to insure that the Osmolarity System meets the Product Requirements and for completion of the Technical File, Design History File and FDA 510(k) Submission.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers representing the general population (a minimum of 120 subjects representing 50% of the total study population,
* Otherwise healthy volunteers previously-diagnosed with moderate or severe chronic dry eye and/or Sjogrens syndrome and/or designated as dry eye disease subjects by the OSDI questionnaire (a minimum of 40 subjects representing 50% of the total study population),
* Men or women,
* Adult 18 years or older,
* Contact lens wearers may participate,
* Patients having undergone refractive surgery may participate,
* Patients having undergone cataract surgery may participate

Exclusion Criteria:

* Eye pathology other than previously-diagnosed moderate or severe chronic dry eye and/or Sjogrens syndrome, Use of topical medication within the last 24 hours,
* Eye drop usage within the last 2 hours,
* Ocular surface staining within the last 2 hours,
* Other invasive ocular diagnostic testing within the last 2 hours,
* Crying within the last 30 minutes,
* Eye makeup present on the eye lid within 10 minutes of tear collection,
* Examination by slit lamp within 10 minutes of tear collection.
Evaluation of the Clinical Performance of Apneal®, a Medical Device on Smartphone, for Sleep Apnea-hypopnea Syndrome Diagnosis.

The goal of this clinical trial is to test the ability of the Apneal application in diagnosing sleep apnea in adult patients.

Participants will be asked to wear the Apneal device during their fulll-night sleep test (polysomnography, the gold standard for sleep apnea)


Eligibility Criteria:
Inclusion Criteria:

* Individuals, men or women, aged over 18 and with no upper age limit;
* Individuals for whom PSG is indicated as part of routine care, regardless of indication.
* Individuals willing and able to comply with study requirements;
* Individuals with a declared total sleep time of at least 6 hours, as recommended by AASM for PSG analysis.
* Individuals affiliated to social security or beneficiary of such a scheme if applicable according to the local regulation ;
* Voluntary individuals who have provided oral and written consent after being informed by the research investigator.

Exclusion Criteria:

* Individuals with active implantable medical devices (e.g. electronic heart implant, electrical neurophysiological stimulator...);
* Individuals with mechanical heart valves;
* Individuals with chest deformity preventing the phone to be correctly placed on the chest
* Individuals with uncontrolled psychiatric conditions impairing their ability to fully consent to the study
* Individuals suffering from epilepsy or an associated disorder;
* Individuals suffering from a moderate to severe valvular disease;
* Individuals under CPAP treatment during the participation.
* Individuals suffering from a nervous system disorder that causes unintended or uncontrollable movements, other than periodic leg movement syndrome and restless leg syndrome.
* Refusal to participate in the study at any time during the clinical investigation;
* Individuals in period of exclusion from another protocol or currently participating in another interventional research study;
* Individuals not able to understand and speak the official language of the research center;
* Vulnerable individuals according to local legislation
Sit-to-Stand Training for Survivors of Stroke in a Long-Term Care Setting

The purpose of this study is to see if providing training using a Sit-to-Stand protocol for residents of Long-Term Care Facilities who have had a stroke will increase their independence in performing Sit-to-Stand.

The implementation of a sit-to-stand protocol and extra practice has been previously validated in a rehabilitation setting, where 68% of survivors of stroke who received the training, learned to stand safely and independently from a 16" surface (the height of a regular toilet). Our findings have been supported by other research that have shown that rising from sitting is a maneuver that has been advocated for strengthening the lower extremities of elderly individuals and patients with specific disorders such as stroke. During the acute care and rehabilitation phases, considerable effort is spent to maximize a person's functional abilities following a stroke; however, continued strengthening and activity appears to stop once an individual is admitted to a LTC facility.

The main purpose of this randomized controlled trial is to examine the efficacy of implementing the Sit-to-Stand (STS) protocol with or without extra sit-to-stand practice for survivors of stroke residing in Long-Term Care (LTC) facilities on (1) their ability to learn how to stand safely and independently from a 16" surface; (2) the number of staff injuries; (3) the number of residents' falls; (4) the quality of life of the residents and staff; and (5) the translation and maintenance of knowledge of the STS protocol by staff into their daily routines.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cerebrovascular accident
* Reside in Long-Term Care Facility
* Have physician approval to participate in the study
* Are unable to stand up independently from a 16" surface without using their hands
* Have given informed consent

Exclusion Criteria:

* Expect to be leaving the facility in less than 24 weeks
* Have a terminal illness
* Have a total hip replacement or other orthopedic complication that prevents them from being able to safely use protocol
* Have pain that prevents their participation
* Are at higher risk for falling (i.e. blood pressure disorder/postural hypotension, vestibular disorder)
Evaluation of Efficacy and Safety of Intradiscal Gelified Ethanol in Refractory Cervical Discogenic Pain

The purpose of this study is to assesse safety and efficacy of the Intradiscal Gelified Ethanol for treatment in refractory cervical discogenic pain.

After being informed about the study and potential tisks, all patients giving written informed consent will undergo a inclusion visit (CT scan and X ray at least) for study entry. At Day 0, operation with Intradiscal Gelified Ethanol will be performed by the investigator. Follow visit will be performed at 3 months and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older;
* Pain refractory to conservative treatments for more than 2 months, non-surgical patients
* Cervicobrachialgia due to disc herniation
* Chronic discogenic pain (1 or 2 cervical discs) with concordant MRI;
* Patient agreeing to participate in the study and having given written consent;
* Patient enrolled in a health insurance plan.

Exclusion Criteria:

* Prior surgical treatment of the disc(s) studied;
* Sick leave of more than 12 months secondary to painful symptoms;
* Patient with Modic 1 score or more
* History of cognitive-behavioral disorders that could affect the completion of self-questionnaires;
* Local or systemic infection, or suspicion of infection;
* Severe coagulation disorders;
* Other inflammatory rheumatic disease;
* Severe underlying pathology with life expectancy \<1 year;
* Women of childbearing age who are pregnant at the inclusion visit or who wish to become pregnant before the administration of the treatment (V0);
* Known allergy to contrast material and/or local anesthetic substances;
* Patients who cannot read or write Italian;
* Major person benefiting from a legal protection regime (guardianship, curatorship, safeguard of justice);