Kornimate/medical-research-clean huggingface dataset:
satisfaction and compliance of risedronate in pmo

Conditions: Osteoporosis, Postmenopausal

Summary: compare subject satisfaction of once a week dosing of 35 mg risedronate to once daily dosing of 5 mg risedronate in postmenopausal osteoporotic women. secondary objectives are to measure compliance (50 % drug taken), and persistence.


Eligibility criteria:
inclusion criteria: * five (5) years or greater postmenopausal who present with a diagnosis of postmenopausal osteoporosis based on standard clinical practice criteria. * subjects must discontinue bisphosphonates, calcitonin, fluoride, glucocorticoids (\> than or = to 5 mg prednisone or equivalent per day) and hormone replacement therapy including estrogen-related compounds at least 6 months prior to randomization. during the study, these drugs are not permitted other than the study medication, risedronate. * other concomitant medications should be kept to a minimum, but if the drugs are considered necessary for the subject's welfare and are unlikely to interfere with study medication they may be given at the discretion of the investigator. exclusion criteria: * had a history of cancer within the past 5 years. relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the subject has been in remission for at least 6 months prior to enrollment. * diagnosis of hypocalcemia, hyperparathyroidism, and hyperthyroidism. * history of alcohol and/or drug abuse. * subjects will be excluded for active gastrointestinal disease that may interfere with absorption or with ability to swallow an oral medication. * subjects will also be excluded for serious concurrent illness that would interfere with their ability to participate in the trial. * excluded medications: bisphosphonates, calcitonin or fluoride or hormone replacement therapy within the last 6 months. * known hypersensitivity to bisphosphonates and/or excipients. * abnormal laboratory parameters, which are clinically relevant according to the investigator (including renal insufficiency; creatinine clearance \< 30 ml/min) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
il-8+ naïve t cells as a biomarker for thymoma identification

Conditions: Thymoma

Summary: according to the existing literature reports, the misdiagnosis rate of ct is as high as 22% - 68%. thymic cyst and lymphoma are usually misdiagnosed as thymoma, resulting in many unnecessary operations; in addition, traditional imaging technologies can also cause a missed diagnosis rate of about 7%, which is common in the missed diagnosis of asymptomatic thymoma, which delays the opportunity of treatment. therefore, in order to accurately treat thymic tumors, the existing diagnostic methods of thymic tumors need to be further optimized. our previous retrospective study found that the level of il-8 + initial t cells can well distinguish thymoma from other types of anterior mediastinal tumors, and the sensitivity and specificity are close to 95%.

this study is a prospective, multicenter diagnostic accuracy study. 310 patients with anterior mediastinal space occupying lesions who meet the enrollment conditions are planned to be recruited continuously. 5ml peripheral venous blood of the patients is taken before surgery or puncture biopsy and sent to the laboratory for blind detection of il-8 + initial t cell level; then the patient underwent anterior mediastinal tumor surgery or biopsy to obtain pathological results (gold standard for diagnosis). after the pathological results were confirmed, all cases were divided into thymoma group and non thymoma group. the sensitivity and specificity of il-8 + initial t cells in the diagnosis of thymoma and the cutoff value of thymoma were calculated.

Eligibility criteria:
inclusion criteria: * adult, aged 18 and above； * patients with anterior mediastinal mass on imaging (chest ct or mri)； * the patient's anterior mediastinal mass can be diagnosed by biopsy or surgery. exclusion criteria: * adolescents and children under the age of 18; * the patient's anterior mediastinal mass can not be diagnosed by biopsy or surgery.

Keywords: thymoma
optimized treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with hbv related liver fibrosis

Conditions: Hepatitis B; Liver Fibrosis

Summary: compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. we design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with hbv related liver fibrosis.

compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis b surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. but there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with hbv related liver fibrosis. we design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with hbv related liver fibrosis.

Eligibility criteria:
inclusion criteria: 1. positive hepatitis b surface antigen or hepatitis b virus dna \> 0.5 year; 2. age from 18 to 55 years old; 3. fibrosis lever of f1 to f3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan; 4. portal vein diameter ≤ 12 mm from liver ultrasound; 5. without treatment of anti-virus treatment ever before. exclusion criteria: 1. decompensated cirrhosis, hepatocellular carcinoma or other malignancy; 2. pregnancy or lactation; 3. other active liver diseases； 4. human immunodeficiency virus infection or congenital immune deficiency diseases; 5. severe diabetes, autoimmune diseases; 6. other important organ dysfunctions; 7. patients can not follow-up.

Keywords: hepatitis b virus peginterferon alfa liver fibrosis
impact of artificial intelligence genius® system-assisted colonoscopy vs. standard colonoscopy (colo-genius)

Conditions: Colonic Polyp; Colonoscopy; Artificial Intelligence; Colonic Adenoma; Colonic Neoplasms

Summary: this controlled-randomized trial compares the artificial intelligence genius® system assisted (genius+) to standard (genius-) colonoscopy. the aim of this study was to evaluate the impact of genius® system on adr in routine colonoscopy. the secondary aims will be the impact of genius® system on polyp detection rate (pdr), serrated polyp detection rate (spdr), advanced neoplasia detection rate (andr), mean number of polyps (mnp), polyp type and localization, and operator type (according to basal adr).

any patient seen by gastroenterologists working in the endoscopy unit and meeting the inclusion criteria may be recruited. the patient will be offered to participate in the study. the information form as well as the consent, will be given to the patient for a good understanding of the study and the investigator in charge of the patient gives all the additional explanations necessary for this good understanding (but of the study, the course, risks and benefits). a period of reflection will be left to the patient or his family to make a free decision whether or not to participate in the study. after the consent to participate will be signed by the gastroenterologist and the patient, the patient will be randomized. the use of the genius® system will depend on the randomization that will be performed at the start of the colonoscopy. this randomization will be done in the computer examination room using the randomization software. the patient will therefore be randomized into 2 groups: arm 1- standard colonoscopy arm 2- colonoscopy assisted by genius® system a comparison of the two groups standard colonoscopy vs colonoscopy assisted by genius® system will be made as following: a-main criterion: - adenoma detection rate (adr) b-secondary criteria: polyps detection rate (pdr) proximal serrated polyps detection rate (pspdr) neoplasia detection rate (ndr) mean number of polyps (mnp) mean number of adenomas (mna) factors associated with adr

Eligibility criteria:
inclusion criteria: * patient scheduled for total colonoscopic exploration, during the period study * patient over or equal to 18 years * asa 1, asa 2, asa 3 * no participation in another clinical study * certificate of non opposition signed exclusion criteria: * patient under 18 years old * asa 4, asa 5 * pregnant woman * patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. * patient referred for resection of a known polyp * inflammatory bowel disease * known colonic stenosis * diverticulitis less than 6 weeks old * patient unable to give consent or protected by law * opposition expressed for inclusion in the study
optimizing protein intake and nitrogen balance in adult critically ill patients

Conditions: Protein Deficiency

Summary: the purposes of the study are: * to strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation; * to determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated bun. * to determine if there is a difference in icu mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.


Eligibility criteria:
inclusion criteria: * age \> 18 years * receiving pn and/or en nutrition * indwelling urinary catheter * mechanically ventilated patients exclusion criteria: * age \< 18 years * chronic renal or hepatic failure * current or history (past 6 months) of gi bleeding * bmi \>30 kg/m2 o \<18 kg/m2 * terminally ill patients * pregnancy

Keywords: protein supplementation nutritional status
longitudinal multimodal neuroimaging studies in patients with first episode psychosis

Conditions: Psychotic Disorders

Summary: the purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.

the purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease. the study design is case-control, there are no interventions.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of first episode of a psychotic disorder * healthy controls with no psychiatric disorder history exclusion criteria: * significant neurological or medical illness history * ages \ 45

Keywords: schizophrenia schizoaffective disorder bipolar disorder
effect of pelvic floor down-training on women with idiopathic overactive bladder

Conditions: Overactive Bladder

Summary: this study will be conducted to investigate the effect of pelvic floor down-training on women with idiopathic overactive bladder

the relationship between overactive bladder (oab), constipation, and overactive pelvic floor muscles is complex and interrelated. oab increases the likelihood of overactive pelvic floor muscles, and conversely, hyperactive pelvic floor muscles can exacerbate oab symptoms. non-relaxing pelvic floor dysfunction often presents with urinary symptoms, including increased frequency, hesitancy, urgency, dysuria, bladder pain, and occasionally urge incontinence pelvic floor down-training exercises targeting the rectum provide a safe, conservative way to manage constipation, which may in turn help relieve oab. unlike medications or surgery; these exercises are generally safe and easy to incorporate into daily life. however, more studies are needed to evaluate their effectiveness, especially for treating idiopathic oab in women. filling this research gap will provide clearer clinical guidance on managing the interplay between oab, constipation, and pelvic floor hyperactivity. so this study will be the first to investigate the effect of pelvic floor down-training on symptoms of idiopathic oab in women.

Eligibility criteria:
inclusion criteria: * multiparous woman with idiopathic oab (2-3 times) who diagnosed by physician and confirmed by the urodynamic study. * woman with high rectal resting tone measured by pressure biofeedback. * woman diagnosed with constipation according to the rome iv criteria and bristol score. * ages ranging from 30 to 45 years. * bmi from 25-29.9 kg/m2 exclusion criteria: women will be excluded from the study if they have: * severe oab as measured by the overactive bladder symptom score for severity * postmenopausal women (a point in time 12 months after a woman's last period.) * any abnormalities around the bladder, such as bladder cancer, bladder calculus, interstitial cystitis, or endometriosis. * untreated urinary tract infections. * psychological or mental health problems. * pregnancy and lactation * a history of previous pelvic surgery. * are receiving any pharmacological treatment at the time of the study.
ameparomo capsules 250 mg drug use investigation

Conditions: Intestinal Amebiasis

Summary: this study is intended to evaluate the safety and effectiveness of ameparomo capsules 250 mg under actual medical practice.


Eligibility criteria:
inclusion criteria: * patients with no history of using this product exclusion criteria: * no exclusion criteria are set out in this study.
cik treatment for hcc patient underwent radical resection

Conditions: Carcinoma, Hepatocellular

Summary: this is a randomized controlled study. about 200 patients with hepatocellular carcinoma who underwent radical resection will be included. the patients will be randomized to group a (receive cik treatment) or group b (just regularly follow up) without any anti-cancer treatment after resection of hcc, and the randomize ratio will be 1:1.


Eligibility criteria:
inclusion criteria: * male or female patients over 18 years of age. * without any prior anti-cancer therapy. * patients who have a life expectancy of at least 12 weeks. * patients already had radical resection of hcc. definition of radical resection in this study: * all tumors were moved out, with a clean resection margin. * number of tumors less than 3. * without tumor invasion of the main trunk and first branch of the portal vein, or hepatic duct, or hepatic vein. * no hepatic hilum lymphnode metastasis. * no distance metastasis. * hepatocellular carcinoma with histological diagnose. * no major post-operative complication. * patients who have an performance status of 0, or 1. * cirrhotic status of child-pugh class a only. * the following laboratory parameters: * patients who give written informed consent. exclusion criteria: * previous or concurrent cancer that is distinct in primary site or histology from hcc. * history of cardiac disease. * active clinically serious infections ( over grade 2 national cancer institute-common terminology criteria for adverse events version 3.0) * known history of human immunodeficiency virus (hiv) infection * known central nervous system tumors including metastatic brain disease. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * history of organ allograft. * known or suspected allergy to the investigational agent or any agent given in association with this trial. * pregnant or breast-feeding patients. * any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * excluded therapies and medications, previous and concomitant: prior use of any anti-cancer treatment for hcc, eg. chemotherapy, radiotherapy. antiviral treatment is allowed.
using rapid cycle trials to increase patient engagement in the community health worker program in the emergency department

Conditions: Patient Engagement; Community Health Workers

Summary: this study is evaluating the effectiveness of the post-discharge program facilitated by the community health worker program in the emergency department at nyu langone health hospital - brooklyn and testing different strategies to increase patient engagement in the program.


Eligibility criteria:
inclusion criteria: * patients who present for a visit at the emergency department at nyu langone brooklyn hospital and who qualify for the community health worker program assessment and enrollment. exclusion criteria: * n/a
paclitaxel in treating patients with recurrent or refractory non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients who have recurrent or refractory non-small cell lung cancer.

objectives: i. determine the response rate and response duration in patients with recurrent or refractory non-small cell lung cancer (nsclc) treated with second line paclitaxel. ii. determine the qualitative and quantitative toxicities of this treatment regimen in relapsed patients with recurrent nsclc. iii. evaluate the time to treatment failure and overall survival in this patient population. outline: patients receive paclitaxel iv over 1 hour weekly for 6 weeks. courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 30-60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed non-small cell lung cancer with documented recurrent or refractory disease progressive disease at more than 3 months from completion of first line chemotherapy or progressive disease during first line chemotherapy clinically stable cns metastases allowed patient characteristics: age: over 18 performance status: ecog 0-1 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9.0 g/dl hepatic: bilirubin no greater than 2.0 mg/dl ast no greater than 5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl or creatinine clearance at least 60 ml/min cardiovascular: no clinically significant bradyarrhythmias other: neuropathy less than grade 2 fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy chemotherapy: see disease characteristics must have had at least 1 prior first line chemotherapy regimen for metastatic or locally advanced disease one prior paclitaxel regimen (every 3 week schedule) allowed if no progressive disease at less than 3 months from completion of therapy at least 4 weeks since prior chemotherapy endocrine therapy: not specified radiotherapy: at least 2 weeks since prior radiotherapy (indicator lesions within the radiation port must have progressed since completion of therapy) surgery: not specified

Keywords: recurrent non-small cell lung cancer
minimal invasive surgery for gastric subepithelial tumor

Conditions: Gastric Subepithelial Tumor

Summary: the investigators conducted a retrospective study of those patients with gastric sets receiving er or lr at the operative theater in the single institution from january 2013 to december 2021. medical records were retrospectively reviewed to define patient/tumor characteristics and operative outcomes.


Eligibility criteria:
inclusion criteria: * patients with gastric subepithelial tumors * patients received minimal invasive surgery (endoscopy or laparoscopy) for tumor resection exclusion criteria: * patients had gastric anatomic changes due to previous surgery * patients converted open surgery

Keywords: gastric subepithelial tumors endoscopic resection laparoscopic resection
impact of a paced breathing exercise intervention on autonomic nervous system function after pediatric concussion

Conditions: Concussion, Mild

Summary: the goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the sub-acute period after concussion, and to document the autonomic function, and symptom severity (post-concussion symptoms, anxiety, sleep) before and after administration of the intervention. participants will: will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from a concussion follow-up program. a weekly phone meeting will be performed with the participants, to review exercise, providing, specific instructions, and making any necessary adjustments. all participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. during the second assessment information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.


Eligibility criteria:
inclusion criteria: * aged 9-18 years * seven days-3 months post-concussion, * at least one post-concussion symptom in the post-concussion symptom inventory (psci) that is relevant to ans dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances). exclusion criteria: * known heart disease, * previous neurological problems other than concussion
immune modulation study in patients with metastatic melanoma treated with anti-pd1 monoclonal antibodies

Conditions: Metastatic Melanoma

Summary: this is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with anti-pd1 monoclonal antibodies (nivolumab). the aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.


Eligibility criteria:
inclusion criteria: * men and women aged ≥ 18 years * patient with metastatic or unresectable melanoma * anti-pd1 monoclonal antibodies treatment indication * patient affiliated to a social security regime * signed written informed consent. * agree with the storage of his biological samples * women of childbearing potential must as mentioned in the summary of product characteristics (spc) using two effective methods of contraception during treatment, and men whose partner is of childbearing potential must use effective contraception during treatment. for all patients treated men and women, contraception should be continued during the four months following the discontinuation of nivolumab. exclusion criteria: * development of haematological tumor during treatment * patients requiring concomitant chronic treatment with systemic corticosteroids or other immunosuppressive agents * patients with autoimmune disease. * patient with occular melanoma

Keywords: melanoma anti-pd1 monoclonal antibodies immune modulation braf