Kornimate/medical-research-clean huggingface dataset:
effect of anesthesia in fracture healing

Conditions: Closed Fracture of Hip

Summary: investigator' s study designed to investigate effect of general and regional anesthesia on fracture healing.the 40 age and older asai-iii patients who will operate due to femur fracture (except femur neck fracture) will be enrolled in this study after informed consent approval. subjects will be divided into two groups by a computerized randomization method. 40 patients will be enrolled in this study. general anesthesia will perform for 20 patients. regional anesthesia will perform for 20 patients. preoperative, 4. week and 12. weeks laboratory test which include blood and urine β-c terminal telopeptid (β-ctx), blood alkaline phosphatase and osteocalcin will test for all patients. all patients will not use nonsteroid anti-inflammatory drugs during study neither perioperative nor postoperative periods. fracture healing will be asses with clinical evaluation and laboratory tests.

investigator' s study designed to investigate effect of general and regional anesthesia on fracture healing.the 40 age and older asai-iii patients who will operate due to femur fracture (except femur neck fracture) will be enrolled in this study after informed consent approval. subjects will be divided into two groups by a computerized randomization method. 40 patients will be enrolled in this study. each group will have 20 patients. however a pilot study will perform for each groups with 10 patients. in group g, all patients will be applied general anesthesia and 2 mg/kg propofol and 0,6 mg/kg rocuronium will administer to patients for induction of anesthesia. maintenance of anesthesia will be made with %50-%50 o2/n2o and %2 sevoflurane. 0,1 mg/kg morphine will be held on last 10 minutes of operation for postoperative analgesia. also, patient controlled analgesia with morphine(1 mg bolus and 20 min lockout time) will apply for postoperative analgesia. if it is necessary additional analgesic will provide with 100 mg peroral and intravenous tramadol. regional anesthesia will perform for 20 patients which named group r. in group r combined epidural-spinal anesthesia will perform. spinal %5 bupivacain 15 mg and 20µg fentanyl will apply and analgesia will provide with epidural bupivacain. preoperative, 4. week and 12. weeks laboratory test which include blood and urine β-c terminal telopeptid (β-ctx), blood alkaline phosphatase and osteocalcin will all patients. all patients will not use nonsteroid antiinflammatory drugs during study neither perioperative nor postoperative periods. fracture healing will be asses with clinical evaluation and laboratory tests. all measurements will be assessed with statistically.

Eligibility criteria:
inclusion criteria: * patients asa i-iii * patients who will be operated for femur fracture * 40 age and up patients exclusion criteria: * patients asaiv and up * haemodynamic unstable patients * no patient's approval * femur neck fractures
open-label study of ard-0403 in testosterone deficient men

Conditions: Hypogonadism

Summary: male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. the purpose of this study is to investigate the efficacy and safety of ard-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility criteria:
inclusion criteria: * testosterone deficiency exclusion criteria: * previous treatment with testosterone replacement therapy within 4 weeks * moderate-severe benign prostatic hypertrophy, or prostatic cancer * haematocrit \>50%
2 doses of an approved drug being studied for a new indication for the prevention of postoperative nausea and vomiting (0869-090)(completed)

Conditions: Postoperative Nausea and Vomiting

Summary: the purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

the duration of treatment is 4 weeks.

Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age. * patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery). * patient is scheduled to receive general anesthesia. * patient is scheduled to receive postoperative medication.
prospective study evaluating dry eye in patients operated on for ametropia by lasik surgery and treated with repadrop

Conditions: Ametropia

Summary: lasik is a refractive surgery technique widely used in france. postoperatively, the classic treatment after lasik consists of instilling drops to reduce dry eyes. repadrop® is an innovative eye drops stimulating corneal innervation. to date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using repadrop®.


Eligibility criteria:
inclusion criteria: age over 18 * planned bilateral lasik surgery * use of repadrop as postoperative eye drops * patient agreement to participate exclusion criteria: * history of corneal pathology * diabetes * history of treatment with repadrop® or cacicol® or ngf® (other eye drops which are no longer available on the market to date but which would also improve corneal healing) * ongoing treatment with topical cyclosporine * presence of punctal plugs * adults who are the subject of a legal protection measure (guardianship, curators) * pregnant or breastfeeding women
effect of guided imagery on well-being in patients with multiple sclerosis

Conditions: Multiple Sclerosis (MS)

Summary: this single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). data were analyzed with treatment allocation masked.

interventions: participants were assigned in alternate order to 10 weekly 1-hour sessions "healing light guided imagery" or at-home positive journaling; drop-outs were replaced. intervention type: behavioral multiple sclerosis (ms) is an autoimmune disease that affects the brain and spinal cord (central nervous system). because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. many multiple sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. drugs prescribed for ms have been shown to not improve these comorbid psychological symptoms. researchers have shown that mindfulness-based training programs can help ms patients, but these therapies are highly resource demanding and taxing for those involved. "healing light" guided imagery (hlgi; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with ms in less time and with fewer support resources. the investigators plan to test whether hlgi can increase patient well-being.

Eligibility criteria:
inclusion criteria: 1. diagnosis of relapsing-remitting multiple sclerosis 2. 18-70 years old 3. able to read and write in english 4. able to attend sessions at the uc san diego school of medicine * age group: adult * gender: both * target enrollment: 20 participant exclusion criteria: 1. severe depression (score of 31 or higher on the bdi) 2. very high levels of fatigue (above an average of 6 on the fss) 3. low levels of mindfulness (below an average score of 2 on the fmi).
clinical outcomes of chronic lymphocytic leukemia (ccl) and mantle cell lymphoma (mcl) participants treated with ibrutinib: a medical chart review from india

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell

Summary: the purpose of this study is to describe the effectiveness (overall response rate \[orr\] and time to progression \[tpp\]) of ibrutinib therapy in participants with chronic lymphocytic leukemia (cll) and mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * must have a confirmed diagnosis of chronic lymphocytic leukemia (cll) or mantle cell lymphoma (mcl) * cll or mcl participants being newly initiated on imbruvica treatment (ibrutinib capsule 140 mg) based on independent clinical judgment of treating physicians exclusion criteria: - any contraindications to ibrutinib use according to the current version of the prescribing information in india
to compare the pharmacokinetics and safety after a single dose administration of in-g00002 and in-r00002 in healthy adult volunteers

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Summary: to compare the pharmacokinetics and safety after a single dose administration of in-g00002 and in-r00002 in healthy adult volunteers

a randomized, open-label, single-dose, crossover study

Eligibility criteria:
inclusion criteria: * healthy adult volunteers aged ≥ 19 years at screening * body weight \> 60kg and body mass index (bmi) in the range of 18.0 and 30.0 kg/㎡ * subjects who do not have congenital or chronic diseases requiring treatment and have no pathological symptoms or findings as a result of physical examination * determined by the investigator to be eligible for study participation based on the results of screening tests (clinical laboratory tests, vital signs, physical examination, 12-lead ecg) conducted according to the ip characteristics * subjects who decided to participate in the study and signed informed consent form voluntarily after receiving detailed explanation of the study and fully understanding exclusion criteria: * subjects who have taken the drug which can induce or inhibit drug metabolism enzyme within 4 weeks prior to the 1st ip administration * subjects who have participated in any other clinical study or bioequivalnece study within 6 months prior to the 1st ip administration * subjects who have donated whole blood within 8 weeks prior to the 1st ip administration or have donated blood components or received transfusion within 2 weeks prior to the 1st ip administration * pregnant(positive urine hcg) or breastfeeding women if female * subject who have continued drink of alcohol within 1 month prior to the 1st ip administration (female: \> 14 glasses per week, male \> 21 glasses per week) * subjects with a presence and a history of surgery or gastrointestinal diseases which might significantly change absorption of medicines * pregnant(positive urine hcg) or breastfeeding women if female * subjects with a hereditary problems, for example, galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption * subjects or spouses (or partners) are unable to use an effective method of contraception (e.g., correctly placed intrauterine device, sterilization surgery (vasectomy, tubal ligation, etc.), barrier method (spermicide and condom, a concomitant use of contraceptive diaphragm, vaginal sponge or cervical cap)), throughout the study * subjects who are judged ineligible for the clinical study by the investigator due to reasons other than the above inclusion/exclusion criteria.
pre-exposure prophylaxis: a miracle drug or a moral hazard

Conditions: Syphilis; Chlamydia; Gonorrhea; Sexually Transmitted Diseases

Summary: the investigators study the behavioral consequences of pre-exposure prophylaxis or prep on sexual health behaviors, sexual health outcomes, and partner selection preferences. the study collects observational, self-reported data on prep status, prep taking-history, prep adherence over the last 30 days, std diagnosis history dating back to january 2015 up to december 2019, sexual health behaviors (e.g., positioning, number of lifetime/recent partners, condom adherence etc.), and various demographic characteristics. the survey finishes with a conjoint experiment which asks respondents to select between two potential partners, and follow-up question about each profiles. potential partners' characteristics include recreational drug use and condom adherence. recruitment is conducted via running an ad on facebook in new york, london, toronto and sydney for comparative purposes, as these metro areas have varying levels of prep use and accessibility.

see statistical analysis plan.

Eligibility criteria:
inclusion criteria: * 18 years or above * living in the london, new york, toronto or sydney metro area * self-reported sex at birth is male * reported ever having sex with a male exclusion criteria: * not meeting the inclusion criteria
palbociclib in combination with letrozole as treatment of post-menopausal women with hr+, her2- advanced breast cancer

Conditions: Breast Cancer

Summary: a study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.

to provide access to palbociclib to post-menopausal patients with hormone receptor-positive \[hr(+)\], her2-negative \[her2(-)\] abc who are deemed appropriate for letrozole therapy.

Eligibility criteria:
inclusion criteria: * post-menopausal women (\>=18 years of age) with proven diagnosis of advanced carcinoma of the breast (er(+) and/or pgr(+) and her2(-)) who are appropriate for letrozole therapy (in the first-line advanced/metastatic disease setting). * eastern cooperative oncology group (ecog) performance status 0-2. * adequate bone marrow, liver, and renal function. exclusion criteria: * prior treatment with any cdk inhibitor . * qtc \>480 msec; history of qt syndrome, brugada syndrome or known history of qtc prolongation, or torsade de pointes. * high cardiovascular risk, including, but not limited to myocardial infarction, severe/unstable angina, severe cardiac dysrhythmias, and symptomatic pulmonary embolism in the past 6 months of enrollment.

Keywords: hormone receptor positive advanced breast cancer
improvement on diagnosis of fetal congenital heart disease based on multi-center collaboration in china

Conditions: Congenital Heart Disease; Echocardiography; Diagnosis

Summary: the objective of this study is to improve the diagnosis level of fetal congenital heart disease by the multi-center collaboration in china.

our center has constructed multi-center collaborative network in 2013, so far which contains more than 170 maternal and child health care hospitals throughout the whole of china. this is a multi-center-based study to improve the integral diagnostic level of fetal congenital heart diseases by fetal echocardiography. sixty pregnant cases (18-45 years) whose fetuses with heart abnormalities will be recruited in a successive manner from every center every year. cases are gravidas with fetal congenital heart disease diagnosed by echocardiography in 16th-24th of gestational weeks. every center will upload the echocardiography materials and the diagnostic reports so that another two experienced echocardiography physicians confirm the diagnosis based on these materials in a double-blinded method. in addition, the golden standard of congenital heart disease depends on the autopsy, heart and vascular casting after abortion and operation after birth. the investigators will provide the report about the rate of missed diagnosis and misdiagnosis and the periodical training on fetal echocardiography for every center every half an year. only gravidas who are willing to have complete pregnancy checks and finally delivery or abortion in the hospital are interviewed are eligible for the study. study participants will be asked for their informed consent.

Eligibility criteria:
inclusion criteria: * 1.gravida with singleton pregnancy with congenital heart disease taking fetal echocardiography in 16th-24nd of gestational weeks. * 2.complete pregnancy check in beijing anzhen hospital and the hospitals contained in our multi-center network collaboration, and finally delivery or abortion in these hospitals. * 3.willing to cooperate with our study. exclusion criteria: * 1. pregnant women with serious pregnancy complications and suffering from mental illness. * 2.pregnant women not willing to cooperate

Keywords: congenital heart disease echocardiography diagnosis
limberg-flap: prospective data collection

Conditions: Pilonidal Sinus

Summary: the investigators think, that the treatment of pilonidal sinus with excision and covering of the defect with a limberg-flap is a very good treatment option. the investigators are introducing this treatment for recurrences of this illness in our clinic and want to analyse the feasibility, the results, the complications and the patients opinion after the treatment. if the results are good, a prospective randomised study is a further option.

1. patients, that come to our clinic with problems caused by a pilonidal sinus are informed about the different treatment options of the illness. * if the patient suffers of a recurrence of the illness, a complete excision, followed by a covering of the defect with a limberg-flap is recommended. * if the patient has the first time problems by a pilonidal sinus, we recommend an open limited excision of the fistulas. * in cases with acute infected situation, we first conduct a very limited incision/excision and treat them with antibiotics. the treatments mentioned before are in such cases offered 3 to 4 weeks after the fist little operation. 2. all patients, that wish their pilonidal sinus treated with a complete excision followed by a covering of the defect with a limberg-flap, are asked if they are willing to participate in the observational study. 3. patients, who gave their informed consent for the operation and the study are included. 4. preoperative data are recorded. 5. the patients are operated on and intraoperative data (e.g. how big was the flap) are recorded. 6. after 3 weeks the patients are checked and complications, happiness and duration of the time off work are recorded. 7. after a year the patients are contacted by sending them a postal questionnaire, which they send back to us. additionally the are contacted by phone. recurrence, other complications and their opinion concerning the treatment and its consequences are recorded.

Eligibility criteria:
inclusion criteria: * recurrence or persistence of a pilonidal sinus * elective limberg-flap operation * written informed consent of the patient for the operation and participation of the study exclusion criteria: * doubts of the capability of the patient to understand the study or to decide.

Keywords: pilonidal sinus recurrence limberg flap
a study on the efficacy of macugen injections in patients with neovascular age-related macular degeneration in real life.

Conditions: Neovascular Age-related Macular Degeneration

Summary: to assess effectiveness of macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. treatment duration, frequency of administration and combination with other treatments will also be evaluated.


Eligibility criteria:
inclusion criteria: * patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration * patients having received at least 1 macugen injection * treatment naive patients, or patients having received conventional therapy * patients having signed and dated informed consent. exclusion criteria: * patients participating in another clinical study with macugen.

Keywords: macugen age-related macular degeneration (amd) observational study
the durability of protection and immuno-persistence study of a recombinant hpv 16/18 bivalent vaccine in female

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection

Summary: the primary objective of this study is to evaluate the durability of protection and immuno-persistence of recombinant human papillomavirus bivalent (types 16,18) vaccine administered in females aged 18-45 years.

this is a follow-up study that is based on phase iii clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females aged 18-45 years (unique protocol id: hpv-pro-003, identifiers: nct01735006). the investigators will recruit people who have participated in phase iii clinical study before and to evaluate the durability of protection and immuno-persistence of the bivalent hpv vaccine on 90m and 114m after dose 1.

Eligibility criteria:
inclusion criteria: 1. participants who participated in the phase iii clinical study of a recombinant human papillomavirus 16/18 bivalent vaccine in females (unique protocol id: hpv-pro-003, identifiers: nct01735006) and received at least one dose; 2. participants can fully understand the study content and sign an informed consent form； 3. able to comply with the requests of the study; exclusion criteria: 1. participants used other hpv vaccine products (including both marketed and unmarketed vaccines) since participating in the phase iii clinical study. 2. according to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

Keywords: durability of protection immuno-persistence human papillomavirus 16 human papillomavirus 18 vaccine females
analysis of neurodegenerative process within visual ways in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will interest in the pathophysiology of silent retinal axonal loss in multiple sclerosis. recent studies have suggested that silent retinal axonal loss (no past history of optic neuritis \[on\]) may be due to inflammatory lesions within the optic radiations and a transsynaptic degenerative process. the objective is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing oct, brain and optic nerve mri in a cohort of patients without recent disease activity.

this study will interest in the neurodegenerative process reported in multiple sclerosis within the visual ways. symptomatic and asymptomatic retinal axonal loss in multiple sclerosis (ms) have largely been described. many recent optical coherence tomography (oct) studies have suggested that subclinical retinal axonal loss (no past history of optic neuritis \[on\]) observed in ms mainly due to inflammatory and demyelinating lesions within the optic radiations and a retrograde transsynaptic degenerative process. none of these studies clearly tried to investigate the role of asymptomatic optic nerve lesion(s) in subclinical retinal axonal loss occurence. the main objective of the study is to measure the exact role of silent optic nerve lesion in the occurrence of silent retinal axonal loss by performing oct, brain and optic nerve mri. the study will focus on a cohort of patients without recent disease activity in order to exclude or minimize the risk of recent and old lesion occurence on the visual ways, which could be a bias in our analysis.

Eligibility criteria:
inclusion criteria: * relapsing remitting multiple sclerosis (rrms) patients treated by natalizumab for more than 6 months * johncunninghamvirus (jcv) index \< 0.9 * patients followed in our ms center from the beginning of the disease exclusion criteria: * ophthalmologic diseases * diabetes mellitus * contra-indication to mri

Keywords: mri axonal loss ms oct