Kornimate/medical-research-clean huggingface dataset:
a phase 2/3 open-label extension study to evaluate long-term safety and efficacy with vx-509 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study is designed to evaluate the long-term safety and tolerability of vx-509 in subjects with active rheumatoid arthritis (ra) on dmard therapy. this study will enroll subjects who completed a previous designated study with vx-509 (e.g., study vx12-509-103).

vx-509 is an oral, selective janus kinase 3 (jak3) inhibitor being developed by vertex. in autoimmune diseases, jak3 is an essential component of the immune signaling cascade. this cascade ultimately contributes to abnormal immune response that results in chronic inflammation and, in the case of rheumatoid arthritis (ra), irreversible damage to cartilage and bones. selective inhibition of jak3 offers a new disease modifying approach to the treatment of ra. this study will follow a "treat to target" (t2t) paradigm. t2t strategies have been followed in non-rheumatologic fields for decades. t2t trials have been conducted for ra from the late 1990's, and have substantiated the concept that treating to a target is associated with a better outcome than standard of care treatment. this has led to recommendations by experts to use t2t strategies in clinical practice.

Eligibility criteria:
inclusion criteria: * subjects must have completed the assigned study drug treatment phase of a previous vx-509 study (e.g., study 103). * subjects must voluntarily sign and date the study 104 informed consent document. * subject must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures. exclusion criteria: * inflammatory and rheumatological disorders other than ra, where arthritis may be a prominent feature. * history of any clinically significant illness that might, in the opinion of the investigator, confound the results of the study or pose an additional risk in administering study drug(s) to the subject * history of tuberculosis (tb), regardless of history of antimycobacterial treatment. * planned surgery during the study. * history of alcohol or drug abuse, or excessive alcohol consumption as determined by the investigator, during the previous 12 months before day 1. * pregnant or nursing an infant or with a life partner who is pregnant, nursing, or planning to become pregnant
longitudinal hemostatic profile after stopping estroprogestative contraceptives

Conditions: Venous Thromboembolism; Contraception

Summary: this prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.

women using a combined oral contraceptive (coc) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. at baseline, before the coc is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.

Eligibility criteria:
inclusion criteria: * women * 18-50 years * current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group) * no current use of an estrogenic contraceptive (control group) exclusion criteria: * personal history of vte * known thrombophilia * recent medical event (hospitalization, surgery, cancer) * pregnancy, post-partum period, current breastfeeding
evaluation of rds multisense® in desaturation analysis in healthy volunteers

Conditions: Hypoxia

Summary: in this clinical study, the investigators will compare vital parameters measurements obtained using continuous data from reference monitors and continuous wireless multisense® monitoring patch in 30 healthy volunteers under induced and controlled hypoxia.

the multisense® strip is a unique, band aid-sized, clinical signal quality, connected strip for real-time monitoring of cardio-respiratory parameters. the multisense® strip measures in real-time, remotely and continuously 11 clinical key-indicators by being attached to the patient thorax: ecg trace, heart rate, oxygen saturation, respiratory rate and relative respiration depth, pulse transit time, plethysmographic trace, perfusion index, skin temperature, physical activity and body position. designed to be worn continuously for at least seven days, the patient can keep the patch during his sleep or in the shower. the aim of this study is to determine the quality of measurements of arterial blood saturation (spo2) provided by the multisense® system in comparison to measurements made with a reference pulse oximetry system under induced hypoxia, in terms of accuracy. the study population includes 30 healthy volunteers.

Eligibility criteria:
inclusion criteria: * men or women between 18 to 50 years of age. * subject able to receive and understand information related to the study and give written informed consent. * subject is a non-smoker or an ex-smoker (stopped smoking for at least 6 months). * subject demographics include a range of dark skin pigmentations, including at least 30% of the total pool, assessed by phototypes v and vi according to the fitzpatrick scale (questionnaire score between 28 and 40). * subject is healthy (assessed by a physical examination and normal ecg and absence of medical treatment except for the birth control pill). * subject authorizing the treatment of their personal data collected during the study (box checked in the consent form). * subject affiliated to the french social security system. exclusion criteria: * subject with antecedent of allergies to adhesives or silicone or a skin disease that would preclude the use of an adhesive. * subject with an implantable device such as a pacemaker. * pregnant or lactating women (assessed by a negative ß-hcg test). * subject with a high-altitude stay during the previous 4 weeks (more than 1 week spent over 3,500 meters). * subject with raynaud's syndrome. * subject in exclusion period (determined by a previous or a current study). * subject under guardianship or trusteeship. * subject under the protection of justice.

Keywords: vital signs connected device real-time monitoring hypoxia spo2 non-invasive blood pressure cardio-respiratory monitoring
active surveillance of papillary thyroid microcarcinoma

Conditions: Papillary Thyroid Microcarcinoma

Summary: the purpose of this study is to better understand the outcomes of active surveillance (observation) instead of immediate surgery, which is the current standard of care for papillary thyroid microcarcinoma (ptmc). patients with a 1.5 cm or smaller thyroid nodule(s) with papillary thyroid carcinoma will be eligible for the study.

the incidence of thyroid cancer has more than doubled in the last 30 years in the united states, europe, canada, and south america. since nearly 50% of this increase is attributable to papillary thyroid microcarcinomas (ptmc), it appears that greater detection and diagnosis of previously subclinical disease is a major factor driving this dramatic rise. the primary objective is to estimate the rate of disease progression (growth of primary tumor or development of loco-regional/distant metastases) over a 3, 5, and 10-year period in a series of ptmc patients followed with active surveillance in the united states. patients who opt for immediate surgery can participate in a sub-study looking at quality of life and anxiety measures as compared to those patients who enroll in the active surveillance main study. patients who enroll in active surveillance can choose to have surgery at any time that they and their treating physician feel that it is in their best interest.

Eligibility criteria:
inclusion criteria: * pathologically confirmed bethesda v or vi thyroid nodules with papillary thyroid carcinoma or high clinical suspicion, or pathologically confirmed bethesda iii or iv nodules with braf mutation. * 2.0 cm or smaller nodules by ultrasonographic criteria * ability to understand and the willingness to sign a written informed consent and hipaa authorization form * must be able to read and write english fluently to participate in the questionnaire portion of the study exclusion criteria: * high-grade or poorly differentiated ptc variants * central or lateral neck lymphadenopathy suspicious for ptc * unfavorable nodule location (e.g. near dorsal surface (by recurrent laryngeal nerve); adjacent to trachea (risk of cartilage invasion) * history of radiation to neck

Keywords: thyroid cancer active surveillance ptmc
a trial investigating the influence of oral semaglutide on the pharmacokinetics of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of semaglutide administered orally in healthy subjects.

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of this trial is to investigate the influence of oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of semaglutide administered orally in healthy subjects.


Eligibility criteria:
inclusion criteria: * male or female aged 18-50 years (both inclusive) at the time of signing informed consent * body mass index (bmi) 20.0 to 29.9 kg/m\^2 (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * smoker (defined as a subject who is smoking at least 1 cigarette or the equivalent per day) * unable or unwilling to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods * any blood draw in excess of 25 ml in the past 30 days, or donation of blood or plasma in excess of 400 ml within the 90 days preceding screening * history (as declared by the subject) of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * history (as declared by the subject) or presence of clinical or non-clinical thyroid disease, including thyroid palpation abnormalities, levels of t3 or t4 (total and free) or tsh outside reference limits, or presence of thyroid antibodies (thyroid stimulating hormone receptor antibody, thyroperoxidase antibody or thyroid antithyroglobulin antibodies)
swallowing intervention during radiochemotherapy on head and neck cancer

Conditions: Head Neck Cancer; Swallowing Disorders

Summary: general objective: to evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy. methods and casuistic: randomized clinical trial phase ii. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from barretos cancer hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. patients are randomized on two groups: control group and speech pathology therapy group

to evaluate and compare the swallowing and life quality swallowing on a group undergoing to speech pathology therapy (intervention) and a control group (no intervention).

Eligibility criteria:
inclusion criteria: * head and neck squamous cell carcinoma * indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy. * oropharynges, larynx and hypopharynx advanced cancer (t3 or t4), classified as resectable; * 18 years old or older; * informed consent signed before any specific procedure exclusion criteria: * previous head and neck surgery * previous radiotherapy or chemotherapy * previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma; * severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy * patients with cognitive deficit which could not comprehend the speech pathology intervention.

Keywords: dysphagia speech language therapy quality of life induction chemotherapy concurrent chemoradiotherapy
regenerative peripheral nerve interfaces to treat painful digit and hand neuromas after amputation

Conditions: Neuroma

Summary: this study is being done to demonstrate the effectiveness of regenerative peripheral nerve interfaces (rpni) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a prospective, observational trial

this will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after rpni surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Eligibility criteria:
inclusion criteria: * 18 years or older * history of unilateral digit, multiple digit, or partial hand amputation * discrete neuroma pain on clinical exam * following standard of care (soc), confirmation through a local block and/or ultrasound imaging will be performed if indicated * must be seen by a hand therapist for at least 6-week trial of desensitization therapy exclusion criteria: * patients with previous surgical treatment for symptomatic neuromas of the digits or hand * patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss * women pregnant at time of enrollment * prisoners * adults who are unable to consent

Keywords: neuroma neuroma pain finger amputation hand amputation
intracavitary fluid and position of c-section-scar

Conditions: Fluid Uterus

Summary: does the presence of intracavitary fluid during hormonal stimulation for ivf depends on the position of c-section-scar ?

to evaluate the correlation between the presence of intracavitary fluid and the position of the c-section-scar in relation to the uterine fundus and the inner cervical os. to this end, we will compare measured variables, in patients with intracavitary fluid and without intracavitary fluid.

Eligibility criteria:
inclusion criteria: * patients above an age of 18 years. * patients performing ivf treatment. * one or multiple c-sections. * c-scar region visible during trans-vaginal scan. exclusion criteria: * patients who were iud carriers in the last 3 months.
cyproheptadine and chlorpromazine effects on spasticity

Conditions: Spinal Cord Injuries; Muscle Spasticity

Summary: the main goal of this research is to understand the neuronal mechanisms that mediate the development of spasticity and motor dysfunction after spinal cord injury. the investigators examine how neurons and neuronal circuits in an injured nervous system adapt to produce the uncontrolled and unwanted muscle contractions that affect the majority (80%) of patients with spinal cord injury. one of the neurons that the investigators study is the motoneuron that excites the muscles of the limbs to produce movement. previously, the investigators have shown that after spinal cord injury, the excessive and uncontrolled activity of motoneurons during muscle spasms is mediated, in large part, by the activation of calcium currents in the human motoneuron. in human patients the investigators have used recordings from single muscle fibres to estimate the contribution of these calcium currents in activating the motoneuron during muscle spasms. in this proposal, the investigators study why motoneurons recover these calcium currents and self-sustained activity after chronic spinal cord injury. because the calcium currents require the presence of the monoamine serotonin (5ht) to activate, and this monoamine is greatly reduced after injury, the investigators examine if the calcium currents recover because the 5ht receptors become spontaneously active without the need for 5ht to bind to the receptor, which the investigators hypothesize to be one of the causes of spasticity after spinal cord injury. this research will pave the way to develop new pharmacological and rehabilitative therapies to both control spasticity after spinal cord injury and augment residual motor movements.


Eligibility criteria:
inclusion criteria: patients must have suffered a trauma to the spinal cord at least 6 months ago or longer. in addition, subjects must exhibit some degree of spasticity as determined by having an ashworth spasticity score, as assessed by a physical therapist, greater than 1. exclusion criteria: * if patients have damage to the nervous system other than to the spinal cord * pregnant women * elderly patients and debilitated patients * alcoholic patients * patients with: * known or suspected allergy to the medication or its ingredients * cardiovascular disease * hypotension * coronary artery disease * reduced liver or kidney function * comatose or depressed states due to cns depressants * blood dyscrasias * bone marrow depression * history of seizures * respiratory problems * hypocalcemia * monoamine oxidase inhibitor therapy * angle-closure glaucoma * stenosing peptic ulcer * symptomatic prostatic hypertrophy * bladder neck obstruction * pyloroduodenal obstruction * history of bronchial asthma * increased intraocular pressure * hyperthyroidism * cardiovascular disease * hypertension * patients taking: * amphetamines * antihistamines-second generation * anticonvulsants * anticholinergics * cns depressants * antidepressants * hypotensive agents * levodopa * lithium
optimal high cpap pressures in preterm neonates post-extubation

Conditions: Preterm Birth; Mechanical Ventilation Complication; Respiratory Distress Syndrome, Newborn

Summary: use of continuous positive airway pressure (cpap) in preterm neonates has traditionally been limited to between 5-8 cmh2o. in recent years, use of cpap pressures ≥9 cmh2o is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. a particular knowledge gap in the current literature is the choice of the level of pressure level when using high cpap as a post-extubation support mode. in this study, we will comparatively evaluate the short-term impact of two different high cpap pressures when used as a post-extubation support mode in preterm neonates.

background: use of continuous positive airway pressure (cpap) in preterm neonates has traditionally been limited to between 5-8 cmh2o. in recent years, use of cpap pressures ≥9 cmh2o is becoming more common in neonates with evolving chronic lung disease, in lieu of other non-invasive modes or invasive mechanical ventilation. however, there are limited data on the effectiveness and safety of this mode. a particular knowledge gap in the current literature is the choice of the level of pressure level when using high cpap as a post-extubation support mode. while it could be argued that the initial high cpap pressure post-extubation should be somewhat higher than the pre-extubation mean airway pressure (paw), there remain concerns of potential complications as well as uncertainty around degree of leak and resulting effectiveness. on the other hand, a suboptimal post-extubation high cpap level may lead to atelectasis and contribute towards extubation failure, potentially prolonging invasive ventilation and associated risks. as such, research towards identification of the optimal high cpap level post-extubation from high invasive ventilation pressures is warranted. objective: to comparatively evaluate the short-term impact of two different high cpap pressures when used as a post-extubation support mode in preterm neonates. hypothesis: we hypothesize that babies extubated from invasive mechanical ventilation with a mean paw between 9-15 cmh2o will demonstrate better physiological and clinical parameters when using high cpap+2 cmh2o vs equivalent cpap levels. methods: design - this will be a prospective, single-centre, randomized cross-over study.

Eligibility criteria:
inclusion criteria: * gestational age \ 7 days; post-menstrual age \<37 weeks; extubation from invasive ventilation with measured mean airway pressure 9-15 cmh2o exclusion criteria: * any congenital or genetic/chromosomal abnormality

Keywords: continuous positive airway pressure electrical activity of diaphragm continuous distending pressure
mometasone furoate nasal spray for treatment of nasal polyposis after surgery (study p03218)

Conditions: Nasal Polyps

Summary: this study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps. patients who met screening eligibility underwent endoscopic sino-nasal surgery (fess) on visit 2. mometasone nasal spray or placebo was started about 2 weeks after surgery and continued for up to 24 weeks or until relapse.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * bilateral nasal polyps * fulfill criteria for polypectomy (be indicated for surgical - fess - treatment) exclusion criteria: * polypectomy within the last 6 months * unhealed nasal surgery/trauma * \>5 previous polypectomies * female of childbearing age who is pregnant, lactating, or not using active contraceptive methods * nasal infection * pulmonary tuberculosis * cystic fibrosis, glaucoma, clinically significant cardiovascular, pulmonary, renal, hepatic, metabolic, hematological, or neurological disease * immunocompromised * rhinitis medicamentosa (rebound congestion following misuse of nasal decongestants) * known hereditary mucociliary dysfunction * significant nasal structure abnormalities * asthmatic attack within the past 30 days * asthmatic patients requiring \>1000 mcg beclomethasone or equivalent * asthmatic patients not stable on corticosteroid therapy

Keywords: functional endoscopic sinus surgery
virtual bronchoscopy (vb) vs. endobronchial ultrasound (ebus) guided mediastinal sampling

Conditions: Lung Cancer,; Mediastinal Tumors,; Lymphomas,; Sarcoidosis,

Summary: the study has been designed to evaluate the clinical application of the new virtual bronchoscopy (vb) -based system for transbronchial sampling of the mediastinal masses or enlarged lymph nodes. the software uses data from thorax ct scan and enables airway segmentation and reconstruction simultaneously with predefined mediastinal targets. the most suitable sites for transbronchial needle aspiration are displayed on the internal surface of the airways showed in vb mode. the diagnostic yield of the new system-assisted tbna will be compared to the reference method (ebus-tbna). the study group includes patients with mediastinal mass or lymph node enlargement in whom diagnostic bronchoscopy and tbna can be applied as diagnostic methods. both, virtual bronchoscopy guided transbronchial needle aspiration (vb-tbna) and ebus-tbna of the mediastinal targets are performed during the same diagnostic bronchoscopy. cytologic material from vb-tbna and ebus-tbna is evaluated by two independent pathologists blinded to the method used to obtain the sample. diagnostic yield and adequacy of aspirates obtained with the two methods will be assessed and compared.


Eligibility criteria:
inclusion criteria: * provided informed consent * mediastinal mass or lymph node enlargement that requires bronchoscopy and transbronchial sampling * quality of the ct scan which allows bronchial tree and mediastinal target segmentation and reconstruction exclusion criteria: * age below 18 years * known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders

Keywords: ebus guided transbronchial needle aspiration (ebus-tbna) virtual bronchoscopy (vb) vb guided transbronchial needle aspiration vb-tbna) mediastinal sampling transbronchial needle aspiration (tbna)