cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC

This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed extensive stage small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.

Patients will receive ivonescimab at 20mg/kg intravenously, on days 1 of every 21-day cycle and irinotecan liposome 56.5mg/m\^2 intravenously, on days 1 of every 14-day cycle. Treatment will be discontnued in case of until the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST V1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to 75 years old (at the time of inform consent obtained).
2. Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
3. Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system).
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy of at least 3 months.
6. ES-SCLC who failed first-line platinum-based chemotherapy with checkpoint inhibitors.
7. At least one measurable tumor lesion according to RECIST v1.1.
8. Adequate organ function.
9. All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment.

Exclusion Criteria:

1. Patients with other cancer in 5 years.
2. Undergone anti-angiogenic therapy prior to the first dose of study treatment.
3. Evidence and history of severe bleeding tendency.
4. History of severe active autoimmune disease that has required systemic treatment in the past 2 years, severe drug allergy or have known allergy to any component of the study drugs.
5. Active central nervous system (CNS) metastases.
6. Active infection requiring systemic therapy.
7. Current presence of uncontrolled pleural, pericardial, and peritoneal effusions.
8. Active hepatitis B/C, or HIV infection.
9. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment.
10. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation.
11. History of alcohol abuse, psychotropic substance abuse or drug abuse.
12. Pregnant or lactating women.
13. Other conditions considered unsuitable for this study by the investigator.
Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.

Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing \< 9 mm for woman and \< 10 mm for man, 2) an excursion after sniff test \< 16 mm for woman and \< 18 mm for man and 3) an excursion during deep breathing \< 37 mm for woman and \< 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.

DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.

The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.

Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.

Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery requiring sternotomy
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Contraindication to preoperative respiratory functional explorations
* Pregnant or breastfeeding women
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder
Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)

The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 18 to 75 years old
* moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
* moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
* Subject who has completed phase 3 study for CFL.
Antidepressant and Antipsychotic to Treat Attenuated Positive and Negative Symptoms

The Recognition and Prevention (RAP) Program is conducting a research study comparing an antidepressant, sertraline, alone versus in combination with a second-generation antipsychotic, risperidone, to evaluate their ability to reduce unusual thoughts, suspiciousness and other unusual experiences, to improve reasoning ability, memory, attention and social skills in adolescents.

Eligible patients are enrolled in a 16-week trial consisting of symptom and side effects ratings (10 visits), monthly blood and urine tests, and neuropsychological testing at the first and last visits. At the initial appointment, all patients are assigned to sertraline and are randomly assigned to an adjunctive risperidone or placebo group. The treating physician is also blind to the medication assignment, which allows both the doctor and the patient to assess side effects and symptom improvement, unbiased by expectation. All patients receive an active medication.

Eligibility Criteria:
Inclusion Criteria:

* Participants are between the ages of 12 and 22.
* Participants are English-speaking.
* Participants are experiencing one or more symptoms like unusual thoughts, suspiciousness, or unusual perceptual experiences.
* Participants meet additional RAP criteria (evaluated during screening and interview).

Exclusion Criteria:

* Participants have been diagnosed with an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features.
* Participants have a history of neurological, neuroendocrine, or other medical conditions known to affect the brain.
* Participants have a medical condition that contraindicates treatment with sertraline or risperidone.
* Participants have past or current substance dependence.
* Participants are currently taking and responding well to antidepressant or antipsychotic medication
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.

The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or postmenopausal.

Exclusion Criteria:

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
* History of any convulsions or seizures
* History of infection or at risk of infection due to recent surgery or trauma
* History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug
Efficacy of Lu 31-130 in Patients With Schizophrenia

The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. However, none of the available drugs is ideal, in particular because of their complex safety profile and the limited effectiveness against certain symptom domains. Whereas positive symptoms respond to treatment the effects on negative symptoms and cognitive impairment are only very modest.

Thus present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, patients suffering from schizophrenia and experiencing clinically significant symptoms of the disease will be included. Eligible patients will be randomised to blinded treatment with either flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms) and the safety of Lu 31-130 will be explored in comparison to olanzapine.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a primary diagnosis of schizophrenia
* The subject experiences clinically significant symptoms
* The subject is willing to be hospitalized during the initial period of the study
* The subject has normal serum values of parameters associated with liver function
iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions

In patients with a walnut allergy double blind placebo controlled food challenge with walnut will be combined with the intake of proton pump inhibitor (PPI) or with placebo to assess the impact of PPI on threshold level and on clinical manifestation.

1. detailed case history, blood sampling and prick testing with different foods will performed.
2. double blind food provocation with with three meals containing either placebo or walnut in walnut allergic patients will be performed.
3. the provocation will be combined with the intake of drug (omeprazole) or placebo (mannitol) blinded in capsules.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent, history of walnut allergy,minimum age 18 years

Exclusion Criteria:

* • Known hypersensitivity or allergy to Omeprazole, other proton pump inhibitors, mannitol, ingredients of placebo meal

  * Drugs not allowed during the study due to proved interaction with Omeprazole: Digoxin, Clopidogrel, Methotrexate, Antiretroviral drugs, Diazepam, Cilostazol, Phenytoin, Warfarin (R-Warfarin) and other Vitamin K antagonists, Phenytoin, Tacrolimus, Clarithromycin, voriconazole, Rifampicin and Hypericum
  * Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge)
* corticosteroids systemically (2 weeks)
* antihistamines (3 days) except hydroxyzine (10 days)
* ketotifen (2 weeks)
* betablocker (1 day)
* angiotensin converting enzyme (ACE) inhibitors (2 days)
* omalizumab (2 months)

  * Women who are pregnant or breast feeding
  * Intention to become pregnant during the course of the study
  * Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices
  * Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  * Uncontrolled asthma, forced expiratory volume \<70% predicted value
  * Acute allergic disease
  * Chronic urticaria
  * Mastocytosis
  * Other clinically significant concomitant disease states (major organic or infectious diseases, e.g., renal failure, hepatic dysfunction, cardiovascular disease, acute febrile infection),
  * Known or suspected non-compliance, drug or alcohol abuse,
  * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  * Participation in another study with investigational drug within the 30 days preceding and during the present study
Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone

To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with \>3cm renal pelvis stone.


Eligibility Criteria:
Inclusion Criteria:

* Adults with \>3cm renal pelvis stone

Exclusion Criteria:

* History of previous surgery on the target kidney
* Active UTI
* Coagulopathy
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

The purpose of this multicenter, open label study, is to evaluate the safety and efficacy of a 12-week treatment with Posaconazole Oral Suspension in participants with IFI


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18-70 years male or female
* Identified or clinically diagnosed IFI participants or high risk population who are resistant to, or recurrent from, or intolerable to, or may suffer toxic reaction from standard antifungal treatment.
* Sign informed consent form

Exclusion Criteria:

* Female participants who are pregnant or are nursing.
* Participants with known or suspected hypersensitivity or idiosyncratic reaction to azole agents or amphotericin B
* Participants with progressive nervous system diseases( excluding those IFI caused)
* Participants who take the following drugs known with interference with azole antifungal preparations

  * terfenadine, cisapride, and ebastine within 24 hours before entry
  * astemizole at entry or within 10 days before entry
  * cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid atharanthine and anthracyclines within 24 hours before entry
* The drugs listed above are prohibited during the investigation
* Serious organ diseases except hematological disorder such as cardiac or neurologic disorders or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, congestive heart failure, atrial fibrillation with ventricular rate \<60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias), unstable electrolyte abnormalities.
* Participants having an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women.
* Expected to take during investigation or is taking systemic antifungal treatment
* Participants with severe renal insufficiency (estimated creatinine clearance less than 50 mL/minute or likely to require dialysis during the study), ALT,AST AKP or total bilirubin are \>2×ULN.
* Participants expected to survive no more than 72hrs
* Participants receiving artificial aeration and will not withdraw within 24hrs
* Participants who have used any investigational drugs or biologic agents or anticipated other clinical trials within 30 days of study entry.
* Prior enrollment in this study.
* History of alcohol and/or drug abuse.
* Participants cannot be compliant in investigator's opinion.
Apraxia in Parkinson's Disease Patients With Deep Brain Stimulation

Deep brain stimulation (DBS) of the subthalamic nucleus or globus pallidus internus can improve motor symptoms Parkinson's disease (PD). However, it is not known whether DBS can help reduce the signs and symptoms of the limb-kinetic, ideomotor or ideational apraxia associated with PD or if apraxia can exist as a stimulation induced side effect from DBS therapy. In this study, we look to conduct a pilot study to examine the feasibility of characterizing the prevalence of apraxia in PD patients with chronic, stable DBS.

This will be a pilot study designed to assess the safety and feasibility of an apraxia testing protocol in chronically implanted PD DBS patients. We hypothesize that apraxia testing in the DBS ON and OFF states will be a safe and well-tolerated testing protocol. We also hypothesize that DBS will affect the severity of limb-kinetic, ideomotor and ideational apraxia in PD patients. This will set the foundation for larger prospective trials to further characterize apraxia in relation to DBS and whether or not DBS programming can modulate this phenomenon.

In this study, we will recruit 60 PD patients with chronic, stable DBS of either the subthalamic nucleus (STN) or globus pallidus interna (GPi). Both unilateral and bilateral DBS patients are eligible for this study. For this study, "chronic, stable DBS" will be defined as patients who have had at least 6 months of optimization programming at the University of Florida. The subjects will be recruited to the Fixel clinic for a 1-day study visit in the medication ON state. The patients will undergo testing for limb-kinetic, ideomotor and ideational apraxia of both upper extremities in the DBS ON state at home therapeutic settings.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with PD as defined by the UK Brain Bank Criteria
2. Male or female, ages 18 to 80 years old
3. Chronically implanted DBS of either the STN or GPi for a minimum of 6 months

Exclusion Criteria:

1. Other neurological diagnoses (e.g. Alzheimer's disease, atypical parkinsonism, stroke)
2. History of previous neurosurgical intervention that was not DBS
3. Patients with DBS of targets other than the STN or GPi, or leads in both targets
4. Patients in whom there is poor manual dexterity for a reason other than PD (e.g. orthopedic injury, amputation)
5. Patients with a diagnosis of PD dementia
Pilot Study of Hepatitis C Virus Entry Inhibitor (ITX 5061) in Liver Transplant Recipients

This is a phase I pilot study to determine the safety and preliminary efficacy of a novel hepatitis C virus (HCV) entry inhibitor (ITX 5061) in patients with HCV infection undergoing liver transplantation.

Hepatitis C virus (HCV) infection is common and treatment options at present are limited. Recurrence of HCV infection after liver transplantation is inevitable and disease progression is rapid when compared with disease in the non-transplanted liver.

Studies of ITX 5061 in vitro have shown it to be a potent inhibitor of HCV entry into hepatocytes, through blocking the interaction of the virus with scavenger receptor BI suggesting it may reduce graft re-infection rates after liver transplant.

There are no studies of treatments to block host receptors for HCV and the investigators hypothesize that ITX 5061 will modulate HCV kinetics in the early phase post liver transplant.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old, ≤ 65 years old
* Plasma HCV RNA positive at time of listing for liver transplantation
* Accepted for liver transplantation for any of:
* End-stage liver disease due to HCV infection
* End-stage liver disease due to HCV infection and alcohol related liver disease (ALD)
* HCC due to HCV

Exclusion Criteria:

* Refusal or inability to give informed consent
* Viral co-infection with either hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Pregnancy or breastfeeding
* Women, of child-bearing potential, who are not willing to practice effective contraception
* Men, sexually active with women of child-bearing potential, who are not willing to practice effective contraception
* Any situation that in the Investigator's opinion may interfere with optimal study participation
* Participation in any clinical study of an investigational agent within 30 days of recruitment
* Transplantation with a donor organ from a HCV positive individual
Hair-sparing Whole Brain Radiotherapy

Up to 10% of patients with cancer will develop symptomatic brain metastases. Given this limited survival it is important to consider quality of life (QOL) when treating these patients. Whole brain radiotherapy (WBRT) can increase survival to 6 month. However, WBRT itself has been shown to reduce QOL by increasing drowsiness, leg weakness and hair loss in patients with brain metastases. Both fatigue and hair loss were reported to have the largest decline in QOL scores when WBRT is used in the prophylactic setting in small cell lung cancer. Recent technological improvements in patient positioning and treatment planning will allow us to treat the whole brain with reduced margins, allowing better sparing of the scalp. In view of the large impact of hair loss on quality of life, the investigators hypothesize to see an improved quality of life with scalp sparing techniques.

Study hypothesis: Volumetric arc therapy results in a reduced hair loss and a subsequent clinically important improvement in QOL.


Eligibility Criteria:
Inclusion Criteria:

* Brain metastases
* Age ≥ 18 years.
* Signed informed consent
* Recursive Partitioning Analysis (RPA) class III patients
* Recursive Partitioning Analysis (RPA) class I-II patients and \>3 brain metastases
* Patients with small cell lung cancer extended disease eligible for prophylactic Whole-Brain Radiotherapy (WBRT).

Exclusion Criteria:

* Previous whole brain radiotherapy
Licensing Flu Shot Study

The mailer will encourage all employees of one of Evive's partner companies to attend an on-site free flu shot clinic they are offering in the fall of 2011. The research will examine differences in follow-through on getting a flu shot at an on-site clinic among the targeted population during the \~1 month period when clinics are being offered (following the mailing) as a function of experimental condition.


Eligibility Criteria:
Inclusion Criteria:

* Employee at partner corporation

Exclusion Criteria:

* Employee already received a flu shot this season