cyrilzakka/clinical-trials huggingface dataset:
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
* Patients have to be chemotherapy naive
* Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
* Age \>18 years.
* Performance status (WHO) 0-2
* Life expectancy of at least three months.
* Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3).
* Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl)
* Informed consent

Exclusion Criteria:

* Pregnant or nursing
* Psychiatric illness or social situation that would preclude study compliance'
* Other concurrent uncontrolled illness
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Mechanical Ventilation on Hippocampus

Ventilator-associated brain injury (VABI) frequently occurs in ICU patients. Although animal studies indicate the hippocampus as a key target of VABI, its relevance in human patients remains uncertain. In this study, the investigators aim to monitor hippocampal EEG activity during the weaning process of patients off mechanical ventilation, and also exploring the coupling between breathing patterns and hippocampal activity.

\[Rational\] Although mechanical ventilation (MV) is crucial for saving lives, the high incidence of ventilator-associated brain injury (VABI) in ICU patients, affecting up to 80% of cases, raises significant clinical concerns. VABI not only increases mortality and morbidity rates but also strains healthcare resources. Despite abundant evidence from preclinical studies, the precise impact of mechanical ventilation on humans remains largely unknown. Understanding these effects is crucial for uncovering the mechanisms behind VABI and subsequently preventing and treating this complication.

\[Methods\] Patients with drug-resistant epilepsy scheduled for stereoelectroencephalography (sEEG) exploration as part of their pre-surgical assessment will undergo eligibility screening. During the study, sEEG signals and respiratory data will be simultaneously collected from the hippocampus and other relevant limbic structures under various mechanical ventilation scenarios. These scenarios include controlled ventilation at different levels of positive end-expiratory pressure (PEEP, 5cmH2O vs. 10cmH2O) and respiratory rates (RR, 10 vs. 20 bpm), assisted ventilation, and natural breathing phases. Following the discontinuation of mechanical ventilation, patients will be monitored for up to 7 days to evaluate the occurrence of delirium. Additionally, simultaneous intracranial EEG recordings from relevant cortical and subcortical regions will be conducted.

\[Aims\] The current study aims to investigate the effects of mechanical ventilation, including variations in RR and PEEP, on neurophysiological electrical oscillations within the hippocampus, as well as the relationship between breathing patterns and hippocampal activity. Furthermore, the investigators will explore the impact of mechanical ventilation on other cortical areas involved in breathing, depending on electrode positioning, and examine the interactions between these brain regions and the hippocampus.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years
* ASA: I - II
* w/ electrode inside hippocampus (≥ 1 contacts)
* Singed consent form

Exclusion Criteria:

* Seizure occurrence ≤ 36 hours before op.
* Structural brain damage
* History of using: opioids, enzyme-inducing medications, sleep aids, or excessive alcohol consumption
* History of mechanical ventilation (\>24h)
* Cognitive impairment
* Operation within 6 months
* Participate in other clinical trials in the last four weeks
* Pregnant or breastfeeding
Carotid Artery Disease in Childhood Cancer Survivors

The goal of this clinical research study is to find out if long-term survivors of childhood head or neck cancer, who received radiation therapy as part of the overall treatment plan, are at increased risk of thickening or blockage of the carotid arteries (the major blood vessels in the neck).

Researchers also want to find out if other medical conditions, such as high blood sugar, high blood cholesterol, or history of tobacco use may contribute to the thickening or blockage of the carotid arteries.

Some research shows that survivors of adult head or neck cancer, who received radiation therapy, are at increased risk for thickening or blockage of the carotid arteries, which may increase the risk for other medical conditions, such as stroke. Researchers want to learn about the possible risks of thickening or blockage of the carotid arteries in survivors of childhood head or neck cancer.

If you agree to take part in this study, researchers will see if there are any possible effects (thickening or blockage) of radiation therapy on your carotid arteries. This will be done by examining the test results from routine testing (mentioned below) that is normally done for your standard long-term follow-up care of the disease. These routine tests would be performed even if you were not in this research study.

During your long-term follow-up clinic appointment, you will have a physical exam and an ultrasound test (performed at the Cardiology Clinic) of the carotid arteries. A carotid ultrasound is a test that uses sound waves to look at the blood vessels in the neck. Blood will be drawn (about 2-3 teaspoons) for laboratory tests, including blood sugar level, blood cholesterol level, blood triglyceride level, thyroid hormone level, and blood levels of certain proteins (C-reactive protein and brain natriuretic peptide).

If any of the tests show any thickening or blockage of the carotid arteries or other medical problems, such as high blood sugar, your study doctor will discuss the test results, treatment options, and/or a follow-up plan with you.

This is an investigational study. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have been less than 21 years of age at time of initial diagnosis.
2. Patients treated at M.D. Anderson Cancer Center for any malignancy (including primary CNS tumors) that required unilateral radiation therapy to the head and neck area and involving the ipsilateral carotid artery as part of the overall treatment plan.
3. Patients must be at least 5 years status post completion of therapy.
4. Must be English speaking, or able to consent through an approved medical language translator.
5. A written informed consent from the patient and/or the patient's legally authorized guardian must be obtained from all patients.

Exclusion Criteria:

1. Leukemia patients receiving craniospinal irradiation
2. Non-English speaking subjects for which no appropriate medical translator is available
3. Patients who received head/neck radiation involving both carotid arteries will not be eligible.
Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study

The primary objectives of the study are to use US and UK data to describe the characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients according to various demographic, lifestyle, clinical, and medication use.


Eligibility Criteria:
Inclusion criteria:

* parent cohort

  -- COPD diagnosis
* child cohort

  -- any initiation of first maintenance therapy after July 1, 2015
* grandchild cohort -- any initiation of second maintenance therapy after August 2, 2015

Exclusion criteria:

- parent cohort

* age \<40 on index date
* any COPD diagnosis in baseline
* any use of long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), or inhaled corticosteroid (ICS) in baseline
* \<365 days of continuous medical and pharmacy coverage
Study to Determine the Safety, Tolerability and Pharmacokinetics Following Multiple Doses of LX4211 in Healthy Subjects

The primary objective of this study is to evaluate the safety and tolerability of multiple oral doses of LX4211 400 mg and LX4211 800 mg (administered once daily for 10 consecutive days) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥ 18 to ≤ 55 years of age
* Vital signs at Screening in the following ranges: systolic blood pressure, 90-140 mm Hg; diastolic blood pressure, 50-90 mm Hg; heart rate, 50-100 bpm
* Body mass index (BMI) ≥18 and ≤35 kg/sq m
* Willing and able to provide written informed consent

Exclusion Criteria:

* Use of any medication (prescription, over-the-counter, herbal tea, or supplements) within 5 days of dosing
* Use of any investigational agent or study treatment within 30 days of dosing
* Use of any protein or antibody-based therapeutic agents within 3 months of Screening
* Prior exposure to LX4211
* Use of cigarettes or any tobacco products within 2 months prior to Screening and while participating in the study
* History of bariatric surgery or any other gastrointestinal surgery that may induce malabsorption
* History of any major surgery within 6 months of Screening
* History of any hypersensitivity to the inactive components of LX4211
* History of renal disease or significantly abnormal kidney function tests
* History of hepatic disease or significantly abnormal liver function tests
* History of any active infection within 14 days prior to Day 1
* History of alcohol or substance abuse within 2 years prior to Day 1
* Donation or loss of \>400 mL of blood or blood product within 3 months of dosing
* Positive urine glucose at Screening
* Positive urine screen for drugs of abuse, or urine test for alcohol at Screening or Day -1
* Inability or difficulty swallowing pills
* Unable or unwilling to communicate or cooperate with the Investigator
Metabolic Availability in Older and Younger Men

The main goal of this study is to determine the metabolic availability of methionine in black beans, lysine in sorghum and lysine in milk using the indicator amino acid oxidation method both in older and in younger men.


Eligibility Criteria:
Inclusion Criteria:

Gender: Male Age: 20-35 years or 65-80 years Body Mass Index (BMI): 18.5 - 30.0 kg/m2 Healthy as assessed with a questionnaire Regular and normal eating habits as assessed with a Food Frequency Questionnaire (FFQ) Willing to comply with study procedures and use of data Having given written informed consent

Exclusion Criteria:

Chronic disease, for example:

* Diabetes mellitus / being treated for high blood glucose
* Severe cardiovascular disease (exception: hypertension)
* Hepatic disease (e.g. hepatitis)
* Renal disease
* Cancer
* Bowel disease (e.g. inflammatory bowel disease, ulcers, bleeding)
* Pancreatitis

History of medical or surgical events that may affect GI function, and the study outcomes or disease risk for participants, for example:

* Bariatric surgery
* Gastrointestinal tract surgery
* Digestive tract disorder
* Chewing problems
* History of deep venous thrombosis without anti-coagulation medication

Medicine use that interferes with, protein metabolism, GI function and the study outcomes, for example:

* Glucose lowering drugs
* Proton pump inhibitors
* Laxatives

Habits that interfere with the study outcomes:

* Protein supplement use (current use or less than 2 weeks past use)
* Smoking
* Drug use
* Alcohol consumption \>21 units/week and/or \>4/day
* Following a weight-loss diet, medically prescribed diet or other diet with a low calorie intake or an unbalanced nutrient intake like a vegan or very low carbohydrate diet
* Moderate to high intense physical activity for more than 5 hours a week

Other:

* Self-reported allergy or intolerance to the tested products
* Weight loss of more than 3 kg in the 3 months prior to study screening
* Current participation in other research and \<2 months prior participation in other research
* Not having a general practitioner
* Not willing to accept information-transfer concerning participation in the study , or information regarding his health to his general practitioner
* Working or doing an MSc- thesis at the department of Human Nutrition and Health at Wageningen University \& Research
Clinical and Cost Effectiveness of Brief Cognitive-Behavioral Therapy (CBT) for Pediatric Internalizing Disorders

This project assesses the clinical and cost effectiveness of brief cognitive-behavioral therapy (CBT) for depressed (ages 11-17) and anxious (ages 8-17) youths seen for services in pediatric primary care. This study is designed to compare the impact of brief CBT delivered on-site in pediatric primary care to referral to specialty mental health care (SMHC), as well as obtain an estimate of the total costs of the CBT protocols for depression and anxiety and the cost-effectiveness of the protocols compared to referral to and utilization of SMHC services.


Eligibility Criteria:
Inclusion Criteria for depression:

* Ages 11 to 17 years
* Meet diagnostic criteria for Major Depression, Dysthymia, or Minor Depression
* Live with a legal guardian

Inclusion Criteria for anxiety:

* Ages 7 to 17 years
* Meet full or probable (missing one, non-core symptom) diagnostic criteria for Separation Anxiety Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
* Live with a legal guardian

Exclusion Criteria:

* Require treatment other than brief CBT (namely, youths with bipolar disorder, psychosis, active suicidal ideation with plan, post-traumatic stress disorder, substance dependence, or mental retardation
* Experience of recent physical or sexual maltreatment
* Serious or unstable physical illness
* Current participation in an alternate, active intervention for the target condition of interest
Efficacy and Safety of XEN® Gel Stent and Post-operative Management in Patients With Open Angle Glaucoma

To evaluate the efficacy of postoperative management with 5-fluorouracil injections after XEN Gel Stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of primary open angle glaucoma
* trabecular meshwork visible in gonioscopy
* medicated IOP of ≥ 15 mmHg and ≤ 35 mmHg
* taking 1 to 5 IOP-lowering medications
* area of healthy, free and mobile conjunctiva in the target quadrant (superior-nasal)
* signed inform consent

Exclusion Criteria:

* angle closure glaucoma
* secondary open angle glaucoma
* previous glaucoma shunt/valve in the target quadrant
* presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
* active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)
* active iris neovascularization or neovascularization of the iris within 6 months of the surgical date
* anterior chamber intraocular lens
* presence of intraocular silicone oil
* vitreous present in the anterior chamber
* impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
* known or suspected allergy or sensitivity to drugs required for the surgical procedure or any of the device components (e.g., porcine products or glutaraldehyde)
* history of dermatologic keloid formation
* previous photorefractive keratectomy
Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)

The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).

1. To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain
2. To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.
3. To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.


Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years of age)
2. A disability score ≥ 40 as per the QuickDASH survey
3. Presence of pain and perceived disability for a minimum of 3 months
4. Willing to engage in a Mind-Body intervention
5. Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)

Exclusion Criteria:

1. Clear organic diagnosis of pain (e.g., cancer, infection, etc...) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis)
2. Age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results)
3. Diagnosis of cognitive impairment or dementia
4. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
5. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered in this category
The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast

Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide. Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal sepsis (EOS, in \<7 days of life) in sSA. In other regions, maternal carriage is associated with early onset neonatal sepsis, but in addition, other adverse perinatal outcomes (stillbirths, early neonatal death, low birth weight and prematurity). Robust data on maternal GBS carriage in sSA and its burden on adverse perinatal outcomes are lacking, with important consequences for public health interventions.

Through investigation of maternal carriage and perinatal outcomes at three different sites: rural, semi-rural and urban, this study will provide a comprehensive description of the burden of GBS in coastal Kenya, informing public health policy and driving forward interventions. Risk factors for maternal colonisation and invasive neonatal disease will be assessed, including through retrospective immunological investigation of cord blood in neonates subsequently identified as having invasive GBS disease or other adverse perinatal outcomes, compared to those without.

GBS isolates from maternal colonisation will be typed (sero-typing and molecular analysis), and these isolates will be compared to existing archived neonatal isolates from investigation of neonatal sepsis in KDH (Kilifi District Hospital). This is important so that we know the prevalent sub-types causing neonatal disease in Kenya, those which are carried by mothers, and therefore whether maternal GBS carriage correlates with a high risk of perinatal disease. GBS vaccines in development are type-specific and this will inform their use in sSA.

Stillbirths will also be investigated, in individual cases, through additional detailed microbiological and other laboratory investigations to make an assessment of the contribution of GBS to stillbirths in Kenya.


Eligibility Criteria:
Inclusion Criteria:

* Admitted for delivery

Exclusion Criteria:

* Consent refusal
A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period

The main aim of this study is to show how well TAK-279 reduces the skin plaques compared to placebo, in participants with moderate-to-severe plaque psoriasis. Participants will be assigned to one of the 3 study treatments (TAK-279, apremilast (an approved treatment), or a placebo). Participants will be in the study for up to 69 weeks.

The drug being tested in this study is called TAK-279. TAK-279 is being tested to treat people with moderate to severe plaque psoriasis.

The study will enroll approximately 1000 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups for TAK-279, placebo, or apremilast in a ratio of 2:1:1 which will remain undisclosed to the patient and investigator during the study (unless there is an urgent medical need):

* TAK-279
* Apremilast
* Placebo

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 69 weeks. Participants will go through a screening process to make sure they meet the rules for taking part in the study. This will take up to 35 days. If participants meet the study rules, they will be treated for up to 60 weeks. There will be a safety follow-up visit 4 weeks after their last day of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Plaque psoriasis for at least 6 months.
2. Moderate to severe disease.
3. Candidate for phototherapy or systemic therapy.

Exclusion Criteria:

1. Other forms of psoriasis.
2. History of recent infection.
3. Prior exposure to TAK-279 or active comparator.

Other protocol defined inclusion/exclusion criteria apply.
In Vivo nCLE Study in the Pancreas With Endosonography of Cystic Tumors

Assess the safety and efficacy of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in differentiating benign from malignant and premalignant cysts (e.g. mucinous from non-mucinous cysts)

The primary aim of the study is to define interpretation criteria to differentiate mucinous from non-mucinous cysts and classify more precisely the cysts. Once these criteria have been defined, the diagnostic parameters of nCLE in differentiating the different types of cysts and the reproducibility of these criteria will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for an EUSFNA procedure of a pancreatic cyst,
* Patients aged 18 years or older,
* Patients is under surgical consideration for management of the cyst
* Patients have provided written informed consent for the study

Exclusion Criteria:

* Allergy to fluorescein
* Pregnancy or breast-feeding
An Investigational Drug in Patients With Osteoarthritis (0663-073)

This study was conducted to assess the safety and tolerability of an investigational drug and to evaluate its effectiveness in the treatment of osteoarthritis of the hip or knee in both men and women.

The duration of treatment is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of the hip or knee who use current approved medication (nonsteroidal anti-inflammatory drugs (NSAIDs)) or tylenol to treat the symptoms of their osteoarthritis. Patients taking NSAIDs are required to discontinue using these drugs and their symptoms must become worse.

Exclusion Criteria:

* Patients with certain medical conditions may not be allowed to participate. These conditions will be reviewed with the study physician.