cyrilzakka/clinical-trials huggingface dataset:
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen

Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).

Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.

Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
2. Pneumonia documented by chest x-ray (CXR)
3. The patient or guardian must have signed a written IRB-approved informed consent.
4. A negative pregnancy test (if woman of childbearing potential).
5. Acceptable liver and renal function:

   1. Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
   2. AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),
   3. Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
6. Acceptable hematologic status:

   1. Absolute neutrophil count ≥1000 cells/mm3
   2. Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)
   3. Hemoglobin ≥ 9 g/dL
7. Clinically acceptable blood sugar control if diabetic
8. EKG showing no QTc prolongation

Exclusion Criteria:

1. Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
2. Pregnant or nursing women
3. Unwillingness or inability to comply with procedures required in this protocol.
4. Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
5. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
6. Patients with QTc prolongation
Effects of Dexmedetomidine and Dopamine on Renal Function After Major Surgery

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure after major surgery. Dexmedetomidine is a highly selective alpha(2)-adreno receptor agonist widely used during anesthesia. In animals, dexmedetomidine has shown protective effects in AKI after surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output during surgery. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major surgery.

Acute kidney injury (AKI) is associated with complications that may lead to multiorgan dysfunction and potentially to multi-organ failure in critically ill patients. AKI accounts for 5-10% after general surgery to 45% after cardiac surgery during hospital stays and tends to be associated with increased length of hospital stay as well as increased morbidity and mortality. Even slight increases in postoperative serum creatinine concentrations have been associated with almost 5-fold increases in mortality. Dexmedetomidine is a potent and highly selective alpha(2)-adreno receptor agonist that has analgesic, sedative, anxiolytic, and sympatholytic effects. In animals, dexmedetomidine has shown protective effects in several models of ischemia-reperfusion, which is thought to be the principal mechanism of AKI in the context of surgery. Dopamine (DA) is an organic chemical of the catecholamine and phenethylamine families that has been widely used to increased renal blood flow and urine output. However, the clinical effects of dexmedetomidine and dopamine on renal function are still controversial. The aim of this study is to investigate whether dexmedetomidine and dopamine have positive effects on renal function after selective major surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing selective major surgery

Exclusion Criteria:

* Patients undergoing urologic surgery or neurosurgery
* Patients with preoperative renal disorder
CHANges iN skEletal muscLe in Heart Failure

The mechanisms behind heart failure are largely unknown. Despite an increasing arsenal of pharmacological therapies, cardiovascular disease is still the most common cause of death in the western world, which demonstrates a pronounced need for more patient-related mechanistic research. Cachexia and limited exercise capacity are the symptoms that best match prediction of heart failure, both of which are symptoms involving a dysfunctional skeletal muscle. An increased understanding of the mechanisms and signaling pathways connects the failure heart with skeletal muscle dysfunction is likely to lead both to discoveries of prognostic factors and possible therapeutic options.

The study is a prospective, non-blinded, study. The study will consist of the assignment of patients with heart failure, New York Heart Association (NYHA) III-IV, 60-80 years old. One hundred (100) patients will be enrolled in this study.

The primary objective is to investigate how changes in the skeletal muscle coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Therefore, the investigators will investigate patients with severe heart failure at 'baseline' and on a second follow-up occasion after 12-16 months.

The secondary and tertiary objective is to investigate how changes in the metabolic signature of blood and satellite cells coincide with changes in physical performance, cardiac function, and prognosis in patients with heart failure, and changes over time. Patient recruitment is expected to occur over 36 months.

The study will be conducted in Sweden at Karolinska University Hospital, Huddinge.

Eligibility Criteria:
Inclusion criteria:

* Signed informed consent
* 60-80 years old upon inclusion
* Chronic heart failure ≥ 45 days.
* Left ventricular ejection fraction ≤ 35%.
* NYHA III-IV
* Receiving medical management with optimal doses of betablockers, acetylcholinesterase (ACE)-inhibitors or angiotensin II receptor blockers (ARB), and mineral receptor antagonists (MRA) for at least 30 days if tolerated.

Exclusion criteria:

* Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 "crash and burn"
* On-going mechanical circulatory support.
* Severe chronic obstructive pulmonary disease (COPD) or severe restrictive lung disease.
* Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance
* Condition, other than heart failure, requiring end-of-life care within \<6 months in time or where the risk of death within \<2 years is considered to be imminent.
* Participation in studies that resulted in departure from normal treatment routine or invasive investigations within \<6 months back in time.
Longitudinal Study for the Development of Innovative Wearable Tools for Foetal Wellbeing Monitoring

The purpose of this study is to support the development of a new generation of the Bloomlife sensor, enabling continuous monitoring of foetal wellbeing.

Data is collected in four Phases, with different experimental setups. Recordings with investigational and reference devices are performed on the subjects, at different gestational ages.

The collected data is used for developing algorithms for the extraction of parameters descriptive of foetal wellbeing.

Clinical information related to subjects' pregnancy and foetal health is also collected.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Gestational age of at least 20 weeks
* Singleton pregnancy
* Willingness to participate in the study

Exclusion Criteria:

* Multiple pregnancy
* Implanted pacemaker or any other implanted electrical device
* History of allergies to silicone-based adhesives
Humidity in Incubators for Tiny Infants

The objective of the study is to assess 2 different initial incubator humidification protocols for infants \<25 weeks' gestation admitted to the neonatal intensive care unit (NICU). The hypothesis is that a higher starting humidity decreases dehydration and results in no difference in survival or morbidity. Higher (90%) and lower (70%) starting humidity will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Inborn infant of \<25 weeks' gestation admitted to the NICU

Exclusion Criteria:

* Infants with known congenital skin conditions
* Outborn infants
* Infants with unknown gestational age prior to birth
Clinical Performance Evaluation of SARS-CoV-2 (COVID-19) Antigen Assay in Point of Care Settings

The purpose of this study is to evaluate the performance of Freedom For All Diagnostics, Inc.'s colloidal gold immune technology SARS-CoV-2 Antigen investigational assay when compared to a high-sensitivity Emergency Use Authorization (EUA) SARS-CoV-2 RT-PCR assay. The study will evaluate the accuracy in the intended use environment of the SARS-CoV-2 antigen assay when testing is conducted in a CLIA-waived setting (e.g., a physician's office or clinic) by non-laboratory personnel serving in a healthcare facility or setting.

The objective of this study is to demonstrate that non-laboratory personnel can accurately perform the SARS-CoV-2 Antigen assay in the intended use environment using nasopharyngeal samples by demonstrating that the assay can achieve a ≥ 80% sensitivity when it is compared to the results of a high sensitivity EUA SARSCoV-2 RT-PCR assay using nasopharyngeal samples. This study is designed as a prospective, blinded study to evaluate the sensitivity and specificity of the SARS-CoV-2 Antigen Assay when non-laboratory personnel conduct testing on Subjects presenting with symptoms of COVID-19.

A minimum of 30 positive and 30 negative samples are required in order to meet EUA submission guidelines. Enrollment will continue until both minimum requirements have been achieved.

Eligibility Criteria:
Inclusion Criteria:

* Subject suspected of having COVID-19 infection and within 7 days of symptom onset. This will include at least one of the following:

  * Fever or chills
  * Cough
  * Shortness of breath or difficulty breathing
  * Fatigue
  * Muscle or body aches
  * Headache
  * New loss of taste or smell
  * Sore throat
  * Congestion or runny nose
* In addition to the above primary symptoms, the Subject might also report nausea, vomiting and/or diarrhea, but these symptoms alone are not sufficient to include the Subject in the study.
* Subject is willing to provide consent/assent.
* Subject is willing to have two (2) nasopharyngeal swabs collected for the study and in the event of inconclusive results, be willing to return to the site to have two (2) more nasopharyngeal swabs

Exclusion Criteria:

To be enrolled in the study, each Subject must not meet:

* Subject unable or unwilling to provide informed consent/assent.
* Subject tested positive for SARS-CoV-2 within the past 3 months.
* Subject has already participated in this study.
* Subject is a vulnerable population and deemed inappropriate for study by site Principal Investigator and/or IRB.
Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma

This study is a single-armed, open-label, single-center phase II trial of signal transduction inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free survival (PFS) and the second endpoints are overall response rate (ORR), overall survival (OS), 1-year OS and safety.

Only patients who meet the inclusion and exclusion criteria will be enrolled. The estimated recruitment duration is 1 year. Imatinib will be given in the dose of 400 mg orally each day unless disease progression or intolerance. The follow-up is 12 months.

Forty-eight subjects will be recruited for this study. This sample size is justified by the number of patients required to establish an improvement in PFS with statistical significance compared to historical control.

The standardized RECIST (Response Evaluation Criteria in Solid Tumors) method of unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months in the determination of response rate and progression free survival. Repeated radiographic assessment at 4 week intervals is consistent with general oncological practice associated with computerized tomography (CT) or magnetic resonance imaging (MRI) scan testing. All efficacy endpoints will be evaluated by the investigator.

Safety will be characterized in terms of the incidence, timing, severity, and relatedness of adverse events and laboratory abnormalities. Severity will be graded according to the NCI CTCAE Version 3.0.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month
2. Evidence of mutations and/or copy number increases of KIT with laboratory examination documented from either primary or metastatic tumor site
3. ECOG performance status 0, 1, or 2
4. Estimated life expectancy of 6 months or greater
5. Age 18 years or older, male of female
6. At least one measurable site of disease
7. Adequate organ function
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Melanoma from primary sites other than acral or mucosal melanoma
2. Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease
3. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
4. Severe and/or uncontrolled concomitant medical diseases
5. pregnant or childbreeding women
6. Known hypersensitivity to imatinib
7. Current treatment on another clinical trial
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures

This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide signed written consent prior to participation in any study-related procedures
* Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery

Exclusion Criteria:

* Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
* Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
* Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
* Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
* Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
* Have participated in another investigational device or drug study within 30 days of the baseline visit
* Anterior chamber cells present at time of enrollment
* Known allergy to dexamethasone or prednisolone
Heraeus MicroDTTect Lyon Pilot Studyprosthetic Joint Infections (PJIs)

Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.

In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Prosthetic joint infections (PJIs) are one of the main causes of implant failure after joint arthroplasty. Identification of the causal organism is crucial for successful treatment. However, microbiological diagnosis of PJIs remains a challenge notably because bacteria are embedded in biofilm adhered to the material. Recently, dithiothreitol (DTT) treatment of prosthesis has been proposed as a new strategy to dislodge bacteria from biofilm, thus becoming an alternative to sonication to improve the yield of the microbiological diagnosis.

In this study, the investigators evaluate the interest of a commercial device using DTT, the MicroDTTect system (Heraeus, Hanau, Allemagne), for the diagnosis of low-grade chronic PJIs compared to the conventional culture of periprosthetic tissue (PPT) samples.

Eligibility Criteria:
Inclusion Criteria:

Adult patients with painful prosthesis or prosthesis loosening \<10 years

* without mechanical explanation,
* without clinical evidence of infection (no fistula, no abscess, no discharge, no local inflammation),
* without microbiological diagnosis (absence of preoperative joint puncture (not performed or not feasible) or with a culture-negative preoperative joint puncture).

Exclusion Criteria:

Patients with painful prosthesis or prosthesis loosening

* with mechanical explanation,
* or with clinical evidence of infection (fistula, abscess, discharge, local inflammation),
* with a previous microbiological diagnosis
Nanoparticles Analysis in Lung and Bronchi During Various Pulmonary Interstitial Diseases and Relationships With Their Aetiology

Nanoparticles (NP) are particles whose length, width and height are less than 100 nanometres. Over the past decade, industrial applications of NP have increased dramatically. Despite their widespread use, their true impact on human health remains unknown and poorly studied. NP exposure in humans primarily occurs via inhalation through the respiratory system. The aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. In the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an interstitial lung disease assessed on clinical signs and CT scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage.

These patients suffer from:

* Idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis OR
* Interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions.

Written consent

Exclusion Criteria:

* Flexible bronchoscopy or BAL not possible.
* Pregnant women
* Patients under legal protection.
* Patients with contagious disease (HIV infection, tuberculosis, viral hepatitis)
The Frequency of Polycystic Ovary Syndrome Among Young Reproductive Females Presenting With Hyperandrogenism: a Mixed Cohort Study

This mixed cohort study will test the frequency of PCOS among young females presenting with one of the clinical hyperandrogenism criteria: acne, hirsutism and/or hair loss. Diagnosis will be based on the recent PCOS clinical, biochemical and biophysical criteria recently published " International evidence-based guideline for the assessment and management of polycystic ovary syndrome (PCOS) 2018".

Irregular menstrual cycles are defined as:

* normal in the first year post menarche as part of the pubertal transition
* \> 1 to \< 3 years post menarche: \< 21 or \> 45 days
* \> 3 years post menarche to perimenopause: \< 21 or \> 35 days or \< 8 cycles per year
* \> 1 year post menarche \> 90 days for any one cycle
* Primary amenorrhea by age 15 or \> 3 years post thelarche (breast development) When irregular menstrual cycles are present a diagnosis of PCOS should be considered.

Biochemical hyperandrogenism: Calculated free testosterone, free androgen index or calculated bioavailable testosterone. Androstenedione and dehydroepiandrosterone sulfate (DHEAS) could be considered if total or free testosterone are not elevated. (ELIZA or radioimmunoassay).

A comprehensive history and physical examination should be completed for symptoms and signs of clinical hyperandrogenism, including acne, alopecia and hirsutism and, in adolescents, severe acne and hirsutism using the modified Ferriman Gallwey score (mFG). Transvaginal (transabdominal if virgins) Ultrasound and polycystic ovarian morphology: Ultrasound should not be used for the diagnosis of PCOS in those with a gynaecological age of \< 8 years (\< 8 years after menarche), due to the high incidence of multi-follicular ovaries in this life stage. Transabdominal ultrasound reporting is best focused on ovarian volume with a threshold of ≥ 10ml. Endovaginal U/S should show a follicle number per ovary of ≥ 20 and/or an ovarian volume ≥ 10ml, ensuring no corpora lutea, cysts or dominant follicles are present.

Eligibility Criteria:
Inclusion Criteria:

* Clinical hyperandrogenism

Exclusion Criteria:

* Age less than 15 or more than 35 years.