cyrilzakka/clinical-trials huggingface dataset:
The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

The use of ganciclovir (DHPG) in combination with interferon beta to prevent relapse of cytomegalovirus retinitis in patients with AIDS. While early clinical trials have shown that 30 mg/kg/week of DHPG is usually sufficient to delay or prevent relapse, neutropenia is a common dose-limiting problem in about 50 percent of patients. Since in vitro data have suggested that there is synergism between DHPG and interferon beta against cytomegalovirus, a reduced dose of DHPG in combination with a low dose of interferon beta may prevent relapse without causing neutropenia. If remission can be maintained with low-dose DHPG and interferon beta, maintenance therapy with a moderate dose of interferon beta alone will be evaluated in a subsequent protocol.


Eligibility Criteria:
Inclusion Criteria

Patients must fulfill the CDC criteria for the diagnosis of AIDS. In addition, patients must have a typical clinical picture of cytomegalovirus (CMV) retinitis, a positive CMV culture from any site, and no other possible explanation for the retinal findings (e.g., toxoplasmosis infection). Patients with AIDS in whom CMV retinitis is suspected will be examined by an ophthalmologist and, if, retinal lesions are seen, shall have a complete set of retinal photographs taken. CMV cultures of throat, buffy coat, urine, and if possible, semen will be obtained.

* Cytomegalovirus and toxoplasmosis serologic (IgG and IgM) tests will also be performed.

Exclusion Criteria

Co-existing Condition:

Patients not meeting inclusion criteria are excluded.

Patients not meeting inclusion criteria are excluded.
Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant

To describe how Nulojix (belatacept) is used and to determine how often Post-Transplant Lymphoproliferative Disorder (PTLD), Central Nervous System (CNS) PTLD and Progressive Multifocal Leukoencephalopathy (PML), rare and serious complications of transplant treatment, occur in patients taking Nulojix (belatacept) in a real-world setting.

Time Perspective: Prospective for the majority of patients who are enrolled at the time they begin Nulojix (belatacept) treatment. Retrospective for any patients receiving Nulojix (belatacept) prior to enrollment into ENLiST Registry

Eligibility Criteria:
Inclusion Criteria:

* Adult kidney transplant recipient (age ≥18 years at time of transplant)
* Kidney-only transplant recipient
* Positive EBV serostatus

  a) EBV serostatus negative or unknown included per the investigator discretion
* Received first dose of Nulojix (Belatacept) within ≤ 14 days of renal transplant
* Received first dose of Nulojix (Belatacept) as part of normal clinical care (i.e. not as part of a clinical trial)

Exclusion Criteria:

* Received Nulojix (belatacept) for non kidney transplants
* \<18 years of age at time of transplant
* Received first dose of Nulojix (belatacept) as an assigned study drug under a clinical trial protocol
* EBV-serostatus negative or unknown patients, except by investigator decision
* Patient who did not receive Belatacept for de novo treatment
* Recipient of concurrent or extant non-kidney organ transplant
* Received first dose of Nulojix (belatacept) \> 14 days after date of renal transplant
Effectiveness of Truclear on Patient Quality of Life

This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Submucosal myomas are a common cause of pelvic complaints and abnormal uterine bleeding (AUB) and there are many available modalities for treatment. Hysteroscopic myomectomy is a minimally invasive approach for removal of submucosal leiomyomas. Alternatively, medical management can be attempted. This study aims to evaluate the quality of life in patients treated for submucosal leiomyomas using the Truclear hysteroscopic morcellator compared to women managed medically. Study population includes women age 18 and older with symptomatic submucosal myomas. Patients will be asked to complete the Uterine Myoma Symptom and Health-related Quality of Life Questionnaire (UFS-QOL) at enrollment and at 1, 3, and 6 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with abnormal uterine bleeding and submucosal fibroid(s) undergoing hysteroscopic myomectomy or medical therapy with oral contraceptive pills
* Patients with Type 0, 1 or 2 submucosal myomas

Exclusion Criteria:

* Pregnant women
* Patients with suspicion of uterine malignancy
* Patients without submucosal fibroid seen during planned hysteroscopic myomectomy
* Patients with active vaginal infection
* Patients with contraindication to hysteroscopic myomectomy
* Patients with cognitive impairment who are unable to provide consent and adequately complete the questionnaire.
Valproic Acid for Idiopathic Nephrotic Syndrome

The trial investigates the use of VPA (Valproic Acid) for the treatment of adult patients with biopsy proven idiopathic focal segmentel glomerulosclerosis (FSGS) or minimal change disease (MCD).

VPA used as an add-on to steroids might induce clinical remission in a first category of patients and potentially reduce the dose of maintenance immunosuppression required to maintain remission thereafter.

In a second category of patients VPA might allow the reduction or even cessation of immunosuppression while clinical remission is maintained.

Idiopathic MCD to treat diseases with a considerable associated morbidity and mortality. Current treatment options are limited, have limited efficacy and a considerable side effect profile. Recent findings in a murine model suggest that VPA treatment in an early phase of renal disease could halt or even prevent the development of proteinuria and the progression of kidney damage. VPA is a commonly used and easy available oral antiepileptic agent with a favorable side effect profile compared to the current standard of care agents for podocytopathies.

This trial investigates wether

1. VPA on top of or in substitution of standard of care agents is effective in remission induction in patients with FSGS or MCD with proteinuria resistant to first line therapy with corticosteroids.
2. VPA is effective in remission maintenance allowing reduction and cessation of chronic immunosuppression without relapse in patients with frequently relapsing FSGS or MCD.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Biopsy proven idiopathic FSGS or MCD
* Organ function:

  * Bilirubin/AST/ALT\< 2 ULN
  * PLT\>100.000 10\*6/L
  * INR 1.5 except if on anti-vitamin K treatment
  * Lipase \<1.5 ULN
  * Creatinine clearance \>30ml/min -

Exclusion Criteria:

* Contraindication for VPA
* Secondary etiologies for FSGS or MCD
* Multiple organ transplantation
* Currently participating in another clinical trial
* Pregnant or lactating women
* Women unwilling to take efficient contraceptive measures for the duration of the study
A Study to Characterize Profile of Participant With Psoriatic Arthritis Depending on Whether Their Disease is Managed by a Dermatologist or by a Rheumatologist, and Starting Ustekinumab

The primary purpose of this study is to describe the Psoriatic Arthritis (PsA) participant profiles depending on whether their disease is managed by a dermatologist or by a rheumatologist in routine practice.


Eligibility Criteria:
Inclusion Criteria:

* Participant with a confirmed diagnosis of Psoriatic Arthritis (PsA) according to the dermatological and/or rheumatologic routine practice, using different diagnosis tools, example, the Classification criteria for Psoriatic Arthritis (CASPAR), or others
* Participant must be starting ustekinumab for PsA according to the local labelling, as a first (biological naïve participant), or second line (biological experienced participants) of bDMARD therapy: First line bDMARD therapy: The first line therapy includes all bio-naïve participants who start their ustekinumab as their first biologic treatment at the study start (within a maximum 1-month window after the baseline visit); Second line bDMARD therapy: The second line therapy includes participants who initiated ustekinumab as their second biologic therapy at the study start (within a maximum 1-month window after the baseline visit)
* Participant for which the ustekinumab treatment has been decided by the investigator prior to and independently of the participant's inclusion into the study
* Participant for which the first administration of the ustekinumab treatment will occur within the 4-week period from inclusion assessment
* Participant has signed an informed consent form

Exclusion Criteria:

* Participant starting ustekinumab as a third or further line of bDMARD therapy
* Already ustekinumab-experienced participants
* Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within at least 30 days before the start of the study or more according to the half-life of the investigational drug
* Participant has refused to participate in the study or unable to give his consent
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously.

The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes.
* Over 18 years.
* Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
* Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
* Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio \<200 mm-Hg.
* Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
* Written or verbal informed consent from the patient, family member or legal representative.

Exclusion Criteria:

* Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
* RT-PCR of SARS-Cov-2 negative.
* Multi-organ failure (more than three organs)
* Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
* Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
* Active tumor disease.
* Previous immunosuppressive treatment.
* Allergy or hypersensitivity to the administered products.
* History of deep vein thrombosis or pulmonary embolism in the last 3 years.
* Participation in other clinical trials during the 3 months prior to the initial visit.
Influence of Obuvacaine Hydrochloride Eye Drops on the Comfort of Meibomian Gland Massage Patients

In this study, there were differences in patients' demands for ephedrine during meibomian gland massage and whether it would affect patients' poor comfort. Therefore, we needed to collect patients' pain grades during meibomian gland massage

Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.Meibomian gland dysfunction is a common eye disease that may be asymptomatic or painful and itchy in the early stages, requiring early daily care and medication. And meibomian gland massage is a very important step in the treatment. Meibomian gland massage is massaging along the direction of meibomian gland drainage to push out secretions that cannot be discharged by themselves, improve meibomian gland function, and delay the development of meibomian gland dysfunction.

Methods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scaleMethods: We selected dry eye patients who visited dry eye clinic of Aier Eye Hospital from June 2020 to March 2021 to conduct questionnaire survey and analysis with pain scale Group: Divided into ephedrine drop group and artificial tear drop group Research tool: Pain rating scale

Eligibility Criteria:
Inclusion Criteria:

Healthy people with no chronic disease

Exclusion Criteria:

People with chronic disease
The Valsalva Urethral Profile : a Measure to Assess Stress Urinary Incontinence

Clinical and paraclinical appraisal of stress urinary incontinence (SUI) is mainly based on the assessment of pelvic floor muscles (PFM) contraction and urethral mobility, the measurement of the maximum urethral closure pressure (MUCP) at rest by urethral pressure profilometry (UPP) and the measurement of the Valsalva leak point pressure (VLPP).

Currently, MUCP and VLPP cannot be used for diagnosing SUI because they appear to be moderately correlated with the severity of SUI.

The lack of a specific SUI biomarker could be the explanation for the poor predictive value of urodynamics and the ongoing debate on whether urodynamic testing before surgery has benefits. Our main objective was to study the value of a new urodynamic parameter in the diagnosis of female SUI: the Valsalva urethral profile (VUP)


Eligibility Criteria:
Inclusion Criteria:

* women over the age of 18 years, referred for urodynamic exploration of the lower urinary tract, with or without lower urinary tract disorders (TUBA)
* women who gave their consent to participate in the study.

Exclusion Criteria:

* pelvic organ prolapse (POP) ≥ stage 2 according to the POP-Q classification
* history of surgery for SUI and / or POP,
* acute urinary tract infection,
* proven neurological pathology,
* urine retention,
* a history of pneumothorax
* a lability of MUCP ≥ 15 cmH2O
Does Eco-driving Assistance (EDA) Have an Impact on Bus Driver's Health and Well-being?

The goal of this pragamatic trial is to assess the impact of eco-driving assistance (EDA) system on professional bus drivers' health and well-being.

The main questions it aims to answer are:

* Does the eco-driving assistance (EDA) act as a stressor for bus drivers ?
* Does the physiological and psychological perceived stress increase when bus drivers are driving bus equipped with eco-driving assistance (EDA) ?

An additional question consists in assessing the association between stress measurements and biomarkers in biological samples.

Researchers will compare the heart rate variability (HRV) and perceived stress level when participant are allocated to EDA-equipped buses and non-EDA-equipped buses

Participants will:

* Drive buses equipped with eco-driving assistance (EDA)
* Drive buses without eco-driving assistance (EDA)
* Wear a wearable electrocardiogram (ECG) device (Bittium Faros) to record the heart rate variability (HRV)
* Answer a questionnaire at the end of each working day (end-of-service questionnaire)
* When allocated to bus with eco-driving assistance (EDA), read the EDA-generated report and answer some related questions in the end-of-service questionnaire
* Upon acceptance only, a collection of biological samples and physiological measurement will be performed

This pragmatic pseudo-randomized trial will allow the investigators to assess the effect of eco-driving assistance (EDA) on bus drivers' health and well-being. Each bus driver will be randomly allocated to either buses equipped with eco-driving assistance (EDA) (i.e. intervention) and buses without eco-driving assistance (EDA) (i.e. control). The research team will use the within-subject design, allowing to allocate both the intervention and the control to each participant.

Throughout the working day, each bus driver will continuously wear an ECG device (Bittium Faros) to record the HRV. At the end of each working day, participants will receive a questionnaire (i.e. end-of-service questionnaire) to fill in. If they have been allocated to at least one EDA-equipped bus during their working day, they will need to read the EDA-generated report and come back to the questionnaire to fill in additionnal questions.

To record enough data, participants will need to reach at least 5 hours driving shifts with an EDA-equipped bus and 5 hours driving shifts without EDA. When this endpoint is reached, the study is over.

Eligibility Criteria:
Inclusion Criteria:

* adult active bus driver
* having signed the informed consent
* having worked for at least one year as TPF bus driver
* working at least 30 hours a week
* no planned extended absences in the next 6 months (civil service, military service, long- term leave, retirement)

Exclusion Criteria:

* wearing a medical active implant (pacemaker, cardiac defibrillator, neurostimulator, other electronic implant)
* known allergy or skin sensitivity to plasters
Tele-rehabilitation for Cognitive Disorders

The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes.

To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ischemic or hemorrhagic stroke;
* Age between 18 and 90 years;
* First stroke event;
* Stroke occurred more than 30 days ago;
* Adequate level of understanding;
* Presence of one or more of the following cognitive disorders:
* Memory disorders
* Attention disorders
* Executive function disorders
* Availability of an internet connection at the patient's home necessary for the telemedicine procedures.

Exclusion Criteria:

* Presence of other neurological disorders;
* Presence of pre-morbid cognitive decline;
* Psychiatric disorders in the medical history;
* Alcohol and/or drug abuse;
* Presence of severe uncorrected visual deficits.
Palliative Care for Heart Failure Patients

The purpose of this study is to assess the impact of palliative care consultation on quality of life and symptom management for patients hospitalized with acute heart failure with a randomized control trial at Abbott Northwestern Hospital.

Research questions:

Q1. Does the provision of palliative care to heart failure patients yield higher quality of life, increased symptom management, or reduced depression compared to heart failure patients not receiving palliative care?

Q2. Does the provision of palliative care to heart failure patients result in differential use of medical services (lower hospital days and readmission) compared to heart failure patients not receiving systematic palliative care?

Eligibility Criteria:
Inclusion Criteria:

* Abbott Northwestern Hospital inpatient adults with a diagnosis of acute heart failure

Exclusion Criteria:

* Are not an inpatient at Abbott Northwestern Hospital
* Are in the ICU
* On a ventilator
* Are pre-or post heart transplant
* Have a ventricular assist device (VAD)
* Determined to be actively dying
* Have cognitive impairments such that informed consent would not be possible,
* Are not proficient in the English language
Tolerance Induction in Living Donor Kidney Transplantation With Hematopoietic Stem Cell Transplantation

Kidney transplantation (KT) requires a life-long immune suppression (IS). It has been well-known that long-term IS inevitably causes various complication e.g. infection, toxicity, diabetes, osteoporosis, avascular necrosis of hip joint, cataract, acne, and malignancies and so on. Tolerance induction showing graft function without maintenance IS has been considered as a final solution in the transplantation recipients. Tolerance induction can be achieved in KT recipients with donor hematopoietic stem cell transplantation (HSCT).

In this study, adult patients (18 and more years of age) with a human leukocyte antigen (HLA)-haplotype match donor are enrolled. Patients receive preconditioning treatment for HSCT 1week prior to KT. Bone marrow is harvested from donor under general anesthesia at the time of nephrectomy for transplantation in donor. Donor BM is infused immediate post-transplantation at intensive care unit (ICU). Immunologic measurements including microchimerism study and protocol biopsy will be followed at several time points. IS will be tapered slowly and withdrawn over a period of several months.


Eligibility Criteria:
Inclusion Criteria:

1. All consenting adult (18 and more years of age) living donor kidney transplant recipients who have a one haplotype match donor.
2. Patients who have no known contraindication to administration of rabbit anti-thymocyte globulin (ATG) or radiation.
3. Patients who agree to participate in the study and sign an Informed Consent.

Exclusion Criteria:

1. Presence of previous episode of transplantation including kidney
2. Simultaneous multi-visceral transplantation
3. Demonstration of donor specific antibody (DSA) or panel reactive antibody(PRA) greater than 20%
4. ABO blood type incompatible
5. Previous treatment with rabbit anti-thymocyte globulin or a known allergy to rabbit proteins.
6. History of malignancy with the exception of non-melanoma skin malignancies.
7. Uncontrolled systemic or concomitant unstable infection
8. Serological evidence of Hepatitis B or Hepatitis C or HIV infection.
9. Severe psychiatric disease
10. Leukopenia (with a white blood cell count \< 3000/mm3)
11. Disagreement to participate in the study and sign an Informed Consent.