cyrilzakka/clinical-trials huggingface dataset:
Patupilone Activity in Advanced/Metastatic Hepatocellular Carcinoma

This study will evaluate the safety, efficacy, and activity of patupilone in patients with advanced unresectable and/or metastatic hepatocellular carcinoma based on tumor response using modified RECIST criteria.


Eligibility Criteria:
Inclusion criteria:

- Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed.

Exclusion criteria:

Additional protocol-defined inclusion/exclusion criteria apply.
The Effect of Continued Mechanical Ventilation on the Occurrence of Myocardial Ischemia

The goal of this study is to examine the influence of mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.

Coronary artery bypass grafting (CABG) surgery is one of the main treatment options for patients suffering from coronary artery disease, a condition characterized by a build-up of cholesterol in the coronary arteries of the heart that affects 126 million people worldwide each year. During this procedure, cardiopulmonary bypass (CPB) takes over the function of the heart and lungs. In recent years, there has been a huge focus on reducing surgical trauma in this procedure, leading to the emergence of minimally invasive cardiac surgery (MICS) such as endoscopic CABG (endo-CABG). In these techniques, peripheral CPB with femoral arterial cannulation is the most commonly used strategy. However, the use of retrograde arterial perfusion is not without risk. It can cause that the upper part of the body only receives deoxygenated blood. The effect on the heart is not yet fully known. The hypoxemia could cause myocardial ischemia and this could damage the heart muscle cells.

It is reported in the literature that establishing adequate ventilation from the initiation of CPB to cardiac arrest can resolve this phenomenon. This approach was investigated in a recently performed double-blinded, randomized, controlled pilot study (n=10) of our research group. However, a larger randomized controlled trial was needed. Therefore, this research aims to investigate the effect of continued mechanical ventilation on the occurrence of myocardial ischemia in patients undergoing endo-CABG.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Patients undergoing their first elective endo-CABG procedure using peripheral cannulation for CPB
* Patients who are able to give their informed consent
* Patients who speak Dutch or French

Exclusion Criteria:

* Patients participating in another clinical trial
* Patients taking corticosteroids
* Patients with an ejection fraction \< 25%
* Patients with lung diseases (chronic obstructive pulmonary disease (COPD), asthma)
* Patients where groin cannulation is not possible
Physical Functional Side Effects of Taxane Chemotherapy for Breast Cancer

Determine the characteristics of symptoms and functional impairment associated with chemotherapy induced peripheral neuropathy.

Taxanes, a type of chemotherapeutic agent prescribed to breast cancer patients, have a known physical side effect of chemotherapy induced peripheral neuropathy (CIPN). The purpose of this qualitative study is to understand the experience and physical functional side effects of taxanes. This is the first of a two phase study. The overall goal is to identify existing objective physical performance measures to assess functional side effects of taxanes.

Eligibility Criteria:
Inclusion Criteria:

* Women 21-70 years old (Women over 70 are offered chemotherapy less frequently because of their risk benefit ratio. Including them would be a selection bias because of their differential underexposure).
* Initiated taxane-based chemotherapy in the neoadjuvant, adjuvant, or previously untreated metastatic setting.
* The range of exposure to taxane-based chemotherapy will include women on active treatment having received two cycles, to women who are within three months of their last infusion.
* Documented symptoms of CIPN per CTCAE grading criteria (half of sample) or NO symptoms (half of sample) Grade 0 = no CIPN symptoms Grade 1 = mild symptoms Grade 2 = moderate symptoms - prescribed Gabapentin (Neurontin) Grade 3\&4= severe symptoms - treated with Gabapentin (Neurontin), treatment plan altered

Exclusion Criteria:

* Physical disabilities - defined by use of assistive devices to complete functional tasks (wheelchair, crutches, prosthetic limbs) prior to starting chemotherapy.
* Current exposure to neurotoxic agents (Navelbine, platinums or other taxanes)
* Pregnancy during chemotherapy treatment
* Diabetes - diagnosed 3 or more years , or insulin dependent, or with clinically established neuropathy
* Previous exposure to chemotherapy or radiotherapy
* HIV positive (high risk for neuropathy)
* Other neurological diseases, such as Multiple Sclerosis
* Other pre-existing neuropathy
Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods Sperm Selection and Embryo Development: Comparison of the Density Gradient Centrifugation and Microfluidic Chip Sperm Preparation Methods

Purpose: To compare the effects of the density gradient centrifugation and microfluidic chip sperm preparation methods on embryo development in a study population with astheno-teratozoospermia.

Materials and Methods: In this prospective study, the semen samples of the patients with astheno-teratozoospermia were divided into two groups for preparation with either the microfluidic or density gradient methods. Selected spermatozoa were used to fertilize the mature sibling oocytes. Semen parameters and embryo development on days 3 and 5 were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Infertile men with astheno-teratozoospermia
* Women were aged from 18 to 39
* Women had at least two mature oocytes.

Exclusion Criteria:

* MI oocytes
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children

This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation. Safety and practicality of administering meropenem as a 3 hour infusion will be measured.

This study will be conducted at 7 pediatric hospitals in the United States (Columbia University Medical Center, New York, New York; University of North Carolina, Chapel Hill, North Carolina; St. Christopher's Hospital for Children, Philadelphia, Pennsylvania, Connecticut Children's Medical Center, Hartford, Connecticut, Riley Hospital for Children, Indianapolis, Indiana, Nationwide Hospital for Children, Columbus, Ohio, and Children's Medical Center, Dallas, Texas). Cystic Fibrosis children (age 6-17 years) admitted to one of these enrolling sites with an acute exacerbation of his or her pulmonary infection who require antibiotic therapy with meropenem will be eligible. Meropenem will be administered as a 3 hour prolonged infusion and blood concentrations will be measured to determine the population pharmacokinetics in 30 patients, the safety of prolonged infusion meropenem, and the practicality as measured be treatment burden using a questionaire. The population pharmacokinetic model developed will be utilized to determine the optimal dose of meropenem to administer to children with Cystic Fibrosis, and define an exposure response relationship for the drug in this population.

Eligibility Criteria:
Inclusion Criteria:

* Cystic Fibrosis
* Hospitalized with acute pulmonary exacerbation
* Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment

Exclusion Criteria:

* Known allergy to meropenem
* Require less than 3 days of meropenem in the hospital
* Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen
* Known fungal or viral infection
* Females in their 2nd or 3rd trimester of pregnancy
* Moderate to severe renal dysfunction, as defined by a creatinine clearance less than 50 ml/min/1.73m2 (by use of Schwartz method)
* History of solid organ transplantation within previous 6 months
* Active or recent (within 30 days) participation in another antibiotic clinical trial
A Pharmacokinetic Evaluation Study in Healthy Volunteers

The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.


Eligibility Criteria:
Inclusion Criteria:

* are nonsmokers or those subjects whom have not smoked within 6 months
* are within 20% of their ideal body weight
* are healthy on the basis of a pre-trial physical examination

Exclusion Criteria:

* history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
* history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
* use of concomitant medication other than hormonal contraceptives and multi-vitamins
* donation of blood in the 60 days preceding the screening visit
* have been diagnosed with HIV, hepatitis B or hepatitis C
A Comparative Study to Evaluate the Effects and Mechanism of Action of Dysport®, Botox® and Xeomin® in the Extensor Digitorum Brevis Model in Healthy Adult Male Participants

Study aimed at comparing the pharmacodynamic profile (including duration of action) of three commercialized toxins by measuring the action potential of the injected muscle (extensor digitorum brevis)


Eligibility Criteria:
Inclusion Criteria:

* Participant must be between18 to 65 years of age inclusive, at the time of signing the informed consent
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring
* A body mass index (BMI) within the range 18 and 30 kg/m2 (inclusive).

Exclusion Criteria:

* Any medical condition that may put the participant at risk with exposure to BoNT, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disease that might interfere with neuromuscular function
* Previous treatment with botulinum toxin (BoNT) (any serotype) during the past 6 months
* Known hypersensitivity to any of the components of the Dysport/ Botox/ Xeomin formulation (which includes human serum albumin, lactose, sucrose) or allergy to cow's milk protein
* Use of agents that could interfere with neuromuscular transmission, including calcium channel blockers, penicillamine, aminoglycosides, lincosamides, polymixins, magnesium sulphate, anticholinesterases, succinylcholine and quinidine
Nutrition, Immunology and Epidemiology of Tuberculosis

The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1

Tuberculosis (TB) remains the single most common infectious disease cause of mortality. We propose to examine the inter- relationships of nutrition, immunology, and epidemiology with respect to TB in Tanzania. Given that TB is so much linked with HIV immunologically, clinically, and epidemiologically, it is essential to examine how these relationships are modified by HIV infection. Published animal and human studies suggest that vitamin deficiency is associated with poor immune response in TB. By modulating immune function, nutritional supplements may be a useful adjunct to anti-TB drugs, and could lead to the development of shorter drug regimens. All patients will receive standard anti-TB therapy. Follow-up visits will occur every two weeks for the first 2 months and monthly thereafter till the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, age 18 to 60 years inclusive
* At least two positive sputum smears for tuberculosis
* Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
* Subjects who grant informed consent to participation

Exclusion Criteria:

* Karnofsky score \< 40%
* Hemoglobin \< 8.5 g/dl
* Having had treatment for TB exceeding 4 weeks in the last 5 years
* Pregnant women
Sensitivity Evaluation of Serological Tests for Covid-19

The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.


Eligibility Criteria:
Inclusion Criteria:

All patients or individuals exposed to Sars-Cov2 Infection.

Exclusion Criteria:

There are no criteria for excluding patients or individuals, if not the refusal to participate to project
Antithymocyte Globulin and Cyclosporine in Treating Patients With Myelodysplastic Syndrome

The main objective of this trial is to evaluate the efficacy and toxicity of intensive immuno-suppression with ATG + CSA versus best supportive care in patients with transfusion dependent low and intermediate risk myelodysplastic syndrome (MDS).

This trial will answer the question whether immuno-suppression improves hematopoesis and reduces transfusion requirements analogous to patients with aplastic anemia as the short-term outcome, and whether immuno-suppression accelerates leukemic transformation and influences survival as the long-term outcome.

Primary endpoint: best response (CR + PR) rate at month 6

Eligibility Criteria:
Hypoplastic MDS, or MDS subtype RA, RAS or RAEB with ≤ 10% blasts, or RAEB with 10-20% blasts and the patient refusing or not eligible for the MDS high risk protocol (EORTC 06961)

* Transfusion dependence \< 24 months or neutrophils \< 0.5 × 109/l.
* ECOG/SAKK performance status ≤ 2
* Age \> 18 years
* No active uncontrolled infection
* No prior chemotherapy or radiotherapy
* No history of heart failure, clinically relevant cardiac arrhythmia or other hemato-oncological disease
Culture is Care: Training Workshop for Care Workers (VerbaCurant)

The study aims to measure the empathic capacity of healthcare professionals belonging to the Alessandria Hospital, by applying validated measuring instruments, before and after a specific training intervention. The secondary objective is to assess how the training initiative impacts on subjects with a different attitude towards cultural participation.

The aim of this project is to identify how a medical humanities intervention can act on the empathic capacity of carers through culture. One of the aims is to introduce an additional element to overcome the problems about language, prejudices, legitimisation by stakeholders who do not yet recognise the value and importance of projects promoting the relationship between culture, wellbeing and health. "Verba Curant" is aimed at generating cultural value, with the hope that it can unite the different professional fields involved and become the heritage of the community.

The project of the Alessandria Hospital Centre in collaboration with the Holden School intends to launch a series of actions aimed at promoting the beneficial impact of culture, in particular storytelling, on the caregivers and patients of the Alessandria Hospital in order to measure how much cultural enjoyment can impact on health literacy. It is planned to define a methodological tool useful for making care workers aware of the importance of culture and dialogue with patients, as well as being able to measure their degree of literacy. The tool will be the object of a widespread training action on care workers, which will also involve all the stakeholders involved in the transmission of health information to patients.

Eligibility Criteria:
Inclusion Criteria:

* Health professionals related to the Alessandria Hospital

Exclusion Criteria:

* none
Sevoflurane for Treatment-Resistant Depression

This study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-65 years
2. meeting DSM-V criteria for major depressive disorder
3. a pretreatment score ≥17 on HDRS-17
4. meeting criteria for TRD, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode.
5. current treatment drugs were stably used for at least 4 weeks

Exclusion Criteria:

1. MDD with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al
2. Drug, tobacco or alcohol abuse
3. active suicidal intention
4. previous administration of NMDA receptor antagonists (e.g., ketamine)
5. previous (\<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS)
6. pregnancy or breastfeeding
7. morbidly obese, BMI\>35kg/m2
8. other diseases that could interfere with the results
Utero-placental Vascularisation in Normal and Preeclamptic and Intra-uterine Growth Restriction Pregnancies

Introduction

Preeclampsia (PE) and intra-uterine growth restriction (IUGR) are two major pregnancy complications related to chronic utero-placental hypoperfusion. Three-dimensional power Doppler (3DPD) angiography has been used for the evaluation of utero-placental vascularisation and three vascular indices have been calculated: the vascularisation index (VI), flow index (FI) and vascularisation-FI (VFI). However, several technical endpoints hinder the clinical use of 3DPD as physical characteristics and machine settings may affect 3DPD indices, and so its clinical significance is not yet clear.

Objectives

The primary objective is to better understand the clinical significance of 3DPD indices by evaluating the relationship between these indices and placental morphometry. Secondary objectives are (i) to determine the impact of machine settings and physical characteristics on 3DPD indices, and (ii) to evaluate physio-pathological placental vascularisation patterns.

Methods and analysis

This is a prospective controlled study. We expect to include 112 women: 84 with normal pregnancies and 28 with PE and/or IUGR (based on our former cohort study on 3DPD indices for PE and/or IUGR prediction (unpublished data)). Within 72 h before planned or semi-urgent caesarean section, utero-placental 3DPD images with five different machine settings will be acquired. Placentas will be collected and examined after surgery and stereological indices (volume density, surface density, length density) calculated. The 3DPD indices (VI, FI and VFI) of the placenta and adjacent myometrium will be calculated. Correlation between Doppler and morphological indices will be evaluated by Pearson or Spearman tests. Agreement between 3DPD indices and morphological indices will be assessed by Bland and Altman plots. The impact of Doppler settings and maternal characteristics on 3DPD indices will be evaluated with a multivariate linear regression model.


Eligibility Criteria:
General Inclusion Criteria:

* Age ≥18 years and ≤65 years Fetal anomalies
* Gestational age ≥30 gestational weeks
* With social insurance
* With written consent for participation
* With medical examination

Physiological group Inclusion Criteria

* Hospitalised pregnant women with scheduled or semi-urgent caesarean section according to national HAS recommendations or Hospitalised pregnant women with scheduled vaginal delivery.
* Normal pregnancy issues
* Normal fetal morphology

Pathological group Inclusion Criteria

* Pregnant women with preeclampsia and/or IUGR pregnancy
* Hospitalised pregnant women with scheduled or semi-urgent caesarean section or hospitalised pregnant women with scheduled vaginal delivery.

Exclusion Criteria:

* Fetal morphological abnormalities that may influence fetal circulation
* Maternal or fetal vital urgency
* Multiple pregnancy
* Non-placental origin IUGR
* Language barrier
* Patient under legal protection
Resveratrol and Type 2 Diabetes

The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in type 2 diabetic patients.

As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age: 40-70 years
* Body fat percentage \> 25, BMI 27-35 kg/m2
* Diagnosed with type 2 diabetes at least one year before the start of the study
* Well-controlled type 2 diabetics: HBA1C \< 8.0%
* Oral glucose lowering medication (metformin only or in combination with sulfonylurea agents)
* Sedentary

  * Not more than 2 hours of sports a week
  * No active job that requires strenuous physical activity
* Stable dietary habits
* Willingness to abstain from resveratrol-containing food products

Exclusion Criteria:

* Unstable body weight (weight gain or loss \> 3kg in the last three months)
* Total body fat percentage \< 25%
* Hemoglobin \< 7.8 mmol/l
* Use of anticoagulants
* Engagement in programmed exercise \> 2 hours total per week
* Impaired kidney and/or hepatic function Creatinine 50-100 umol/L Liver enzymes, within 2 times of normal range of laboratory standard (ASAT \< 60 U/L, ALAT \< 70 U/L, Billi \<40 umol/L, gamma-GT \< 80 U/L)
* No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
* Insulin dependent Diabetic subjects
* Any medical condition except type 2 diabetes mellitus requiring treatment and/or medication use except metformin only or in combination with sulfonylurea agents
* Intake of dietary supplements except multivitamins and minerals
* Current alcohol consumption \> 20 grams/day
* Subjects who don't want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study.
* Participation in another biomedical study within 1 month before the first screening visit
* Any contraindication to MRI scanning. These contra-indications include patients with following devices:

  * Central nervous system aneurysm clip
  * Implanted neural stimulator
  * Implanted cardiac pacemaker of defibrillator
  * Cochlear implant
  * Insulin pump
  * Or metal containing corpora aliena in the eye or brains