cyrilzakka/clinical-trials huggingface dataset:
A Subject Treatment Preference Study of Tivozanib Versus Sunitinib in Subjects With Metastatic RCC

Randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC).

This is a randomized, double-blind, 2-arm crossover study comparing tivozanib hydrochloride and sunitinib in subjects with metastatic RCC who have received no prior systemic therapy for Renal Cell Carcinoma (RCC). Approximately 160 subjects will be stratified for ECOG score (0 vs 1) and histology (clear cell vs non-clear cell) and then will be randomized 1:1 to 1 of 2 treatment arms. The study consists of two 12-week treatment periods with a 1-week washout in between. Subjects will receive double-blind (over-encapsulated) tivozanib hydrochloride and sunitinib sequentially. The study is designed to compare subject treatment preference, as well as overall safety and tolerability, frequency of dose modifications and kidney-specific health outcomes/QoL.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable mRCC
* Histologically or cytologically confirmed RCC of any histology
* Subjects with or without prior nephrectomy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Any prior systemic therapy for treatment of mRCC (including investigational or licensed drugs that target VEGF or VEGF receptors/pathway, or are mammalian target of rapamycin \[mTOR\] inhibitors)
* Central nervous system malignancies or metastases
* Significant hematologic, gastrointestinal, thromboembolic, vascular, bleeding, or coagulation disorders
* Significant serum chemistry or urinalysis abnormalities
* Significant cardiovascular disease, including symptomatic left ventricular ejection fraction or baseline LVEF of ≤ institutional lower limit of normal, uncontrolled hypertension, myocardial infarction or severe angina within 6 months prior to administration of first dose of study drug, history of class III or IV congestive heart failure, or history of serious ventricular arrhythmia, cardiac arrhythmias, or coronary or peripheral bypass graft within 6 months of screening
* Corrected QT interval (QTc) of \>480 msec using Bazett's formula
* Currently active second primary malignancy
The Swedish Study of Irrigation Fluid Temperature in the Evacuation of Chronic Subdural Hematoma

The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic subdural hematoma requiring burr hole evacuation.
* Patients older than 18 years of age.

Exclusion Criteria:

* Chronic subdural hematoma requiring surgical treatment other than burr hole evacuation.
* Chronic subdural hematoma in a patient with an intracranial arachnoidal cyst.
* Chronic subdural hematoma in a patient with a Cerebro Spinal Fluid-shunt.
* Patients who have undergone intracranial surgery before.
Case Management of Complex Pluripathology in Primary Care

Aims

To assess the effect of the implementation of the Community Nurse Case Manager (CNCM) in the care of complex and pluripathological chronic patients (CPCP) with dependence, from Primary Care, on functional capacity, cognitive performance, quality of life, consumption of health resources, clinical parameters, overload of the main caregiver, and satisfaction of the user and/or caregiver.

Design

Pre- and post-intervention quasi-experimental study in CPCP.

Methods

212 subjects will be recruited from two urban health centers in Salamanca (Spain) with complex and chronic pluripathology (CCP) associated to cardiac, respiratory pathology and/or diabetes mellitus, who are dependent and have a planned hospital discharge.

An initial evaluation will be performed after hospital discharge in both groups, including: anamnesis (prescribed drugs and symptoms attributable to the underlying pathology), physical examination (blood pressure, heart rate and oxygen saturation), determination of capillary HbA1c, and assessment of functional capacity (Barthel), cognitive performance (MoCA), quality of life (COOP-WONCA), therapeutic adherence and overload of the main caregiver (Zarit). There will be another evaluation at 3,6 and 12 months, when these same variables will be collected, in addition to the number of readmissions in each period and the satisfaction of the user and/or caregiver (Satisfad 14). The nurse from the Primary Care team will provide both groups with the usual care contemplated for this type of patient in the Portfolio of Services of the Health Service of Castilla y León. Additionally, in the experimental group there will be telephone follow-up and the caregiver will be trained on the signs of decompensation and the care required.

Conclusion

The deployment of the NCM (Nurse Care Manager) in Primary Care will provide comprehensive and individualized care to the CPCP and the main caregiver with proactive monitoring. In addition, it will reinforce the involvement of the caregiver and the patient to improve their self-care and will detect early signs and symptoms of decompensation to avoid hospital readmissions.


Eligibility Criteria:
Inclusion Criteria:

* Dependent complex and pluripathological chronic patients (CPCP) with associated cardiac and/or respiratory pathologies and/or diabetes mellitus
* Frail ≥1 point
* Require a main caregiver to perform basic activities of daily living (ABVD)
* Barthel ≤60 points and/or grade II or III dependency recognised by Social Services
* Are immobilised at home and/or require social resource management
* Agree to sign (themselves or their legal guardians) the informed consent for participation in the study

Exclusion Criteria:

* Patients with other pathologies associated with complex pluripathology
* With non-habitual caregivers
* Barthel ≥60 points or grade I dependency recognised by Social Services
* Who reside outside the area assigned to the Garrido Sur and Miguel Armijo health centres despite being assigned to them
Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution

Phase I Study to evaluate safety and tolerability of PRO-230 (atropine sulphate 0.05%) ophthalmic solution through evaluation of incidence of non-expected adverse events (AE), photophobia, pupillary diameter, incidence of expected adverse events, and best near corrected visual acuity (BNCVA)

A total of 29 healthy volunteers will apply PRO-230 ocular solution on both eyes QD (one time per day) for 14 days. The safety variables will include non expected AE, pupillary diameter and expected AE; tolerability variables will include incidence of photofobia, and BNCVA. Exploratory variables include best corrected visual acuity (BCVA), intraocular pressure (IOP), corneal an conjunctival staining with fluorescein and lissamine green, vital signs (heart rate and blood pressure), and results of the Ocular Confort Index (OCI) questionnaire.

The presence of non-expected AE \< 10% will deem PRO-230 as safe; while an incidence of photophobia \< 30% will deem PRO-230 as tolerable.

Eligibility Criteria:
Inclusion Criteria:

* Being clinically healthy
* Ability to voluntarily sign an informed consent form (ICF).
* Ability and willingness to comply with the scheduled visits according to the intervention plan and other procedures of the study.
* Age between 18 and 35.
* Absence of history of contact lens use.
* Women of childbearing age must agree to continue (starting ≥ 30 days previous to the ICF) the use of a hormonal contraception method of a intrauterine device (IUD) during the period of the study.
* Best corrected visual acuity (BVCA) of at least 20/30 (logMAR 0.2) or better in both eyes.
* Best near corrected visual acuity (BNVCA) of at least 20/25 (logMAR 0.1) or better in both eyes.
* Presenting vital signs within normal parameters.
* Presenting an IOP ≥10 and ≤ 21 mmHg

Exclusion Criteria:

* Using any kind of ophthalmic topical products.
* Presenting known allergy or intolerance to any ingrediente of atropine eyedrops or any other derivatives of antimuscarinic agents.
* Using any medication of herbolary products (plant extracts, infusions, naturist preparations, homeopathy, etc) through any route of administration
* For women: being pregnant, breastfeeding or planning to get pregnant during the period of the study.
* Having participated in any clinical study 90 days prior to the inclusion in this study.
* Having participated in this clinical study.
* History of any chronic degenerative disease, including diabetes and hypertension.
* Presenting active inflammatory or infectious diseases when entering this study.
* Presenting unresolved lesions or trauma when entering this study.
* History of any ocular surgery.
* History of any surgery, non-ocular, within the previous 3 months of entering this studies.
* Being or having an direct family member (spouse, parent/legal guardian, sibling, etc) as employee of the investigation site or the sponsor, who participates directly in this study.
Study of Naltrexone for Methamphetamine Addiction

The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 50 years
* Patient is agreeable to conditions of study and signs consent form
Glioma Supra Marginal Incision Trial

G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following:

Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?

This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time of the first surgical resection of HGG in appropriately selected patients. This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and patient allocation, allow for refinement of eligibility criteria for optimal recruitment, confirm safety of procedure and ability to retain participants for the duration of the trial. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial.

Eligibility Criteria:
Inclusion Criteria:

1. Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
2. Age ≥18 ≤ 85 years;
3. Karnofsky Performance Score ≥ 60;
4. Location of tumor in a safe anatomical location and
5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.

Exclusion Criteria:

1. Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
3. Known metastatic cancer;
4. Uncorrectable coagulopathy;
5. Unable to obtain GAD-enhanced brain MRI.
Home Pulse Oximeter Use in Patients With COVID-19

The purpose of this study is to investigate the use of home pulse oximetry monitoring in patients with COVID-19 to trend disease progression and identify need for hospitalization.

This protocol studies patients with suspected non-severe Corona Virus Disease (COVID-19) being discharged to home from an emergency department (ED) or outpatient testing center. Patients will be provided a portable fingertip home pulse oximeter that measures peripheral oxygen saturation (SpO2). Patients will be instructed to check their resting home oxygen saturation three times per day and record these findings. They will be instructed to return to the emergency room for sustained oxygen saturation below 92% or if their symptoms are worsening and they feel they need medical attention. Patients will be called once daily by the research team to collect data in real time. Patients will be monitored for seven days, and at the end of the seven day period, they will return the pulse oximeter as well as a spreadsheet of their home oximetry readings. The purpose is to see if home pulse oximetry identifies disease progression and need for hospitalization in patients with COVID-19. Additionally, there will be analysis of trends in home oximetry readings wand predictors of morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected COVID-19 as defined by the World Health Organization
* Age \> 18

Exclusion Criteria:

* Pregnancy
* Prisoners
* Lack of decision making capacity or cannot provide consent
* Patients being admitted to the hospital
* Patients on home oxygen
* Patients being discharged to a skilled nursing facility
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol

This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Measurable disease as per RECIST v1.1 criteria
* Adequate hematologic status
* Adequate liver function.
* Adequate renal function
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months.
* Women must be postmenopausal or surgically sterile.
* Sexually active male subjects must use a barrier method of contraception during the study.
* Able to consume the prescribed meals

Exclusion Criteria:

* Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
* Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
* Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
* Women of childbearing potential who are pregnant or breastfeeding.
* Currently taking a concomitant medication, other than a premedication, that is:

  * A strong P-glycoprotein (P-gp) inhibitor or inducer.
  * An oral medication with a narrow therapeutic index known to be a P-gp substrate.
  * Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
* Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
* Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
* History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension

The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18-75 years old, with symptomatic PAH
* PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
* Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
* Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
* Signed informed consent

Exclusion Criteria:

* Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria
* Patients who have received prostacyclin or its analogs within 1 month before Baseline Visit, or are scheduled to receive any of these compounds during the trial
* Patients with moderate or severe obstructive lung disease
* Patients with moderate or severe restrictive lung disease
* Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
* Patients with documented left ventricular dysfunction
* Patients with severe renal insufficiency
* Patients with BMI \<18.5 Kg/m2
* Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit
* Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT
* Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training
* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
* Life expectancy less than 12 months
* Females who are lactating or pregnant or plan to become pregnant during the study
* Known hypersensitivity to any of the excipients of the drug formulations
Cisplatin and Pemetrexed With Radiation Followed by Lobectomy

This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.

The purpose of this study is to:

* Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues.
* Test the safety of different dose levels of radiation when given with each combination of chemotherapy;
* Determine what side effects are associated with combining radiation with these two chemotherapy combinations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically and cytologically confirmed non-squamous NSCLC.
* Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1
* Resectable T3 includes patients with a satellite lesion in the same lobe as the primary.
* Male or Female, aged \> or = 18 years and be able to give informed consent.
* Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection.
* Patient should be medically operable
* ECOG Performance Status 0 or 1.
* Adequate bone marrow, hepatic and renal function assessed within 28 days
* Signed informed consent.
* Women of childbearing potential should have negative pregnancy test prior to enrollment to study.
* Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.
* The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
* The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
* Patients must have a negative MRI or CT Scan of the brain.

Exclusion Criteria:

* Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients may not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds or other agents used in study.
* Pregnant or lactating women.
* Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
* Patients with concurrent serious infections.
* Patients with an unstable or serious concurrent medical condition are excluded.
* Presence of third space fluid which cannot be controlled by drainage.
* Weight loss \> 10 percent from baseline weight.
* HIV-positive patients on combination antiretroviral therapy are ineligible
* Patients with hypercalcemia will be excluded.
* Patients who require a pneumonectomy will be excluded.
Whole Blood Specimen Collection From Pregnant Subjects

To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to:

1. be at an increased risk for fetal genetic abnormalities
2. be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy.
3. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits
* Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive
* Subject is 18 years of age or older
* Subject is at an increased risk for one or more of the following:

  * fetal gene and chromosome abnormalities
  * congenital fetal infection
  * known to possess irregular blood group antigens (subject or father of the baby)
  * known to have some other condition amenable to noninvasive prenatal testing

Exclusion Criteria:

* Pregnancy is non-viable