Kornimate/medical-research-clean huggingface dataset:
fertility, pregnancy, contraception after breast cancer in france

Conditions: Breast Cancer Female

Summary: fertility, pregnancy, contraception after breast cancer in france

breast cancer is the most common cancer among women. with the increase of the survival rates, a growing attention is paid to the side effects of the treatments, particularly chemotherapy-induced infertility. the feeric study will give insights into spontaneous fertility outcomes following breast cancer in comparison with a control cohort and will provide data to help patients counselling towards spontaneous fertility rates following breast cancer. it will also provide data on contraceptive prevalence and unintended pregnancy rates in french breast cancer survivors. reasons for unmet need for family planning will be deciphered, in order to point out pitfalls (lack of patient's information or orientation/ignorance of contraception methods available/topic insufficiently or not discussed with the physician/ lack of family planning offer etc...); and target the appropriate actions to lead (oncologist and oncology nurses education/ dedicated consultations in breast cancer centers/etc...).

Eligibility criteria:
inclusion criteria: * females aged from 18 to 43 at inclusion * previous diagnosis of breast cancer and time from diagnosis comprised between one and five years or women free from breast cancer or other malignancy (healthy volunteers) . exclusion criteria: * hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy * healthy volonteer with history of malignant disease.

Keywords: breast cancer survivors, spontaneous fertility rates, pregnancy, birth rate, chemotherapy-induced infertility
an 8 week study of depression in adults diagnosed with major depressive disorder

Conditions: Depressive Disorder, Major

Summary: a placebo controlled study evaluating efficacy, safety and tolerability of medication in patients with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder (mdd) * duration of current depressive episode 12 weeks - 24 months * patients can read and write at a level sufficient to provide a signed consent * if female, patients must be practicing an acceptable method of birth control exclusion criteria: * patients have other psychiatric disorders that would affect patient's response to treatment * patients have not responded to two or more adequate courses of antidepressant therapy * patients cannot be currently abusing illicit drugs or alcohol * patients are not currently receiving psychotherapy * patients have received electroconvulsive therapy within 6 months prior to screening * patients are pregnant or lactating

Keywords: major depressive disorder (mdd), flexible gw353162,
candesartan for migraine prevention:

Conditions: Migraine

Summary: the main objective of this study is to see whether the favorable preventative effect of candesartan 16 mg per day in episodic migraine, that was found previously in two smaller randomized controlled cross-over studies, can be confirmed in a larger, multicenter, randomized controlled parallel group study. in addition it will be investigated whether 1) also a smaller dose of 8 mg is effective, and 2) whether the favorable side effect profile, seen in previous studies, can be confirmed, and whether it is even better with the smaller dose.


Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. episodic migraine with or without aura according to ichd-3 criteria 3. at inclusion, patients should retrospectively have from 2 to 8 migraine attacks per month during the last 3 months. this frequency must be confirmed in the headache diary before randomization to treatment. 4. debut of migraine at least one year prior to inclusion 5. start of migraine before age 50 years 6. no use of other migraine prophylactics during the study 7. for women of child-bearing potential, use of highly effective contraception. exclusion criteria: 1. interval headache not distinguishable from migraine; 2. chronic migraine, chronic tension-type headache, medication overuse headache or other headache occurring on ≥ 15 days/month 3. pregnancy, planning to get pregnant, inability to use contraceptives, lactating 4. clinical information on or signs of cholestasis or decreased hepatic or renal function. if in doubt, relevant blood tests should be performed 5. high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator 6. hypersensitivity to candesartan 7. history of angioneurotic oedema 8. current use of antihypertensive medication 9. current use of potassium supplements 10. current use of spironolactone 11. primary hyperaldosteronism (conn's syndrome) 12. significant psychiatric illness 13. use of medicines for migraine prophylaxis less than 4 weeks, or of botulinum toxin less than 16 weeks, prior to start of study 14. having tried ≥ 3 prophylactic drugs against migraine during the last 10 years 15. previous use of candesartan 16. requiring detoxification from acute medication (triptans, opioids) 17. consistently failing to respond to any acute migraine medication 18. alcohol or illicit drug dependence. 19. inability to understand study procedures and to comply with them for the entire length of the study

Keywords: prevention and control candesartan
ocular availability in human tears after topical administration of 1.5% levofloxacin compared to active comparators

Conditions: Healthy

Summary: the primary objective of this study is to compare the concentration in human tears of levofloxacin and the active comparators at 15 minutes, 2,6, 12, and 24 hours after instillation of a single drop of medication.


Eligibility criteria:
inclusion criteria: * be willing and able to provide written informed consent and hipaa indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study * be willing and able to follow all instructions and attend all study visits * if female and of childbearing potential, not be pregnant, nursing or planning a pregnancy and agree to submit to a pregnancy test. the result of the test must be negative and female subjects of childbearing potential must also agree to use an acceptable method of contraception for the duration of the study (acceptable method of contraception includes oral, implantable, transdermal, or injectible contraceptives, spermicide with barrier, iud, or surgical sterilization of partner) exclusion criteria: * have a known allergy and/or sensitivity to the test article(s) or its components or any therapies associated with the study * have active signs or symptoms of any clinically significant ocular disorder (other than refractive disorders) * have a history of dry eye syndrome * use disallowed medications (systemic or topical) (i.e. any fluoroquinolone anti-infective agents or any topical ophthalmic products) during the appropriate pre-study washout period and during the study. * be a contact lens wearer who is unwilling to forego contact lens wear within 3 days prior to the start of the study and for the duration of the study * have had any ocular surgical intervention 12 months prior to the study or anticipate having ocular surgery during the study * be pregnant or nursing women; or women who have a positive urine pregnancy test at screening or women of childbearing potential who refuse to use an adequate hormonal or mechanical means of birth control * be concurrently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of entry into this study * employees of the investigator or study center, with direct involvement in th proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.

Keywords: study drug concentration in human tears
evaluate the safety and efficacy of a new artificial tear for use after lasik surgery

Conditions: Dry Eye Syndrome

Summary: this study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after lasik surgery


Eligibility criteria:
inclusion criteria: * candidate for bilateral lasik surgery for myopia correction in the range of -1.00 to -8.00 diopters exclusion criteria: * dry eye signs and symptoms * preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively * pregnancy or planning pregnancy * uncontrolled systemic disease * use of systemic medications affecting dry eye
respiration rate monitoring in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: assess the feasibility of using remote respiration rate monitoring as a component of home care, how respiration rate data may be used in combination with other data to potentially improve response to symptoms, and to generate data to inform the endpoints and effect sizes of future studies.

the research question is whether monitoring of respiration rates and variability can be helpful in management of copd patients in conjunction with or separately from self-reported symptom scores using the copd co-pilot application. current techniques (such as patient's self-reported symptoms) have limited sensitivity and specificity with regard to predicting decompensation. measurement of respiration parameters and the variability of the parameters may detect worsening copd. changes in respiration patterns may occur sufficiently far in advance of decompensation (e.g. \>5 days prior to patient symptoms) such that it would allow an opportunity for earlier intervention with medical assessment and current therapeutic approaches. the specific primary aim includes evaluation of the correlation of respiration rate parameters to indicators of healthcare utilization including drug changes, office or er visits, hospitalization, or other clinical interventions. secondary aims include evaluation of (i) the sensitivity and specificity of respiration rate monitoring results to predict copd worsening requiring medical intervention, (ii) the sensitivity and specificity of respiration rate monitoring results in conjunction with copd co-pilot scores or components to predict copd worsening requiring medical intervention, and the correlation of respiration rate parameters to episode duration as defined by number of days from copd co-pilot score \>1 to resolution (copd co-pilot score \<1 for 7 consecutive days).

Eligibility criteria:
inclusion criteria: * males or females age ≥35 years old * documented diagnosis of moderate to very severe copd (gold level ii-iv) * weight ≥35 kg * currently using the copd co-pilot application (at least 3 months with 70% compliance) * must be able to read and understand english and consent for themselves exclusion criteria: * currently using any form of non-invasive positive airway pressure ventilation * diagnosis of significant heart failure (nyha class iii or iv) * cognitive impairment (determined by physician) that will make it hard to follow instructions regarding device usage * bmi ≥45.5 * residing in hospice care, skilled nursing facilities or long term acute care facilities * currently using a wearable drug infusion pump to deliver medication * planned procedures at time of enrollment that will occur within timeframe of study and require hospitalization etc. * declines to participate at any time. * in the opinion of the investigator, may be non-compliant with study schedules or procedures * no cellular coverage at their primary residence
postmarket evaluation of the phased radio frequency ablation system (gold af registry)

Conditions: Atrial Fibrillation

Summary: prospective, multi-center, single-arm, non-interventional and open-label registry. the purpose of the registry is to document use of phased radio frequency ablation (rfa) (hereafter "phased rfa") system in a real world patient population with atrial fibrillation (af) and evaluate its performance. gold af will enroll a minimum of 1,000 patients who undergo phased rfa in approximately 38 sites in western, central europe, israel and south korea.

this registry will collect data prospectively on patients with paroxysmal, persistent and longstanding persistent atrial fibrillation (hereafter "af") undergoing phased rfa treatment. phased rfa will be applied according to the 'intended use' in ce mark (european conformity) release and product packaging. the treatment will be performed according to routine hospital practice and no additional tests are required specific to the registry. this registry will serve as a tool to collect clinical data in order to expand the knowledge base of safety, effectiveness and functionality of the medtronic phased rfa system in a real world patient population. the key measures collected for the patients will be inclusive of, but are not limited to, clinical data pertaining to af and individual disease state(s) characterized by form of af and underline diseases, phased rfa procedure details including timing and catheters in use, procedure and system related adverse events, af recurrence, re-ablations and left atrial flutter rate after the index phased rfa procedure. additionally, this study will provide further information in the evolving anticoagulation strategies (e.g. continuous versus bridging and vitamin k antagonist versus novel oral anticoagulants) in the setting of af ablations. patients will be followed minimum for 12 months and maximum for 14 months after the phased rfa ablation procedure. the twelve month follow-up can be done by telephone if it is not standard of care in the hospital's practice. during the twelve month follow-up patients will be interviewed with a quality of life questionnaire and results will be compared to the quality of life questionaire completed before the procedure.

Eligibility criteria:
inclusion criteria: * patient with af who is scheduled for phased rfa procedure * patient signed patient informed consent or patient data release form * age ≥18 years old to avoid enrollment bias in this cohort of patient and reflect "real world" clinical practice for phased rfa no exclusion criteria will be defined.

Keywords: pulmonary vein isolation phased radiofrequency ablation
cbd in postmenopausal women with osteopenia

Conditions: Osteopenia

Summary: this is a phase 1, double-blind, placebo-controlled, repeated-dose study to assess the safety, tolerability, and preliminary effects of chi-554 in postmenopausal women ages 50-80 years who have osteopenia.


Eligibility criteria:
inclusion criteria: * is a female aged 50-80 years, inclusive, at the time of screening. * is postmenopausal, defined as \> or = 12 months amenorrhoea. * has osteopenia, defined as t score at lumbar spine or femoral neck or total femur of less than -1.0, but not less than or equal to -2.5, according to dual energy x-ray absorptiometry (dxa) completed at the screening visit or performed at nm clinical research \& osteoporosis center up to 6 months prior to the screening visit. * has been on a stable dose of 500 mg calcium daily for at least 7 days prior to visit 1. * has a body mass index between 18 and 35 kg/m2 (inclusive). * is judged by the investigator to be in generally good health at screening based on participants' medical history. * must be adequately informed of the nature and risks of the study and give written informed consent prior to screening. exclusion criteria: * has a history of epilepsy, hepatitis, or human immunodeficiency virus. * current or history of use of one or more prohibited medications (as described in section 8.2.1.1). * changes in the use of a prescription, over-the-counter (otc), systemic or topical drug(s), herbal supplement(s), or vitamin(s) for the 4 weeks prior to the screening visit. * evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>1.5× the upper limit of normal (uln), or bilirubin \>2× uln. * has any clinically significant condition or abnormal finding at screening that would, in the opinion of the investigator, preclude study participation or interfere with the evaluation of the study ip. * has a history of a known significant allergic condition, significant drug-related hypersensitivity, or allergic reaction to any compound or chemical class related to cannabis, including phytocannabinoids and cannabinoid analogues, or excipients utilized within the ip (e.g., coconut; coconut oil; medium-chain triglycerides). * has taken grapefruit products and/or seville oranges within the 7 days prior to visit 1. * positive urine dipstick results for thc at the screening visit. * has a history or current diagnosis of a significant psychiatric disorder, including alcohol or substance use disorder, that would, in the opinion of the investigator, affect the subject's ability to comply with the study requirements. * has participated in any investigational product or device study within 30 days prior to the screening visit, or is scheduled to participate in another investigational product or device study during the course of this study. * demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. * history of osteoporosis diagnosis.
extraperitoneal single-port robotic-assisted radical prostatectomy (rarp) versus transperitoneal multi-port rarp in the treatment of prostate cancer (sino-top)

Conditions: Prostate Adenocarcinoma; Localized Prostate Carcinoma

Summary: this study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal vip rarp is non-inferior to multi-port transperitoneal rarp in terms of functional recovery rate and other key metrics.

multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal vip radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.

Eligibility criteria:
inclusion criteria: 1. men aged 18 years ≤ age ≤ 75 years; 2. prostate biopsy within 6 months with diagnosis of organ-localized prostate cancer with preoperative staging of t1c to t2b,n0m0;. 3. gleason score\<8. 4. psa\<20ng/ml. 5. pathologic diagnosis of prostate follicular adenocarcinoma or prostate ductal adenocarcinoma; 6. the patient has healthy sexual function before surgery and intention for sexual activities after surgery; 7. physiological condition acceptable for laparoscopic surgery; 8. willing to cooperate and complete the study follow-up and related examinations; 9. the subject or his agent voluntarily participates in this trial and signs the written informed consent; 10. the questionnaire can be completed in chinese. 11. the patient has been informed of the trial; exclusion criteria: 1. high-risk and non-organ localized prostate cancer (clinical stage ≥ t2c, gs ≥ 8, psa \> 20ng/ml); 2. special type of prostate cancer， such as neuroendocrine etc.; 3. history of previous abdominal surgery and radiotherapy which may affect abdominal incision and port placement; 4. recent surgery of rectum, perianal abscess or around fistula and perineal area; 5. patients who have undergone previous electro-prostatectomy/enucleation of the prostate; 6. non-recurrent patients with less than 12 months of follow-up; 7. ecog\>1. 8. combination of other systemic tumors; 9. had received any type of preoperative antitumor therapy; 10. suffering from poor general condition with the presence of one of the following conditions: including severe mental disorders, cardiovascular disease, active infections, bone marrow transplantation within 3 months, or significant abnormalities in organ function; 11. participation in other clinical studies or previous treatment with any gene therapy product within the last 3 months; 12. other conditions that the researchers believe may affect the experimental results or are unethical;

Keywords: prostate cancer robotic-assisted radical prostatectomy da vinci surgical robot potency non-inferiority rct continence
autologous bone marrow mesenchymal stem cells transplantation for articular cartilage defects repair

Conditions: Osteoarthritis

Summary: this is a non-randomized study aimed to determine the safety and efficacy of intra-articular injection of autologous bone marrow-derived mesenchymal stem cells in patients with knee articular cartilage defects.

osteoarthritis is the most prevalent joint disease, create articular cartilage defects is a frequent cause of joint pain, functional loss, and disability. osteoarthritis often becomes chronic, and conventional treatments seek to ameliorate pain or improve mobility. however, these treatments rarely modify the course of the disease.recent studies cell-based have shown encouraging results in both animal studies and a few human case reports. we designed a study to assess the safety and efficacy of osteoarthritis treatment with intra-articular injection of autologous bone marrow-derived mesenchymal stem cells.

Eligibility criteria:
inclusion criteria: * diagnosed with mild to moderate osteoarthritis (visual analogue scale) * history of joint swelling, pain, stiffness, altered gait and loss of motion due to degenerative cartilage exclusion criteria: * any past history of neoplasia and primary hematological disease * autoimmune disease or the medical history * systemic bone or cartilage disorders * acute or chronic communicable diseases including hepatitis b, hepatitis c and hiv * co-morbidity which the physician deems as a contraindication to stem cell transplantation and bone marrow biopsy * evidence of infection or fractures in or around the joint * contraindication to bone marrow aspiration * deviation from the axial axis (varus or valgus) greater than 12 degrees.

Keywords: cartilage injury osteoarthritis mesenchymal stem cells