cyrilzakka/clinical-trials huggingface dataset:
Neoadjuvant Nivolumab with CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC)

The purpose of this research study is to study the effect of giving nivolumab with CCR2/5-inhibitor or anti-IL-8 before surgery, and after surgery, with the goal of determining if this medicine results in:

1. A significant immune response against their tumor (which the study team will see in the tumor that is taken out at the time of surgery)
2. Improvement in long term survival rates

Objectives:

Cohorts A,B (NSCLC):

Primary Objective: Major Pathologic Response (MPR) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response

Cohorts C,D,E (HCC):

Primary Objective: Significant tumor necrosis (STN) Secondary Objectives: Time to surgery, tolerability and safety, radiographic response

Diagnosis and Main Inclusion Criteria:

Patients must have disease deemed resectable before enrollment.

Study Product:

Nivolumab 480mg (q4w, dosed twice before surgery and three times following recovery from surgery) BMS-813160 (CCR2/5-inhibitor) 300mg oral twice a day for 28 days BMS-986253 (anti-IL-8) 2400mg once

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NSCLC or HCC
* Willing to provide blood samples
* Willing to undergo leukapheresis at Mount Sinai Hospital or New York Blood Bank
* Willing to have excisional or core needle biopsies
* At least 18 years of age
* ECOG 0-1
* Surgical candidate for resection of their tumor
* Agree to use adequate contraception
* Adequate organ and marrow function

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 4 months for a different primary tumor or patients who have received locoregional therapy for the target lesion
* Patients receiving any other investigational agents
* Patients with metastatic disease for whom the intent of surgery would not be curative
* Uncontrolled intercurrent illness
* Pregnant or nursing
* Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days
* Has active autoimmune disease that has required systemic treatment in the past year
* Has a known additional malignancy that is progressing and/or requires active treatment
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not the in the best interest of the patient to participate
* HIV positive with detectable viral load or anyone not on stable anti-viral regimen
* Has known active Hepatitis B
* History of allogeneic hematopoietic cell transplantation or solid organ transplantation
* Documented allergic or hypersensitivity response to any protein therapeutics
* Patients may not have prolonged QRS or QTc
Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

RATIONALE: Perifosine may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have locally advanced, unresectable, or metastatic pancreatic cancer.

OBJECTIVES:

* Determine the activity of perifosine, in terms of objective response, in patients with locally advanced, unresectable, or metastatic pancreatic cancer.
* Determine the response duration, progression-free survival, and overall survival of patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral perifosine every 6 hours for a total of 6 doses and then once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 3 years.

PROJECTED ACCRUAL: A total of 35-84 patients will be accrued for this study within 21 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas
* Locally advanced, unresectable, or metastatic disease
* Measurable disease
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* WBC at least 3,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

* AST no greater than 2 times upper limit of normal (ULN)
* Bilirubin no greater than 2 times ULN

Renal

* Creatinine no greater than 1.4 mg/dL

Cardiovascular

* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for pancreatic cancer
* More than 6 months since prior chemotherapy for other diseases

Endocrine therapy

* Not specified

Radiotherapy

* At least 4 weeks since prior radiotherapy and recovered

Surgery

* At least 4 weeks since prior surgery and recovered

Other

* No other concurrent investigational agents for pancreatic cancer
* No concurrent combination antiretroviral therapy for HIV-positive patients
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III;
* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestation;
* Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History or photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Tongue Brush (Orabrush) for Reducing Aspiration Pneumonia in Stroke Patients

The investigators conduct a controlled prospective experimental intervention study to examine whether the use of a tongue brush (Orabrush) can improve the rate of aspiration pneumonia and dysphagia in patients with ischemic stroke. Secondary outcomes include the impact on bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients.The patients will be recruited in the Stroke Unit of the Department of Neurology from November 2024 until approximately October 2026.

As part of a prospective controlled experimental intervention study, patients with ischemic stroke will be recruited in the Stroke Unit of the University Hospital Marburg, who are admitted between November 2024 and approximately October 2026. The primary objective of this study is to investigate the impact of a tongue brush (Orabrush) on the rate of aspiration pneumonia and dysphagia. Secondary outcomes include the analysis of bacterial tongue colonization, the Tongue Coating Index, and the length of stay of the patients. Key study parameters include the aspiration rate, the EAT-10, the GUSS, a tongue swab, and a photograph of the tongue to determine the Tongue Coating Index. Data will be collected on the day of admission and after a duration of 3-5 days. The study has been approved by the relevant ethics committee.

Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke and admission on the stroke unit at the University Hospital Marburg
* minimum age: 18 years
* patient is able to consent
* consent has been obtained

Exclusion Criteria:

* surgery in the oral-pharyngeal region
* irradiated patient with a history of tumor in the head and neck region
* missing compliance
* intake of medications with saliva-altering side effects, existing desire to have children, or pregnancy
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies

The purpose of this study is to determine if recipients of non-myeloablative ex-vivo T-cell depleted peripheral blood (PBSC) stem cell transplantation using a mismatched related donor will have less severe graft versus host disease (GVHD), transplant related mortality, and less graft failure compared to alternative haploidentical stem cell transplantation.

One major obstacle to further advancement in the role of bone marrow transplant (BMT) in hematological malignancies is graft-versus-host-disease (GVHD), which can best be prevented by removing T-cells from the donor stem cell product. However, previous experience with T-cell depletion has been associated with an increased rate of engraftment failure and leukemic relapse. Another obstacle is that a large fraction of leukemia and lymphomas afflict older patients who are more prone to GVHD and have co-morbid conditions that prevent them from being a candidate for BMT.

This trial uses a non-myeloablative conditioning regimen with cyclophosphamide, MEDI-507, fludarabine, and thymic irradiation followed by a T-cell depleted PBSC infusion. Cyclosporine is used for GVHD prophylaxis, and tapered beginning on day 35. Data from our mouse model and previous clinical trials have demonstrated that this approach can induce mixed chimerism without GVHD, with the potential for conversion of mixed chimerism to full donor hematopoiesis following donor leukocyte infusions.

Eligibility Criteria:
Inclusion Criteria:

* Disease Status: NHL, HD, MM that are chemorefractory or relapsed; CLL that is Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I/II resistant to \> 2 cycles of chemotherapy regimens; CML in accelerated or blast phase; MDS with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
* estimated disease free survival of less than one year
* ECOG performance status of 0, 1, or 2
* HLA 1 to 3 mismatched (at A, B, DR loci) related donor

Exclusion Criteria:

* Cardiac disease: symptomatic congestive heart failure, ejection fraction of \< 45%, active angina pectoris or uncontrolled hypertension.
* Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
* Renal disease: serum creatinine \> 2.0 mg/dl or creatinine clearance \< 50 ml/min
* Hepatic disease: serum bilirubin \> 2.0 mg/dl or alkaline phosphate, SGPT or SGOT \> 3 x normal
* Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
* HIV antibody or Hepatitis B surface antigen positivity
* Uncontrolled infection
* Presence of HAMA or HAHA in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis

Nasal continuous positive airway pressure (nCPAP), widely used in neonatal intensive care is also more and more used in infants with severe acute bronchiolitis. There is no evidence that nCPAP improves outcome, but several studies showed that it reduces work of breathing (WOB), improves gas exchange and decreases intubation rate. High flow nasal prong (HFNP) therapy, also used in neonatal units, has recently been suggested for bronchiolitis management. This technique allows warmed and moist gas administration protecting nasal mucosa, and preventing variations of inspired gas FiO2. HFNP also creates a continuous positive pressure, reducing WOB, and seems much more comfortable and better tolerated by babies than nCPAP. There are no studies comparing both techniques for bronchiolitis management. The main objective of this study is to compare WOB with nCPAP and HFNP therapy in infants with severe bronchiolitis in pediatric intensive care unit. Secondary purpose is to compare efficacy and tolerance of both techniques. We propose to lead an open, single center, crossover randomized study. Each patient will receive the two treatments. Three consecutive periods will be studied: first one (minimum 2 hours), with the first technique CPAP or HFNP according to randomization (treatment 1); second period (2 hours) with the second technique (treatment 2); Third period (6 hours) with the second technique. The primary endpoint will be the comparison of WOB (estimated by the calculation of the transdiaphragmatic pressure-time product) at the end of the two firsts periods. Efficacy and tolerance of each technique will be evaluated and compared by compared measuring respiratory rate, heart rate, FiO2, SpO2, transcutaneous PCO2, modified Wood score, and EDIN score during the third period. Nine subjects by groups are required.


Eligibility Criteria:
Inclusion Criteria:

* Infants less than 3 months
* Infants hospitalized in the pediatric intensive care unit of the hospital in northern Marseille for an episode of acute viral bronchiolitis, defined by the French consensus conference of 2000 (1) clinical signs of infection of the upper airways with tachypnea, brake expiratory and / or wheezing auscultation, signs of struggle
* Infants with acute respiratory distress score with Wood changed\> 3 and requiring ventilatory Support
* Infants whose parents or legal guardians have accepted their participation in the research and signed informed consent.
* With Social Security

Exclusion Criteria:

* - Clinical condition requiring immediate intubation before the start of treatment to the:

  * severity of respiratory distress: FiO2\> 60% to maintain SpO2\> 92%
  * hemodynamic instability
  * the occurrence of apneas désaturantes (respiratory pauses greater than 20 seconds duration associated with desaturation \<80% and / or bradycardia \<80/min)
  * the presence of neurological disorders with altered consciousness
* Presence of co-morbidities:

  * chronic respiratory failure
  * heart
End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness

The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgical patients
* hypotension after induction of anesthesia
* required volume expansion by clinical judgement of the anesthesiologist

Exclusion Criteria:

* younger than 18 years
* severe valve regurgitation or systolic dysfunction of the right ventricle
* contraindication of the transesophageal echocardiography examination
* cardiac arrhythmia
* left ventricular ejection fraction less than 30% before surgery
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage

EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.

Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).

We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.

A randomised control pilot study will be undertaken for 100 women who have implantation failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are having a further IVF cycle.

At oocyte retrieval each couple will be randomised using numbered envelopes containing pre randomised group allocations by a person uninvolved in the trial to:

1. BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media) for remaining 2 days or
2. Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium for 5 days.

The best single embryo will be transferred on day 5.

The clinical staff and participating couple will be blinded as to whether BlastGen or standard media was used in culture to day 5. Fertility SA embryologists will not be blind as to which study group a couple is in and which media is being used. The embryos will be cultured using the usual methods and lab facilities by Fertility SA's current embryology staff members who will not be blind to the media being used.

Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* women undertaking an IVF or ICSI cycle

  * aged between 25 and 41 years
  * 2 or more embryos transferred without a positive pregnancy outcome OR a history of at least 1 previous pregnancy loss, OR
  * Poor embryo development (\<20% of embryo developing on time at Day 3 or no blastocyst above Grade 2 on Day 5)

Exclusion Criteria:

* male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
* the use of another investigational drug within 30 days
* any severe chronic disease that would significantly influence an IVF cycle
* less than 3 follicles\>14mm on ultrasound on the day of HCG trigger
The Effects of a Positive Expiratory Pressure (PEP) on Dyspnea and Dynamic Hyperinflation During Exercise in Chronic Obstructive Pulmonary Disease (COPD) Patients

From the relationship between pathophysiology of chronic obstructive pulmonary disease (COPD), dyspnea, and dynamic hyperinflation during ventilatory increasing, the investigators hypothesize that

1. Positive expiratory pressure (PEP) breathing will reduce dyspnea more than normal breathing during exercise in mild to moderate COPD patients.
2. PEP breathing will improve dynamic hyperinflation during exercise more than normal breathing in mild to moderate COPD patients.
3. PEP breathing will improve cardiorespiratory function during exercise than normal breathing in mild to moderate COPD patients.

Expiratory airflow limitation is the pathophysiological hallmark of chronic obstructive pulmonary disease (COPD) that leads to air trapping and increases in dynamic hyperinflation (DH) and consequently causes dyspnea during exercise. Although pursed lips breathing is a simple technique that provides a positive back pressure may retard the airway collapsed, but previous studies showed an unsuccessful reduction of DH which might cause by insufficient back pressure. And thereby a conical positive expiratory pressure (C-PEP) has been developed in our laboratory to generate back pressure higher than pursed lips breathing. Moreover, an effect of PEP on DH has not carried out in patient with COPD. Therefore, the objective of the present study was to examine effects of a C-PEP on DH and respiratory response during exercise in patient with COPD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable mild-to-moderate COPD (Both stages: FEV1/FVC \< 70%. Mild stage: FEV1 ≥ 80% predicted; Moderate stage: 50% ≤ FEV1 \< 80% predicted according to Global Initiative Obstructive Lung Disease (GOLD) guideline).
* Free of exacerbations for more than 4 weeks (as defined by a change to pharmacological therapy, admission to hospital or ER or unscheduled clinic visit).
* Good communication

Exclusion Criteria:

* Older than 70 years old
* Musculoskeletal problems that limit mobility
* Cardiovascular disease
* Neurological or psychiatric illness
* Patient on long term oxygen or domiciliary noninvasive positive pressure ventilation
* Any other comorbidities which would affect ability to undertake exercise test