Kornimate/medical-research-clean huggingface dataset:
interest of medial partial arthrodesis in degenerative and inflammatory damage of lisfranc tarsometatarsal joint.

Conditions: Arthritis Foot

Summary: research hypothesis: lisfranc tarsometatarsal joint arthrodesis is a reliable surgical procedure, allowing the restoration of satisfactory function and a painless foot with an acceptable complication rate. objective of the study: to analyze the clinical and radiographic results in the medium term of arthrodesis of the lisfranc tarsometatarsal joint in cases of primary osteoarthritis, post-traumatic osteoarthritis or in cases of inflammatory pathology.

data collection by return to the patient record: * clinical score * analysis of imagery (x-rays, ct scan, ) the patients included were those who had undergone arthrodesis of the medial lisfranc joint

Eligibility criteria:
inclusion criteria: * all patients who underwent lisfranc arthrodesis for primary post-traumatic osteoarthritis or inflammatory disease between january 2008 and december 2020 in * age \> 18 ans exclusion criteria: * follow-up \< 6 months * lost to follow-up * lack of data in the patient record.
perioperative immune function in patients undergoing colorectal cancer surgery

Conditions: Colorectal Cancer; Surgery

Summary: at zealand university hospital, denmark, the investigators will examine the immune function of patients with colorectal cancer before and after tumor resection. the immune function will be assessed with functional profiling of the immune function (truculture®) the study aims to describe alterations in the perioperative immune response to surgery. the generatied knowledge will lead to better under standing of perioperative pathophysiology.


Eligibility criteria:
inclusion criteria: * patients scheduled for laparoscopic resection of colorectal cancer with curative intent exclusion criteria: * age under 18 * neoadjuvant chemo or radiation therapy
sacro-spinous ligaments anterior apical anchoring

Conditions: Pelvic Organ Prolapse

Summary: anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the sacro-spinous ligaments and evaluated being a feasible and effective method.

anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the arcus tendinous fascia pelvis (atfp) rather than to the sacro-spinous (ss) ligaments commonly used for the posterior compartment reconstruction. the ss ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the atfp. the authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Eligibility criteria:
inclusion criteria: * pelvic floor prolapse \> gr 2, * anterior \> posterior defect, * apical supportive defect exclusion criteria: * active pelvic inflammation, * patient refusal
depakote er plus an atypical antipsychotic vs. an atypical antipsychotic alone in the treatment of schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to assess the 14-day and 12-week safety and efficacy of depakote er used in combination with either olanzapine or risperidone versus antipsychotic monotherapy with olanzapine or risperidone for the treatment of schizophrenia.


Eligibility criteria:
key inclusion criteria: * acute exacerbation of schizophrenia as defined by: subject recently hospitalized or is in the process of being admitted to a hospital or an acute care inpatient psychiatric treatment facility; and has a panns total score of 70 or greater at the time of screening and at randomization based on a 1-7 point scale; and has a score on any two of the four items from psychosis cluster of the bprs (extracted from the panss) that correspond to the positive symptoms (hallucinatory behavior, unusual thought content, conceptual disorganization and suspiciousness) totaling 8 or greater; and has a total of 6 or greater on one of the following two pairs of items from the bprs (extracted from the panss): hostility and uncooperativeness or excitement and tension. * current dsm-iv-tr diagnosis of schizophrenia as confirmed by the scid * positive response to antipsychotics in the previous 2 years key exclusion criteria: * current diagnosis of schizoaffective disorder, drug-induced psychosis, manic episode or major depressive episode. * at the time of screening, has been hospitalized for more than 14 days for the current episode * has ever taken clozapine * has had more than 3 psychiatric hospitalizations in the previous 6 months or has had more than 8 weeks of psychiatric hospitalization in the previous 12 months * has serious violent, homicidal, suicidal ideation * has received depot medications fluphenazine decanoate and/or haloperidol decanoate within 2 or 4 weeks prior to randomization respectively * urine toxicology screen is positive for phencyclidine (pcp), opiates, cocaine or amphetamines * history of alcohol or substance dependence within the past month * has taken any valproate product for a psychiatric indication within the previous 30 days * has received an investigational drug within the last 30 days
immunologic and genetic characteristics of monoclonal immunoglobulins in patient with tuberculosis

Conditions: Monoclonal Gammopathy; Tuberculosis

Summary: the purpose of this study is to determine whether the monoclonal protein in patients with tuberculosis and monoclonal gammopathy has anti-tuberculous activity, and whether genes coding their monoclonal proteins show characteristic mutations.

monoclonal immunoglobulins arise from abnormal proliferation of a single clone of plasma cells. they are composed of a single light and/or heavy chain class, in contrast to polyclonal immunoglobulins. they may occur in malignant lymphoproliferative diseases, such as multiple myeloma, waldenstrom's macroglobulinemia, lymphoma, chronic lymphocytic leukemia, amyloidosis, or more benign conditions such as monoclonal gammopathy of undetermined significance (mgus). recently we have observed monoclonal gammopathy occurring in patients with tuberculosis. whether tuberculous infection plays a role in the production of monoclonal protein, and whether the monoclonal immunoglobulins possess anti-tuberculous activity are unknown. in the current project we plan to study: (1) whether the monoclonal immunoglobulin developed in patients with tuberculosis reacts with tuberculous antigen (using elisa), and (2) whether the vh gene sequence analysis of such patient shows different mutation patterns (indicating the presence of intraclonal mutation variation) or not. if there is no intraclonal mutation variation, it suggests that the plasma cell clone is not under current exposure to the mutator, and the production of monoclonal gammopathy is probably not related to tuberculous infection. if, however, the vh gene sequence analysis shows the presence of intraclonal mutation variation, it indicates that the plasma cell clone is continuously under the influence of the mutator. in such case the production of monoclonal protein may be related to tuberculous infection.

Eligibility criteria:
inclusion criteria: * monoclonal gammopathy with tuberculosis exclusion criteria: * no
topical silver for prevention of wound infection after cesarean delivery

Conditions: Wound Infection

Summary: a common concern in any surgical procedure is the occurrence of infection. silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. we plan to investigate the rate of infection in women experiencing cesarean sections at vanderbilt university medical center (vumc) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.


Eligibility criteria:
inclusion criteria: * cesarean delivery with pfannenstiel incision exclusion criteria: * incision other than pfannenstiel * silver allergy * inability to provide informed consent

Keywords: wound infection prevention silver-containing surgical dressing cesarean delivery infection prevention
a study of combination amivantamab and carboplatin-pemetrexed therapy, compared with carboplatin-pemetrexed, in participants with advanced or metastatic non-small cell lung cancer characterized by epidermal growth factor receptor (egfr) exon 20 insertions

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (pfs), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (nsclc) characterized by egfr exon 20ins mutations.


Eligibility criteria:
inclusion criteria: * participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (nsclc) with documented primary epidermal growth factor receptor (egfr) exon 20ins activating mutation * participant must have measurable disease according to response evaluation criteria in solid tumors (recist) v1.1. * participant must have eastern cooperative oncology group (ecog) performance status 0 or 1 * participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream * a female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study exclusion criteria: * participant has evidence of synchronous nsclc disease (as suggested by genetic characterization or radiographic appearance) * participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible) * participant has history of spinal cord compression that has not been treated definitively with surgery or radiation * participant has a medical history of interstitial lung disease (ild), including drug-induced ild, or radiation pneumonitis * participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). participant has a history of hypersensitivity to, or cannot take, vitamin b12 or folic acid

Keywords: egfr exon20ins mutation nsclc
safety and tolerability study of azd7762 in combination with gemcitabine

Conditions: Cancer; Solid Tumors; Advanced Solid Malignancies

Summary: the primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called azd7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.


Eligibility criteria:
inclusion criteria: * japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective. * must be suitable for treatment with gemcitabine * relatively good overall health other than cancer exclusion criteria: * poor bone marrow function (not producing enough blood cells). * poor liver or kidney function. * serious heart conditions

Keywords: phase i cancer solid tumors advanced solid malignancies dose escalation combination treatment chk inhibitor japanese
a randomized trial of human growth hormone (hgh) vs placebo in intensively treated haemato-oncology patients.

Conditions: Multiple Myeloma; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: about 90% of patients with haemato-oncologic malignancy lose their body muscle mass and also lose weight either due to chemotherapy induced nausea/vomiting or the high catabolic state due to fever, sepsis or chemotherapy. this impacts tremendously on the days in hospital and also on the treatment-related complications. studies with human growth hormone (hgh) have shown that it increases lean body mass in adult patients with aids and animal models of cancer. at the same time, in vitro studies have shown that hgh has no effect on tumor cell growth. this study is designed to see if the use of hgh in immunocompromised patients with haematological malignancies prevents the loss of muscle mass and weight loss to some extent. this will be a blinded 1:1, randomised study including 150 patients whereby the patients will either receive hgh or a placebo. the doctors and the nurses will not know what drug the patient is receiving. both hgh and the placebo will be given intravenously (if patients are receiving other intravenous antibiotics or haemopoietic support ) or subcutaneously (if platelets are above 20 x 109/l) the treatment will start on the first day of treatment and continue for 6 weeks.


Eligibility criteria:
inclusion criteria: - age \>= 18 years 2. patients with haematological malignancies receiving neutropenia (\< 0.5 x 109/l) inducing chemotherapy (+/- tbi) requiring hospitalisation. 3. negative pregnancy test if the patient is of childbearing potential 4. informed consent exclusion criteria: * . previous treatment with growth hormone 2.unstable psychiatric conditions 3. uncontrolled endocrine disorders 4.chronic severe liver disease: ast or alt\>3x upper limit of normal range 5. chronic severe renal disease: creatinine\>150 µm or repeated positive test for haematuria or proteinuria 6. severe congestive heart failure 7. aortic stenosis associated with clinical symptoms eg syncope of angina pectoris 8. hypertrophic cardiomyopathy 9. uncontrolled hypertension (diastolic blood-pressure \> 105 mm hg) 10. diabetes mellitus that is not well controlled with insulin/antidiabetic drugs 11. severe respiratory disease 12. known or suspected allergy to growth hormone or any of its constituents 13. history of drug or alcohol abuse within two years prior to study enrolment 14. exposure to another investigational medication or device currently or within three months prior to enrolment.
study on migraine and headache in epileptic patients

Conditions: Epilepsy

Summary: the purpose of this study is to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics.

headaches and epilepsy are chronic disorders with episodic manifestations characterized by recurrent attacks of nervous system dysfunction with a return to baseline between attacks. although it is not uncommon that patients with epilepsy suffer from headaches, the relations between seizures and headaches is multi-factorial. headaches may occur immediately before (preictal), during (ictal), or after (postictal) a seizure. in addition to seizure-associated headaches, patients often experience headaches that are not temporally related to seizures-interictal headaches. moreover, epidemiological studies indicate an association of migraine and epilepsy with an increased prevalence of migraine in patients with epilepsy. up to now, there is still limited information about the relationship between the frequency of seizure attacks and headache occurrences. thus, we purpose this study to investigate the incidence of headaches, to explore the relationship between seizure attacks and headache occurrences, to classify the headache, and to document the frequency, characteristics, and effects of migraine and headaches among patients with epilepsy. this study is a multi-centre survey to collect data from patients who are diagnosed with epilepsy and are followed up in epilepsy clinics. patients can only participate in this study after signing and dating the inform consents. there are two stages of this study: stage i: on enrollment, data on demographic characteristics, epilepsy profile, seizure frequencies, and epilepsy treatment would be obtained. body weight and height would be measured. information of prior headache occurrences and their relationships with seizures would also be collected. stage ii: patients enrolled into this study will be divided into three group: patients who are seizure free for past 6 months, patients with \> 1 attack every month within past 6 months, and other patients. participants of each group will be enrolled into stage ii for 24-week follow-up. information of seizure attacks, headache occurrences, and treatment will be collected. this is an observational study and no study drug is administered.

Eligibility criteria:
inclusion criteria: * patients diagnosed with epilepsy * patients or parent(s)/caregiver(s) have signed and dated an informed consent. exclusion criteria: * patients who have non-epileptic events in addition to epilepsy, such as pseudoseizures or an acute symptomatic cause of seizures (e.g., a metabolic disturbance, toxic exposure, active cns infection) * patients with progressive or degenerative neurological disorder * patients with an active malignancy * patients or parents/caregivers with known or suspected psychotic disease, mental retardation, or any mental situation which may cause the concern to properly complete this survey.

Keywords: epilepsy headache migraine
a remote, 9-week insomnia treatment trial to collect real world data for a digital therapeutic

Conditions: Chronic Insomnia

Summary: the purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers cbt-i through a decentralized clinical trial, open to participants with chronic insomnia.

this is an open-access, open-label, decentralized clinical trial to collect real-world evidence for pear-003a, a digital therapeutic delivering cbt-i. potential participants will answer an online prescreening questionnaire to determine eligibility. qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. a series of the assessment and questionnaires will be administered at set points during the study. participants will be asked to complete a follow-up module about 26 weeks, and at days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. a subset of approximately 34 participants may be asked to partake in a optional user experience sub study. the participant will be asked to provide study feedback by either completing a five-day diary or an interview.

Eligibility criteria:
inclusion criteria: 1. provide electronic informed consent prior to any study specific assessments being performed 2. between 22 and 75 years old, inclusively 3. insomnia as defined by an isi score of 8 or above 4. insomnia symptoms for at least 3 months 5. \< or = 6.5 hours of sleep per night 6. access to a mobile device 7. resident of the united states and currently living in the united states for the duration of the trial. exclusion criteria: 1. presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) 2. unstable medication regimen (change to schedule or dosage within the past 3 months) 3. diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction 4. have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am. 5. individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. examples include: long-haul truck drivers, long-distance bus drivers, air traffic controllers, operators of heavy machinery, some assembly line jobs. 6. pregnant or planning to become pregnant during the course of the trial. 7. other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias) 8. participated in an investigational research study in the past 30 days

Keywords: digital therapeutic cbt-i chronic insomnia
evaluation of effect of renal impairment on the pk of tenofovir exalidex

Conditions: Renal Impairment

Summary: this is a phase 1 study to investigate the effects of renal impairment on the pharmacokinetics of tenofovir exalidex

this is a phase 1 study to investigate the effects of renal impairment (mild, moderate and severe) on the pharmacokinetics of tenofovir exalidex

Eligibility criteria:
inclusion criteria: * age: 18 years of age and over * capable of giving written informed consent * capable of completing study requirements exclusion criteria: * positive result for hiv, hbv, or hcv * history or medical condition which could impact patient safety * current or past abuse of alcohol or drugs * participation in another clinical trial within the past 30 days
clinical effectiveness and safety of trastuzumab deruxtecan (t-dxd) in chinese patients with her2m nsclc (rerun)

Conditions: Non-small Cell Lung Cancer

Summary: trastuzumab deruxtecan (t-dxd) is an approved therapy for non-small cell lung cancer (nsclc) in china. despite the clinical trial evidence, there is no real-world data of t-dxd used in chinese lung cancer patients with her2 mutations. this real world, prospective study will assess the effectiveness and safety of t-dxd in patients with locally advanced or metastatic, her2 mutation-positive nsclc in real-world setting.

t-dxd is an approved therapy in china for locally advanced or metastatic nsclc patients with human epidermal growth factor receptor 2 mutations (her2m). in previous clinical trials, t-dxd demonstrated efficacy and manageable safety profiles in the ≥ second-line setting for nsclc harboring her2m. however, patient populations are more diverse in routine practice and no real-world data of t-dxd used in chinese lung cancer patients with her2 mutations exist. this study will assess the effectiveness of ≥ second-line treatment of t-dxd in real-world setting as the primary objective. secondary objectives will further assess the effectiveness and overall survival of ≥ second-line treatment of t-dxd in real-world setting as well as evaluate the safety and tolerability of any-line treatment of t-dxd in real-world setting. this is an non-interventional, observational study. no drug will be provided or administered as part of this protocol; however, participants on t-dxd will be enrolled in this study.

Eligibility criteria:
the key inclusion criteria for this study are: 1. age ≥18 years at signing informed consent form (icf). 2. pathologically documented unresectable and/or metastatic non-squamous nsclc. 3. documented any known activating her2 mutation. 4. eastern cooperative oncology group (ecog) performance status (ps) 0-2. 5. patients who receive t-dxd based on physicians' discretion (newly received or just have started the first dose no longer than 2 months before enrollment). the key exclusion criteria for this study are: 1. previously treated with her2-targeted/directed therapies, including: * tyrosine kinase inhibitors \[tkis\] targeting her2 mutations, except for pan-her class tkis. * an adc, containing a chemotherapeutic agent targeting topoisomerase i 2. has spinal cord compression or clinically active cns metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 3. any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension active bleeding diatheses, etc.

Keywords: locally advanced or metastatic nsclc her2 mutations t-dxd