Kornimate/medical-research-clean huggingface dataset:
multicenter study to assess the efficacy and safety of methyl aminolevulinate hydrochloride (mal) 16.8% cream (cd06809-41) versus vehicle cream for actinic keratosis of the face

Conditions: Actinic Keratoses

Summary: a randomized, double-blind, vehicle-controlled, multicenter study to assess the efficacy and safety of methyl aminolevulinate hydrochloride (mal) 16.8% cream (cd06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (dl-pdt).

this was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate aks on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the united states. sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.

Eligibility criteria:
inclusion criteria: * participants aged ≥ 18 years at the screening visit. * participants had at least 4, but no more than 12, clinically-confirmed thin or moderately thick, non-hyperkeratotic, non-pigmented aks located on the face (e.g., forehead, cheek, chin), and balding scalp. * female participants of non-childbearing potential. * participants fully understood and signed an icf before any investigational procedure(s) are performed. exclusion criteria: * participants with pigmented ak in the treatment areas. * female participants who were pregnant, nursing, or planning a pregnancy during the study. * participants with a clinical diagnosis of a skin disease other than ak. * immunocompromised participants. * participants with any condition that may be associated with a risk of poor protocol compliance.
arsenic trioxide in treating patients with urothelial cancer

Conditions: Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter; Recurrent Urethral Cancer; Transitional Cell Carcinoma of the Bladder; Ureter Cancer

Summary: phase ii trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.

primary objectives: i. to determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. ii. to determine the toxicity of arsenic trioxide administered to patients with urothelial cancer. outline: patients receive arsenic trioxide iv over 1 hour on days 1-5. treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. patients who achieve complete response receive 2 additional courses. patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse.

Eligibility criteria:
inclusion criteria: * diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required * patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine * \>= 4 weeks since prior rt or chemotherapy * patients must have measurable disease * ctc (ecog) performance status =\< 1 * no evidence of nyha functional class iii or iv heart disease * baseline ekg with qtc \< 500 ms * non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study * granulocytes \> 1500/ml * platelet count \> 100,000/ml * bilirubin =\< upper limits of normal (uln) * serum creatinine \< 2.0 x uln
effect of metformin therapy on serum under-carboxylated osteocalcin levels in hyperandrogenic lean polycystic ovarian syndrome women

Conditions: Polycystic Ovarian Syndrome

Summary: high ucoc may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity. meformin is an insulin sensitizing agent will be given for these women trying to interfere with the pathophysiology of pcos in these women as followed up by serum uc-oc levels.

under-carboxylated osteocalcin (ucoc), the precursor substrate of bone biomarker oc is a potent regulator of energy metabolism by promoting insulin production and adiponectin synthesis and decreasing fat stores.ucoc has a potential role in the physiopathology of polycystic ovary syndrome (pcos), a common disorder defined by the constellation of anovulation, insulinresistance, hyperinsulinemia, obesity and androgen excess.circulating ucoc concentration is related to key endocrine pcos characteristics in a weight-dependent manner. within the bone-pancreas loop, high ucoc may favor insulin release in lean hyperandrogenic women to compensate for impaired insulin sensitivity.we will investigate serum uc-oc responses to insulin sensitizing therapies in lean hyperandrogenic polycystic ovary syndrome (pcos).

Eligibility criteria:
inclusion criteria: * lean women bmi 25 or less * hyperandrogenic clinically and/or biochemically. * androgen excess-polycystic ovary syndrome (ae-pcos) society 2006 criteria exclusion criteria: * bmi more than 20 * other causes of hyperandrogenism * other causes of metabolic disorders or diabetes.

Keywords: pcos
a non-interventional pilot study to explore the role of gut flora in depression

Conditions: Depression; Clinical Depression; Depression, Anxiety; Depression, Postpartum; Depression, Endogenous; Depression in Remission; Depression Chronic; Depression Moderate; Depression Severe

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to depression.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study a. may be signed by parent or legal guardian in the case of minor or adult unable to provide consent 2. male or female of all ages. (interest is given to children who present with autism or crohn's and whose parents wish to analyze their children's gut flora. also of interest analysis of development of the child's microbiome. in the case of autism, the younger the child, the better to correct the neurological problems if an association is found between autism and the microbiome) 3. diagnosis of depression based on dsm-v criteria exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition
rituximab-methotrexate-temozolomide-thiotepa (rmtt) regimen as first-line therapy for pcns dlbcl

Conditions: Primary Central Nervous System Lymphoma

Summary: this study aims to observe and explore the efficacy and safety of rituximab-methotrexate-temozolomide-thiotepa (rmtt) regimen as first-line therapy for primary central nervous system diffuse large b-cell lymphomas(pcns dlbcl)


Eligibility criteria:
inclusion criteria: * patients voluntarily joined the study, signed the informed consent, and had good compliance; * patients with 18 years to 75 years(at the time of signing the informed consent); eastern cooperative oncology group performance status (ecog-ps) score: 0-3; * patients with histopathologically confirmed newly diagnosed primary central nervous system diffuse large b-cell lymphoma, and there were intracranial evaluable lesions (long diameter greater than 1.5cm, short diameter greater than 1cm); * patients who have not received any systemic therapy, except those who use hormones to control complications * expected survival of more than 3 months. * female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; male patients should agree to use contraception during the study period and for six months after the end of the study. exclusion criteria: * patients who have previously received antitumor therapy or targeted therapy * patients who have undergone major surgery within the past 3 weeks . * presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia a, hemophilia b, von willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions. * any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections. * patients who are pregnant or breastfeeding. * current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment. * patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
polyneuropathy, impairments and physical activity - the polyimpact study

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Vasculitic Neuropathy; POEMS Syndrome; Multifocal Motor Neuropathy; Charcot-Marie-Tooth; hATTR Amyloidosis; Diabetic Polyneuropathy; Idiopathic Neuropathy; Polyneuropathies

Summary: the project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.

in four phases the investigators will evaluate physical activity and the validity, reliability, and responsiveness of the outcome measures in patients with polyneuropathy. during the four phases clinical outcome measures, patient-reported outcomes measures, and accelerometer data on physical activity will be evaluated. the investigators plan to include 400 adult patients with polyneuropathy (acquired, hereditary, and idiopathic) from our clinic and 120 adult healthy controls. the 400 patients with polyneuropathy include the following subtypes of polyneuropathy: chronic inflammatory demyelinating polyneuropathy (cidp), vasculitis polyneuropathy, polyneuropathy-organomegaly-endocrinopathy-monoclonal protein-skin changes (poems syndrome), multifocal motor neuropathy (mmn), charcot marie tooth (cmt), hattr amyloidosis, diabetic polyneuropathy (dpn), and idiopathic neuropathy.

Eligibility criteria:
inclusion criteria: inclusion criteria patients: \> 18 years diagnosed with polyneuropathy (verified by nerve conduction) inclusion criteria healthy controls: \> 18 years healthy exclusion criteria: exclusion criteria patients: not verified polyneuropathy exclusion criteria healthy controls: diabetes, brain-, nerve-, muscle-, kidney-, or liver disease. diagnosed with polyneuropathy

Keywords: polyneuropathy clinical outcome measures patient reported outcome measures (proms) physical activity accelerometer validity reliability responsiveness
application of mri radiomics features in neoadjuvant therapy of head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer; Neoadjuvant Therapy; Immunotherapy; Chemotherapy; Pathologic Complete Response

Summary: head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. neoadjuvant therapy, including neoadjuvant chemotherapy and immunotherapy, is recommended for patients with locally advanced head and neck cancer. the response to neoadjuvant therapy varies among the patients. it is reported that about 37% of the patients achieve pathological complete response after receiving neoadjuvant therapy, who would achieve a better prognosis compared with the patients with non-pathological complete response. it is significant to predict and assess response to neoadjuvant therapy for the patients with head and neck cancer accurately, which could assist in formulating individualized therapeutic regimens. mri has good soft tissue resolution and is a common preoperative examination method. however, this method lacks the ability to accurately predict the probability of patients achieving pathological remission after neoadjuvant therapy. at present, it is a novel and effective method to construct a model to predict the efficacy of neoadjuvant therapy based on mri image omics analysis, and certain achievements have been made in breast cancer and rectal cancer. in this study, multi-sequence mri was combined with clinical risk factors to construct an imaging omics model to predict the probability of pathological complete remission of patients with head and neck squamous cell carcinoma after neoadjuvant therapy, and to accurately identify diagnostic imaging remission, so as to better assist clinical decision-making.


Eligibility criteria:
inclusion criteria: * (a) patients pathologically diagnosed as head and neck squamous cell carcinoma; * (b) patients receiving two or three courses of neoadjuvant therapy (traditional chemotherapy plus pd-1 inhibitor); * (c) mr scan within 30 days before the first course of neoadjuvant therapy; * (d) patients undergoing radical surgical dissection following neoadjuvant therapy; * (e) complete clinical data available. exclusion criteria: * (a) previous head and neck treatment history; * (b) obvious motion or metal artifacts on the mri image; * (c) distant metastasis; * (d) concurrent malignancies.
to study the effect of magnetic activated sperm sorting on the outcome of in vitro fertilization-embryo transplantation

Conditions: Infertility, Male

Summary: recent studies have evaluated the use of magnetic-activated sperm sorting (mass) to reduce apoptotic spermatozoa and improve the outcome of infertile male with assisted reproductive technology (art). however, some results were inconsistent with above. the sperm of male with abnormal semen analysis tend to be accompanied with high apoptotic and high dna fragmentation index (dfi). hence, this study aimed at determining the efficiency of mass in improving the clinical outcome of patients with high dfi).

patients will be recruited from our reproductive medicine center in nanjing drum towel hospital, from july 2019 to july 2020. after semen analysis and selection of infertile men with at least two abnormal sperm parameters and obtaining the informed consent of the patients according to the admission criteria, the patients who enter the project will be randomly divided into the control group (n=30) whose sperm will be screened by density differential centrifugation (dgc) with swim up, and the observation group will be screened by mass, followed by dgc. then the procedure of in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) will be performed. embryo transfer will be underwent according to the developmental speed and morphological characteristics of the embryo. the clinical outcomes after transplantation will be followed up.

Eligibility criteria:
inclusion criteria: * patients were diagnostic as infertile according to 2007 who guidelines; * dfi\>25%. exclusion criteria: * with obvious female infertile factors; * sperm count \<10 million; * chromosomal abnormalities in either or both of the couple; * loss of follow up or incomplete information of patients.

Keywords: magnetic activated sperm sorting dna fragmentation index sperm up density differential centrifugation clinical outcome
an adaptive clinical trial of antivirals for covid-19 infection

Conditions: COVID

Summary: this is a randomised placebo controlled phase ii trial to examine the efficacy of antivirals to treat covid-19 infection compared to placebo for virological cure and improved clinical outcomes. individuals will be randomised to the candidate antiviral which in the first instance is favipiravir or matched placebo and randomisation will be stratified according to whether the participant requires hospitalisation or not. this treatment will be given in addition to the usual standard of care in the participating hospital.


Eligibility criteria:
inclusion criteria: * provision of informed consent by the participant or authorized representative * age ≥18 years * confirmed sars-cov-2 by nucleic acid testing in the past 5 days * covid-19 related symptom initiation within 5 days * female patients of childbearing potential must have a negative pregnancy test at screening. female patients of childbearing potential and fertile male patients who are sexually active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment. exclusion criteria: * known allergy to the study medication * is on another antiviral for the treatment of covid-19 * pregnancy * patients with severe hepatic dysfunction equivalent to grade c in the child-pugh classification * patients with renal impairment requiring dialysis * is deemed by the investigator to be ineligible for any reason
a fmri(functional magnetic resonance imaging) research study to learn more about multiple sclerosis and individuals potentially experiencing memory difficulties

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the purpose of this study is to determine if medication designed to improve memory will help patients with multiple sclerosis (ms) who are experiencing memory problems using fmri to track brain activity.

donepezil hci (aricept®) is an fda-approved drug now used to enhance memory in patients with alzheimer's disease. the aim of this project is to examine the effects of donepezil hci (aricept®) on memory induced brain activation patterns in the context of a double-blind, crossover trial of patients with multiple sclerosis (ms). we will perform task activation experiments involving two cognitive domains. the proposed work on ms patients should yield new information regarding functional anatomic relationships during cognitive activity, and how these relationships change as a function of drug treatment.

Eligibility criteria:
inclusion criteria: * between 18 and 65 years of age and experiencing some forgetfulness * diagnosed with ms, currently taking rebif® and experiencing mild memory problems * participants will have stable medication dosages 1 month prior to testing * with no past or present neurological disorders (e.g. head trauma, seizures, encephalitis, stroke) except ms * with no known medical illnesses (e.g. diabetes, uncontrolled hypertension, arthritis) * with no psychiatric illness * with no current substance abuse * females should not be pregnant or nursing * with no metallic devices in the body or claustrophobia exclusion criteria: * previous history of cns disturbance other than ms * severe motor or visual impairment that might interfere with the cognitive activation tasks * prescribed psychoactive medications * memory deficits caused by other significant neurological disease or psychiatric disorder * active malignancy within one year of study participation * known human immunodeficiency virus (hiv) * current diagnosis of unstable glaucoma; history of myocardial infarction * symptomatic coronary artery disease within the last 12 months or evidence of ongoing ischemia or uncontrolled atrial or ventricular arrhythmias as shown by ecg; poorly controlled or labile hypertension * history of epilepsy or other seizure disorder within the past 12 months * allergy or hypersensitivity to amphetamines or other sympathomimetic amines

Keywords: multiple sclerosis memory impairment
evaluating pharmacogenomics-based pharmacotherapy in real-world settings for schizophrenia

Conditions: Schizophenia Disorder

Summary: an 8-week, rater-blinded, real-world observational study to investigate the benefits of pharmacogenetics-based pharmacotherapy in patients suffering from schizophrenia.

this study, conducted at the shanghai mental health center, aims to compare changes in treatment efficacy and the frequency and severity of adverse reactions in patients with schizophrenia who have experienced treatment failure, before and after implementing a pharmacogenomics-based precision medication guidance strategy. the research is set in real-world conditions, without a predetermined treatment regimen for participants; instead, medication optimization is guided by pharmacogenomic testing results. following the receipt of precision medication recommendations for each participant, the study physicians optimize the treatment regimen based on these recommendations and their clinical expertise. optimization may involve adjusting the dose of current medications (if the existing regimen is largely suitable), switching medications (in cases of inappropriate treatment), or modifying the dose or replacing one of the combined medications (to manage drug-drug interactions). the rationality of the medication regimen will be assessed at the end of weeks 4 and 8, with additional recommendations provided as needed. treatment effectiveness and safety will be evaluated during follow-up visits at these intervals. a total of 400 patients are planned to be included in the study.

Eligibility criteria:
inclusion criteria: 1. suffer from schizophrenia (as assessed in agreement with icd-11 criteria). 2. age between ≥18 and \<65 years. 3. currently receiving inpatient or outpatient psychiatric treatment. 4. experienced any of the following suboptimal treatment conditions while receiving antipsychotic medication within the therapeutic dosage range: 1. standard antipsychotic treatment for more than 2 weeks with the occurrence of drug-induced adverse effects requiring dose adjustment or a switch of medication. 2. antipsychotic treatment within the therapeutic dosage range for more than 4 weeks, with the presence of at least two items of the positive and negative syndrome scale (panss) (p1, p2, p3, n1, n4, n6, g5, and g9) score ≥4, or a total panss score \>70, or a cgi-s score ≥4. 3. other situations where a change in medication is deemed necessary, as assessed by senior clinical physicians. 5. understand the study requirements and provide written informed consent to participate; a signed and dated informed consent form (icf) will be obtained from each patient before participation in the study. exclusion criteria: 1. presence of organic brain disease or a severe and/or unstable physical condition. 2. substance abuse or dependence within the past 6 months or currently. 3. presence of elevated levels of agitation, impulsivity, or risk of self-injury or suicide. 4. pregnant or breastfeeding women. 5. the presence of any other conditions that may render the individual ineligible for participation in this clinical trial.