Kornimate/medical-research-clean huggingface dataset:
human follicular fluid markers and reproductive outcomes in ivf

Conditions: IVF; Infertility

Summary: the goal of this observational study is to understand the processes in the growing follicles development in more detail and to improve in vitro fertilisation (ivf) treatments. this involves measuring laboratory values in the blood, in the follicular fluid of the woman and in the sperm of the man as well as questionnaires concerning lifestyle factors. these values are then linked to the success of the fertility treatment to find out which of these values increase the success of the ivf treatment. furthermore, the investigators want to investigate if there are differences between ivf treatments with or without hormonal stimulation of the ovaries.

this is a one-site prospective exploratory study at the university clinic for gynaecological endocrinology and reproductive medicine in bern. data of influencing factors on ivf success in women and men will be collected in two types of ivf treatment, i.e. with or without hormonal stimulation of the ovaries. the investigators want to * compare the follicular fluid values between the two ivf treatment groups. * assess the associations and predictive power of follicular fluid / blood and sperm parameters for success of the ivf treatment. * compare the ivf success in the two treatment groups. the study aims to enrol approximately 200 couples. the data will be collected by the physicians and added to the redcap study registry. access to the total data set is only permitted for the principal investigator.

Eligibility criteria:
inclusion criteria: * willing to participate * written consent * couples undergoing in vitro fertilisation (natural cycle or conventional ivf) exclusion criteria: * not willing to participate * missing consent * female of the couple does not want to participate or missing consent * language barrier * medical freezing * social freezing * thawed cycles * genetic disorders * preimplantation genetic testing (pgt) * medication for chronic condition * surgery in the last 4 weeks * significant trauma in the last 90 days * severe reduced sperm quality * kryosperm * poor responder or expected poor response

Keywords: natural ivf follicular fluid oxidation-reduction potential gonadotrophin lifestyle
immunogenicity，safety and cross - immune response with mutant strains of a third dose of an inactivated covid-19 vaccine

Conditions: COVID-19

Summary: this is a phase ⅳ follow-up clinical trial based on the previous phase ⅳ clinical trial of an inactivated covid-19 vaccine (coronavac) manufactured by sinovac life sciences co., ltd.the purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using covid-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis a and evaluate the immune persistence of the one dose immunization schedule of hepatitis a vaccine in healthy population aged 18 years and older.

this study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using covid-19 vaccine，to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis a and evaluate the immune persistence of the one dose immunization schedule of hepatitis a vaccine in healthy population aged 18 years and older. the experimental vaccine is manufactured by sinovac life sciences co., ltd.. a total of 180 healthy subjects received two dose of inactivated covid-19 vaccine (coronavac) based on primary immunization in previous phase ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.subjects in each age group will receive the booster immunization of coronavac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.

Eligibility criteria:
inclusion criteria: * participated in the clinical studies on the safety and immunogenicity of inactivated covid-19 vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in rushan city, shandong province from july to october 2021; * the interval between complete immunization with two doses of covid-19 vaccine is 6-8 months; * subjects will be willing to participate in the study and follow the study procedure to collect venous blood; * proven legal identity; exclusion criteria: * history of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema; * severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; * fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease; * pregnancy or lactation; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
postoperative delirium in adult patients after elective craniotomy under general anaesthesia

Conditions: Intensive Care; Surgical; Postoperative Care; Neurosurgery

Summary: postoperative delirium may result in many adverse complications. at present little is known about postoperative delirium in patients after crniotomy because they may manifest similar symptoms to definitely delirium for some structural brain disease. objective of this study is to find out incidence and risk factors of postoperative delirium in patients after elective craniotomy and also the relationship of postoperative delirium with clinical outcome.

the study is a prospective single-center cohort study. consecutive adult patients admitted to the icu after elective craniotomy is enrolled. richmond agitation sedation scale (rass) is used to assess level of consciousness of patients; if conditions met "rass≥-3", the confusion assessment method for the intensive care unit will proceed to evaluate delirium signs in patients. delirium is assessed every 12-hour shift within 3 days during the patient's icu stay and ended when discharged from icu or dead, time started at 9am and 9pm. on the third day after operation when most patients have been transferred to general ward, delirium was assessed only at 9am for follow-up studies. patients is divided into two groups via assessment of cam-icu: delirium groups and non-delirium groups. factors potentially related to postoperative delirium are collected and categorized as preoperative, intraoperative and postoperative in chronological order. univariate analyses between delirium groups and non-delirium groups is performed. the stepwise backward logistic regression is carried out to identify the independent predictors of delirium. patients will be followed up until hospital discharge, death or 90 days after the enrollment. clinical outcome such as days on the mechanical ventilator, endotracheal extubation time, need for re-intubation and tracheotomy, unexpected reoperation within 72 h after surgery, length of stay in the icu , hospital costs and mortality will be registered.

Eligibility criteria:
inclusion criteria: * adult patients after elective craniotomy under general anaesthesia and admitted to the icu directly after surgery. exclusion criteria: 1. patients younger than 18 years 2. patients with emergency operation 3. patients with preoperative impairment of consciousness (gcs\<8) 4. patients with a past medical history of delirium or schizophrenia(evaluated by the medical document) 5. patients withventriculoperitoneal shunt or endoscope operation 6. patients with inability to communicate in the preoperative period(including language barrier) 7. pregnant or lactating women.
the effect of physical therapy on raynaud's phenomenon secondary to systemic sclerosis

Conditions: Raynaud's Phenomenon; Systemic Sclerosis

Summary: the effect of deep oscillation and biofeedback on raynaud's phenomenon secondary to systemic sclerosis (ssc) remains to be determined. a prospective randomized controlled pilot study was performed in ssc patients receiving either deep oscillation, biofeedback thrice a week for four weeks or were randomized to the control group.


Eligibility criteria:
inclusion criteria: * acr criteria for ssc exclusion criteria: * acute inflammatory disease, valentini score\>3

Keywords: raynaud's phenomenon biofeedback deep oscillation systemic sclerosis physiotherapy
efficacy and tolerability of ginkgo biloba extract in patients with raynaud´s phenomenon

Conditions: Raynaud Disease

Summary: the aim of the study is to investigate the efficacy and safety of egb 761® in patients with the primary raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.

despite more than 150 years of research into the pathophysiology of raynaud´s phenomenon it is still not understood sufficiently. three mean mechanisms responsible for raynaud´s phenomenon are discussed and fall into the following three categories: * neurological malfunction * pathological blood vessel wall and blood cell interactions * inflammatory and immunological responses based on these concepts different classes of drugs have been tested. although some therapies have shown effects, prolongation of the therapy is often difficult due to side-effects. considering a prevalence of 5-10% in the general population, there is still a place and probably a need for the development of new treatment concepts. ginkgo biloba has shown to have anti-oxidative and anti-platelet activities. in a small placebo controlled trial in patients with the raynaud´s phenomenon promising results for the ginkgo biloba extract were shown. egb 761® is known to be safe and well tolerated. based on the above considerations, egb 761® may be an effective treatment for raynaud´s phenomenon. aim: to determine the efficacy and safety of egb 761® in patients with raynaud´s phenomenon on the frequency, duration, and severity of vasospastic attacks compared to placebo.

Eligibility criteria:
inclusion criteria: * primary raynaud´s phenomenon * history of episodic digital or toe pallor * duration of raynaud´s phenomenon at least 2 years * suffering form regular occuring attacks prior to enrolment exclusion criteria: * secondary raynaud´s phenomenon * connective tissue disease * large vessel disease * cryoglobulinemia, cold agglutinins disease, thrombocytosis * concomitant pharmacological treatment with effects on the vasculature * pregnancy or lactation * severe internal or systemic disease

Keywords: raynaud´s phenomenon vasospastic attacks ginkgo biloba
trial observationnal

Conditions: Fetal Anomaly; Ultrasound

Summary: the aim of this retrospective longitudinal study was to describe a key factor in the prenatal diagnosis of isolated cleft palate on the axial transverse view, in order to provide better understanding, detection and diagnosis of this anomaly.

objective: the study aims to evaluate the role of the posterior hard palate angle in the prenatal diagnosis of cleft palate. methods: stored images of the axial transverse view of the fetal secondary palate, obtained at three-level ultrasounds, were used to evaluate the posterior border of the hard palate. the investigators studied the visualization of the posterior nasal spine and the presence of a gap within the hard palate. the investigators also assessed the posterior angle of the hard palate, formed by the posterior borders of the palatine bones next to the most posterior middle point of the palatine bone. the study population comprised 65 consecutive pregnancies of unaffected cases and 17 pregnancies with 24 assessments at different time points, suspected for a cleft palate without cleft lip, including 7 cases of cleft palate, 4 cases of high arched palate and 6 false positive cases.

Eligibility criteria:
inclusion criteria: - all patients suspected for a cleft palate without cleft lip referred to the multidisciplinary center for prenatal diagnosis in poitiers (france) between january 2019 and january 2023. exclusion criteria for the control group: * major congenital anomalies or chromosomal aberration, * premature rupture of the membranes, * fetal demise, * patients aged under 18 years. * if the available images did not allow the evaluation of the hard palate, the case was excluded from further consideration.
mechanisms of alcohol sensitivity in aerd

Conditions: Aspirin-Sensitive Asthma With Nasal Polyps; Samter's Syndrome

Summary: the purpose of this study is to determine what type of reactions in the body may be responsible for the respiratory symptoms that occur when patients with aspirin exacerbated respiratory disease (aerd) drink alcoholic beverages. these reactions are most often seen with red wine.

this is a prospective trial of approximately 60 subjects with aerd to explore the mechanisms behind the physiologic reactions that occur when drinking alcoholic beverages. at various time points patients will be asked to ingest a variety of substances found in red wine after which blood and urine markers of the reaction will be measured.

Eligibility criteria:
inclusion criteria: * healthy controls - must be 21 years or older * aspirin tolerant asthma and aerd arms must note a sensitivity to alcoholic beverages exclusion criteria: * enzymopathies * mastocytosis * alcoholism * prior severe respiratory reaction to alcohol consumption * current pregnancy * monoamine oxidase inhibitor (maoi) use * age under 21 * use of leukotriene modifier 1 week before study intervention * having undergone and maintained aspirin desensitization

Keywords: alcohol sensitivity red wine aerd
comparison of melatonin or metformin and dacarbazine combination versus dacarbazine alone in disseminated melanoma

Conditions: Melanoma

Summary: treatment of disseminated melanoma is still a difficult issue. obvious achievements of recent years proves efficacy of immunologic approachees in this field. the ability of melatonin and metformin to decrease metabolic immunosuppression was shown in many experimental studies. some literature data confirm the possibility of increasing efficacy of melatonin with dacarbazine (dtic) and metformin with dtic combinations. we hypothesized that this combinations could be more effective than dtic monotherapy in terms of response rate and time to progression.


Eligibility criteria:
inclusion criteria: * age \>18. * obtained inform consent * morphologically confirmed disseminated stage iv melanoma * eastern collaborative oncology group performance status scale 0 - 2. * expected survival \>3 month exclusion criteria: * evidence of active brain lesions (brain lesions after stereotaxic ray therapy allowed) * evidence of liver and bone marrow clinically meaningful disfunction * severe uncontrolled concomitant conditions and diseases * pregnancy or lactation * systemic therapy for disseminated melanoma * second malignancy * diabetes mellitus requiring drug therapy * any condition preventing study participation by investigator opinion

Keywords: melanoma melatonin metformin dacarbazine
factors and perceptions affecting treatment choices of breast cancer patients

Conditions: Breast Cancer

Summary: a multi-center cross-sectional quantitative study with a preliminary qualitative study part aiming to identify and analyze demand factors, supply factors and perceptions affecting breast cancer patients' treatment choices of breast cancer patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. 25 patients and caregivers will participate in the qualitative part and 425 israeli breast cancer patients will participate in the quantitative study.

background: breast cancer (bc) is the most common cancer in women worldwide. newly diagnosed bc patients are asked to participate in a number of treatment related decisions. no research has systematically studied the full decision sequence in a disease such as bc, analyzing demand factors, supply factors and patient perceptions. study goal: identify and analyze demand factors, supply factors and perceptions affecting bc patients' treatment choices, and model the demand function of bc patients in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice. study hypothesis: patient perceptions will have at least as much impact as demand and supply factors. study design: two stage study. a preliminary qualitative study, holding depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members is taking place these days. the qualitative study findings will be used to develop a survey questionnaire for a cross sectional quantitative study, interviewing a quota sample of 425 breast cancer survivors, diagnosed up to 5 years prior to joining the study, who have successfully completed all radiation therapy and chemotherapy. data analysis: qualitative data will be analyzed according to the criteria bases qualitative methodology. quantitative data will be analyzed by two-variable statistical analysis and multi-variable statistical analysis adjusted to the nature of the dependent and independent variables. possible policy recommendations: forming consulting teams for cancer patients. improving medical information communication. focusing patients on the key decisions they face. evaluating patient needs using demand factors, supply factors and perceptions to create systemic tools helping them face treatment decisions.

Eligibility criteria:
inclusion criteria: * hebrew speaking jewish women * aged 30 - 75 years * diagnosed with breast cancer up to 5 years prior to study recruitment * successfully completed all chemotherapy and radiotherapy treatments * considered cancer free exclusion criteria: * any type of residual cancer * any type of chemotherapy or radiotherapy

Keywords: breast cancer treatment choice factor perception
validation of the implantation of a new electrode for the treatment of dystonia

Conditions: Generalized Dystonia; Segmental Dystonia; Tardive Dystonia

Summary: the main objective of the trial is to study the technical feasibility of the implantation of a new electrode monocontact deep brain stimulation electrode in dystonia.

deep brain stimulation (dbs) is a validated therapy for treating dystonia and other movement disorders. the main therapeutical target used for treating dystonic syndromes is the internal globus pallidum (gpi). given the morphology and the topography of this nucleus and, based on the experience of an efficient therapy by using only one or two contacts out of the available four contacts of the standard dbs lead, we designed two new electrodes, one one contact-electrode and one two contact-electrodes, with the aim to limit side effects related to internal globus pallidum dbs and to provide a more homogeneous electric field around the electrode within the gpi and maintaining the same therapeutical outcome. the main objective of the trial is to study the technical feasibility of the implantation of a new one contact-electrode (monopolar dbs lead model 09064-40cm) for treating isolated generalized/segmental dystonia or tardive dystonia. the second main objective of the study is to assess the safety of the implantation of the new device. the secondary objective is to explore the therapeutical effect of dbs using the new monocontact electrode and to study the electrical field generated around the monocontact electrode within the gpi. the study is prospective and patients are recruited from a tertiary movement disorders clinic. seven subjects will be recruited for the study.

Eligibility criteria:
inclusion criteria: * age superior to 18 years and inferior to 65 years * generalized or segmental isolated dystonia or tardive dystonia * diagnosis is based on history, clinical examination, check-up without abnormalities and normal brain mri allowing exclusion of secondary and degenerative dystonias * unsufficient response to pharmacological treatment (improvement \< 30/% on clinical dystonia scales) * no comorbidity interfering with general anesthesia, or representing contraindication for neurosurgical procedure or with the follow-up during the trial * consent of the patient * insurance affiliation * follow-up possible for 12 months * available insurance for the operated patient exclusion criteria: * no possibility for clinical follow-up * acquired dystonia except for tardive dystonia * mri or generalized anesthesia contraindicated * anticoagulant treatment or antiaggregant treatment * pregnancy * ongoing participation to another clinical trial * guardianship or trusteeship * person deprived of liberty
pulmonary function after arterial sleeve lobectomy

Conditions: Lung Cancer, Nonsmall Cell

Summary: lung cancer is the leading cause of cancer death worldwide. despite the evolution of medical and multimodal treatments, surgical treatment remains the curative management in the localized cancer. historically, in central lung tumors, pneumonectomy was the gold standard. currently, bronchial sleeve lobectomy is recommended as first-line treatment over pneumonectomy when complete resection is possible (grade 2c). in the case of pulmonary artery invasion, lobectomy with arterial resection and reconstruction is now an accepted option for central localized cancer. despite surgical challenge, arterial sleeve lobectomy is oncologically comparable with pneumonectomy while avoiding the high morbi-mortality. indeed, this surgery has shown better results than pneumonectomy in terms of overall survival, post-operative mortality, and quality of life. initially performed in patients with impaired cardio-pulmonary reserves, this parenchymal sparing procedure can be realised in all patients, when anatomical conditions allow a complete resection. in the literature, no study has yet specifically investigated postoperative respiratory function after arterial sleeve lobectomy. the investigators designed a retrospective monocentric study at the university hospital of montpellier on 81 lobectomies with pulmonary artery sleeve resection for lung cancer, from january 2001 to december 2020.


Eligibility criteria:
inclusion criteria: * all major lung resection with pulmonary artery reconstruction for lung cancer * from january 2001 to december 2020 at university hospital of montpellier * patient \> 18 years exclusion criteria: 0

Keywords: artery pulmonary reconstruction sleeve lobectomy lobectomy with angioplasty arterial sleeve lobectomy pulmonary function
real-world clinical experience of patients with metastatic castration-resistant prostate cancer treated with olaparib + abiraterone (proceed)

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: proceed is a multisite, prospective, observational study that describes the real-world use and clinical experience of mcrpc patients treated with the combination of olaparib and abiraterone in the mcrpc setting. clinical outcomes will be assessed in patients who are either nha-naive or nha-exposed prior to initiating olaparib + abiraterone treatment, respectively. patient demographic and clinical characteristics, as well as treatment received prior and subsequent to olaparib + abiraterone, will also be described. the study plans to enroll patients for a maximum of 2 years and follow up patients from initiation of olaparib until 1 year post last patient in.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent; * 18 years of age and above; * documented histopathology or cytopathology of pca, adenocarcinoma; * confirmed as mcrpc; * initiated olaparib + abiraterone after site activation exclusion criteria: * patients participating in a clinical trial with an investigational prostate cancer treatment within 30 days prior to olaparib initiation