cyrilzakka/clinical-trials huggingface dataset:
Cultivation of Hyalocytes From ILM and ERM Samples: a Pilot Study

ILM and ERM are routinely excised during surgery, as part of the surgical technique, and cultivation of hyalocytes will be performed ex vivo after surgery.

Hyalocytes, typically located 20 to 50μm anterior the internal limiting membrane (ILM), have the potential to contribute to development of epiretinal membranes (ERM) in presence of vitreoschisis. For macular holes, hyalocytes located on the ILM are hypothesized to contribute to the closure of the macular hole after application of the inverted ILM flap technique.

ILM is routinely excised during surgical repair of macular holes. During peeling of ERM it is excised in case of persisting wrinkling of the retinal surface or partial en bloc excision with the ERM. Furthermore, excision of ILM during ERM peeling is associated with significantly lower recurrence rates of ERM and better Long term visual acuity, according to the results reported by Chang et al. Removal of ERM and ILM is part of the surgical routine during surgical repair of macular holes and peeling of epiretinal membranes. Therefore, cultivation of excised ERM and ILM samples does not increase risks for patients in any way. During study it is planned to cultivate hyalocytes for investigation of their role in macular hole closure.

Eligibility Criteria:
Inclusion Criteria:

* Macular hole or epiretinal Membrane

Exclusion Criteria:

* Pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)
Vocational Rehabilitation for the Return to Work of Breast Cancer Patients: a Feasibility Study

In Italy, 50% of new breast cancer (BC) diagnosis occur in female of working age. Although return to work (RTW) is strongly desired by BC patients, cancer survivors are more likely to be unemployed than healthy individuals. Moreover, work difficulties may hindrance this process. Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. To date, the feasibility of the multidisciplinary vocational rehabilitation interventions has not been verified for BC patients.

BC is a public health burden with increasing trends in Western countries. In Italy, 50% of the new BC diagnosis have occurred in female of working age. Even though the return to work (RTW) is strongly desired, cancer survivors are 1.4 times more likely to be unemployed than healthy individuals. Furthermore, work difficulties may occur during this process. To promote the RTW, multidisciplinary interventions have shown moderate quality evidence in cancer survivors.

Since 2018, the investigators have planned a local social-healthcare pathway which provides a multidisciplinary vocational rehabilitation intervention with the aim to help cancer survivors in their RTW process. During the implementation of the pathway, BC patients were referred mainly by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). As standard care, BC patients can participate to an educational group session held by the physiotherapists after surgery. During this session, work difficulties have emerged.

Thus, the investigators aim to verify the feasibility of the multidisciplinary vocational rehabilitation intervention for a sample of BC patients whit work difficulties who will participate to an educational group session held by the physiotherapists.

Eligibility Criteria:
Inclusion Criteria:

* breast cancer diagnosis (regardless of stage and treatment)
* breast cancer patients in working age
* breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU
* breast cancer patients with work difficulties

Exclusion Criteria:

* Breast cancer patients with work issues that cannot be addressed by any of the interventions (e.g., patients who would like to change their job)
VIH-1 Colo-rectal Transmission by Infected Semen Cells and Effects of Seminal Plasma ex Vivo (CellspermVIH)

The objective of our project is to determine the infected seminal cell types and the molecular mechanisms involved in HIV cell-associated transmission in the colo-rectal mucosa, using conditions as close as possible to real life, i.e. seminal leukocytes and seminal plasma from HIV-infected donors and tissue explants

This project relies on:

* our expertise of HIV in semen and male genital tract and our experience in organotypic cultures;
* a network of infectious diseases and reproductive biology clinicians to collect, analyze and process seminal cells and seminal plasma from HIV+ donors;
* the expertise in confocal microscopy and ex vivo colo-rectal model. State of the art culture of colo-rectal tissues, primary cell culture and infection, confocal microscopy, flow cytometry, Polymerase Chain Reaction and Luminex assays for cytokine measurements will be the methodologies primarily used in this project.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected patients who have never been treated by antiretroviral therapy
* Signature of informed consent
* Affiliation to social service

Exclusion Criteria:

* Patients' general condition not allowing protocol follow-up
* Patients with an ejaculation disorder
* Patients unable to perform semen sampling
* Patients with chemotherapy or radiotherapy antecedents
* Patients with very severe oligospermia (≤1million/mL of spermatozoa)
* Patients with active genital infection
* Protected subjects
Proteomics Study by Serum and Platelet With Neurodegeneration Disease Patients

Using to method of Proteomics, for aims to conquer intractable disease, try to access variety experiment. Biomarker is necessary to develop new diagnosis method and target of treatment.

Following Seoul National University Hospital Institutional Review Board approval, obtain serum and platelet with neurodegeneration patients and control group visited the part of neurology, there'll be analysis to differentiate each other diseases use to method Proteomics. Biomarker will be screening via 1D/2D analysis, Mass analysis, database searching- the MASCOT search tool, SWISS-PROT and etc.

Eligibility Criteria:
Inclusion Criteria:

* neurodegeneration patients and control group include dementia patients visited the part of neurology.
* over the age of 18
* when participants can understand subject of this study
* Total point of Mini Mental state exam(MMSE)should be Under 26 include MCI (mild cognitive impairment) and over GDS score 3points.

exclusion criteria:

* under eighteen years of age
* when participants cannot understand subject of this study
* cannot accept this study
Randomized Influenza Vaccine Evaluation of Immune Response

Licensed influenza vaccines are manufactured with a variety of technologies. The majority are split, inactivated vaccines derived from egg-adapted, high growth reassortant viruses. Two US licensed products do not use egg-adapted viruses: Flucelvax (mammalian cell culture) and FluBlok (recombinant). There is increasing evidence that egg propagation induces virus mutations that impair the immune responses to circulating viruses. However, the impact of egg-propagation on clinical vaccine effectiveness is uncertain, and there is no preferential recommendation for any specific influenza vaccine product or technology. A direct comparison of serologic response to egg based and non-egg based vaccines in adults has not been performed. This randomized trial will compare serologic responses to the egg- and non-egg A(H3N2) vaccine component. The study cohort will be followed for two influenza seasons to evaluate sequential vaccination effects on immune response.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-64 years
* Marshfield Clinic patients living in or around Marshfield, Wisconsin since July 2015
* Willing and able to give informed consent and comply with study requirements

Exclusion Criteria:

* Receipt of 2018-19 influenza vaccine prior to study enrollment
* Known to be pregnant at the time of enrollment
* Current participation or plans to participate in another clinical trial involving an experimental agent
* Presence of a contraindication to influenza vaccination
* Plans to relocate outside the geographic location in the next two years
Efficacy and Safety Study of Protein C Concentrate in Subjects With Severe Congenital Protein C Deficiency

The purpose of this study is to show that Protein C Concentrate is a safe and effective treatment for subjects with congenital protein C deficiency. Depending on the type of treatment required, patients are assigned to one of 3 study parts: Part 1 is for the treatment of acute episodes, Part 2 is for short-term prophylaxis, and Part 3 is for long-term prophylaxis in infants aged less than 6 months only.


Eligibility Criteria:
Inclusion Criteria:

* Newborn subjects \<= 6 months of age: diagnosis of severe congenital protein C deficiency, with documented functional protein C level \< 20%. If a genetic diagnosis is not available prior to initiation of Protein C Concentrate treatment, a documented family history of protein C deficiency is required.
* Subjects \> 6 months of age: confirmed diagnosis of severe congenital protein C deficiency, i.e., by
* a genetic analysis of severe congenital protein C deficiency (i.e., homozygous or double heterozygous) OR
* a documented family history of protein C deficiency AND a documented functional protein C level \< 20% while the subject is in an asymptomatic state and not receiving oral anticoagulation therapy
* Signed and dated informed consent from either the subject or the subject's legally authorized representative prior to enrollment. Informed consent includes consent for conducting a genetic analysis (if the genetic defect is unknown).

Exclusion Criteria:

* Subjects with a history of allergic reactions to Protein C Concentrate. In the case of allergic reactions occurring at the Protein C Concentrate injection site; exclusion from the study is at the discretion of the investigator but should be reported as an AE regardless of the subject's inclusion in or exclusion from the study.
* Participation in any clinical study in which another investigational agent is used within 30 days prior to enrollment or its use is expected at any time for the duration of study participation.
An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B

This observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of HEMGENIX in patients with hemophilia B. The study will also include a cohort of patients with hemophilia B treated with FIX prophylaxis to enable interpretation of relevant efficacy and safety findings of HEMGENIX.


Eligibility Criteria:
Inclusion Criteria:

HEMGENIX Cohort:

* Treatment with commercial HEMGENIX.
* Have provided signed written informed consent within 3 months before or within 6 months after HEMGENIX treatment, or within 6 months of when the study is initiated at the participating site.

FIX Prophylaxis Cohort:

* Adult patients (≥ 18 years) with hemophilia B who have consented and enrolled in ATHN Transcends Hemophilia Cohort (or a similar registry) and are receiving FIX prophylaxis therapy.

Exclusion Criteria:

HEMGENIX Cohort:

* The patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.
The Association of Sleep and Psychological Symptoms With Prognosis of MSK Pain in Danish General Practice

Musculoskeletal (MSK) pain is a major public health concern. Approximately one in four consult their general practitioner (GP) with a musculoskeletal problem during the course of a year, making it the largest diagnostic group.

Modifiable factors including affective disorders (e.g. anxiety and depressive symptoms) and sleep problems may be important prognostic factors for MSK pain. However, there is a lack of prospective research examining the interaction between these conditions in patients with MSK pain in a GP-setting.

This is a prospective cohort study of 299 participants from a GP-setting. Investigators will evaluate the occurrence of MSK pain at one-year follow-up and how the predictors (anxiety, depressive, and sleep problems and multi-site MSK pain) are associated with prognosis of MSK pain.

A secondary aim will be to identify those factors associated with new onset MSK pain. Participants will complete a sleep questionnaire (the ATHENS insomnia questionnaire) containing 8 questions about sleep quality and quantity and a questionnaire (The Hospital Anxiety and Depression Score)) containing 14 questions focusing on anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 12 years visiting the GP who contributed baseline data and over who consented to be contacted as part of a prospective cohort study

Based on baseline assessment, patients were divided into two separate groups: The MSK pain group and the control group (representing the pain-free background population in general practice).

Inclusion Criteria for MSK pain group:

* Musculoskeletal pain at any body site
* Pain least once a week during the preceding month
* Pain that negatively interfere with the participant's usual activities.

The same criteria for 'MSK pain' apply for the follow-up study.
IL-6 Regulation of Substrate Metabolism and Influence of Obesity

The aim of the study is to investigate the effects of blocking IL-6 signaling with tocilizumab on lipid, glucose and protein metabolism during rest and exercise in healthy and obese humans.

Interleukin-6 is a molecule produced by a variety of cells and impacts on energy metabolism during fasting and fed conditions. Systemic IL-6 levels are low but increase acutely in response to fasting, exercise and infection, and also chronically in response to obesity and other conditions of lowgrade inflammation.Our recent human intervention study showed that IL-6 receptor blockade prevents exercise training from reducing visceral fat mass.

Whether IL-6 receptor blockade directly regulates lipolysis and/or lipid oxidation in humans is however unclear. Therefore, this study will be performed to investigate the physiological role of IL-6 on lipid, glucose and protein metabolism in humans.

The aim of the study is to assess changes in substrate kinetics, that is, lipolytic rate, rate of appearance and disappearance of free fatty acids, fatty acid oxidation, glucose rate of appearance and disappearance and protein synthesis and degradation during rest and exercise with and without IL-6 receptor blockade. We will assess the acute effects of blocking IL-6 as well as the long-term consequences of IL-6 receptor blockade on all the above parameters.

Overall, we hypothesize that blocking IL-6 changes substrate kinetics. More specifically we hypothesize that blocking IL-6 reduces the appearance of free fatty acids, reduces the lipolytic rate and lipid oxidation. We hypothesize that the consequences of blocking IL-6 will be observed during resting and exercising conditions and both immediately and longterm after IL-6 receptor blockade. We hypothesize that IL-6 receptor blockade results in an increased respiratory exchange ratio (RER) and thus increased reliance on glucose as substrate.

In this study 10 healthy males and 10 obese males will be included. Subjects will be infused with saline on 2 of the study days and tocilizumab on 1 of the study days.

Isotope dilution techniques with \[6,6-2H2\]Glucose, \[1,1,2,3,3-D5\]glycerol, K-\[U-13C16\]palmitate, L-\[ring-D5\]phenylalanine, L-\[D2\]tyrosine will be applied to assess lipid, glucose and protein kinetics. Respiratory exchange ratio will be measured by indirect calorimetry. The BORG scale will be used to assess the perceived exertion during exercise.

Eligibility Criteria:
Inclusion Criteria:

* BMI \< 18 and \> 25 kg/m2 or ≥ 30 and ≤ 40 kg/m2
* Healthy (based on screening)

Exclusion Criteria:

* Smoking
* Severe thyroid or heart disease
* inflammatory diseases
* current infection
* liver disease
* kidney disease
* immunosuppressive disease
* corticosteroid use
* regular NSAID usage
* aspirin use \>100 mg/d
* history of carcinoma
* history of tuberculosis
* anemia
* neutropenia
* low platelets
* bleeding disorders
* obstructive pulmonary disease
Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts

This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass.

The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses.

In each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device.

Subjects will be followed for 5 years, with interim follow ups at 12 and 24 months.

MACCE and EQ5D3L will be documented at every follow up visit.


Eligibility Criteria:
Inclusion Criteria:

1. Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.
2. Saphenous vein graft length and diameter are adequate for the planned intervention.
3. Patient is willing and able to give their written informed consent to participate in the registry study.
4. Patient is over 18 years of age

Exclusion Criteria:

1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
2. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Biomarkers of Atrial Fibrillation Complicated With Stroke Based on Proteomics and Metabolomics

Thrombus shedding in patients with atrial fibrillation (AF) can lead to cerebral artery embolism. Stroke caused by AF is very dangerous, which not only threatens the life of patients, but also seriously affects the quality of life. This study aims to explore the biomarkers of stroke in patients with AF by integrating proteomics and metabolomics data, and establish the network relationship of stroke in patients with AF, so as to reveal the molecular mechanism of stroke in patients with AF.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above
2. Admission with atrial fibrillation or clinic visit for atrial fibrillation
3. Receive routine anticoagulant therapy;
4. Signing the consent form

Exclusion Criteria:

1. Pregnant women;
2. Lactating women;
3. Severe mitral stenosis;
4. Severe impairment of liver function;
5. Severe renal insufficiency;
6. Thyroid dysfunction requiring treatment.
A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).


Eligibility Criteria:
Inclusion Criteria:

* Documented initial diagnosis of multiple myeloma according to international myeloma working group (IMWG) diagnostic criteria
* Part 3: Measurable disease cohort A, cohort B, cohort C and cohort D: multiple myeloma must be measurable by central laboratory assessment; Cohort E: Multiple myeloma must be measurable by local laboratory assessment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (beta human chorionic gonadotropin \[hCG\]) or urine
* Willing and able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria:

* Part 3 only: Cohort A and Cohort C only: exposed to a CAR-T or T cell redirection therapy at any time. Cohort B, Cohort D and Cohort E: T cell redirection therapy within 3 months
* Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
* Received a cumulative dose of corticosteroids equivalent to \>= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
* Stroke or seizure within 6 months prior to signing the informed consent form (ICF)
Hallmarks of Protective Immunity in Sequential Rhinovirus Infections in Humans

The primary objective of this study is to assess the relationship between rhinovirus specific T-cell immunity and the human host response to primary rhinovirus challenge and subsequent secondary challenge with either homologous or heterologous rhinovirus serotypes.

The primary objective of this study is to assess the relationship between RV-specific T-cell immunity and the human host response to primary RV challenge and subsequent secondary challenge with either homologous or heterologous RV serotypes. The overall hypothesis that will be addressed by the mechanistic studies in this proposal is that T helper (Th) and T follicular helper (Tfh) cells directed against conserved RV epitopes expand upon RV exposure and some of these cells persist as stable cross-reactive memory populations capable of displaying lineage-specific protective functions upon re-infection with related or unrelated strains of RV. The human specimens collected in this study will be analyzed with a variety of state-of-the-art techniques to provide an in depth description of T-cell responses to RV infection, and the correlation of these responses with viral infection, antibody responses, and illness. Beyond this objective, by using a systems biology approach, we aim to gain new insight into the role of diverse cell types involved in adaptive immunity to RV. .

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 18-40 years of age
2. Subject must read and sign a copy of the approved Consent Form
3. Subject must have a serum neutralizing antibody titer of ≤1:2 to rhinovirus type 39 and rhinovirus type 16
4. Female subjects must be using an effective birth control method.
5. Total IgE \<150 IU/ml.

Exclusion Criteria:

1. Any clinically significant abnormalities of the upper respiratory tract
2. Any clinically significant acute or chronic respiratory illness
3. Any clinically significant bleeding tendency by history
4. Hypertension that requires treatment with antihypertensive medications
5. History of angina or other clinically significant cardiac disease
6. Any upper respiratory infection or allergic rhinitis in the two weeks prior to the start of the study
7. Any medical condition that in the opinion of the Investigator is cause for exclusion from the study
8. Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold preparation in the 1 month prior to the study
9. Regular use of tobacco in the last 6 months (ie. more than 2 days out of 7) or inability to refrain from smoking during the study
10. Inability to refrain from the use of common cold therapies in the 5 days after each rhinovirus challenge.
11. Participation in any other clinical drug trial in the month prior to the study
12. Female subjects with a positive urine pregnancy screen.