cyrilzakka/clinical-trials huggingface dataset:
First in Human Study of TORL-2-307-ADC in Participants With Advanced Cancer

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-2-307-ADC
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with placebo when applied topically in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* best corrected visual acuity in both eyes of at least +0.7
* six-month documented history of dry eye disease
* at least mild severity in 2 of the 4 dry eye symptoms
* unanesthetized Schirmer score of less than or equal to 7mm
* corneal fluorescein staining of greater than or equal to 4 (out of 15)

Exclusion Criteria:

* nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
* ongoing contact lens wear
* current topical ophthalmic medication use
Minimally Invasive Surgical Technique in Management of Intrabony Defects

In the fast-growing era of contemporary periodontology, the understanding of biological concepts in wound healing together with the evolution of the flap design and biomaterials applied in periodontal regeneration allowed for improved minimally invasive surgical techniques. As minimally invasive approaches reduce the surgical trauma, maintain soft tissue support which allow stable primary closure of the wound. These advantages have led more researchers to apply the concept of minimally invasive surgical techniques (MISTs) in the treatment of infrabony lesions.

Granulation tissue is an immature connective tissue that appears naturally during chronic inflammation or wound healing. This tissue is not a cause of periodontitis.

So, no need to remove it during periodontal treatment. The aim of preservation of the defect-filling granulation tissue after detachment of its base is assumed to act as a soft tissue support, and to increase wound stability especially in the area of the interdental papilla and avoid post-operative marginal recession. One of the alloplastic bone grafts is βeta tri-calcium phosphate (β-TCP). β-TCP has been widely used in periodontal regeneration, where many studies used beta tri-calcium phosphate alone or in combination with other grafting materials in different surgical regenerative procedures have shown promising results for bone filling and new vital bone formation. Hyaluronic acid gel shows anti-inflammatory, antibacterial, and antioxidant properties in the treatment of periodontal diseases. In addition, due to its viscoelastic properties, it can be used as an adjunct to maintain space during periodontal tissue regeneration.

A concentration of 0.8% hyaluronic acid gel has been used effectively in the non-surgical and surgical management of periodontal diseases.

Aim of The Study The aim of the present study is to evaluate the effects of the minimally invasive surgical technique with and without granulation tissue preservation using a combination of beta tri calcium phosphate and hyaluronic acid gel.


Eligibility Criteria:
Inclusion Criteria:

1. Patient age ranged from 30 to 50 years old for both genders.
2. Patients are medically free according to the American society of anesthesiologists (ASA) considered as ASA I.
3. The selected participants with a diagnosis stage III grade B periodontitis.
4. Defect morphology: Isolated interproximal infrabony defect of at least 5mm CAL which does not extend beyond the adjacent interproximal region.
5. Optimal compliance as assessed during the case related phase I therapy and evidenced by no missed treatment appointments and positive attitude toward oral hygiene.
6. Bleeding on probing \<25%.

Exclusion Criteria:

1. Smoker and pregnant patients.
2. Multiple, interconnected vertical defects.
3. Generalized horizontal bone defects.
4. Teeth with incorrect endodontic treatment or restoration.
5. Stage I, II or IV periodontitis.
6. Patient who need complex prosthetic rehabilitation.
A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-squamous NSCLC
* Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4-6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
* No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
* Randomization within 4 weeks of progression of disease
* At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Participants with adequate hematological, liver, and renal function
* Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)

Exclusion Criteria:

* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
* History of hemoptysis greater than or equal to (\>/=) grade 2 within 3 months of randomization
* History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
* Major cardiac disease
* Treatment with any other investigational agent within 28 days prior to randomization
* Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
* Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
Optimizing Communication During Ventilation

Mechanical ventilation is one of the only treatment that has improved survival of patients with neuromuscular respiratory failure. As disease progresses, some patients may require longer ventilation period. Non invasive mechanical ventilation is the preferred method of ventilation but it may interfere with speech and communication of patients who require ventilation throughout the day. The investigators are evaluating the effect on speech and communication of a ventilation device which allows patients to momentarily and voluntarily withhold ventilation if they want to speak. This should allow the patients to have a more fluid speech.


Eligibility Criteria:
Inclusion Criteria:

* Patient with restrictive respiratory failure secondary to a neuromuscular disorder, without any bulbar involvement.
* Age greater than or equal to 18.
* Hospitalization in Home Ventilation Unit of the intensive care department of R. Poincaré Hospital.
* Non invasive mechanical ventilation for a duration equal or above 14h per day.
* Patient in a steady state at the time of the study
* written informed consent

Exclusion Criteria:

* patient's refusal to participate to the study
* Inability to read the selected text
* Inability to use the ventilator switch
* Inability to cooperate
* Hemodynamic instability
* Acute respiratory failure
* No affiliation to social security
Study to Evaluate Immune Responses in Neurologically Normal Cancer Patients

The purpose of this study is to study whether immune cells capable of killing tumors that express proteins associated with paraneoplastic neurologic syndrome (PNS) can be found in small cell lung cancer and ovarian cancer patients. The presence of these cells may play a role in tumor immunity in these patients. The protocol involves neurological examinations and collection of blood.

See brief description

Eligibility Criteria:
Inclusion Criteria:

1. Males and females ages 25 -75
2. If leukapheresis:

   Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* Venereal disease reaction level (VDRL) negative if tested\* No known IV drug users Hemoglobin \> 8.5 White blood cell count \> 3,800 Platelets \> 120,000 International normalized ratio (INR) \< 2 (verified only if clinically indicated)
3. If large blood draw (1/2 to 1 unit) in lieu of leukapheresis:

Hepatitis B surface antigen negative if tested\* Hepatitis C antibody negative if tested\* HIV antibody negative if tested\* VDRL negative if tested\* No known IV drug users HgB \> 10.0 WBC \> 3,800 Platelets \> 120,000 INR \< 2 (verified only if clinically indicated)

Exclusion Criteria:

No known neurologic disease 2. No known central nervous system (CNS) metastasis on clinical exam 3. No chemotherapy within 1 month 4. No New York Heart Association class III/IV status 5. No pulmonary disease which limits daily activities 6. No anticoagulation therapy
Inpatient Blood Glucose Control in Taichung Veterans General Hospital

This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.

This study will be conducted in the ward of Taichung Veterans General Hospital. The type 2 diabetic patient with hyperglycemia in hospitalization are candidates. The glucose will be controlled using the insulin protocal based on the glucose monitor systems. We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic inpatient
* Fasting glucose \>140 mg/dl or random glucose \>180 mg/dl

Exclusion Criteria:

* incooperative for glucose monitor
* refusal of insulin
* pregnancy
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal

This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.

Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.

Retrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of nAMD
2. Male and Female patients with ≥40 years of age at index
3. Receipt of at least one injection of brolucizumab during the recruitment period
4. Signed written informed consent

Exclusion Criteria:

1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date
2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date
3. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \>50% of the total lesion in the study eye at Screening
4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC
7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation
8. Patients participating in parallel in an interventional clinical trial
9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug
10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline
11. Subretinal blood affecting the foveal center point and/or \>50% of the lesion of the study eye at Screening
Methods of Confirmation of Brain Death

The purpose of this study is to describe the use of methods confirming brain death in the real clinical practice of the transplant program in the Czech Republic.

Organ donation is possible in the Czech Republic only after meeting the legislative requirements. These require confirmation of brain death by one of the statutory methods before organ harvesting. The use of these methods in clinical practice has not yet been described.The aim of this retrospective observational study is to describe the use of these methods in the real clinical practice of the transplant program in the Czech Republic, taking into account the legislation of other European countries.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* organ donor

Exclusion Criteria:

* age under 18 years
Is There a Correlation Between Endometrial CD56 Levels and the Unfavorable KIR AA Genotype in IVF Implantation Success?

This prospective observational study was conducted over 12 months and involved 80 IVF patients aged 20-40 years. Patients were divided into two groups based on KIR genotype (KIR AA and non-KIR AA). Endometrial biopsies were collected during the mid-luteal phase for immunohistochemical analysis of CD56+ NK cell levels. Statistical analyses, including logistic regression and ROC curve evaluation, assessed the relationship between CD56 levels, KIR genotype, and implantation success.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 20-40 years.
* Normal uterine cavity confirmed by hysteroscopy or sonohysterography.
* At least three previous failed IVF cycles or a history of recurrent pregnancy loss (RPL).

Exclusion Criteria:

* uterine abnormalities,
* systemic autoimmune diseases,
* severe male infertility factors.
Prevention of Acute Radiation Enteritis With Glutamine

Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yr
* Gynaecological,prostatic, rectal or other abdominal cancer
* Radiotherapy with/without chemotherapy

Exclusion Criteria:

* life expectancy \< 1 yr
* Age \< 18 yr
* gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
* moderate to severe chronic renal failure
* hepatic cirrhosis
Lipid Emulsion in Cardiac Valve Replacement Surgery

Myocardial protection has become an essential adjunctive measure in cardiac surgery to bail the myocardium out of ischemia/reperfusion-induced damage during the operation.

Experimental studies have shown that lipid emulsion infusion just before reperfusion (i.e., intralipid postconditioning (ILPC)) could reduce myocardial infarct sizes, improve cardiac function, and reduce myocardial I/R injuries, despite the interesting experimental findings, the potential clinical usage of lipid emulsion in preventing myocardial I/R injury needs to be further investigated.

The study of myocardial protection has improved aiming to prevent intraoperative myocardial injury, which can lead to ventricular dysfunction, arrhythmias, low cardiac output and other complications, often irreversible ones.

Nowadays there are numerous methods of myocardial protection during cardiac surgery, But still there is no best myocardial protection technique.

Despite improved myocardial protection strategies, cardioplegic arrest and ischemia still result in ischemic reperfusion injury during cardiac surgery.

Many drugs have proved a pharmacological postconditioning effect on the heart at the onset of reflow and had been shown to limit infarction size and decrease the ischemic/reperfusion injury ,Postconditioning (POC) has been reported to promote left ventricular functional recovery after global ischemia with cardioplegic arrest on cardiopulmonary bypass in a large animal model Smoflipid is a sterile safe lipid emulsion comprised of soybean oil (30%), medium chain triglycerides (30%) olive oil (25%) \& fish oil (15%) that has been associated with decreased oxidative injury, improved liver function and increased antioxidant activity.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing rheumatic valve replacement surgery
* elective surgery
* age between 18 and 80 years old
* left ventricular ejection fraction \> 0.4

Exclusion Criteria:

* Emergency and Re do surgery,
* Positive base line CTnI or CK-MB,
* Preoperative treatment with intralipid in the last 1 month.
* History of allergy to (peanut, eggs, and soya bean)
* Implanted pacemaker,
* previous myocardial infarction,
* Diabetic or other metabolic disorders,
* Significant Renal impairment (Cr \> 1.5) or on hemodialysis
* Significant hepatic dysfunction (INR\>2)
* Drugs interfere as (cyclosporine)
* Infection (WBC \>12)
A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease in predialysis (stage 3 and 4) and dialysis
* Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent

Exclusion Criteria:

* Participation in an interventional clinical trial within the retrospective observation period
* Contraindications to Mircera administration as per label or judged by the investigator
Mainstream Sleep Tracking Devices vs Polysomnography

The purpose of this study is to compare two popular portable sleep monitoring devices-the Fitbit Charge®, Jawbone UP®, and SleepTime smartphone app-to the "gold standard" Polysomnography (PSG). Parameters that will be analyzed include sleep onset latency, sleep efficiency, and sleep staging. Specifically, this study will investigate the validity of the Jawbone UP®, Fitbit Charge®, and SleepTime app in detecting sleep and wakefulness in comparison to conventional Polysomnography (PSG).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing Polysomnography

Exclusion Criteria:

* severe sleep apnea
* severe insomnia with less than two hours of sleep per night
* epileptiform activity
* electrical status epilepticus of sleep
Anterior Lingual Frenectomy is Inadequate in Improving Breastfeeding Outcomes: a Prospective Cohort Study

A previously published study (https://www.ncbi.nlm.nih.gov/pubmed/27641715) identified breastfeeding improvements following lingual frenotomy and/or maxillary labial frenectomy. In the previous cohort, babies were excluded from the study if they had previously undergone an attempted frenotomy prior to seeing the P.I. in the office. The proposed study will only look at those babies who did undergo a previous frenotomy to determine:

1. the presence of continued problematic breastfeeding symptoms
2. if further tongue tie or lip tie release improves those outcomes


Eligibility Criteria:
Inclusion Criteria:

* Healthy babies who are breastfeeding
* Had a previous frenotomy prior to presenting to the P.I.

Exclusion Criteria:

* Twins, triplets
* Maternal breast surgery or IGT
* Premature birth
* Significant heart/lung/brain disease of infant
Rapid Detection of COVID-19 by Portable and Connected Biosensor

The objective of study is to estimate the sensitivity and specificity of the COR-DIAL based on nasopharyngeal samples taken at the patient's admission in relation to the final diagnosis of COVID-19 made by the medical team.


Eligibility Criteria:
Inclusion Criteria:

* Male or female or child without age limit
* Admitted to a Reference Health Establishment in an emergency unit, hospitalisation or intensive care unit for suspicion of SARS-CoV-2 infection, regardless of the clinical presentation and degree of severity.
* Patient to be diagnosed using a PCR test on nasopharyngeal swab.
* Social insured

Exclusion Criteria:

* Atypical or suspicious cases without a final diagnosis of COVID-19 positive or negative
* Patient refusal to participate