cyrilzakka/clinical-trials huggingface dataset:
Cost Study of Linezolid Versus Vancomycin Among Previously Hospitalized Patients

This is a retrospective, observational, non-interventional drug study using de-identified data from two administrative claims datasets. The study design and analysis will reflect the perspective of the commercially insured. The objectives of this study are twofold:

1. To compare the rates of re-hospitalization among patients treated with either linezolid orally or IV, or vancomycin IV for complicated skin and skin structure infections (cSSSI) or pneumonia hospitalization.
2. To compare the total direct medical costs of patients treated with linezolid orally or IV, or vancomycin IV for cSSSI or pneumonia hospitalization.

A sampling method is not used in this study since it is a retrospective, non-interventional claims database analysis. Pre-specified inclusion/exclusion criteria and ICD-9, NDC, HCPC codes are applied to identify the study cohorts.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

* Patients with a hospitalization for cSSSI or pneumonia for which the discharge date (i.e. index date) is between January 1, 2007 and September 30, 2009.
* Patient must have a claim for either vancomycin (IV) or linezolid (IV or oral) within 7 days following their cSSSI or pneumonia hospitalization discharge date (i.e. index date). We will exclude patients who initially receive both vancomycin and linezolid on the same day. We will apply an intention-to-treat approach and use the first drug as the index drug, even if the "comparator drug" (e.g. vancomycin for linezolid and vice-versa) is used subsequently on a future date. If there are both oral and IV formulations of the same index drug on the same index date, the patient will be kept and categorized as an IV user. As with all duplicate claims, for two claims that have both oral and IV index drug as well as the same IV and oral costs on the same index date, the claim with the oral drug will be removed, and the patient will be called an IV user.
* 18-64 years of age at index date.
* Continuous eligibility for six months prior to the index hospitalization date. No minimum of post-index continuous enrolment is required to assure that early mortality patients are included (maximum of 180 days after the index vancomycin or linezolid claim).

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Patients who were enrolled in Medicare.
* Patients who were over age 65 or younger than 18.
* Patients with fewer than 3 days of oral therapy.
* Patients with index hospitalization of greater than 30 days.
* Patients with osteomyelitis, infective endocarditis, meningitis, joint infections, necrotizing fasciitis, gangrene, prosthetic joint infection, or prosthetic implant/ device infection during index hospitalization.
Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography

hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.


Eligibility Criteria:
Inclusion Criteria:

• The infertile women who indicated for HSG

Exclusion Criteria:

* contraindications to Hyoscine or lidocaine
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy
Cost and Quality in Consumer Sunscreen Preferences

This study seeks to determine what price consumers are willing to pay for a sunscreen product containing their ideal combination of attributes or qualities. This study will assess consumer preferences for various sunscreen qualities, as well as the relative contribution of each preference to the consumer's monetary valuation of a complete sunscreen product. The hypothesis is that respondents' willingness to pay for each sunscreen attribute will vary by demographic characteristics, especially self-identified race and socioeconomic class


Eligibility Criteria:
Inclusion Criteria:

* Subjects age 18 years old or older.
* Subjects who are capable of completing an online, English survey.

Exclusion Criteria:

* Subjects less than 18 years old
* Subjects who have previously completed the study.
* Subjects who are not able to complete an online, English survey.
Assessing ImmunoResponse Post Eribulin: Eribulin and Immunogenicity in Advanced Breast Cancer

After progression of disease after one chemotherapy, metastatic breast cancer patients will be randomized 1:1 to one of the following treatment arms:

Arm A. Eribulin Arm B. Paclitaxel

Blood draws for immune analysis will be performed before start of therapy, on day 1 of cycle 2 and on day 21 of cycle 4 (end of therapy) for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

This is a prospective, randomized Phase IV study. Patients who progressed after one chemotherapy in the metastatic setting will be randomized 1:1 to one of the following treatment arms. Arm A. Eribulin 1.23 mg/m2 on days 1 and 8 q21d Arm B. Paclitaxel 80 mg/m2 on days 1, 8, and 15 q21d Blood draws for immune analysis will be performed before start of therapy on day 1 of cycle 1, on day 1 of cycle 2 (pre dose each) and on day 21 of cycle 4 (end of therapy) and assessed for the primary study aim. Patients will be treated under study conditions for a maximum of 4 therapy cycles.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to beginning of trial specific procedures
* Subject must be female and aged ≥ 18 years on day of signing informed consent
* ECOG 0-1
* Histologically confirmed, HER2 negative breast cancer determined by core biopsy of tumor lesion. Human epidermal growth factor receptor 2 (HER2) negativity is defined as either of the following by local laboratory assessment: In situ hybridization (ISH) non-amplified (ratio ≤ 2.2), or IHC 0 or IHC 1+.
* Indication for chemotherapy
* Previous therapy with one chemotherapy line
* Target lesion (RECIST 1.1)
* Adequate organ function defined as:

Creatinine Clearance \> 50 ml/min ANC ≥ 1.5 x 10 3 /μL Thrombocytes \> 100 x 10 3 /μL

Exclusion Criteria:

* HER2 positive disease
* Indication for an anti-hormone treatment
* Active infection requiring systemic therapy.
* Active autoimmune disease or other diseases that requires systemic treatment with corticosteroids or immunosuppressive drugs.
* History of primary or acquired immunodeficiency (including allogenic organ transplant).
* Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
* Severely impaired liver function (Child Pugh C)
* Hypersensitivity to study medication or any of its components
* Neuropathy (PNP) \> Grade 2 (CTCAE 5.0)
* Congenital long QT syndrome
* Preexisting concomitant use of strong CYP3A4 and CYP2C8 inhibiting or inducing drugs
* Life expectancy of less than three months
* Pregnancy (contraception is required according tocontraceptive guidance)
* Lactation
* Known history of following infections: Human immunodeficiency virus (HIV), History of acute or chronic Hepatitis B or Hepatitis C
* Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
* Does not agree to blood collection
Prediction of Risk of Vascular Structural Damage in Patients with Large Vessel Vasculitis (LVV) Based on PET/MRA Image Evaluation System

Large vessel vasculitis (LVV) causes vascular inflammation, leading to serious complications such as aneurysm formation and stroke. It is difficult to identify the inflammation of the vessel wall by the current imaging methods, thus affecting the timing of treatment and selection of treatment options. Improved examination methods to determine disease activity are highly needed to guide treatment.

This study was designed to assess vascular wall inflammation in patients with large vessel vasculitis by positron emission tomography and magnetic resonance imaging (PET/MRA). The study has a 12-month follow-up period. After completing the baseline clinical assessment, laboratory test and PET/MRA assessment, the intervention protocol will be determined by clinicians. The patients will visit the clinic every 1-2 months according to their specific conditions. Clinical assessment, laboratory test and PET/MRA re-examination will be completed at 6 and 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinically suspected or confirmed LVV and willing to undergo PET/MRA
2. Compliance with long-term follow-up
3. Sign informed consent.

Exclusion Criteria:

1. Patients with other serious cardiovascular and cerebrovascular diseases, malignant tumors, infectious diseases, severe renal insufficiency.
2. Severe mental disorders, severe claustrophobia unable to cooperate with the examination.
3. Patients equipped with cardiac pacemaker, artificial heart valve, ferromagnetic vascular clamp after vascular surgery, aneurysm clamp, artificial cochlea, insulin pump and other drug dosage control devices, steel nail plate and other metal internal fixation, artificial joint, electronic eye, artificial eye.
4. Allergic to contrast medium.
5. Pregnant or lactating women.

Withdrawal criteria:

1. Any exclusion criteria emerged during patient follow-up.
2. Voluntarily withdrew from the study.
Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial)

Due to medical advances and quality of care, mortality in adult intensive care units (ICUs) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the ICU.

A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days).

This study aim to assess whether an optimization of the nutritional therapy coupled with an early mobility during and after the ICU stay allows an improvement in the muscle function at hospital discharge compared to patients receiving the standard care.

Due to medical advances and quality of care, mortality in adult intensive care units (ICUs) has decreased significantly in recent years, leading to a significant increase in the number of patients with high rehabilitation needs on discharge from the ICU. Indeed, these patients are at high risk of complications related to their ICU stay (cognitive impairment, ICU acquired weakness, diaphragm dysfunction, ICU polyneuropathy, post-traumatic stress, malnutrition, etc.). Despite prolonged periods of rehabilitation, there is a significant decrease in functional status and quality of life compared to the previous status of these patient.

A specific management by a multidisciplinary team has been set up since 2017 at the Geneva-ICU for long-stay patients (hospitalised ≥ 7 days) including special attention to weaning from ventilation, nutrition, mobilisation, anxiety, pain, skin condition etc.

The culture of nutritional therapy and early mobilisation is already well established at the Geneva-ICU. However, a comprehensive approach to nutrition and mobilisation during and after the ICU stay could be optimised.

The objective of the study is to determine whether optimization of nutritional therapy combined with early mobilization for patients with long ICU stay will improve muscle function at discharge compared with patients receiving standard care.

Eligibility Criteria:
Inclusion Criteria:

Any patient admitted to the adult ICU :

* ≥18 years old
* On mechanical ventilation with an expected length of stay ≥ 7 days
* Requiring artificial nutrition (enteral and/or parenteral nutrition)

Exclusion Criteria:

Therapeutic withdrawal Pregnant or breastfeeding patients

Neurological disorders with motor deficits:

* New or pre-existing neuromuscular or nervous system disease
* Spinal cord injury Severe polytrauma of the lower limbs (amputation etc.) Non-independent ambulation (including walking aids) before ICU admission

For organizational reasons not allowing follow-up :

* Transfer to another ICU
* Patient living abroad from Switzerland
* Patient living in nursing homes preceding to ICU admission
* Incarcerated patients
* Intellectual/cognitive disabilities or language barrier, limiting ability to follow the instructions
Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.

PRIMARY OBJECTIVES:

I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.

II. To facilitate clinically annotated genomic analyses.

OUTLINE:

Patients submit blood samples for genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
* Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
* For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)

  * Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
* At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Life expectancy \>= 3 months per estimation of investigator
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Capable of understanding and complying with the protocol requirements and has signed the informed consent document
* Satisfy at least one of the following two conditions:

  * Willing and able to provide blood sample for screening purposes
  * Guardant 360 testing completed =\< 60 days prior to registration

Exclusion Criteria:

* Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of \< 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
* Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
* History of solid organ transplantation
* Pregnant or planning to become pregnant within the next 12 months
Natriuretic Brain Pro-peptid Changes in Patients With Chronic Heart Failure Within a Cardiac Rehabilitation Program

Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.

Clinical controlled trial with a double blinded with a aleatory number sequence as the randomization method, patients will be assigned to one of two groups, intervention program (supervises exercise program) and control group (community based exercise)

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years, diagnosed with heart failure (NYHA) II-IV for more than six months

Exclusion Criteria:

* patients with NYHA functional class I, who had attended a cardiac rehabilitation program previously, patients with decompensated diabetes mellitus, hypertension difficult to control, ischemic heart disease in the last month, prior pulmonary embolism, chronic obstructive pulmonary disease, restrictive lung disease , aortic stenosis, new episode of atrial fibrillation and musculoskeletal diseases that limit the performance of physical activity
Stroke Rehabilitation: A Systemized and Hierarchized Rehabilitation Program for the Brazilian Unified Health System

The goal of this clinical trial is to systemize and hierarchize a rehabilitation program for the Brazilian Unified Health System in patients with stroke above 18 years of age and of both sexes. The main question it aims to answer is:

* Do patients with ischemic first episode of stroke have central nervous systems consequences due to peripheral and central nervous system sensibilization?
* Can stroke patients benefit from a systemized and hierarchized rehabilitation program with desensibilization interventions combined with multidisciplinary and educational programs?

We will randomize 60 patients, 30 in each study arm.

Researchers will compare the intervention group with an active control whose treatment is the institutional conventional program to see if innovative desensibilization strategies yield superior results. Authors will also investigate the role of genetic polymorphism and ancestrality in the outcome measures.

Participants will undertake an innovative or conventional rehabilitation program, according to the randomization.


Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological (magnetic resonance or tomography) diagnosis of ischemic stroke;
* Single episode of stroke;
* Clinical stability according to medical assessment;
* Time since stroke onset no longer than 24 months;
* Capacity to understand the study procedures;
* Eligible to be admitted to hospitalization at the institute where the study will be conducted
* Agree to sign the Informed Consent Form (ICF).

Exclusion Criteria:

* Presence of psychiatric disorders;
* Presence of subarachnoid hemorrhage;
* Presence of intracerebral hemorrhage;
* Presence of neuromuscular disorders;
* Presence of other neurological diseases or brain neoplasm;
* Presence of cognitive disorders measured with Montreal Cognitive Assessment (MoCA), scores below 20 points;
* Presence of systemic arterial hypertension (systolic blood pressure ≥ 185mmHg or diastolic blood pressure ≥ 110 mmHg).
Possibilities of Use MRI-Guided Laser Interstitial Thermal Therapy in Medically Intractable Tremor

Medically intractable tremors are a common difﬁcult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Less invasive lesional brain surgery (thalamotomy) procedures by radio-surgery or MRI-guided focused ultrasound have emerged and have proven to be effective in these third-line indications. Recently, a new technology has emerged allowing the performance of minimally invasive lesion surgeries by MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT). MRIg-LITT has been shown to be effective and safe in management of epilepsies and brain tumors. However, no study has evaluated MRIg-LITT for performing thalamotomy in medically intractable tremor.In a pilot study, the investigators propose to evaluate the effect and safety of unilateral thalamotomy by MRIg-LITT in the management of medically intractable tremor of parkinsonian or essential origin.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years age or older with Parkinson\&#39;s disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation

Exclusion Criteria:

* Contraindication to MRI
* Contraindication to general anesthesia
* Patient unable to give their free and informed consent because of cognitive or psychiatric disorders
* Brain anatomical abnormalities not allowing intervention
* Adults protected (guardianship, curators) or deprived of liberty.
Measurement of Psychomotor Recovery After Anesthesia Using 4CRT

The aim of the investigation is to validate the SmartPhone-based 4-Reaction Choice Time Test (4CRT) as a measure for recovery of the psychomotor function in patients after general anesthesia. One hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (N=50) and to the group without midazolam (N=50). All patients will be monitored using 4CRT before and after standardized general anesthesia. The reaction time, measured with 4CRT is the primary outcome parameter of the investigation.

4CRT is a classical psychological test, used to measure the psychomotor speed. This test measures choice reaction time. The participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (PDA, SmartPhone). The average of the response latency, measured during the 10 trials is usually taken as 4CRT outcome.

Eligibility Criteria:
Inclusion Criteria:

* Physical status I-III according to American Society of Anesthesiology
* ambulatory gynecologic surgery of 10-40 min
* patient is able to use VAS and to use SmartPhone-based 4CRT
* given informed consent

Exclusion Criteria:

* age \< 18 or \> 50 years
* patients who are not able to give their informed consent
* surgery lasts more than 40 min.
* history of psychopharmaceuticals or analgesics