Kornimate/medical-research-clean huggingface dataset:
antral follicle priming prior to icsi (intracytoplasmic sperm injection) in previously diagnosed low responders

Conditions: Ovarian Diseases

Summary: the aim of this study is to compare the effectiveness of testosterone,estradiol and a combined treatment with estrogens/progestagens prior to ivf-icsi in previously diagnosed low responder patients.

during controlled ovarian hyperstimulation (coh), most of the early antral follicles are required to grow coordinately. marked follicular size discrepancies during coh imply that an important number of follicles undergo unsatisfactory maturation. it has been proved that follicular priming with estradiol during the luteal phase of the cycle prior to coh or testosterone treatment during the early follicular phase of the coh cycle may increase the amount of oocytes and embryos retrieved. nevertheless there are no prospective studies comparing such approaches. the present study consist of two phases: the present study consists of two different phases: * phase i: (non randomized) identification of confirmed low responder patients. potential low responder patients will be subjected to an standardized ovarian hyperstimulation protocol * phase ii: (randomized) those patients, once confirmed as low responders, will be offered the opportunity to enter the interventional part of the study, being randomized to three different treatment groups: estradiol, testosterone or combined progestagens and estrogens prior to the ivf-icsi cycle. the previous cycle (phase i) will be used as a self-control for each patient.

Eligibility criteria:
inclusion criteria: 1. phase 1 (non randomized. the patient must fit the first plus at least other 2 criteria) * infertility requiring an ivf/icsi treatment * age ≥ 38 years * basal fsh ≥ 10 mui/ml (day 3 of the cycle) * serum amh ≤ 5 pmol/l * antral follicular count ≤ 6 (day 3 of the cycle) 2. phase 2 (randomized. the patient must fit at least one criterion regarding the day of gnrh analogue administration during the cycle performed in phase 1) * less than 4 follicles which mean diameter measuring more than 16mm * serum estradiol levels ≤ 500 pg/ml * 4 mii or less than 4 mii oocytes retrieved exclusion criteria: * patients suffering of endometriosis * patients having progesterone levels ≤ 4 ng/ml (day 21 of the cycle) * patients having a partner affected by severe oligo/astheno/teratozoospermia

Keywords: estradiol testosterone combined oral contraceptive low responders icsi
sleep and breathing in the general population - chemical stimuli

Conditions: Sleep-disordered Breathing

Summary: central sleep apnea (csa) is a common condition and its treatment remains elusive. the focus of this proposal is to identify the role of the physiologic path involving cortical arousals in csa by decreasing arousal frequency using the pharmacological agent zolpidem. the goal is to identify the acute effects of administering zolpidem on sleep and respiratory outcomes, and subsequently, its effect on the severity of csa and propensity to develop csa. this study will shed light on the mechanisms underlying csa that involve cortical arousals and will guide future therapeutic interventions for csa.

the literature suggests that zolpidem may be effective in the treatment of central sleep apnea (csa). however, evidence regarding the efficacy of zolpidem and the underlying mechanisms involved in its effect on csa are not well-studied. furthermore, respiratory-related arousals are hypothesized to contribute csa symptoms and severity. the aim of the study is to determine the effect of decreasing respiratory-related arousals on the propensity to develop central apnea. the investigators hypothesize that administration of the nonbenzodiazepine hypnotic zolpidem will decrease the frequency of respiratory-related arousals, lower the central apnea-hypopnea index, and widen the co2 reserve during sleep in patients with csa compared to no treatment. participants will complete a night study on a low dose of zolpidem and another night study without zolpidem in a crossover manner. the order of night studies is randomized. the results will help unveil the role of arousals in csa and the acute effect of zolpidem on csa severity and the propensity to csa.

Eligibility criteria:
inclusion criteria: * men and women veterans with central sleep apnea, defined as apnea hypopnea index (ahi)\>15/hour with cahi\>5/hour, will be included in the experiments. exclusion criteria: * less than 18 years old * pregnant or breastfeeding female * have severe respiratory disease that require to be on oxygen * recent health event that may affect the ability to participate in the study, * body mass index (bmi) is \>40 kg/m2 * significant insomnia * mental instability * recent health event that may affect sleep * if at any time the principal investigator (pi) identifies that a certain drug is not suitable, or are unable to use the device that is used to treat sleep apnea, will be not be allowed to participate in the study

Keywords: sleep-disordered breathing central sleep apnea
risk-adapted stereotactic body radiotherapy for early non-small cell lung cancer using the vero stereotactic body radio therapy system

Conditions: Non-Small Cell Lung Carcinoma

Summary: the purpose of this study is to perform prospective data analysis on tumor response in terms of local tumor control after 2 years, potential acute and late toxicity and survival in patients with non-metastatic, non-small-cell lung cancer treated by radiotherapy that are medically inoperable due to coexisting comorbidities or that refuse surgery. sbrt regimens used will be 4 fractions of 12 gy or 3 fractions of 17 gy depending on tumor location in a risk-adapted approach.


Eligibility criteria:
inclusion criteria: 1. stage t1,t2,t3n0m0 nsclc, histological confirmation either by biopsy or cytology 2. maximal tumor diameter of 6 cm 3. only t3 lesions based upon thoracic wall involvement, only 1 lesion 4. informed consent is required 5. life expectancy of at least 6 months 6. age \>/= 18 y. 7. karnofsky score ≥ 70 or ecog score ≤ 2 8. inoperable patients or patients refusing surgery 9. patients with measurable lesion (according to recist criteria) exclusion criteria: 1. diagnosis of small cell lung cancer 2. lymph node involvement 3. prior radiotherapy to the chest and/or mediastinum 4. no chemotherapy and/or targeted treatment within 3 months before sbrt 5. pregnant or lactating women 6. known allergy for ct contrast 7. no fdg-pet 8. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. 9. patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.

Keywords: non-small cell lung cancer lung carcinoma nsclc
design improvements with sonnet 3

Conditions: Hearing Loss, Sensorineural

Summary: measuring user-reported satisfaction with the latest behind-the-ear (bte) audio processor model.

this prospective study will use a single-arm, repeated measures design with subjects serving as their own control. participants will be experienced cochlear implant (ci) users wearing an approved bte med-el audio processor. participants will complete a take-home trial with the latest audio processor and then complete a custom questionnaire comparing design and usability to their existing audio processor.

Eligibility criteria:
inclusion criteria: * implanted with a med-el cochlear implant in at least one ear * ≥ 12 months since activation of the med-el audio processor * consistently using a sonnet (eas) or sonnet 2 (eas) audio processor * ability to complete all study procedures * participant and parental (if applicable) commitment to comply with all study procedures for the duration of the study exclusion criteria: * evidence that hearing loss is retrocochlear in origin * unable to provide reliable feedback during cochlear implant programming * skin or scalp condition precluding use of the study device * unrealistic participant or parent (if applicable) motivation or expectations * participants without a stable fitting map at enrollment e.g., due to changes in hearing, global health status, etc.
silent hypoxia and awake proning in covid-19 patients

Conditions: Covid19; Hypoxemia

Summary: the investigators want to examine patients infected with sars-cov-2 for the phenomenon "silent hypoxia", which is clinically significant hypoxia without corresponding degree of dyspnea. the patient population is infected individuals without any serious symptoms and is at home. the participants will be equipped with a pulse oximeter and a pef-measurement device. four times daily the participants will register saturation, degree of dyspnea and pef. if the participants experience desaturation or increasing dyspnea, physiotherapy is to be performed, and if that doesn't relieve symptoms or increase oxygen saturation, the hospital should be contacted for admission. the first part of this study is a feasibility study, and if found feasible, the investigators will expand the study to more participants.


Eligibility criteria:
inclusion criteria: * non dyspneic (nrs =/\< 1) patients with positive sars-cov-2 test * age 18 - 80 years * patients managed at home * inclusion within 72 hours from positive test exclusion criteria: * chronic hypoxia (spo2 \< 93 %) and/or first measured spo2 \< 93 % * admitted to hospital for covid-19 prior to inclusion * unable to perform pulse oximetry * unable to perform physiotherapy

Keywords: silent hypoxia lung physiotherapy home monitoring
a study to learn how the body processes the study medicine called osivelotor (pf-07940367) in people with loss of liver function

Conditions: Liver Diseases

Summary: the purpose of this study is to understand how osivelotor is processed in people with loss of liver function. this study is seeking participants that are: * stable loss of liver function with mild or moderate severity * none of underlying conditions possibly affecting the study medicine being absorbed by the body all participants will receive one amount of osivelotor by mouth before breakfast on the first day at the study clinic. a number of blood samples will be collected to understand how osivelotor is changed and removed from the body. participants will also have to undergo physical examination and other tests. this will help to understand if osivelotor is safe. participants will take part in the study for a maximum of 112 days. during this time, participants will have to stay onsite for 5 days. there will be 5 study visits at the study clinic.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb) * stable hepatic impairment that meets the criteria for class a or b of the child pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit * stable concomitant medications for the management of individual participants' medical history exclusion criteria: * any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery); * hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy; * a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or mri; * presence of clinically active stage 3 or 4 hepatic encephalopathy. clinically active stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.
telerehabilitation in hemato-oncological survivors

Conditions: Hematologic Malignancy; Lymphoma

Summary: this study investigates whether the 12-week home-based exercise training with remote guidance and telemonitoring compared to regular center-based training leads to better long-term cardiorespiratory fitness and physical activity levels in post-treatment patients with lymphoma.

80 lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition, quality of life, costs and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment. investigators assume that home-based training with remote guidance and telemonitoring with objective training data obtained during rehabilitation after cancer treatment will improve long-term motivation and effectiveness of independent training in cancer survivors, resulting in superior cardiorespiratory fitness and physical activity levels.

Eligibility criteria:
inclusion criteria: participants * with hemato-oncological malignancy / lymphoma (in last two months) * after cancer systemic chemotherapy-based treatment * with clinically stable state * with the ability to perform a cardiopulmonary exercise test * with the ability to understand and write in the czech language * with an internet connection at home * literacy with information and communication technology exclusion criteria: participants * with acute heart disease or decompensation in the previous six weeks, * with psychological severe, cognitive disorders, * serious training limitations (musculoskeletal disorders) * currently carried out the recommendations for physical activity (150min per week) * who take part in a training program under supervision elsewhere
d-dimer guided oral anticoagulant treatment (oat)

Conditions: Deep Venous Thrombosis

Summary: this clinical trial will investigate the hypothesis that d-dimer testing can be successfully used to tailor the duration of oat in patients after an unprovoked episode of deep venous thrombosis (dvt) using a prospective, randomized, and controlled design.

after a first episode of acute deep venous thrombosis (dvt) the risk of recurrence is relatively high and clinical consequences are important. therefore, secondary prophylaxis using oral anticoagulant treatment (oat) is usually established in these patients. this treatment very effectively reduces the risk of recurrences but induces an increased risk of bleeding. major bleeding complications can be expected in \~2% patient-years. therefore, current recommendations limit oat to a period of 3 to 12 months. after stopping of oat, however, \~10 % of patients with an initial episode of unprovoked dvt will develop a recurrent event within 1 year. this group of patients may benefit from prolonged oat. the results of 2 independent observational studies showed a significantly higher risk of recurrence in patients showing increased levels of d-dimer after withdrawal of oat. d-dimer is a biomarker that indicates fibrin formation followed by fibrinolysis. based on these data we hypothesize that d-dimer testing can be successfully used to tailor the duration of oat in patients after an unprovoked episode of dvt. this clinical trial will investigate this hypothesis using a prospective, randomized, and controlled design.

Eligibility criteria:
inclusion criteria: to be enrolled in this study, patients must: * have an objectively confirmed first episode of unprovoked vte or of vte during a minor transient risk factor. minor transient risk factors include 6 weeks of estrogen therapy, prolonged air travel (i.e., \> 6 hours), pregnancy, less marked leg injuries or immobilization without injury or surgical intervention * be scheduled to receive oral anticoagulant treatment for at least 3 months * be willing to be randomized * be willing to participate for the full duration of the study exclusion criteria: * pregnancy or breast feeding * contraindications against oat (i.e., intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) * age \< 18 years * presence of antiphospholipid antibodies or any other thrombophilic risk factor requiring long-term oat (i.e., antithrombin deficiency, hereditary pc deficiency) * poor patient compliance

Keywords: dvt venous thromboembolism d-dimer thrombophilia secondary prophylaxis secondary prophylaxis using oral anticoagulant treatment (oat) higher risk of recurrence in patients showing increased levels of d-dimer after withdrawal of oat d-dimer-based treatment
rebound pain after operations for distal radius fractures with a volar plate in brachial plexus block

Conditions: Brachial Plexus Block; Pain, Postoperative

Summary: many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. this study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. the primary endpoint is difference in the highest pain score first 24 hours after surgery. the investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.

this double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. all patients will receive paracetamol and etoricoxib as oral premedication. patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. patients in the control group will receive nacl iv. after surgery, iv and oral rapid release oxycodone as needed while in hospital. after discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. rapid release oxycodone as needed. patients will be followed up by telephone interviews at different times after surgery.

Eligibility criteria:
inclusion criteria: * distal radius fracture planned for operation with a volar plate * 0-20 days after trauma * ao classification a, b, and c * asa 1 and 2 * age 18-65 * bmi 18-35 * able to communicate in norwegian exclusion criteria: * chronic pain * other injuries * pregnancy * known allergic reactions to medicines used in the study
effects of dietary antioxidants on cardiovascular risk factors

Conditions: Obesity; Hyperlipidemia; Hypertension

Summary: the aim of the antioxidant study was to compare the efficacy of foods naturally rich in antioxidants with that of antioxidants in a pill form on markers of inflammation and plasma cholesterol in healthy adults at risk of cardiovascular disease.

increasing the amount of antioxidants in your diet is thought to be one way to improve your health. if antioxidants do have a beneficial effect, one way to measure that is to examine possible changes in the levels of inflammatory markers in your blood. participants were asked to consume an antioxidant supplement including carotenoids, mixed tocopherols, vitamin c and selenium, or a placebo for 8 weeks. the doses of antioxidants will be similar to the amounts suggested by the united states department of agriculture (usda) recommended daily allowances (rda). in addition, a group of participants will be asked to change their usual eating habits and consume more of certain foods that are naturally good sources of the four antioxidants contained in the pills. eligible participants were asked to come to the stanford campus for 3 fasting blood draws over the period of 8 weeks and to complete diet and physical activity questionnaires at the beginning, middle, and end of the study period.

Eligibility criteria:
inclusion criteria:overweight/obesity; high ldl cholesterol, pre-hypertension. exclusion criteria:1. daily intake of \> 5 servings of vegetables and fruits 2. fasting blood glucose \>140 mg/dl 3. bmi \>40 4. liver or renal disease; atherosclerosis (e.g., cad, pad); malignant neoplasm; ongoing infection; inflammatory disease 5.currently taking the following medications: anti-inflammatory drugs lipid lowering drugs anti-hypertensive drugs calcium containing drugs drugs known to affect blood coagulation drugs known to affect antioxidant status 6. pregnant or lactating 7. inability to communicate effectively with study staff

Keywords: adults antioxidants inflammatory markers diet supplements
niv for hypercapnic respiratory failure: avaps vs s/t bipap

Conditions: Hypercapnic Respiratory Failure

Summary: the goal of this study is to compare two different modes of noninvasive ventilation in hypercapnic respiratory failure. the investigators will compare avaps and bipap s/t and hypothesize that avaps will result in a decreased length of stay in the icu or on telemetry. currently, noninvasive ventilation is the standard of care for hypercapnic respiratory failure. however, the most effective mode for patients with hypercapnic respiratory failure is unclear.

1. overall study design and plan this is a single center, randomized trial that will include a total of 100 adult subjects aged 18 or older with hypercapnic respiratory failure of all etiologies (i.e. "all comers"). the investigators will randomize patients in a single-blinded (patient blinded) fashion to bipap s/t or avaps during the duration of their hospitalization. the investigators will assess abg at baseline, 1 hour after initial placement on bipap s/t or avaps, and between hours 24-48 of use. the investigators will record the pre-niv ph and paco2, post-niv ph and paco2, length of hospital stay in the medical icu or telemetry unit, days on niv, need for intubation (if occurred), transition to medical icu care in patients who were initially admitted to telemetry, and in-hospital mortality. all collected laboratory data are already done as part of usual care for all patients placed on niv when a patient is on the telemetry unit or medical icu. the groups will undergo stratified randomization based on whether they are initially admitted to medical icu or medical telemetry. patients from medical icu or telemetry units will be randomized to one of the following arms: arm 1: avaps mode arm 2 2: bipap s/t mode

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form directly by the patient; consent can also be obtained via a legal patient representative/health care proxy/surrogate 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 18 or older 4. diagnosed with hypercapnic respiratory failure on admission (abg) 5. admitted to lenox hill hospital medical intensive care unit or telemetry unit 6. requiring noninvasive ventilation as determined by the treating physician for the treatment of hypercarbic respiratory failure exclusion criteria: 1. patients who require ventilation at predetermined tidal volumes 2. patients who require rapid and frequent ipap adjustments to maintain a consistent tidal volume 3. age less than 18 years of age 4. currently intubated 5. chronic tracheostomy 6. pregnancy 7. hypotension 8. epistaxis (nosebleed) 9. untreated pertussis 10. acute sinusitis or otitis media 11. patients at risk of aspirating gastric contents 12. patients with lack of spontaneous respiratory drive 13. patients with the inability to maintain a patent airway or adequately clear secretions 14. prisoners or other institutionalized individuals

Keywords: avaps bipap hypercapnic respiratory failure noninvasive ventilation