cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Bevacizumab Therapy With or Without Erlotinib for First-Line Treatment of Non-Small Cell Lung Cancer (ATLAS)

This is a Phase IIIb, multicenter, randomized, placebo-controlled trial to evaluate the safety and efficacy of chemotherapy+bevacizumab followed by bevacizumab+erlotinib versus bevacizumab+erlotinib placebo in subjects with locally advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Histologically or cytologically confirmed NSCLC
* Advanced NSCLC or recurrent disease
* INR no greater than 1.3 and aPTT no greater than upper limits of normal (ULN) within 28 days prior to enrollment for subjects not on low molecular weight heparin or fondaparinux. Subjects on low molecular weight heparin or fondaparinux are not required to meet INR or aPTT limits. Chronic full-dose anticoagulation with warfarin is not permitted.
* 18 years of age or older
* For women of childbearing potential and sexually active men, use of an accepted and effective method of contraception (hormonal or barrier methods, abstinence) prior to enrollment and for the duration of the study

Exclusion Criteria:

* Prior systemic chemotherapy in the metastatic setting
* Treatment with an investigational or marketed agent that acts by either EGFR inhibition or anti-angiogenesis mechanisms
* Pregnancy or lactation
* Any other medical condition, including mental illness or substance abuse, deemed by the clinician to be likely to interfere with a subject's ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
* Active infection or a fever within 3 days of enrollment
* Active malignancy other than lung cancer
* Radiation therapy to sites other than whole brain within 14 days prior to enrollment
* History of gross hemoptysis within 3 months prior to enrollment
* Known hypersensitivity to any of the components of cytotoxic chemotherapy combinations, bevacizumab, or tyrosine kinase inhibitors
* Inadequately controlled hypertension
* Unstable angina or New York Heart Association Grade II or greater CHF
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to enrollment
* History of myocardial infarction within 6 months prior to enrollment
* History of stroke within 6 months prior to enrollment
* Symptomatic peripheral vascular disease within 6 months prior to enrollment
* Evidence of bleeding diathesis or coagulopathy
* Serious, non-healing wound, ulcer, or bone fracture
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment; anticipation of need for major surgical procedure during the course of the study
* Current, recent, or planned participation in an experimental drug study other than this Genentech-sponsored bevacizumab/erlotinib study
* Progressive neurologic symptoms in subjects with a history of brain metastases
* History of significant vascular disease (e.g., aortic aneurysm)
Correlation Between Computer Tomography Angiography and D-Dimer Level for the Diagnosis of Pulmonary Embolism

A blood sample was taken before starting the patients on any thrombolytic treatment. The positivity threshold for D-Dimer was above 250 ng/ml. CTPA was performed after performing blood sampling. Patients with confirmed pulmonary embolisms were admitted to ICU for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. Signs of shock or hemodynamic instability should be observed regularly. Patients were managed in the ICU with anticoagulants by parenteral use. The most commonly used items were Heparin, either Unfractionated (UFH) or low-molecular-weight heparin (LMWH).D-dimer levels can leverage to detect PE. D-dimer levels can help in guiding the option of CTPA and the initiation of treatment for patients with suspected PE.

A blood sample was taken before starting the patients on any thrombolytic treatment. The positivity threshold for D-Dimer was above 250 ng/ml. CTPA was performed after performing blood sampling. Patients with confirmed pulmonary embolisms were admitted to ICU for continued monitoring of vitals, consciousness level, and signs of tissue perfusion. Signs of shock or hemodynamic instability should be observed regularly. Patients were managed in the ICU with anticoagulants by parenteral use. The most commonly used items were Heparin, either Unfractionated (UFH) or low-molecular-weight heparin (LMWH).Presenting symptoms were mainly dyspnea, chest pain or discomfort, cough, and shortness of breath. Twenty-four patients of the total number of cases were positive for CTPA while four patients were negative for PE by CTPA. embolism was detected in the anterior, posterior, medial, and lateral basal segmental branches of the right lung, the lateral, posterior, and anterior basal segmental branches of the left lung, and the posterior segmental branch of the left lung. The D-dimer test and CTPA both provided similarly accurate PE diagnoses with no significant differences between them. There were 28 patients total, 3 of those patients had D-dimer levels below the cut-off value of 250 ng/ml, whereas the remaining 25 had D-dimer levels over the diagnostic threshold. Those with a positive CTPA diagnosis of PE had greater levels of D dimers than those with a negative CTPA diagnosis of PE. plasma D-dimer concentration did not correlate with the cross-sectional diameter of the blocked pulmonary vessel.D-dimer levels can leverage to detect PE. D-dimer levels can help in guiding the option of CTPA and the initiation of treatment for patients with suspected PE.

Eligibility Criteria:
Inclusion Criteria: Acute chest pain, dyspnea, tachypnea, and suspicion of PE -

Exclusion Criteria:the history of PE, the administration of anticoagulant medication before blood sampling, an allergic response to the CTPA contrast agent, impaired hepatic function or renal function, inability to cooperate during examinations, and an absence of relevant medical records for analyses

-
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease

This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) \<30, including those on hemodialysis or peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

1. Positive for anti-HCV Ab (Antibody) and HCV RNA \>1,000 IU/mL at Screening.
2. Screening laboratory result indicating HCV genotype 1 infection.
3. Subject has never received antiviral treatment for hepatitis C infection (treatment-naive subject) or subject has received previous treatment with peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of treatment or relapsed after end of treatment).
4. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m\^2 as estimated by the Modification of Diet in Renal Disease (MDRD) method.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency Virus (HIV Ab).
3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
Interest of Wicking for Ossicular Surgery and Myringoplasty

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

Putting in place a wicking often requires to remove this wicking, feared by the patient. In addition, wicking leads to obstruction of the external acoustic meatus responsible for functional discomfort (feeling of fullness in the ear, pain, significant conductive deafness) which can last from one to several weeks depending on the type of wicking.

Despite these drawbacks, the rationale for wicking has never been established, the choice of wick type is often empirical, and its necessity is sometimes controversial in the literature. Recent studies have studied the absence of wicking as an alternative to overcome its many drawbacks. No prospective, randomized, multicenter study has been performed to show the superiority of wicking in healing following middle ear surgery (myringoplasty, stapedo-vestibular ankylosis, ossiculoplasty) via the duct or the endaural route. The only study with a high level of evidence concerns only endoscopic surgery. This study has the advantage of showing that with comparable audiometric and healing results, the absence of wicking allows a reduced operating time, an earlier reduction in otorrhea and the feeling of blocked ears, and an earlier improvement of hearing. Given this work in the literature, our hypothesis is that tympanic healing is not impaired in the absence of wicking.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (age 18 = or + ), whose mother tongue is French or who understands French language
* Ossicular surgery (fitting of a partial or total ossicular prosthesis) or myringoplasty performed endoscopically, from the speculum, from the duct or from the endaural.
* Tympanic reconstruction by all types of grafts: cartilage, fascia, autologous fat
* Written consent signed by the participant
* Affiliation to a social security scheme,

Exclusion Criteria:

* Pregnant or breastfeeding woman, patient under legal protection, guardianship or curatorship.
* Need for a retroauricular approach.
* Need for annulus detachment\> 60%
* Presence of cholesteatoma or middle ear tumor
Diabetic Kidney Alarm (DKA) Study

The overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated kidney injury molecule 1 \[KIM-1\], neutrophil gelatinase-associated lipocalin \[NGAL\] and matrix metallopeptidase 9 \[MMP9\]) exist in diabetic ketoacidosis (age 3-18), whether it is reversible and whether it is related to uricosuria and copeptin. The investigators propose to study a cohort of youth (ages 3-18, n=40) with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up.

Every year over 86,000 children (0-14 years) worldwide are diagnosed with type 1 diabetes (T1D) translating to a lifetime of exposure and risk for early death from cardiovascular disease (CVD) and diabetic kidney disease (DKD). DKD, which manifests in children and adolescents, remains the leading cause of renal failure and dialysis in the Western world (4). While diabetic glomerulopathy has received significant attention from researchers, determinants of tubular injury in diabetes are less well examined. Compared to glomerular injury, tubular injury is known to associate better with renal function. The majority of youth diagnosed with T1D in the US present with diabetic ketoacidosis (DKA), a condition associated with risks factors for tubular injury including dehydration, metabolic acidosis and acute glycemia. It is unknown whether DKA is associated with tubular injury. The investigators published the first report showing that youth with established T1D have more acidic urine and higher fractional excretion of uric acid (FeUA) than their non-diabetic peers, which may predispose to UUA-mediated tubulopathy. Furthermore, T1D is associated with vasopressin overactivity, and the investigators reported strong relationships between serum copeptin, a reliable surrogate marker for vasopressin, and DKD in T1D. The overarching goals of this study are to determine whether tubular dysfunction (elevated urine sodium, bicarbonate and amino acids) and injury (elevated KIM-1, NGAL and MMP9) exist in DKA, whether it is reversible and whether it is related to uricosuria and copeptin. The investigators propose to study a cohort of youth (ages 3-18, n=40) with T1D who have serum and urine collection at DKA diagnosis and 3-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* New onset T1D and known T1D
* DKA (mild, moderate and severe DKA eligible)
* 3-17 years of age
* Toilet trained
* Boys and girls
* All ethnicities
* Initial presentation to Children's Hospital Colorado (CHCO) Main ED

Exclusion Criteria:

* Non-T1D etiology
* History of chronic kidney disease (eGFR \<60ml/min/1.73m2) or dialysis dependent
* History of tubulopathy (e.g. Fanconi syndrome)
* Currently menstruating
* Patient visiting Colorado with plan to establish diabetes care outside of Colorado
* On ACE-inhibitors or angiotensin II-receptor blockers (ARB)
* On sodium-glucose co-transporter 2 inhibitors (SGLT2 inhibitors)
Comparison Of The Berlin Questionnaire To The Portland Sleep Quiz

This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

The purpose of this study is to determine whether the Portland sleep apnea quiz has a higher specificity and negative predictive value then the Berlin Sleep Questionnaire in a patient population with a high predisposition to sleep apnea presenting to a sleep center.

This trial is enrolling patients who are already being seen at OHSU sleep disorder center or have been referred for clinical reasons by their physician to the OHSU sleep disorder center and are going to have a sleep study that would be paid for by their insurance company for clinical reasons.

400 consecutive adult subjects who have been referred by their doctor to the sleep disorder center and are undergoing a diagnostic sleep study at the OHSU sleep disorders center will be requested to fill out both a Berlin questionnaire and Portland sleep quiz on the night of the initial diagnostic polysomnography. The questionnaires will be collected and scored in a confidential manner. The predictive value of the questionnaires will be compared with the results of overnight polysomnography (Apnea Hypopnea Index).

Eligibility Criteria:
Inclusion Criteria:

* Adults more than 18 years old

Exclusion Criteria:

* Subjects Unwilling to Complete the Questionnaire
Eczema Reminder and Accountability Program

Eczema is a chronic disease that requires long term and extensive treatment. However patient adherence to the treatment plans provided to them by their healthcare providers is poor. Frequent follow-up appointments have been demonstrated to improve treatment adherence, this may be due to patients feeling a sense of accountability which motivates them to adhere to their treatment. However, although frequent follow-up appointments are effective, they are not feasible. The goal of the Eczema Reminder and Accountability Program (ERAP) is to assess the effectiveness of a patient reminder system on patient adherence to treatment and the outcome of eczema. Participants will receive weekly/biweekly text messages that encourage them to adhere to their treatment plan, and asks them to assess the severity of their eczema and adherence to treatment for that week using questionnaires. Participants are then asked to send the completed questionnaires to Hamilton Allergy. Should the ERAP improve eczema outcome and treatment adherence, the goal is to use the ERAP as a virtual follow-up to reduce the need for frequent in-office follow-ups.


Eligibility Criteria:
Inclusion Criteria:

* Chronic atopic dermatitis.
* Age 0 to 16.

Exclusion Criteria:

-
The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates

This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.

Heel prick blood collection, which is one of the painful medical procedures, is one of the diagnostic methods used in newborns and is a more painful procedure compared to other blood collection procedures. Prevention of pain in newborns should be the primary goal of all healthcare personnel working with newborns, both because it is an ethical obligation and because repeated painful exposures have the potential to cause harmful consequences. Nonpharmacologic methods used for the control of acute pain associated with medical procedures are easy to use, have no side effects, are inexpensive and time-saving. Mechanical vibration and ShotBlocker application are among the non-pharmacologic methods frequently used in the management of pain associated with heel prick procedure in term infants.

Previous studies have shown that parent-related methods (kangaroo care, mother/father hug, breastfeeding, etc.) are commonly used for pain management of the newborn during heel prick. In this respect, it is important to determine the effectiveness of mechanical vibration and ShotBlocker methods that can be used independently of the parent, especially in intensive care settings where access to the parent is not always possible.

Eligibility Criteria:
Inclusion Criteria:

* with a postnatal age of 24-72 hours,
* birth weight of 2500 g and above,
* 5th minute APGAR score above 6,
* able to carry out vital activities without support,
* fed within one hour before the procedure,
* calm and not crying before the procedure,
* babies who had heel prick for the first time

Exclusion Criteria:

* with genetic or congenital anomaly,
* with neurological, cardiological and metabolic diseases,
* in need of respiratory support,
* having a history of sedative, analgesic, or narcotic use within 24 h before admission,
* hospitalization and surgical procedure experience in neonatal intensive care unit,
* experience with needle interventions other than vitamin K and Hepatitis B vaccine,
* babies of mothers with a history of substance abuse
Microvascular Decompressive Surgery for Hemifacial Spasm

* Review the clinical outcomes of Micro vascular decompression of Hemi facial Spasm.
* Assess safety and efficacy of Micro vascular decompression.
* Improve the outcome of these patients and decease rate of recurrence and complications.

Hemi facial spasm (HFS), a term described in 1905 by Babinski but first reported by Schultz in 1875, is a highly morbid movement disorder characterized by intermittent involuntary movement of muscles innervated by the facial nerve.

(HFS) affects roughly 10 in 100,000 individuals in fifth or sixth decades of life.

Primary HFS is commonly attributed to vascular loops compressing the seventh cranial nerve at its exit zone from the brainstem. The facial nerve compression is thought to lead to ephaptic transmission and to hyperactivity of the facial nucleus, resulting in the involuntary facial movements.

Secondary HFS frequently follows peripheral facial palsy or may arise from facial nerve damage produced by tumours, demyelinating disorders, traumatisms, and infections accounting for 1-2 \& of HFS.

Over four in five primary HFS cases involve either anterior or posterior inferior cerebellar artery as the primary offender although vertebral artery, multiple vessels and veins may be involved.

EMG recordings confirm the diagnosis by showing a typical electrophysiological signature: clonic facial muscle contractions, hyperactivity, and synkinesis, lateral spread evoked responses.

Imaging can be useful for confirming that HFS is primary in nature and due to a neurovascular compression. In most cases (95% of the patients) the compressive vessel, generally an artery, is seen on MRI combined with MR-Angiography (MRA). High resolution T2-sequence is to be used to get good delineation of the facial nerve.

Many treatments for HFS have been reported, including pharmacological agents, botulinum toxin injection, facial nerve blockage, physical therapy, radiofrequency ablation, acupuncture, as well as facial nerve combing and microvascular decompression (MVD).

However, while MVD is effective, there are still significant postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

Primary Hemi facial spasm Unilateral Adults 20-60 years Clinical Diagnosis confirmed by Facial Evoked potential \& Neuroimaging

Exclusion Criteria:

Secondary Hemi facial spasm caused by intracranial masses or other lesions Recurrent Hemi facial spasm Patients who are unfit for any neurosurgical interventions.
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).


Eligibility Criteria:
Inclusion Criteria:

* primary, end-stage hip osteoarthritis requiring total hip arthroplasty

Exclusion Criteria:

* inflammatory arthropathies
* liver disorders
* neoplastic conditions
* clotting disorders
Emotions, Dopamine, Brain and Body

The study will examine the influence of domperidon (20mg) on brain and hebavioral responses to emotional stimuli (videos) using fMRI


Eligibility Criteria:
Inclusion criteria

* 18-40 years old men and women
* Consent to participate
* Fluent in German
* Physically and mentally healthy. No regular medication
* BMI 18-25 kg/m2
* Alcohol consumption less than 15 glasses a week (wine / beer, a glass of higher-percentage alcohol counts as two glasses of beer)
* No illegal drug consumption in the week previous to the experiment
* No smoking
* No extreme athletes
* No vegetarians or vegans or any other dietary restrictions due to allergies or intolerances
* Normal day-night rhythm (no shift work)

Exclusion criteria

* Former or current illnesses of:
* Brain or mind (including anxiety disorders, depression, eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache, psychiatric or neurological abnormalities)
* Heart or blood circulation
* Gastro-intestinal or endocrine disorders
* Other serious past or present medical conditions (for example, metabolic syndrome, diabetes).
* Current medication and medication over a period of two weeks prior to the examination.
* Other serious health problems or present strong mental or physical stress.
* No current infection or excessive stress
* Missing consent to receive information about incidental findings from the MRI
* Tendency to claustrophobia, dizziness or panic attacks.
* Wear a non-removable pacemaker, defibrillator, hearing aid, drug pump, neurostimulator or implant with solenoid valve (e.g., artificial bowel outlet).
* Metal parts or implants inside the body, for example, due to surgery or injury with a metallic foreign object (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coil, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents).
* Have non-removable metal parts or metal-containing devices on or in the body.
* Have ferromagnetic metal parts or implants inside the body (e.g., hip replacements, artificial joints, heart valves, vessel occlusions or dilatations, surgical clips, bone screws or plates, coils, shunts, catheters, electrodes, coils, radiation sources, shrapnel, projectiles, stents)
* Wearing magnetically fixed implants (e.g., amalgam fillings, glass eye).
* Professionally or privately being involved in the processing of metals.
* Have large tattoos (whole limbs).
* Being pregnant.
* Wear a intra-uterine device.
* Having tinnitus.
* Hypersensitivity or allergy to Domperidone or common excipients (lactose-1, corn Starch, potato starch, microcrystalline cellulose, castor oil, povidone, sodium lauryl sulfate, magnesium stearate, hypromellose)