cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise on Retinal Microvascular Regulation Measured by Dynamic Vessel Analysis in Healthy Individuals

Objective The investigators assessed the acute impact of physical exercise on retinal vessel regulation. This might be of clinical importance if retinal vessel regulation is examined with the very sensitive method of the dynamic vessel analyzer Design Forty middle aged (age range 18 to 31 years, mean age 24 years) healthy subjects (26 female / 14 male) had retinal examinations with static and dynamic vessel analysis prior and after (0.5h, 1.5h, 2.5h) intense exercise of 20 minutes.


Eligibility Criteria:
Inclusion Criteria:

* healthy middle-aged subjects

Exclusion Criteria:

* volunteers with systemic or ocular diseases
The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients

Recovery of the cognitive functions and recovery features after general anaesthesia in Down syndrome patients. A comparison of Sevoflurane and Desflurane.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) classification I, II or III
* Down syndrome patients
* must be able to undergone general anaesthesia
* dental surgery necessity

Exclusion Criteria:

* severe dementia
* severe hearing, vision, speaking problems
Trial of FFP+HDMP+Rituximab for Ultra-high Risk Chronic Lymphocytic Leukemia

The purpose of this study is to investigate efficacy and safety of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemia.

Chronic lymphocytic leukemia remains incurable and particularly in ultra-high risk subgroup, and the prognosis of these patients is still dismal.

This is a phase III, multicenter perspective clinical trial of combination of fresh frozen plasma(FFP), high dose methylprednisolone(HDMP) and rituximab for ultra-high risk chronic lymphocytic leukemiaThe. The main purpose of this study is to investigate efficacy and safety of this combinated regimen in subgroup of CLL patients.

All the enrolled patients will be followed during and after the treatment period up to one year. Interim and final evaluation will be done after each cycle of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80 years old.
2. Diagnosis of chronic lymphocytic leukemia.
3. Active disease meeting at least one of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment.
4. Ultra-high risk CLL(Meets at least one of the following criteria) (1)ultra high-risk genetics (17p deletion and/or TP53 mutation) (2)short PFS(\<24 months)after intense immunochemotherapy treatment(i.e. FCR, FR, PCR, BR etc) (3)fludarabine-refractory
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

1. Severe allergic constitution or asthma.
2. Recent myocardial infarction or hypotension.
3. ECOG performance status of ≤ 2 at study entry.
4. Active hepatitis B(DNA \>1×103/ml)
5. Severe and uncontrolled diabetes mellitus.
6. Severe and uncontrolled hypertension(BP\> 150/90 mmHg after treatment).
7. Active and uncontrolled systematic infection which need treatment of antibiotics.
8. Clinical symptoms of dysfunction of central nervous system.
9. Unstable and severe gastrorrhagia and peptic ulcer.
10. Major surgery within three weeks.
11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
12. In any conditions which investigator considered ineligible for this study
Kayak Polo Athletes

Kayak polo (KP) is a sport that, as a breviary, can be defined as the union between water polo and canoeing. The objective of this study is to compare anthropometric parameters, joint assessment, strength and functional capacity between two groups of KP players from the Valencian Community. The sample will be divided into a Sub21 group and a Senior group. Anthropometric variables (body mass index \[BMI\], percentage of fat mass, waist - hip index \[CHF\], body perimeters ...), shoulder assessment (Range of movement in rotations, Scapular Dyskinesis Test \[SDT\]) will be assessed. glenohumeral instability ...), hip assessment (modified Thomas test), strength (Hand Grip Strength test and upper limb thrust), lower limb power (Counter Movement Jump \[CMJ\]) and functional capacity (1 'push-ups for limbs upper and 1 'Sit-to-Stand test for lower limbs).


Eligibility Criteria:
Inclusion Criteria:

* kayak polo athletes

Exclusion Criteria:

* other sports
* current injuries the previous 6 months
Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

Cabozantinib will be taken by mouth daily. The first five treatment cycles will be 21 days. All cycles after that will be 42 days long. Patients will keep a diary to record study drug dosing.

During the screening phase patients will receive a physical exam, blood and urine tests, a bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI scans will be performed at the start of cycles 3 and 5, and then repeated once every 12 weeks.

Patients will continue to receive study treatment as long as they are receiving benefit from the treatment, do not experience any severe or unmanageable side effects, and disease does not get any worse.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate adenocarcinoma
* Bone metastases confirmed by bone scan
* Current androgen deprivation therapy
* Castration-resistant disease based on progression in bone and/or PSA progression
* Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events
* Life expectancy of greater than 3 months
* Normal organ and marrow function
* Capable of understanding and complying with the protocol requirements
* Agree to use medically accepted methods of contraception
* Able to swallow capsules

Exclusion Criteria:

* More than two prior chemotherapy regimens for metastatic prostate cancer
* Known untreated, symptomatic or uncontrolled brain metastases
* Serious or unhealed wound
* Treatment with anticoagulants
* Previously identified allergy or hypersensitivity to components of the study treatment formulation
* History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin
* Current antiretroviral therapy
* Uncontrolled hypertension
* Uncontrolled intercurrent illness
Pharmacokinetic Study of Two HIV Protease Inhibitors in Patients

The objective of this study is to determine the pharmacokinetics of lopinavir, ritonavir, and atazanavir when lopinavir/ritonavir and atazanavir are used in combination.

Thirty patients with HIV infection will be enrolled in this open-label, parallel arm pharmacokinetic study. Subjects receiving either lopinavir/ritonavir or atazanavir/ritonavir as part of their antiretroviral therapy will have a pharmacokinetic study performed over 12-20 days to examine whether coadministration of lopinavir and atazanavir alters the pharmacokinetics of either agent. The safety of these agents in combination will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* HIV-seropositive
* Currently receiving atazanavir/ritonavir or lopinavir/ritonavir in combination with 2-3 nucleoside RT inhibitors or are antiretroviral treatment-naïve
* If female, is not of childbearing potential or is of childbearing potential and agrees to use a barrier method of contraception throughout the study

Exclusion Criteria:

* HIV-1 RNA \> 400 copies/mL if currently receiving antiretroviral therapy
* Concurrent use of CYP450 inhibitors or inducers
* Concurrent use of P-glycoprotein substrates, inhibitors, or inducers
* Concurrent use of medications known to interact with ritonavir or atazanavir
* Presence of a chronic health condition deemed by the investigators to potentially impair lopinavir, ritonavir, or atazanavir pharmacokinetics
* Presence of conduction abnormalities on electrocardiogram
* Women who are pregnant or breastfeeding
* Laboratory Abnormalities at baseline:

  * Aminotransferases \> 3x ULN
  * Serum bilirubin \> 5x ULN
  * Serum creatinine \> 1.5x ULN
  * Hemoglobin concentration \< 8.0 g/dL
  * Absolute neutrophil count \< 800 cells/μL
  * Platelet count \< 50,000 cells/μL
High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy

This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.

This is a prospective trial to evaluate the effectiveness of 18F-PSMA PET-hrMRI versus standard mpMRI at identifying prostate cancer targets for HIFU therapy.

Participants with clinically localized, unilateral high grade prostate cancer (Gleason score 7-10 prostate cancer localized to one lobe on prior biopsies) OR at high risk for having unrecognized high grade prostate cancer (overall Gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core), interested in HIFU would receive both a standard mpMRI and 18F-PSMA PET-hrMRI.

Participants would then undergo a mapping biopsy using a standard sextant template plus MRI/US-fusion targeted biopsy of any lesion suspicious lesion on mpMRI or PET-hrMRI.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy consisting of ≥ 10 tissue cores sampled
2. PSA \<20 ng/mL (for HIFU arm only)
3. cT1-cT2c
4. Either overall Gleason score \> 7 with Gleason grade 4 or 5 component localized to one lobe (i.e. right or left) OR overall Gleason score 6 with \> half of systematic biopsy cores positive and \> 50% of core involvement in at least one core (for HIFU arm only)
5. Patient considering focal HIFU therapy or robotic radical prostatectomy

Exclusion Criteria:

1. Previous local therapy for prostate cancer
2. Inability to receive PET tracer
3. Inability to receive MRI
4. Estimated glomerular filtration rate (GFR) \<15 mL/min/1.73 m2
5. Any other condition which, in the investigator's option, may make the patient a poor candidate for participation in a clinical trial.
Sensory Processing Difficulties in Adults and Adolescents

The purpose of this study is to establish normative data for the Adult/Adolescent Sensory History (ASH) and to determine if the ASH is able to discriminate between individuals aged 13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically functioning.

It is anticipated that individuals with ASD will have the most problems with sensory processing, those with SPD will also have problems in comparison to typical individuals. It is also hypothesized that the measure will be able to discriminate between the three groups.


Eligibility Criteria:
Inclusion Criteria:

* Autism and Sensory Processing groups aged 18-95 years, Typical group aged 13-95 years
* Have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral palsy)
* Have no mental health diagnoses involving psychosis (e.g. manic-depression or schizophrenia)
* Be able to read and speak sufficient English as survey is only available in English.

Exclusion Criteria:

* Outside of the designated age range
* Unable to complete the survey independently
Vitamin D Pilot Study in Patients With Multiple Sclerosis

Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.


Eligibility Criteria:
Inclusion Criteria:

* relapsing remitting MS

Exclusion Criteria:

* MRI contraindicated
Follow-up of Patients With Talocalcaneal Coalitions

The objective of this study was to develop a new classification system based on the articular facets involved to cover all coalitions and guide operative planning.

Patients were diagnosed with talocalcaneal coalition using a CT scan, between January 2009 and February 2021. We classified the coalition into four main types according to the shape and nature of the coalition: I, inferiorly overgrown talus or superiorly overgrown calcaneus; II, both talus and calcaneus overgrew; III, coalition with an accessory ossicle; (I-III types are non-osseous coalition) IV, complete osseous coalition. Then each type was further divided into three subtypes according to the articular facets involved. A, the coalition involving the anterior facets; M, the coalition involving the middle facets, and P, the coalition involving the posterior facets.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed as talocalcaneal coalition by CT or MRI at the outpatient
* Underwent arthroscopic talocalcaneal coalition resection due to failure of conservative treatment

Exclusion Criteria:

* The affected side underwent other foot and ankle operations
* Combined with other ankle diseases
* Refused to participate in the study
Contact Lens Insertion and Removal in a Senior Subject Demographic

This will be a pilot, one-visit, open-label, non-dispensing study. Subjects will be given instructions and then attempt to insert and remove a contact lens in each eye.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Must be at least 60 years of age at the time of screening.
  4. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  5. The subject must have best corrected visual acuity (BCVA) of 20/30 or better in each eye.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. A habitual and adapted wearer of contact lenses (have worn a contact lens at least one time in the past 5 years).
  2. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  7. History of binocular vision abnormality or strabismus.
  8. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  9. Suspicion of or recent history of alcohol or substance abuse.
  10. History of serious mental illness.
  11. History of seizures.
  12. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
  13. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
  14. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale
  15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
Evaluation of a Systematic Approach to Weaning From Mechanical Ventilation

Prolongation of mechanical ventilation poses serious personal and financial threats to healthcare consumers.

The investigators objectives are create and implement an multidisciplinary evidenced-based ventilator-weaning protocol to assess whether a systematic approach compared with the physician's judgment only decreases time spent on the ventilator, complications of mechanical ventilation and length of stay in critical care unit.


Eligibility Criteria:
Inclusion Criteria:

* remain in mechanical ventilation for more than 24 hours
* begin weaning from mechanical ventilation

Exclusion Criteria:

* admitted in the unit already in weaning from mechanical ventilation
Study of Amblyomin-X in Advanced Solid Tumor

Amblyomin-X is an inhibitor of Factor Xa that also acts as an apoptotic agent for tumor cells. In the case of in vitro assays, Amblyomin-X induces tumor cells to death and does not affect the viability of normal cells. When in vivo assays were performed on mice bearing tumors, treatment with Amblyomin-X caused a significant reduction in tumor mass and number of metastases.

This trial will be the first clinical study in humans with the product, which until then has been studied only in experimental models. Given the current epidemiological impact of cancer and the need to improve its systemic treatment, making it available to a larger portion of the Brazilian population, it is proposed to conduct the first Amblyomin-X study in cancer patients, more specifically those with advanced solid tumors For which there is no contraindicated or inaccessible therapeutic option established as the standard at the time of inclusion in the study.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients must sign the Free and Informed Consent Term (TCLE),
* be between 18 and 75 years of age,
* present a solid tumor proven by anatomopathological examination at an advanced or metastatic stage and refractory to conventional treatment or without current indication or access to conventional treatment ,
* have a life expectancy of at least 12 weeks.
* presence of measurable disease according to Response Response Criteria in Solid Tumors (RECIST, version 1.1),
* medullary, renal and hepatic functions within acceptable limits (defined in protocol),
* end of the previous antineoplastic treatment at least 4 weeks (since the last dose of any antineoplastic medication, radiotherapy, or surgical procedure).

Exclusion Criteria:

* The presence of previously non-irradiated brain metastasis;
* Prediction of the use of radiotherapy, surgery, systemic antineoplastic treatment, or any other form of treatment for cancer after inclusion in the study;
* Prediction of corticosteroid use, hematopoietic growth factors or inhibitors of bone resorption during the first course of treatment (4 weeks);
* Regular use of anticoagulants or known previous coagulation disorder;
* Severe comorbidity (at the discretion of the researcher);
* Gestational, lactating, pregnant women, or who have not been surgically infertile or menopausal for at least 12 months;
* Men and women who refuse to use an adequate contraceptive method during the study period;
* Participation of another clinical study in the last 12 months (unless justified by the investigator);
* Or inability to comply with study requirements and procedures.
Caloric Restriction and Body Weight in Adults

The purpose of this study is to determine the role of

1. dietary calcium in fecal fat loss and the association between lactose maldigestion, dietary calcium level and source, and weight loss induced by caloric restriction.
2. caloric restriction on biomarkers of inflammation and oxidative stress


Eligibility Criteria:
Inclusion Criteria:

* 18 -65 years old
* Healthy

Exclusion Criteria:

* Body weight more than 300 lbs (body composition measurement instrument limit) diabetes
* Heart disease
Mucosal Immunity Against SARS-CoV-2 Infection in COVID-19 Patients

In this study nasal fluid (mucosal lining fluid), nose and throat swabs and blood was collected from patients with a confirmed SARS-CoV-2 infection who remained in home isolation, as well as from their household contacts who remained in home quarantine. On the collected nose and throat swabs a coronavirus PCR was performed. Antibodies against SARS-CoV-2 were measured in the mucosal lining fluid and blood samples.

Objective:

Primary Objective: to analyse the development of mucosal immunity against SARS-CoV-2 in nasal fluid of Covid-19 patients and their household contacts

Secondary Objective(s):

* To descriptively analyse the correlation of mucosal antibodies with viral diagnostics and disease symptoms
* To determine the correlation between mucosal and serum antibody levels
* To study the functionality of serum and mucosal antibodies

Study design: A single-site, observational, prospective cohort study among COVID-19 patients and their household contacts Study population: The study will be conducted among COVID-19 patients with a laboratory-confirmed infection with SARS-CoV-2, as well as household contacts remaining in home quarantine at the same address, among secondary and tertiary hospital careworkers in the provinces of Gelderland and Noord-Brabant in The Netherlands.

Intervention (if applicable): N/A

Main study parameters/endpoints:

Mucosal antibodies: descriptive analysis of SARS-CoV-2 IgG, IgA, IgM and IgD concentrations in nasal fluid at the various collection moments.

Viral diagnostics: presence of SARS-CoV-2 in diagnostic specimens collected at inclusion visit.

Disease symptoms: presence of respiratory complaints in participants. Serum antibodies: descriptive analysis of SARS-CoV-antibody concentrations in serum at day 28 Antibody functionality: descriptive analysis of antibody functionality of serum and nasal fluid samples, including virus neutralization

Eligibility Criteria:
Inclusion Criteria:

* Index case:

  * Laboratory-confirmed case of SARS-CoV-2, with a positive indication for home isolation, and;
  * With at least 2 household contacts remaining in home quarantine at the same address
* Household contacts For each index case, the study will seek to recruit as many household contacts as possible in the same house as the index case. All household contacts of the index case remaining in home quarantine in the same house as the index case will be asked to participate.

Exclusion Criteria:

* Covid-19 patients with a negative indication for home isolation, or having less than 2 household contacts remaining in home quarantine at the same address. For fingerprick blood collection, participants who have a medical indication against fingerprick blood collection will be excluded.