cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of Oxaliplatine-Paclitaxel in Patients With Metastatic Germ Cell Tumor Refractory to Cisplatin

To evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using World Health Organization/Union Internationale Contre le Cancer (WHO/UICC) and Indianapolis tumor marker (human chorionic gonadotropin \[hCG\], alpha fetoprotein \[AFP\]) criteria in metastatic germ cell cancer patients


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a GCT with elevated AFP level and/or hCG level (\> or =to 100 x ULN) when a biopsy was not available
* Metastatic GCT patients:
* Progression disease defined as \> 10% increase in hCG and/or AFP markers (and/or documented progressive disease \[PD\]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma)
* At least 1 prior line of chemotherapy containing CDDP + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted)
* Eastern Cooperative Oncology Group PS (ECOG PS) grade \< or =to 2
* At least 1 bidimensionally measurable lesion by imaging (CT scan) of \> or =to 20 mm outside an irradiated area OR significantly increased tumor markers \> 2 x ULN (on \> or =to 2 consecutive tests, even in the absence of measurable lesions)
* Age \> or =to 18
* Adequate bone marrow reserve
* Neutrophil count \> or =to 1500/mm3
* Platelets \> or =to 100,000/mm3
* Renal function:Creatinine \< 3 x ULN
* Liver function:Transaminases \< or =to 2.5 x ULN, total bilirubin \< 1.5 x ULN (if liver metastases, transaminases \< or =to 5 x ULN)
* Laboratory values obtained in the week preceding study entry
* Neurosensory \< or =to grade 1 NCI CTC
* Signed informed consent obtained prior to all study procedures

Exclusion Criteria:

* Concomitant high-dose steroids (except for antiemetic prophylaxis)
* Pregnancy, breast-feeding or absence of contraception in sexually active patients
* Prior treatment with oxaliplatin or taxanes
* History of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma
* Symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed)
* Treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study
* Other serious illness or uncontrolled infection
* Psychological, social or geographical situation preventing regular follow-up
* Primary tumor in brain/central nervous system
Social & QoL Behaviors in Parkinson's Disease

Adults with Parkinson's Disease experience an array of challenges and changes in daily living, behaviors, and functioning throughout the progression of their condition. The investigators want to learn more about the effects of Parkinson's Disease on individuals' social behavior and quality of life (QoL) compared to people of the same age without Parkinson's Disease.


Eligibility Criteria:
Parkinson's disease group

Inclusion Criteria:

* Have been diagnosed with Parkinsons Disease by a healthcare professional
* Are at least 40 years old

Exclusion Criteria:

* Possess a diagnosis of autism or any other developmental disability (e.g., Down syndrome)

Neurotypical group

Inclusion Criteria:

* Are at least 40 years old

Exclusion Criteria:

* Have been diagnosed with Parkinson's disease by a healthcare professional
* Possess a diagnosis of autism or any other developmental disability (e.g., Down syndrome)
A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise

The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient male or female 12 to 50 years of age
* Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
* Diagnosis of persistent asthma for at least 6 months
* Best pre-bronchodilator FEV1 of at least 70%.
* Current use of a low- to moderate-dose inhaled corticosteroid
* Ability to withhold albuterol 6 hours prior to visits.
* Physically able to perform exercise testing on a treadmill when albuterol has been withheld

Exclusion Criteria:

* Intermittent asthma, seasonal asthma, or exercise-induced asthma only
* Symptomatic allergic rhinitis and/or thrush
* Abnormal, clinically significant electrocardigraph
* Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
* Asthma exacerbation within 12 weeks of first visit
* Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
* Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
* Allergy to study drugs or study drug excipients
* Concomitant medications that could interact with study medications or affect the course of asthma
* Tobacco use within last year and/or a 10 pack-years history
* Inability to comply with requirements of the study
* Affiliation with investigator's site (example: family member)
French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

The novel coronavirus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 emerged in December 2019 and was declared pandemic in March 2020.

Although the majority of reported COVID-19 cases are mild, approximatively 5% of patients require a stay in intensive care unit, with mechanical ventilation.

Post intensive care syndrome (PICS) consists of physical, cognitive and psychological dysfunctions.

Little is known about the rate and clinical presentations of PCIS among patients surviving to COVID-19.

The objective of this study is to describe the clinical manifestations of PCIS in COVID-19 patients, and their rehabilitation process until home return.

Eligibility Criteria:
Inclusion Criteria - patients with covid19 infection :

* COVID 19 infection (PCR or CT-scan)
* ICU stay requiring mechanical ventilation
* Age ≥18 years old

Inclusion Criteria - control group :

* Age ≥ 18 years old
* Able to walk without technical assistance,
* Having no orthopedic or neurological disorder likely to disturb balance and walking
* Have not had a severe form of Covid 19 disease in the last 12 months
* Collection of non-opposition

Exclusion Criteria:

- Inability to give consent
ARC in Hemorrhagic Stroke

To determine the incidence and predictors of augmented renal clearance (ARC) in patients with hemorrhagic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years
* Patients with hemorrhagic stroke
* Anticipated length of stay in the neuroscience intensive care unit \> 48 hours
* Informed consent provided by the patient or by the patient's designated medical proxy

Exclusion Criteria:

* Pregnancy
* Patients with pre-existing renal dysfunction (chronic kidney disease stages 3 - 5)
* Patients receiving renal replacement therapy
* Patients with an admission serum creatinine \> 1.4 mg/dL
* Patients with non-aneurysmal subarachnoid hemorrhage
* Patients with history of nephrectomy or body mass index \< 18 kg/m2
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events

This was a multi-national, long-term safety study. Patients enrolled in study FTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study.

Patients who experienced a qualifying event in study CFTY720D2406 started study CFTY720D2409 approximately 6 months after the occurrence of the CFTY720D2406 qualifying event.

Patients underwent mandatory assessments on a 6-monthly basis including 12-lead ECG, vital signs. Other assessments were performed as per routine practice.

The primary objective of the study was to estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation.

The study has no stand-alone secondary objective. However data from the CFTY720D2409 and CFTY720D2406 studies will be pooled to supplement CFTY720DD2406 study and support its primary and secondary objectives of evaluating the safety profile of fingolimod.

The pooled data will be appended to this result upon completion of FDA submission.

Eligibility Criteria:
Inclusion Criteria:

* Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
* Patients still on fingolimod after the this first dose serious event

Exclusion Criteria:

-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month
The Turkish Validity-Reliability Study of the European Heart Failure Self-Care Behavior Scale-Caregivers Version

The aim of this study was to evaluate the translation, cross-cultural fit, and psychometric properties of the European Heart Failure Self-Care Behavior Questionnaire for Caregivers.

This research will be of descriptive type. The population of the study will be heart failure patients who applied to the University Hospital Cardiology clinic and polyclinic. The sample of the study will consist of patients who meet the research criteria and agree to participate in the study. The data collection tools of the study are the patient questionnaire (17 questions), the European Heart Failure Self-Care Behavior Scale for Caregivers (9 questions) and the Caregiver Contribution Scale in Heart Failure Self-Care, which was conducted by the researchers by scanning the literature.

English Turkish translations will be made before starting the research. Afterwards, expert opinion will be taken for the suitability of the scale items. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language and content validity will be done for the scale form. The scale items will be translated into Turkish and expert opinions will be taken. Then, the Turkish scale items will be translated back into English and the linguist's opinion will be taken that the scale can be applied. Language validity and content validity will be done in the study. Explanatory Factor Analysis will be applied for the validity of the questionnaire. Kaiser Meyer Olkin(KMO) Test, which measures the adequacy of sample size as antecedent tests, and Bartlett's Test For Sphericity will be used to test sphericity. Factor Analysis Principal Component Analysis Method will be applied.

Eligibility Criteria:
Inclusion Criteria:

* be over 18
* To be a caregiver for patients with heart failure for at least 1 year.
* Volunteer to participate in the research.

Exclusion Criteria:

* Having communication problems and mental problems.
* be under the age of 18.
* Receiving hemodialysis treatment for less than 6 months.
The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days

The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.


Eligibility Criteria:
Inclusion Criteria:

1. Surgical patient
2. Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
3. Hospital length of stay (LOS) \< 10 days at the time of VAP diagnosis.
4. Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)

Exclusion Criteria:

1. Age \< 18 years
2. Prior episode of VAP for the index admission
3. VAP caused by any of the following pathogens:

   * Methicillin-resistant Staphylococcus aureus (MRSA)
   * Vancomycin-intermediate Staphylococcus aureus (VISA)
   * Pseudomonas aeruginosa
   * Vancomycin-resistant Enterococcus (VRE)
   * Acinetobacter baumanii
   * Stenotrophomonas maltophilia
   * Carbapenem-resistant Enterobacteriaceae (CRE)
   * Extended-spectrum beta lactamase-producing gram-negative bacilli
4. Causative pathogen not sensitive to choice of initial empiric antibiotic
5. Antibiotic therapy for \> 5 of the last 10 days preceding VAP diagnosis
6. Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring \> 1 vasopressor (17)
7. Current or recent (within 30 days) use of immunosuppressive medications
8. LOS \> 72 hours at a transferring facility
9. Pregnancy or lactation
10. Legal arrest or incarceration
11. Moribund state in which death is imminent
12. ECMO (Extracorporeal membrane oxygenation)
13. Extubation prior to randomization
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.

Eligibility Criteria:
Inclusion Criteria:

1. age \>= 50
2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
4. Area of CNV clearly visible in ICGA is more than half of the total CNV area.

Exclusion Criteria:

1. CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
2. Blocked fluorescence in ICGA is more than half of the total CNV area.
3. Disciform scar
4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
5. Previous any treatment of photodynamic therapy or photocoagulation
6. Previous intraocular or periocular injection of steroid within 3 months
7. Previous intraocular surgery except cataract surgery
8. Vitreo-retinal interface disease on the macula
9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
10. Uncontrolled periocular or intraocular infection
11. History of hypersensitivity to ranibizumab treatment
12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
Evaluation of an Intervention Program for the Prevention of Anemia

The purpose of the study is to determine whether improvement in the accessibility to iron supplement will decrease anemia rates in infants.

Iron deficiency anemia is the most common type of anemia in infants, children and women of reproductive age. The most frequent cause of iron deficiency in infants at 6 months of life is poor nutrition during a period of rapid growth and a diet lacking in iron rich foods. Children who suffered from anemia in infancy demonstrated slower cognitive development, were low achievers in school and had a high rate of behavioral disturbances.

The Ministry of Health implements a primary prevention program for anemia. If by making iron supplements more accessible would increase parental compliance in acquisition of the iron supplement and subsequently reduce the rate of iron deficiency anemia, the result would be the immediate application of the finding. It is possible to implement a program whereby the supplement will be directly available at the family health centers for purchase by the parent.

Eligibility Criteria:
Inclusion Criteria:

* Infant who visit Family Health Centers
Study to Evaluate Multiple Ascending Dose and Multi-Dose of DT-216 in Adult Patients With Friedreich Ataxia

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of multiple doses of intravenous DT-216 in adult patients with Friedrich Ataxia.


Eligibility Criteria:
Inclusion Criteria:

* Genetically confirmed diagnosis of Friedreich Ataxia with homozygous GAA repeat expansions.
* Able and willing to sign informed consent form prior to study enrollment.
* Stage 5.5 or less on the Functional Staging for Ataxia (FSA) at screening.

Exclusion Criteria:

* Has any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study.
* Has clinically significant abnormal laboratory results.
* Has significant cardiac disease.
* Received an investigational drug within 3 months of screening.
A Psychosocial Program Impact Evaluation in Jordan

The study aims to deliver a robust pre-post evaluation of the wellbeing impacts of an innovative, brief, and scalable psychosocial intervention, delivered to refugee youth living in urban settlements in Jordan. The study was conducted using two waves of data collection: the first featured an intervention and a matched control group, the second featured a full randomized control trial.

This study will provide a robust evaluation of the Mercy Corps 'Advancing Adolescents, No Lost Generation' program that targets stress alleviation in refugee youth (12-18 years) with specific measures of psychosocial stress, biological stress, and cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Eligible and enrolled in Mercy Corps Advancing Adolescents program
* Syrian refugee and Jordanian host-community youth residing in 4 urban centers in northern Jordan

Exclusion Criteria:

* Not available for study recruitment (started sessions or deferred sessions before study start date).
ESPB vs.Combination of ESPB and Superficial PIPB in Cardiac Surgery

Cardiac surgery is associated with significant postoperative pain. Pain control is an essential part of enhanced recovery protocols. The aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (ESPB) and the combination of ESPB and superficial parasternal intercostal plane block (PIPB) in patients undergoing elective cardiac surgery.

Many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. Increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. Due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (US) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery.

This study aims to evaluate and compare the effects of ESPB versus ESPB plus Superficial PIPB on pain scores and opioid consumption in patients undergoing elective cardiac surgery.

Patients will be divided into two groups:

Group ESPB:

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group ESPB+Superficial PIPB:

In this group, patients will be administered Bilateral ESPB (total of 40 ml, %0.25 bupivacaine) and bilateral Superficial PIPB (total of 20 ml, %0.25 bupivacaine). In addition, IV morphine PCA will be administered for the first 24 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- valve replacement or isolated valve surgery)
* BMI \<35 kg / m2

Exclusion Criteria:

* Emergent surgeries, redo cases, minimally invasive procedures
* Patients who do not want to participate
* Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
* Hypersensitivity or history of allergies to local anesthetics
* Major liver or kidney dysfunction or other pre-existing major organ dysfunction
* Left ventricular ejection fraction \<30
* Individuals with mental health disorders (for example bipolar disorder or depression)
* Pregnancy or breastfeeding
* Presence of hematological disease
* Patients with alcohol-drug addiction