cyrilzakka/clinical-trials huggingface dataset:
HLX35(EGFR×4-1BB Bispecific) in Patients With Advanced or Metastatic Solid Tumors

This Phase1, multicenter, first-in-human, open-label, dose-escalation, and dose expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX35 administered as a single-agent by IV infusion every 2 weeks to patients with locally advanced or metastatic solid malignancies, who have failed or are intolerant to standard therapy, or for whom no standard therapy is available. This study has two parts: phase 1a dose escalation and phase 1b dose expansion.


Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
* Age ≥ 18 years;
* Phase 1a dose escalation: patients must have histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
* Phase 1b dose expansion: patients must have a histological or cytological diagnosis of Squamous Non-Small Cell Lung Cancer (EGFR H score ≥200 confirmed by central lab) which is advanced or metastatic, have failed prior standard treatment, and be intolerant or ineligible for standard therapy;
* Measurable disease according to RECIST Version 1.1;
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1;
* Expected survival 12 weeks;
* Adequate organ function;

Exclusion Criteria:

* Systemic anti-cancer treatment or investigational agents in the 28 days prior to the first study dosing;
* Patients who still have persistent ≥ grade 2 toxicities from prior therapies;
* Active CNS metastasis;
* History of any secondary malignancy in the past 5 years;
* Active autoimmune disease;
* Human immunodeficiency virus (HIV) infection;
Provincial Roll-Out Bone Health Strategy

The main purpose of this study is to investigate the effect of two different group-based exercise programs on fall risk (muscular strength and balance) and bone strength in older women aged over 65-75 years who have low bone mass. We are also trying to determine if once a week exercise is as effective on health outcomes as twice a week. We hypothesize that twice a week exercise will be more effective than once a week or sham exercise.


Eligibility Criteria:
Inclusion Criteria:

* inactive (less than twice weekly exercising) women aged 65-75 years old
Understanding How Medication is Stored in the Home

The goal of this study is to increase safe medication storage practices in homes with young children in order to prevent unintentional childhood poisonings.

As a step toward meeting this goal, this study aims to determine if an intervention to promote safe storage to patients who have young children in their home, including provision of a lock box or lock bag along with brief counseling versus brief counseling alone, results in 1) increased locked storage (and overall safe medication storage practices) of high-risk prescription medications in the home; 2) increased safe medication storage practices of other medications in the home; and 3) improved safe medication storage related knowledge and attitudes.


Eligibility Criteria:
Inclusion Criteria:

* Patient in the buprenorphine clinic, high A1c clinic, or palliative care clinic at NYC Health + Hospitals/Bellevue
* Patient prescribed at least one high-risk mediation. A high-risk medication defined as a prescription medication that may cause significant toxicity or death with the ingestion of only one pill or a single adult dose.
* A child less than six years old is present in the patient's home on average at least 8 hours per week.

Exclusion Criteria:

* Inability to speak and read English or Spanish
* No phone number for follow-up or unwilling to do follow-up by phone or in person
* Prior enrollment
* Patient was involved in pilot study
Study of the Short-term Mortality and Morbidity of Newborns Born at a Gestational Age <32 Weeks of Amenorrhea

An "outborn" birth is a premature birth that occurs in an unsuitable level center at the end of the child (unlike "inborn" births).

This study aims to describe the morbidity and mortality of very premature newborns (gestational age less than 32 weeks of amenorrhea) born outside a maternity hospital of appropriate level between January 1, 2016 and December 31, 2020, and assessment of the preventable or non-preventable nature of these so-called "outborn" births.

The aim of this research is to write down the short-term mortality and morbidity of newborns born at a gestational age \<32 weeks of amenorrhea outside a level III maternity hospital in Alsace between January 1, 2016 and December 31, 2020.


Eligibility Criteria:
Inclusion criteria:

- Newborn under 32 weeks of amenorrhea at the time of birth, born in Alsace in one of the level I, IIa, or IIb maternity hospitals, between January 1, 2016 and December 31, 2020

Exclusion criteria:

- Fetal death in utero
Obesity and Mortality of Critically Ill Patients With COVID-19

Disproportionate impact of COVID-19 in patients with obesity is now well established.

Obesity is associated with severe forms of COVID-19 and may be a risk factor of intensive care unit (ICU) admission. Obesity is associated with COVID-19 related hospital death in a large United Kingdom cohort study. However, there is a gap of knowledge on assessment of outcomes such as severity of Acute Respiratory Distress syndrome (ARDS), duration of hospitalisation and mortality in ICU. Moreover, an obesity survival paradox has been observed in patients with ARDS. This raises the question whether the obesity paradox has been broken by COVID-19.

The investigators aim to explore risk factors of in-ICU death for patient with COVID-19, including obesity and other chronic diseases and to describe the clinical course and outcomes, including the management of acute respiratory failure and other intensive care management.

The investigators aim to report ICU mortality for patients according to BMI category and to describe the detailed ICU clinical course of illness :

* Risk factors for ICU mortality : age, sex, baseline comorbidities
* Causes of death
* Risk factors for use of non invasive mechanical ventilation
* Non-fatal outcomes
* Ventilator-free days
* ICU length of stay.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COVID-19 pneumonia admitted to ICUs between February 27th and April 18th 2020.
* Infection confirmed by reverse transcriptase polymerase chain reaction assay or radiologically by chest computed tomography scan

Exclusion Criteria:

* No weight or height measurement available in the medical files
A Phase II Trial of Weekly Alternating Sequential Administration of BIBF 1120 and BIBW 2992 in Patients With Advanced Colorectal Cancer

The primary objective of this trial is to explore the overall objective best response rate and the rate of non-progression at 16 weeks of sequential, alternating weekly administration of BIBF 1120 and BIBW 2992 in patients with metastatic CRC based on the RECIST criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years.
2. Signed informed consent.
3. Histologically proven colorectal adenocarcinoma
4. History or presence of metastatic colorectal cancer (stage IV)
5. Measurable (\>1 cm) or evaluable tumour deposit (according to RECIST criteria)
6. Documented progression or unacceptable toxicity on the last therapy
7. Progression on oxaliplatin-based chemotherapy or unacceptable residual neurotoxicity on oxaliplatin
8. Progression on irinotecan-based chemotherapy or unacceptable toxicity on irinotecan
9. If patients have been previously exposed to Cetuximab or other EGFR inhibitor, they must have shown progression or unacceptable toxicity
10. If patients have been previously exposed to Bevacizumab or other VEGF inhibitor, they must have shown progression or unacceptable toxicity
11. Life expectancy of at least 12 weeks.
12. WHO (ECOG) performance status \<= 2, \<= 1 if age \> 75 years.
13. Adequate hepatic function
14. Adequate renal function

Exclusion Criteria:

1. Prior treatment with small molecule EGFR, HER2 or VEGFR tyrosine kinase inhibitors
2. Treatment with standard chemotherapy or cetuximab within the last 14 days
3. Treatment with bevacizumab within the last 28 days
4. History of other malignancies in the last 5 years, which could affect compliance with the protocol or interpretation of results. Patients with adequately treated basal or squamous cell skin cancer are generally eligible.
5. Serious illness or concomitant non-oncological disease such as neurologic, psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or laboratory abnormality
6. Significant cardiovascular diseases
7. History of haemorrhagic or thrombotic event in the past 12 months. Known inherited predisposition to bleeds or to thrombosis.
8. Patient with history or clinical or radiological evidence of CNS disease or brain metastases.
9. Pregnancy or breast-feeding
Respiratory Management of Children Under Anaesthesia

Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.


Eligibility Criteria:
Inclusion Criteria:

* Children less than 18 years of age
* Admitted in one of the participating centers
* over 2 days (21 and 22 June 2017)

Exclusion Criteria:

* Children extracorporeal circulation
* Children who required ventilation with lung exclusion
* Opposition of the parents or legal guardians
Microbiota and Carcinogenesis of Small-intestine Neuroendocrine Tumors

The aim of the study is to investigate the impact of the microenvironment on tumorigenesis of small intestinal neuroendocrine tumors often located in the terminal ileum, without identified driver mutations.


Eligibility Criteria:
Inclusion Criteria:

* Patient with one or more small-intestine neuroendocrine tumor with indication of surgery
* Patient with consent for the collection, storage and reuse of data associated with his/her disease
* Age ≥ 18 years at the time of inclusion
* Non-objection statement obtained for participation in the study

Exclusion Criteria:

* Patients with poorly differentiated neuroendocrine carcinoma or NET (neuroendocrine tumors) of non-intestinal origin or mixed tumors (MiNEN)
* Pregnant, parturient or breast-feeding women
* Minors
* Persons deprived of liberty by judicial or administrative decision
* Adults under legal protection (guardianship, curatorship)
Pirfenidone Combined With Methylprednisolone Versus Methylprednisolone in the Treatment of CIP

Checkpoint inhibitor-related pneumonitis (CIP）is a common fatal immune-related adverse event of PD-1/PD-L1 inhibitors. Some CIP patients have poor effect on hormone therapy, and the remission time of CIP varies greatly. Antifibrotic drugs may be effective in patients with CIP.

Pirfenidone can inhibit the occurrence and development of pulmonary fibrosis, reduce pulmonary exudation by inhibiting VEGF and promote pulmonary recovery. In our study, subjects with checkpoint inhibitor-related pneumonitis receive pirfenidone plus methylprednisolone or methylprednisolone.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female who is 18 to 75 years old.
2. Malignant tumors proved by pathology.
3. The subject has received at least one course of immune checkpoint inhibitor treatment.
4. The subject developed grade 3-4 CIP.
5. Take proper contraceptive measures.
6. Appropriate organ system function.
7. Subjects voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. Previous treatment with pirfenidone.
2. Clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis greater than 50ml per day); Or significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or macrovasculitis.
3. Arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism.
4. Abdominal surgery was performed 4 weeks before enrollment, or there was a history of hollow organ perforation.
5. Use nintedanib, cyclophosphamide or cyclosporin within 56 days before enrollment.
6. Suffering from active pulmonary tuberculosis.
7. Patients with mental illness and poor compliance.
8. Sperm / egg donors within 6 months.
9. Lactating women.
10. Persons allergic to pirfenidone.
11. In the investigator's judgment, there are other factors that may have led to the termination of the study.
Propofol Versus Sevoflurane for Induction of GA in Infants

This comparative study aims to investigate the haemodynamic safety profile for induction of general anesthesia in infants 3 months or less guided by electrical cardiometry parameters versus sevoflurane.

This study aims to investigate the hemodynamic effects of both propofol and sevoflurane for induction of anesthesia in infants less than 3 months of age by electrical cardiometry. The investigators hypothesized that propofol will have a safe hemodynamic profile for induction of anesthesia in infants less than 3 months of age as measured by electrical cardiometry in addition to its favorable pharmacokinetic profile of rapid induction and optimal intubation conditions.It is conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University based on an institutional protocol used as a standard of care to induce anesthesia

Eligibility Criteria:
Inclusion Criteria:

* infants aged 3 months or less scheduled for elective surgery

Exclusion Criteria:

* significant structural congenital heart disease
* intracranial malformation.
* preexisting hemodynamic instability.
* history of seizures, opioids, and/or hypnotic administration.
* prematurity (defined as gestational age \<37 weeks)
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT
* Active CNV

Exclusion Criteria:

* CNV due to causes other than AMD
* Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
* Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
* Major illness or surgery within 1 month prior to Screening
* Glycosylated hemoglobin (HbA1c) above 7.5%
* Uncontrolled blood pressure
Evaluation of Carbohydrates

The study is open-label with a randomized, cross-over design using standard Gl methodology.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are males or non-pregnant females in good health.
* Subjects must be eligible to receive income in Canada and must demonstrate OHIP or equivalent medical coverage.

Exclusion Criteria:

* Subject with any type of food allergy or with a known history of AIDS, hepatitis, diabetes or a heart condition.
* Subject taking medication, or with any condition which might, in the opinion of the PI either make participation dangerous to the subject or to others or affect the results.
Duloxetine Versus Pregabalin for Alcohol Dependence

A 12-week, double-blind, placebo-controlled parallel group study will be conducted with 150 outpatients with alcohol dependence, with random assignment to pregabalin 300 mg/d, duloxetine 40 mg/d, or placebo in conjunction with manual-guided behavioral counseling and follow-up visits 1 week and 3 months post-treatment.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 18 years of age
* Meets DSM-IV criteria for current alcohol dependence and drinking an average of ≥21 drinks weekly for males, ≥14 females,
* Seeking research-based outpatient treatment for alcohol problems
* Willing to attend 12 weekly study visits and 2 follow-up visits
* Have normal bilirubin, and ALT, AST, and GGT values no more than 3x the ULN, and no evidence of hepatic insufficiency

Exclusion Criteria:

* Active suicidal ideation
* Medical disorders that will increase potential risk or interfere with study participation
* Sexually active female subjects with childbearing potential who are pregnant, nursing or refuse to use a reliable method of birth control
* Males who refuse to use a reliable method of birth control
* Meets DSM-IV criteria for any other current major AXIS I disorder other than alcohol or nicotine dependence.
* Inability to understand and/or comply with the provisions of the protocol and consent form
* Treatment with an antidepressant medication during the two weeks, or fluoxetine during the month, prior to randomization
* Ongoing treatment with disulfiram (Antabuse), naltrexone (ReVia), acamprosate (Campral) or other medications that may affect study outcomes, e.g., anticonvulsants or other drugs that act on serotonin in the brain
* Ongoing treatment with drugs that may increase potential risk (Actos),
Glycemic Optimization On Discharge From the Emergency Room

Continuous glucose monitors can help people with diabetes avoid blood sugar levels that are either dangerously high or low. This study evaluates whether continuous glucose monitoring after discharge from the emergency room can help people with type 1 or type 2 diabetes avoid repeat emergency room visits, achieve improved blood sugar control, and feel less distressed about managing their diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Seen in the Emergency Department for hypo- or hyperglycemia
* Either an existing diabetes center patient or a new referral
* Type 1 or type 2 diabetes
* Able to provide informed consent
* Fluent in English or Spanish

Exclusion Criteria:

* Current CGM use
* Need for hospital admission
* Upcoming CT or MRI within 2 weeks
* Pregnancy
* Altered mental status
* Not appropriate for diabetes center follow up
* Prisoners
Stopping and Preventing Epileptic Seizures Using a Partial Rebreathing Mask

By enabling a partial rebreathing of expired gas, a moderate respiratory acidosis is induced, without causing hypoxia in the patient.

Based on the scientific literature on the subject, the study hypothesis is that the fall in body pH will be able to stop and/or prevent epileptic brain activity.


Eligibility Criteria:
Inclusion Criteria:

* Epilepsy
* 18-80 years

Exclusion Criteria:

-
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer

The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on locally advanced pancreatic cancer.

Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the pancreas.
2. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
3. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
4. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
5. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
6. All patients must have radiographically assessable disease.
7. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
9. Required entry laboratory parameters: granulocytes \>/= 1,800/µl, platelet count \>/= 100,000/µl, bilirubin \< 2.0 mg/dL, alanine aminotransferase (ALT) \< 3 x upper limit of normal, and creatinine \< 3.0 mg/dL.
10. Signed study-specific consent form prior to study entry.

Exclusion Criteria:

1. Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
2. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
3. Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
4. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.