Kornimate/medical-research-clean huggingface dataset:
resiliency in total joint arthroplasty

Conditions: Osteoarthritis

Summary: the investigators primary objective is to determine how does participation in streamd affect patient reported outcomes after total hip arthroplasty (tha) or total knee arthroplasty (tka)?

osteoarthritis is a leading cause of disability in the us. by conservative estimates, about 54 million adults in the us have doctor-diagnosed arthritis. the number of people expected to have arthritis by the year 2040 is more than 78 million. total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. currently, more than 1 million hip and knee replacements are performed each year in the us. by 2030, primary thr is projected to grow 171% and primary tkr is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. the incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after tja. better resilience could improve patients overall satisfaction with the procedure.

Eligibility criteria:
inclusion criteria: * all patients aged 18 and older who are receiving a total hip or knee replacement. exclusion criteria: * patients enrolled in the mymobility study * patients who do not have cell phones with text messaging capability * non-english speaking patients

Keywords: total hip arthroplasty total knee arthroplasty patient reported outcomes resilience
the price trial: pain reduction for intrauterine contraception experiment

Conditions: Contraception

Summary: intrauterine devices (iuds) are a highly effective form of reversible contraception with a less than 1% failure rate. they can be easily placed in the office and require little maintenance care. however, despite their benefits, pain during insertion remains a barrier for patient uptake. currently there is no standard of care for pain management during iud insertion. the aim of this study is to determine whether local anesthetic, in the form of injecting 1 percent lidocaine into the cervicovaginal junction, reduces pain during insertion. participants will be randomly assigned to receive 1 percent lidocaine, placebo, or no injection. all patients presenting for iud placement, regardless of indication, will be offered participation in the study. following iud placement, patients will be asked to rate their pain at key "pain points" during the procedure as the primary outcome. other outcomes collected will include provider-related complications, length of time to place iud, and overall patient and provider satisfaction.


Eligibility criteria:
inclusion criteria: * any participant presenting for an iud placement, either for contraception or treatment of abnormal uterine bleeding or to regulate menstrual periods * all iuds (copper, hormonal) eligible * all parities of patients are eligible exclusion criteria: * use of pain medication that is not an nsaid or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours * confirmed pregnancy * any diagnosed chronic pain conditions (fibromyalgia, vaginismus, interstitial cystitis) * misoprostol administration within 24 hours of enrollment * known contraindications to iud placement * contraindication to lidocaine * iud exchange * previous unsuccessful attempt for iud by the same practitioner

Keywords: contraception intrauterine device paracervical block
phase ii study of oxaliplatine-paclitaxel in patients with metastatic germ cell tumor refractory to cisplatin

Conditions: Neoplasms, Germ Cell and Embryonal

Summary: to evaluate the efficacy of the oxaliplatin-paclitaxel combination i.e. evaluation of tumor response rate using world health organization/union internationale contre le cancer (who/uicc) and indianapolis tumor marker (human chorionic gonadotropin \[hcg\], alpha fetoprotein \[afp\]) criteria in metastatic germ cell cancer patients


Eligibility criteria:
inclusion criteria: * histologically proven germ cell cancer: gonadal (including ovarian) or extragonadal, seminomatous or non seminomatous, or clinical presentation of a gct with elevated afp level and/or hcg level (\> or =to 100 x uln) when a biopsy was not available * metastatic gct patients: * progression disease defined as \> 10% increase in hcg and/or afp markers (and/or documented progressive disease \[pd\]) during a platinum-based chemotherapy or less than 6 months after the last cycle (in the case of growing non seminomatous tumor, without increased markers, a histological documentation of malignant tumor was required, to exclude growing mature teratoma) * at least 1 prior line of chemotherapy containing cddp + etoposide; (prior regimen with high dose chemotherapy and hematopoietic stem cell support was permitted) * eastern cooperative oncology group ps (ecog ps) grade \< or =to 2 * at least 1 bidimensionally measurable lesion by imaging (ct scan) of \> or =to 20 mm outside an irradiated area or significantly increased tumor markers \> 2 x uln (on \> or =to 2 consecutive tests, even in the absence of measurable lesions) * age \> or =to 18 * adequate bone marrow reserve * neutrophil count \> or =to 1500/mm3 * platelets \> or =to 100,000/mm3 * renal function:creatinine \< 3 x uln * liver function:transaminases \< or =to 2.5 x uln, total bilirubin \< 1.5 x uln (if liver metastases, transaminases \< or =to 5 x uln) * laboratory values obtained in the week preceding study entry * neurosensory \< or =to grade 1 nci ctc * signed informed consent obtained prior to all study procedures exclusion criteria: * concomitant high-dose steroids (except for antiemetic prophylaxis) * pregnancy, breast-feeding or absence of contraception in sexually active patients * prior treatment with oxaliplatin or taxanes * history of second malignancy, except for cured non melanoma skin cancer or excised in situ cervical carcinoma * symptomatic cerebral and/or leptomeningeal metastasis (irradiated brain metastases not requiring corticosteroid treatment were allowed) * treatment with another experimental drug or anticancer agent or participation in another clinical study within 30 days prior to study * other serious illness or uncontrolled infection * psychological, social or geographical situation preventing regular follow-up * primary tumor in brain/central nervous system
the effect of intravenous nalbuphine on ponv with intrathecal morphine in abdominoplasty.

Conditions: Abdominal Obesity

Summary: how effectively intravenous nalbuphine can reduce the incidence of ponv after intrathecal administration of morphine in abdominoplastic surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing abdominoplasty under spinal anesthesia * american society of anesthesiologists (asa) class i and ii. exclusion criteria: * allergy to local anesthetics * bleeding diatheses * local infection or sepsis
anxa5 m2 haplotyping in ivf patients and embryos

Conditions: Infertility; Miscarriage, Recurrent; Pregnancy Complications

Summary: this study aims to characterize the association between history of pregnancy complications and m2 carrier status in ivf patients and the utility of m2 haplotype preimplantation genetic testing (pgt) in embryos produced by carrier couples. participants in this study will be screened for the m2 variant. history of pregnancy complications and miscarriages will be studied in order to determine potential associations with m2 carrier-ship.

patients consenting to participation in the study will receive a saliva collection kit for m2 testing. genomic prediction clinical laboratory will perform testing and issue a report per routine clinical procedures. upon completion of issuing a report, the patients' medical records will be obtained from the ivf center providing care to the patient. information obtained may include: history of miscarriage, embryo transfer outcomes, preeclampsia, small for gestation age baby, or thrombophilia disorders. in addition to obtaining records related to history of pregnancy complications, carrier couples will be offered the use of preimplantation genetic testing for m2 carrier status (pgt-m2) in their embryos. patients electing to perform pgt-m2 will receive pgt-a according to standard clinical practice, along with m2 carrier status. a total of 500 patients will complete the study and may be recruited from any ivf clinic in the united states. patients will undergo ovarian hyper-stimulation, oocyte retrieval, fertilization and embryo culture per standard clinical protocol determined by each clinic.

Eligibility criteria:
inclusion criteria: * all couples above the age of 18 exclusion criteria: * any case where biological parental dna is unavailable.
hormones and decision making

Conditions: Dyssocial Behavior

Summary: an investigation of the neuropsychological processes underlying ethical decision making.

this study will investigate the influence of reward sensitivity on cheating behavior via experimental manipulation of reward sensitivity using testosterone.

Eligibility criteria:
inclusion criteria: * males between 18 and 25 exclusion criteria: * recruitment will be limited to male participants between 18 and 25 years who have no current conditions that would preclude the use of testosterone. specific exclusion criteria are: * women of all ages * males younger than 18 years and older than 25 years * self-report discomfort with ingestion of testosterone for the purpose of this study * body mass index lower than 18 or higher than 27 * prior diagnosis of major depression, posttraumatic stress disorder, phobia, anxiety disorder, or other psychiatric conditions * first-degree relatives diagnosed with a psychiatric disorder * presence of a medical condition that would preclude the use of testosterone * use of medications that would preclude the use of testosterone * consumption of more than 5 cigarettes a day * current use of testosterone enhancing products, such as gels, creams, and injections
parkinson's disease and digestive health

Conditions: Parkinson Disease; Constipation; Gastro-Intestinal Disorder

Summary: this study focuses on the relationship between the brain and the gut, and additionally will foster collaboration between movement disorder experts and neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat gi dysfunction of parkinson's disease.

parkinson's disease affects 1 million people in the us with a rising prevalence. in addition to neurological problems, patients with parkinson's disease often suffer from debilitating gastrointestinal (gi) symptoms related to delayed stomach emptying, gas/bloating, and constipation. gi complaints of patients suffering from parkinson's disease are poorly understood. this proposal aims to characterize gi disturbance in patients with parkinson's disease and provide deeper understanding by investigating symptoms, regional and whole gut transit, anorectal physiology, and the brain-gut axis. the investigator believes patients with parkinson's disease will show altered gi sensation, slower gi motility and demonstrate deranged regulation of the brain-gut axis correlated to severity of parkinson's disease. results from this study of gi motility and brain-gut axis will define a subset of parkinson's disease patients that can benefit from tailored treatment. this study will foster collaboration between movement disorder experts and neurogastroenterologists to provide critical information and lead to innovative therapies in the future to treat gi dysfunction of parkinson's disease.

Eligibility criteria:
inclusion criteria: * presence of 2 of 3 cardinal features of pd (resting tremor, bradykinesia, and rigidity) * hoehn and yahr scale stage i-iv * men or women aged 18+ * stable dopaminergic treatment for ≥4 weeks. * women of childbearing potential must agree to a urine pregnancy test at screening and to avoid pregnancy throughout the study. exclusion criteria: * secondary parkinsonism. * parkinson-plus syndromes. * montreal cognitive assessment score \<17. * unstable dosage of drugs active in the cns (e.g., anxiolytics, antidepressants) during the 60 days before the visit. * participation in drug studies within 30 days of screening. * structural brain disease. * women who are pregnant or likely to conceive (women with potential for pregnancy must use contraceptive measures to be included); * active or personal history of epilepsy. * acute illness or active, confounding medical, neurologic, or musculoskeletal conditions. * alcoholism or other forms of drug addiction. * significant prior gastrointestinal surgery. * ongoing chemotherapy or other treatment for cancer. * dysphagia * implanted or externally worn medical device such as, but not limited to, a pacemaker. (gastric stimulators, bladder stimulators, spinal stimulators, medication infusion devices, insulin pumps, continuous glucose monitors are permitted).

Keywords: brain-gut relationship anorectal manometry
herbal therapy for subcutaneous injection site reactions in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine if an herbal over-the-counter cream can decrease skin site reactions in multiple sclerosis patients who currently take either betaseron, copaxone or rebif as their subcutaneous medication for managing their multiple sclerosis. injection site reactions have been indicated as one of the major reasons for discontinuing treatment with the subcutaneous medications (betaseron, copaxone, and rebif) for multiple sclerosis.

skin site reactions account for one of the most likely reasons for discontinuation of subcutaneous injections of ms medications. it is imperative that additional methods be determined to decrease the reactions and/or treat the reactions that occur. individuals continue to use over the counter preparations (e.g. benadryl or steroid creams) or other treatments recently described (warm compresses) to improve tolerance to the subcutaneous injections and the reactions. both short (3 to 6 months) and long term skin reactions have been reported by patients. they complain about this at office visits and calls to nurses in clinics or to those who teach injection technique. recently, this investigator and a nurse colleague found that an herbal cream (bach's rescue remedy cream) reduced the redness and skin site reactions. a small investigator funded mini-pilot demonstrated a decrease in resolution and in size of skin site reactions and satisfaction of herbal cream versus the placebo cream. this proposed research study builds upon moore's previous success that documented significant decrease in injection site reactions by adding an air bubble to the injection before injection, which is now described in the injection instructions of copaxone, rebif, and axonex. the specific hypotheses for this study as end points include: 1. the herbal cream will significantly decrease time of redness based on daily measure of skin site reactions compared to placebo cream. 2. the herbal cream will decrease discomfort of skin site reactions as measured by a visual analogue scale compared to the placebo cream. 3. participants will indicate how the herbal cream has made a difference to their quality of life based on a qualitative description of effects of skin site reactions before herbal cream and following use of herbal cream

Eligibility criteria:
inclusion criteria: * participants must demonstrate redness of skin site reactions * must demonstrate accurate injection technique prior to initiating the study exclusion criteria: * cannot read the flexible measure and record the results. * are diagnosed with secondary progressive, primary progressive or devic's ms. * are not taking one of the three subcutaneous injections (betaseron®, copaxone® or rebif®). * are pregnant. * are younger than 18 years of age. * are using combination therapy (e.g., 2 of the immunomodulators, chemotherapy) * have allergies to any topical creams used on skin.

Keywords: subcutaneous injections skin abnormalities
neoadjuvant and adjuvant therapy studies of sindilizumab in resectable lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this study is a randomized, double-blind phase 3 study to compare the efficacy and safety of sindilizumab combined with chemotherapy or placebo combined with chemotherapy for neoadjuvant and adjuvant therapy for resectable stage ii to iiib (resectable n2 only) non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: 1. subjects must sign the written informed consent form (icf), and be able to follow the visits and relevant procedures specified in the protocol. 2. age ≥ 18 years. 3. cytologically or histologically confirmed primary nsclc (including adenocarcinoma, squamous cell carcinoma). 4. subjects with stage ii, iiia or iiib (resectable n2 only) disease based on the 8th edition of the tnm staging classification for lung cancer issued by the international association for the study of lung cancer and the american joint committee on cancer classification (ajcc8). 5. deemed radically resectable with curative intent. 6. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 7. have not received any prior systemic anti-tumor therapy or local radiotherapy for nsclc. exclusion criteria: 1. subjects with confirmed or suspected brain metastases. 2. currently participating in an interventional clinical study or treatment with another study drug or study device within 4 weeks prior to randomization. 3. received chinese herbal medicine, chinese traditional medicine with anti-tumor indications, or drugs with immunomodulatory effects (including thymosin, interferon, interleukin) within two weeks prior to randomization 4. received a live attenuated vaccine 4 weeks prior to randomization (or planned to receive a live attenuated vaccine during the study). 5. requiring long term systemic corticosteroids 6. known history of human immunodeficiency virus (hiv) infection (i.e., hiv 1/2 antibody positive), known active syphilis. 7. active hepatitis b.
efficacy of dexpanthenol in thermic erythema

Conditions: Erythema

Summary: the study focuses to prove the equivalent efficacy of two different dexpanthenol formulations.


Eligibility criteria:
inclusion criteria: * healthy subjects * phototype: i to iv according to fitzpatrick scale exclusion criteria: * pregnant or nursing women * subjects registered as being in exclusion period in the french health minister file of subjects * subjects with known allergy to cosmetics, skin care products, or topical drugs, a sensitivity related to any component of any formulations being tested

Keywords: thermal erythema dexpanthenol erythema efficacy
virtual reality-based interactive treadmill gait training system for parkinson's disease

Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease

Summary: virtual-reality-based interactive treadmill system will be applied to the parkinsons' disease patients who can walk (hoehn and yahr stage 2 to 4). subjects will be randomly allocated to either vr-based treadmill training group or treadmill training without vr-based interaction. the training will be provided for 3 sessions (30min/session)/week for 4weeks, the total of 12 sessions. the outcomes will be measured at baseline, immediately after the completion of the intervention and 1 month after the intervention.


Eligibility criteria:
inclusion criteria: * definite or probable idiopathic parkinson disease patient * age from 18 to 80 years old * h\&y stage 2 to 4 and who can walk 10 meter independently regardless of the use of gait aids exclusion criteria: * unstable medical conditions * cognitive impairments which interfere with participation in virtual-reality based training * hemispatial neglect, visual disturbance, apraxia * other pre-existing disease involving the central nervous system (e.g. stroke, brain tumor) * requiring the continuous manual assist with touch during the treadmill training * can not give a consent
relapse prevention with escitalopram or nortriptyline following electro-convulsive treatment (duag-7)

Conditions: Major Depression

Summary: the main purpose of this study is to investigate the relapse preventing efficacy of escitalopram in a dose range and nortriptylin in a single dose in patients having been treated successfully with a course of electroconvulsive treatment (ect).

this study records severity of depression and relapse in patients treated for a major depressive disorder with electroconvulsive treatment (ect)in a period og 6 month after end of ect treatment. patients will be randomized into four groups treated with escitalopram 10 mg, 20 mg, 30 mg or nortriptylin 100 mg daily dosages. the primary outcome measure is relapse and secondary outcome measure is tolerability. the study is a multicenter trial within denmark.

Eligibility criteria:
inclusion criteria: * remission from a major depressive episode after ect treatment exclusion criteria: * suicidality (hamilton item 3 score of 3 or more) * symptoms mania (mas score of 15 or more) * duration of actual depressive episode more than 2 years * compulsory measures of any kind * dementia * severe somatic illness * pregnant or lactating subject * known clinical relevant malabsorption. * epilepsia * clinically substantial cognitive deterioration due to ect treatment * schizophrenia, schizopreniform or schizo-affective disorder * bipolar i, bipolar ii eller * rapid cycling bipolar disorder * abuse of alcohol or drugs * early relapse (less than 2 month) after ect * inadequate contraception * known intolerance to any of the used study medications * myocardial infarction in the last 6 month * clinical important liver disease * any known disturbance of the cardiac conduction system, cardiac insufficiency,or other clinical important cardiac disease * treatment with a mao-inhibitor * treatment with norepinephrine or epinephrine * known hyperthyroidism or treatment with thyroid hormones * known ortostatic hypertension. * glaucoma * known hereditary galactoseintolerance, lapp lactase deficiency) or gluco-se/galactosemalabsorption. * ongoing treatment with sympatomimetica efedrine, isoprenaline, physostigmine, dopamine, levodopa, phenylephrine. * ongoing treatment with anticholinergica, antiparkinson treatment, antihistamines, atropine, biperiden, * ongoing treatment with drugs that prolongs the cardiac qt-interval, such as quinidine, antihistamines, terfenadine og sotalole * ongoing treatment with fluconazole or terbinafine * ongoing treatment with mefloquin. * known intolerance to escitalopram * ongoing treatment with serotonergic acting substances such as tramadole, sumatriptane

Keywords: major depression relapse prevention ect escitalopram nortriptyline