Kornimate/medical-research-clean huggingface dataset:
high flow nasal cannula as a treatment for obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: a single center, prospective study to assess the efficacy of high flow nasal cannula (hfnc) in improving obstructive sleep apnea (osa) parameters in patients with reduced tolerance to continuous positive airway pressure (cpap) treatment.

a single center, prospective study. the study would include 30 patients diagnosed within the past 2 years with moderate to severe osa (ahi\>=15) at the rabin medical center (rmc) sleep lab, and who are intolerant to cpap treatment. following signing an informed consent form, these patients would undergo polysomnography (psg) while treated with hfnc. the hfnc psg outcome measures will be compared to the baseline psg done within the past 2 years and to an additional psg while connected to a cpap device.

Eligibility criteria:
inclusion criteria: * age 18-80 years * confirmed diagnosis of obstructive sleep apnea, diagnosed at rmc sleep lab in the past 2 years * apnea hypopnea index (ahi)≥15 * patient has difficulties to adjust or comply with cpap treatment * signed informed consent form exclusion criteria: * patients who need bilevel positive airway pressure (bipap) * known carbon dioxide (co2) retainers * weight change\>10% compared to time of osa diagnosis * clinically unstable patients * pregnant women or special populations (e.g. children or patients unable to give informed consent)
acupuncture in prevention of postoperative sore throat due to classical laryngeal mask

Conditions: Acupuncture; Laryngeal Mask Airway; Pain, Postoperative; Sore Throat

Summary: the aim of our study is to investigate if stimulation of the p6, li4 and li11 acupuncture points via laser acupuncture prevents sore throat caused by the classic laryngeal mask.

our study is planned as a prospective, randomized, controlled, single blind. the details of the study are explained to the patients and their written informed consents are obtained. using the randomization program, the patients are divided into group 1 (acupuncture group) and group 2 (control group). preoxygenation (100% oxygen with balloon and mask for 3 minutes) and midozolam 0.02 mg / kg and fentanyl 2 mcgr / kg are administered to both groups. in group1, laser acupuncture is applied to each of the previously described p6, li4 and li 11 points on both arms with laser acupuncture device (sedatelec premio 32) for 30 seconds. in group 2, same procedure is performed for 30 seconds while laser acupuncture closed. then, propofol 2mg / kg is administered and a laryngeal mask is placed after 90 seconds in both groups. maintenance anesthesia is provided with sevofurane and remifentanil infusion.

Eligibility criteria:
inclusion criteria: * patients who recieved general anesthesia with lma * surgery duration \< 2 hours * between 18-60 years of age * asa1-2 scores exclusion criteria: 1. being younger than 18 years old or being over the age of 60 2. patients with an asa score of 3 and greater than 3 3. active infections in the area to be acupuncture. 4. prolonged bleeding time 5. liver failure 6. renal insufficiency 7. pregnancy 8. heart failure 9 . patients less than 30 kg 10. uncontrolled hypertension 11. uncontrolled diabetes, pheochrocytoma, thyroid dysfunction 12. those who do not have the ability to read and sign the consent form 13. patients with gastroesophageal reflux 14. history of any herbal medicine use 15. patients who do not want to sign the consent form 16. patients with difficult lma placement 17.patients who cannot have lma placement at one time 18. intubated patients in whom lma could not be placed 19 patients whose operation time exceeds two hours 20 .patients whose operation time is less than 30 minutes

Keywords: sore throat laryngeal mask airway acupuncture
the efficacy & safety of the uas immunotherapy protocol

Conditions: Perennial Allergic Rhinitis With Seasonal Variation

Summary: hypothesis: the uas immunotherapy protocol is efficacious and at least as efficacious as protocols described in the allergy literature.

patients will be assessed for efficacy of the immunotherapy protocol by completing consented-irb approved clinical, medication, quality of life survey questions comparing current status while on therapy in contrast to 12 months before the inception of therapy.

Eligibility criteria:
inclusion criteria: * allergic rhinitis between 18 and 65 years old who have chosen to undergo immunotherapy. exclusion criteria: * no beta blocker use, * no pregnancy, * no systemic steroids, * no severe asthma/copd, * no severe collagen vascular disorders, * no neoplastic or uncontrolled seizure activity, * no previous anaphylaxis, no significant cardiovsacular disease.

Keywords: allergic rhinitis allergen immunotherapy
comparison between two fertility protocols in obese polycystic ovary syndrome patients

Conditions: Obese; Infertility; Polycystic Ovary Syndrome

Summary: the purpose of this study is to compare two fertility protocols in obese women with polycystic ovarian syndrome who are candidates for in vitro fertilization (ivf). these protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.

the purpose of this study is to compare two fertility protocols in obese women with polycystic ovarian syndrome who are candidates for in vitro fertilization (ivf). these protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.the patients in the ivm group will not be exposed to gonadotropin treatment for controlled ovarian hyperstimulation. in the antagonist group we will use gnrh agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.

Eligibility criteria:
inclusion criteria: * bmi \> 30 * pcos * failure of coh treatment

Keywords: best fertility protocol (bmi > 30) women pcos
consolidation versus induction chemotherapy in total neoadjuvant therapy of rectal cancer with high risk for recurrence

Conditions: Locally Advanced Rectal Cancer

Summary: the purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

international recommendations for the treatment of larc with a high risk of disease recurrence are inconsistent, regarding tnt. in germain randomised study more pcr were achieved with consolidation chemotherapy. we will compare our standard approach (induction plus consolidation ct) with consolidation ct.

Eligibility criteria:
inclusion criteria:- histologically proven rectal adenocarcinoma * no distant metastases on ct scan (m0 disease) * at least one high risk factor for disease recurrence identified on mr imaging: * t4 tumor (ct4) * n2 disease (cn2) * extramural venous invasion (cemvi+) * positive lateral lymph nodes * distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cmrf+) * capacity for informed consent * willingness to attend regular check-ups during and after treatment exclusion criteria:history of previous irradiation in the pelvic area * absolute contraindications for mr imaging * distant metastases cannot be reliably excluded * synchronous cancer * chronic inflammatory bowel disease

Keywords: rectal cancer total neoadjuvant therapy induction chemotherapy consolidation chemotherapy
extension study of subjects from study a3921030 for the prevention of acute rejection in kidney transplant patients

Conditions: Kidney Transplantation

Summary: this is a study that will follow transplant patients from study a3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in portugal where the study will follow transplant patients through month 36 posttransplant. patients will continue their study medications that were previously assigned.


Eligibility criteria:
inclusion criteria: * subjects who successfully completed study a3921030 exclusion criteria: * subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants

Keywords: immunosuppression jak inhibitor kidney transplantation
peroral endoscopic myotomy for primary esophageal achalasia

Conditions: Primary Achalasia

Summary: recommended therapies for esophageal achalasia are endoscopic pneumatic dilation and heller-dor surgical myotomy. endoscopic myotomy has been recently proposed in human patient in expert centers in japan, us and germany. in theory, endoscopic myotomy is as effective as surgical myotomy but less invasive and more effective with less complications than endoscopic pneumatic dilation. up to now, published studies have confirmed these expectations, with 100% efficacy and no clinically significant complications. the present clinical trial with study the security and efficacy of peroral endoscopic myotomy in primary achalasia patients.


Eligibility criteria:
inclusion criteria: 1. patients of both sexes aged over 18 years old 2. patients who have signed the informed consent form before any study related procedure 3. primary achalasia of the cardia with eckardt score \> 3 4. non sigmoid achalasia or s1 sigmoid type achalasia at barium meal rx study 5. asa score (american society of anaesthesiologists) 1 or 2 6. patients affiliated to a social security health system exclusion criteria: 1. patients with age less than 18 years old 2. patients without discernment with legal protection 3. patients who will not be able to abide with study follow-up as judged by the investigator 4. patients which cannot provide a written informed consent 5. patient refusing to participate in the study, without informed consent 6. pregnant or breastfeeding women, women in fertile age for procreation without efficient contraception, and/or positive serum βhcg test 7. concomitant participation in other clinical trial 8. s2 sigmoid type primitive achalasia of the cardia 9. pseudo-achalasia (esophageal carcinoma), 10. history of barrett's esophagus with or without dysplasia, malignant tumors of the esophagus 11. history of esophageal strictures, systemic sclerosis 12. history of esophageal varices 13. history of endoscopic or surgical therapy of the esophageal achalasia 14. history of inferior endoscopic or surgical esophageal sphincter manipulation (sutures, polymers injection, adhesive bands) 15. history of surgical interventions of the esophagus or stomach (fundoplication, heller-dor myotomy, gastric resections, vagotomy with or without gastric drainage) 16. history of congenital of acquired coagulation anomalies: hemorrhagic diseases, hemostasis disturbances (tp \ 40 seconds, platelets \< 60000/mmc) 17. asa score (american society of anaesthesiologists) 3, 4, 5 or 6 18. cancer, liver, respiratory, renal or heart failure which put the patients in the asa risk group 3,4,5 or 6.

Keywords: primary esophageal achalasia endoscopic myotomy high resolution manometry
clinical effectiveness of newer antipsychotics in comparison with conventional antipsychotics in schizophrenia

Conditions: Schizophrenia

Summary: this study is designed to compare the efficacy and drug tolerability of two strategies for the treatment of schizophrenia. the two strategies consist of utilizing, on the one hand, a conventional antipsychotic like haloperidol or flupentixol and, on the other hand, a newer antipsychotic compound like olanzapine, quetiapine or aripiprazole in patients with schizophrenia.

there is agreement in the psychiatry community that the so-called atypical antipsychotics should be considered first choice in the treatment of schizophrenic disorders. however, the general superiority of these newer antipsychotic drugs over the older conventional drugs could not be clearly demonstrated in recent controlled clinical trials. the discrepancy between every day's clinical perception and the results of clinical trials raises the question whether the studies performed so far employed the adequate methodological approach to represent the daily practice situation which is characterized by a wide variety of duration and type of the schizophrenic disorder, concomitant diseases, and medications. moreover, some studies might not have been focused adequately on patient-relevant outcome variables. the present study project is designed to answer these open questions. the innovative character of the study design is 1. that different neuroleptic strategies will be compared rather than single antipsychotic drugs, using 2. an enhanced biometric design, that provides a choice of treatment with respect to the individual patient though the trial as such is randomised controlled and double blind; 3. that clinically relevant endpoints such as quality of life will be the primary variables, and 4. inclusion and exclusion criteria lead to a study population representing clinical every day practice as near as possible. another innovatory procedure is that serum levels of the study drugs will be recorded twice during the study. the authors hope that their design might yield transfer effects for other clinical trials facing similar problems.

Eligibility criteria:
inclusion criteria: * schizophrenia * age 18-65 years * necessity to establish new or change antipsychotic treatment due to unsatisfying results or side effects * written informed consent exclusion criteria (amongst others): * known or suspected hypersensitivity to olanzapine, quetiapine, aripiprazole, flupentixol or haloperidol * acute suicidal tendency * "einwilligungsvorbehalt (bgb)" or "unterbringung (psychkg)" * epilepsy * organic psychosis * parkinson disease * dementia * history of malignant neuroleptic syndrome * qtc interval ≥ 0.5s / history of congenital qtc prolongation

Keywords: schizophrenia atypical antipsychotic drugs conventional antipsychotic drugs olanzapine quetiapine aripiprazole haloperidol flupentixol
vitamin d for cognition in bipolar disorder

Conditions: Bipolar Disorder

Summary: conduct randomized double-blind controlled trial (rct), to examine the effects of vitamin d on cognitive performance in euthymic bd.

bipolar disorder (bd) is a chronic mental disease related to recurrent episodes along with cognitive or functional decline. comparing efficacy of pharmacological interventions targeting to treat cognitive deficit in bd is unexplored. the majority of the observational studies demonstrate a significant association between low serum vitamin d and compromised cognition in a wide range of neuropsychiatry diseases. recent survey further revealed the high prevalence of hypovitamin d in bd. the effect of supplement and association between vitamin d and cognition in bd and the underlying mechanism is unclear. the investigators will collect vitamin d levels and assess their association with cognition in a euthymic bipolar cohort (n=200) for screen. then, the investigators estimate to recruit 120 of participants with cognitive deficits and combined vitamin d deficiency, to conduct a rct. participants will keep their usual treatment and will be randomized to receive either vitamin d supplement or a placebo for eight weeks. cognitive test, adverse side effect, mood status and blood 25(oh)d levels and biomarkers will be measured before and after intervention.

Eligibility criteria:
inclusion criteria: 1. patients who diagnosed with bd-i based on the diagnostic and statistical manual (dsm-iv) criteria are consecutively referred by board-certified psychiatrists in taipei city hospital, songde branch. 2. age of participants should range from 20 to 65 years old. 3. no history of vitamin d supplementation within three months before the study. 4. the bd patients in their euthymic state (both hamilton depression rating scale and young mania rating scale ≤ 8) and no change of their psychoactive medications in recent three months. exclusion criteria: 1. with known substance use disorder (except nicotine use disorder) 2. with any disorder with known neurological symptoms or complications (ex. brain injury, stroke or brain lesions) 3. comorbid with schizophrenia spectrum disorders 4. with active physical condition (such as renal impairment, hepatic failure...) or pregnancy 5. inability to complete the standard assessment or incapability of providing informed consent

Keywords: bipolar disorder vitamin d cognition
topotecan in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. chemotherapy drugs may have different effects in patients who have a poor performance status. purpose: this phase i trial is studying the side effects and best dose of topotecan in treating patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer with a poor performance status.

objectives: primary * determine the maximum tolerated dose of weekly topotecan in patients with progressive or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer and a poor performance status. secondary * estimate the response rate of women with poor performance status for use in future clinical trials. outline: this is a dose-escalation study. patients receive topotecan intravenously (iv) over 30 minutes on days 1, 8, 15, 22, and 29. treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. a total of 6 patients will be treated at the mtd. patients are followed periodically for up to 2 years.

Eligibility criteria:
inclusion criteria: * histological diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer * progressive or recurrent disease * received ≥ 1 prior course of chemotherapy * measurable or evaluable disease or disease assessable by ca 125, defined as ca 125 \> normal that has increased over 2 readings \> 14 days apart * karnofsky performance status 10-50% * absolute neutrophil count ≥ 1,500/mm\^3 * platelet count ≥ 100,000/mm\^3 * creatinine ≤ 1.5 mg/dl * alkaline phosphatase ≤ 3 times upper limit of normal (uln) * total bilirubin ≤ 1.5 times uln * sgot ≤ 3 times uln * life expectancy ≥ 12 weeks * not pregnant or nursing * negative pregnancy test * fertile patients must use accepted and effective non-hormonal contraception exclusion criteria: * other neoplasm within the past 5 years except for nonmetastatic, nonmelanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or chemotherapy * septicemia, severe infection, or acute hepatitis * severe gastrointestinal bleeding, defined as requiring a blood transfusion or hospitalization

Keywords: fallopian tube cancer peritoneal cavity cancer recurrent ovarian epithelial cancer
perpetual observational study - ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: ventilator-associated pneumonia (vap) is a bacterial respiratory infection that patients in the intensive care unit (icu) often get when they cannot breathe for themselves and require mechanical ventilation. it is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics. options to help prevent or treat this disease are in development and will require evaluation in future clinical trials. the goal of pos-vap is to build and continuously train a network of icus to be prepared for doing these trials, to facilitate their execution.

ventilator associated pneumonia (vap) is one of the most frequent healthcare associated infections in the intensive care unit (icu) and a significant burden among icu patients under invasive mechanical ventilation (imv). several preventive and therapeutic treatment options are being developed in the field of vap that will require evaluation in future randomized controlled trials (rcts). rcts are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, vap. these trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., vap due to a specific pathogen), for which site selection can be even more challenging and time consuming. there is a need for a well-organized and well-trained international network of icus focusing on vap research that enables efficient execution of rcts on diagnostic, preventive and curative interventions in this population. through a perpetual observational study (pos) we can provide quick access to a network of sites that fulfill pre-specified criteria. additionally, the structured network of pos sites within ecraid will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.

Eligibility criteria:
inclusion criteria: * age≥18 years * at risk of acquiring vap during icu stay, defined as: * requiring admission or being admitted to the icu. * expected or documented to be under imv for more than 48 hours. * consent, either a written informed consent given by the study patient in full medical, psychological, cognitive, social or legal capacity to give an informed consent, or, if not possible, by a legally authorized representative of the study patient or any applicable locally accepted form of consent or consent waiver allowing data collection and sharing of data according to ecraid's principles exclusion criteria: * death is deemed to be imminent or inevitable during this hospital admission and one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.

Keywords: ventilator associated pneumonia hospital acquired infection mechanical ventilation intensive care unit
sutureless cryopreserved amniotic membrane graft (prokera) and wound healing after photorefractive keratectomy

Conditions: Corneal Wound Healing

Summary: the purpose of this study is to evaluate the effect of prokera on corneal wound healing after photorefractive keratectomy (prk) in terms of re-epithelialization, pain, adverse effects, visual recovery, refractive accuracy, and corneal clarity.


Eligibility criteria:
inclusion criteria: * active duty us army soldiers eligible for care at wramc. * male or female, of any race, and at least 21 years old at the time of the preoperative examination, and have signed and informed consent. the lower age limit of 21 years is intended to ensure documentation of refractive stability. * subject must expect to be located in the greater washington, district of columbia area for a 12 month period post-operatively. * consent of the subject's command (active duty) to participate in the study. * access to transportation to meet follow-up requirements. exclusion criteria: * any reason to be excluded for prk. * female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. female subjects will be give a urine pregnancy test prior to participating in the study to rule out pregnancy. \[pregnancy and breastfeeding are contraindications to refractive surgery in general, including prk, whether participating in this study or not\]. * patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course. * any physical or mental impairment that would preclude participation in any of the examinations. * anterior basement membrane dystrophy. * history of recurrent epithelial erosion. * significant dry eye (symptomatic with schirmer test \< 5 mm at 5 minutes). * other corneal epithelial disorder or healing abnormality. * patients with unusually tight eyelids close to the eyeball making it difficult and/ or painful to insert anything (e.g., prokera) between the eyelid and globe.

Keywords: prokera amniotic membrane photorefractive keratectomy prk time to re-epithelialization