Kornimate/medical-research-clean huggingface dataset:
act34-cmi -- adult autologous cd34+ stem cells (follow-up study)

Conditions: Myocardial Ischemia

Summary: the purpose of this 12-month, observational, follow-up study is to collect additional data (by telephone contact) with which to assess the efficacy, safety, and effects of intramyocardial injections of adult autologous cd34+ cells on quality of life (qol) in subjects with chronic refractory myocardial ischemia. no treatments will be administered during this study. however, the investigators and other study site personnel and the subjects will remain blinded to the treatment assignments from the core therapeutic study (# 24779) so as to provide a total of 24 months of blinded data.


Eligibility criteria:
inclusion criteria: * subjects who have received treatment with auto-cd34+ cells or with placebo and who have completed the final study visit (month 12) of the core therapeutic study 24779 * subjects who are willing to comply with the specified follow-up evaluations in this study and to provide written informed consent to participate in this study
evaluate the safety of hbm9161 (hl161) subcutaneous injection in patients with generalized myasthenia gravis

Conditions: Myasthenia Gravis

Summary: the primary study objective is to evaluate medium- and long-term safety of hbm9161 in combination with background treatment for gmg patients through the observation on adverse events and laboratory abnormalities during study period.


Eligibility criteria:
inclusion criteria: 1. completed the hbm9161.3 phase 3 study 2. signed written informed consent. 3. suitable for continued treatment with hbm9161 as judged by the investigator. 4. female patients of childbearing potential and male patients with female partners of childbearing potential can participate in this study, but reliable contraceptive measures must be taken (such as physical barrier contraception (patients and their partners), contraceptive pills or patches, spermicide and barrier or intrauterine device). up to 60 days after the last dose. 5. a negative urine pregnancy at baseline must be observed for women of childbearing age. exclusion criteria: 1. had received any other clinical study drug since the administration of the study drug in the 9161.3 phase 3 study. 2. females who are pregnant or lactating or planning to become pregnant during the study period, or females of childbearing potential who are not using an effective method of contraception.
68ga-fapi-04 and 18f-fdg pet/ct in patients with epithelial ovarian cancer: compared with histological findings

Conditions: Epithelial Ovarian Cancer

Summary: epithelial ovarian cancer (eoc) is a tumor entity featured by frequent involvement of peritoneum, also called peritoneal carcinomatosis. it is a type of metastasis accompanied by significant cancer-associated fibroblasts (cafs) accumulation. fibroblast activation protein (fap) is a protein that is overexpressed on cafs and can be non-invasively monitored by a novel radiotracer called 68ga-fapi-04 positron emission tomography/computed tomography (pet/ct). in this study, we will explore the value of 68ga-fapi-04 pet/ct in patients with epithelial ovarian cancer who are scheduled for surgical intervention. the findings of 68ga-fapi-04 pet/ct will also be compared with that of 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose (18f-fdg) pet/ct, which is one of the most commonly used modalities in evaluating eoc, and histological findings.

patients with epithelial ovarian cancer who are scheduled for surgical intervention will be recruited in this study. they will undergo a comparative 68ga-fapi-04 and 18f-fdg pet/ct study before the surgery. no tumor-specific treatment is allowed between the scan and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. three types of lesions will be marked based on 68ga-fapi-04 and 18f-fdg pet/ct findings, which is fapi+/fdg-, fapi-/fapi+, and fapi+/fdg+ lesions. the marked lesions will be explored by the surgeon, resected if possible, and compared with histological results. a fourth type of lesion will be added into the analysis if that lesion is both fapi and fap negative but is a histological-confirmed positive lesion.

Eligibility criteria:
inclusion criteria: * written informed consent signed * eoc patients who are scheduled for surgery. the diagnosis of eoc should be based on the previous histological results or cytological evaluation combined with a serum ca-125 to carcinoembryonic antigen ratio\>25 to confirm the primary diagnosis and exclude a nongynecologic cancer. exclusion criteria: * known hypersensitivity to any of the excipients of 18f-fdg and 68ga-fapi-04. * tumor-specific treatment is necessary between the scans and surgery, e.g. adjuvant chemotherapy, neoadjuvant chemotherapy, and intraperitoneal chemotherapy. * pregnant or breast-feeding women. * any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude.
gene therapy for subjects with rpgr mutation-associated x-linked retinitis pigmentosa

Conditions: X-Linked Retinitis Pigmentosa

Summary: a clinical trial of gene therapy for patients with x-linked retinitis pigmentosa (xlrp).


Eligibility criteria:
inclusion criteria: 1.subjects that are willing and able to follow study procedures; 2.males aged 8-45 years old at the time of signing the informed consent form; 4.subjects who are confirmed with variants of rpgr ; exclusion criteria: 1.have other retinal degenerative diseases, such as retinal degeneration caused by other known inherited retinal disease gene variants or previously received an gene therapy product.
a comparison between posterior, lateral and medial approaches for ultrasound-guided popliteal block

Conditions: Nerve Pain

Summary: background: popliteal block is a widely used technique to provide anesthesia or analgesia for below-knee surgical procedures. in this study, the investigators compare ultrasound-guided popliteal blocks via posterior, lateral, and medial approaches to find out the approach with the best outcome.

methods: in this randomized, controlled clinical trial, one hundred and twenty asa physical status of class i and ii patients undergoing below-knee surgery were involved. these patients were divided into three equal groups at randomly based on the route assigned for the us-guided popliteal block: the posterior, lateral, and medial approach groups. in this study, technical characteristics \[number of attempts to get the proper injection site and block performance time\], anesthetic and analgesic characteristics \[success rate, block onset, potency, and duration, time to ask, and the consumed amount of postoperative analgesia\], discomfort rate in respect to position and needle insertion and the associated complications were recorded.

Eligibility criteria:
inclusion criteria: this study included * asa physical status (ps) class i and ii * weighing 70-85 kg, * undergoing elective below knee surgeries exclusion criteria: * patients who refused to participate in the study * those having an allergy to local anesthetics * peripheral neuropathy, coagulopathy * diabetes mellitus * severe hepatic * renal impairment * infection, mass and crush injury or open wound at the nerve block site * patients receiving chronic analgesic therapy.
effect of low-intensity laser and photodynamic therapy on infected dentin of permanent teeth with mih

Conditions: Molar Incisor Hypomineralization

Summary: the objective of this research was to evaluate the clinical effect of photodynamic therapy on dentin infected by caries lesion in permanent teeth with molar incisor hypomineralization (mih). the study was composed of groups (1 and 2). the methodology was based on the selection of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. the selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity, indicated for clinical restorative treatment. photodynamic therapy was applied with the use of low-intensity laser in permanent teeth selected for the treatment of infected dentin in g1. in this group, antimicrobial photodynamic therapy (apdt) and atraumatic restorative treatment (art) were made. in g2, only art was performed. the teeth were restored with high viscosity glass ionomer cement. all patients had clinical and radiographic follow-up with a time interval of 6 and 12 months. data were submitted to descriptive statistical analysis. for the evaluation of the association of categorical variables like age and gender, the chi-square test and fisher's exact test were used. to analyze the correlation between the continuous variables, the pearson correlation test was applied. anova and kruskal-wallis were applied for the analysis of dentin density in the radiographic images scanned and the microbiological results for colony forming units.


Eligibility criteria:
inclusion criteria: * healthy children, without systemic alterations; * collaborative children; * present at least one permanent molar with active and acute caries lesion in dentin, not exceeding 2/3 and involving only the occlusal, with direct vision and access, without clinical and radiographic signs and symptoms of pulp involvement. exclusion criteria: * child with systemic impairment; * non-cooperative behavior; * carious lesion of class ii, iii, iv or v type of black; * clinically: carious lesion involving enamel, deficient restorations, small carious lesions in dentin (without access to hand excavators), occult caries lesions, clinical sign and/or symptom of pulp involvement, clinical impossibility of restoration; * radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3 of the dentin.
docetaxel in hormone refractory prostate cancer (hrpc)[weekly or 3weekly tax + prednisone in hrpc]

Conditions: Prostatic Neoplasms

Summary: primary objectives: * to determine the response rate, measurable and non measurable, to taxotere® in the second line setting. secondary objectives: * to evaluate the overall safety and toxicity of taxotere®/prednisone combination as second line therapy in hrpc * to evaluate psa response (psa: prostate specific antigen) * to evaluate symptomatic response * to evaluate quality of life * to evaluate patient safety of weekly versus q3 weekly regimens of taxotere®.


Eligibility criteria:
inclusion criteria: * histologically/cytologically proven prostate adenocarcinoma * progression or non response with previous chemotherapy regimen (excluding taxotere®) * received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine * castration levels of testosterone (\<50 ng/dl ) * ecog performance status 0-2 * laboratory requirements : 1. hematology: * neutrophils ≥ 1.5 x 10\^9/l * hemoglobin \> 10 g/dl (prior transfusion permitted). * platelets ≥ 100 x 10\^9/l 2. hepatic function: * total bilirubin \< the upper-normal limit of the institution. * alat (sgpt) and asat (sgot) ≤ 1.5 times the upper-normal limit of the institution. 3. renal function: * creatinine ≤1.5 times the upper normal limit (i.e., nci grade ≤1) * no severe or uncontrolled disease exclusion criteria * chemotherapy within the last 4 weeks * anti-androgen therapy within the last 4 weeks. * prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for \>2 years. * concurrent treatment with other experimental drugs. participation in another clinical trial with any investigational drug within 30 days prior to study screening. * treatment with any other anti-cancer therapy (except lhrh agonists) including any prescribed compounds and/or otc products for the treatment of prostate cancer must be stopped prior to study entry. * other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.
natural history study of patients with chronic myelogenous leukemia

Conditions: Leukemia

Summary: rationale: gathering information about patients with chronic myelogenous leukemia may help doctors learn more about the disease and find better methods of treatment and on-going care. purpose: this natural history study is collecting health information and disease-related information over time from patients with newly diagnosed chronic myelogenous leukemia.

objectives: * determine the impact of current procedures for diagnosis, management, and follow-up on disease status of patients with newly diagnosed chronic myelogenous leukemia (cml). * determine the natural history of patients with cml who achieve response to imatinib mesylate. * determine the health perceptions, symptoms, insurance issues, and work issues of these patients. * determine whether medication compliance and planned dose reduction affect imatinib mesylate effectiveness in these patients. * determine the molecular and biologic factors associated with disease progression and good and poor response to imatinib mesylate in these patients. outline: this is a longitudinal, prospective, cohort study. patients complete quality of life, functional status, medical and treatment history, and medication questionnaires at baseline and then every 6 months for 5 years. blood samples are collected at baseline and then every 6 months for 5 years. specimens may be examined in the future in gene array studies and mutation analyses.

Eligibility criteria:
age 18 years and over diagnosis within one year of enrollment

Keywords: accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia meningeal chronic myelogenous leukemia
short-term effects of aromatase inhibition in obese men

Conditions: Hypogonadotrophic Hypogonadism; Obesity

Summary: in this study, 50 obese men with a hormonal imbalance will be treated with letrozole or placebo for six months in order to examine the effects on the hormonal balance, and on weight loss. the study will also address the side effects and psychological effects of letrozole as compared to placebo.

the aim of the study is to establish the short-term efficacy and safety of aromatase inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men. secondary aim is to detect the short-term somatic and psychological effects. study design: double blind randomized placebo-controlled trial. treatment: 26 weeks of either letrozole or placebo. all patients will start on 1 tablet per week, dose adjustments will be performed if serum testosterone or estradiol are outside the target range. all men will be prescribed a mildly hypocaloric diet. endpoints: bmi, body weight, waist circumference, body composition, exercise capacity, serum levels of several hormone markers, glucose tolerance, psychological characteristics. all patients will be measured 6 times during the study.

Eligibility criteria:
inclusion criteria: * bmi between 35 and 50 * male sex * ages between 20 and 50 * serum total testosterone under 10 nmol/l * serum luteinizing hormone (lh) under 9 mu/l * serum estradiol over 40 pmol/l exclusion criteria: * comorbidity * serum prostate-specific antigen (psa) over 4.0 u/l * discontinuation of smoking less than six months ago * medication known to affect hormonal parameters

Keywords: obesity hypogonadotrophic hypogonadism aromatase inhibition
adaptive dbs to offset stn dysregulation during exercise in pd

Conditions: Parkinson Disease

Summary: the investigators conduct a prospective study to evaluate the effects of exercise on parkinson's disease brain biomarkers detected with the percepttm pc neurostimulator.

the investigators will conduct a prospective study to evaluate the effects of exercise on local field potential biomarkers detected from the subthalmic nuclues in parkinson's disease with the percepttm pc neurostimulator. subsequently, adaptive deep brain stimulation applied in response to low beta peak (l-beta; 13-20hz) will be performed to evaluate feasibility of whether adbs can offset the effects of exacerbation of parkinsonism during exercise performance and recovery.

Eligibility criteria:
inclusion criteria: persons with pd who have a medtronic dbs sensight implant and a percept ipg. - exclusion criteria: persons not meeting the above listed implant criteria persons not meeting the age limit criteria persons who are not able to complete the study exercise persons not able to comprehend and consent to study participation.
a prospective study of cyclophosphamide treatment for idiopathic retroperitoneal fibrosis

Conditions: Idiopathic Retroperitoneal Fibrosis

Summary: this prospective, interventional, controlled study is aimed to evaluate the efficacy and safety of cyclophosphamide in the treatment of idiopathic retroperitoneal fibrosis, which refers to the chronic nonspecific inflammation of retroperitoneal fascia and adipose tissue that gradually evolves into fibroproliferative disease.

idiopathic retroperitoneal fibrosis is a chronic disease that requires treatment for a few years. patients with this disease respond well to glucocorticoid therapy, so you need to take glucocorticoid medication once the diagnosis is established. in addition, most patients need to use immunosuppressants when taking glucocorticoids. at present, the most commonly used immunosuppressants in the world are cyclophosphamide, azathioprine, methotrexate and mycophoranate, etc. the function of the above drugs is to improve the disorder of the immune system function, in order to restore the normal immune state, so that the inflammation and swelling of the affected organs disappear, restore the normal function. it should be emphasized that if the use of hormones and immunosuppressant is not standard or stopped too early, it can lead to disease recurrence. therefore, after the disease is under control, long-term adherence to medication is needed to maintain a stable state of the disease. at present, there is no clear treatment guideline for idiopathic retroperitoneal fibrosis in the world, and the addition of immunosuppressant is also out of debate. therefore, a comprehensive evaluation of its pathogenesis, clinical characteristics and treatment response is needed.

Eligibility criteria:
inclusion criteria: * age 18-75 diagnosed as irpf. the diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) a large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which igg4-positive cells accounted for less than 50% of plasma cells; (3) increased inflammatory markers, such as esr and crp; (4) good response to glucocorticoid therapy. exclusion criteria: * malignancy retroperitoneal fibrosis secondary to other diseases or drugs or abdominal surgeries.
a positron emission tomography study of slv354 in healthy subjects and subjects with schizophrenia

Conditions: Schizophrenia

Summary: this open-label, phase 1 study will investigate the 5-hydroxytryptamine 6 (5-ht6) receptor occupancy in the brain using positron emission tomography (pet) following single oral doses of slv354. up to 22 healthy male subjects and male subjects with stable schizophrenia, between 18-55 years of age are to complete the study.

this is an exploratory, open-label pet study designed to examine the relationship between slv354 plasma concentration and 5-ht6 receptor occupancy in the brain following single oral doses of slv354 in healthy male subjects and male subjects with stable schizophrenia. a total of up to 22 subjects are to complete the study, including approximately 12 subjects with schizophrenia on a stable dose of an atypical antipsychotic medication. within 60 days prior to the pet scan, subjects will be screened based on medical history, physical examination, vital signs, ecg, clinical laboratory tests, response to columbia-suicide-severity rating scale (c-ssrs) and for schizophrenia subjects only, the diagnosis of schizophrenia based on diagnostic and statistical manual of mental disorders-fourth edition-text revision (dsm-iv-tr). following screening, eligible subjects will have a magnetic resonance imaging (mri) scan, unless one was performed within one year of the pet scan, to delineate the region of interest for the individual pet images. the radiotracer \[11c\]-quics will be used for the pet scans. all subjects will receive a single oral dose of slv354. healthy subjects will have one pet scan prior to and two pet scans after administration of slv354. schizophrenia subjects will have two pet scans prior to and one pet scan after administration of slv354.

Eligibility criteria:
inclusion criteria 1. male, age between 18 and 55 years, inclusive. 2. body mass index 18 to 30 (healthy) and 18 to 38 (schizophrenia). 3. a condition of general good physical health. 4. schizophrenia subjects must have a diagnosis of schizophrenia based on diagnostic and statistical manual of mental disorders-fourth edition-text revision (dsm-iv-tr). 5. schizophrenia subjects must be on a stable dose of an atypical antipsychotic for at least 4 weeks prior to screening. exclusion criteria 1. presence of a metal implant that would preclude a magnetic resonance imaging (mri) scan. 2. radiation exposure for research purposes within the past year that will exclude participation in the study. 3. significant current suicidal ideation within the past month as evidenced by columbia-suicide severity rating scale (c-ssrs) completed at screening. 4. history of psychiatric diseases or disorders (healthy subjects) 5. unsuitable to receive slv354 or the radiotracer, \[11c\]-quics.
universal germline testing in the community

Conditions: Cancer; Solid Tumor; Solid Tumor, Adult

Summary: this study seeks to enroll participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk. at baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. a tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. the clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms.

this study seeks to enroll adult participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk using invitae's multi-cancer gene panel. at baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. a tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. the participant's clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms at 3 timepoints: 1 month following the results of the participants genetic testing, one year post genetic testing, and 2 years post genetic testing.

Eligibility criteria:
inclusion criteria: * patient has consented to germline genetic testing * patient has a histologically confirmed diagnosis of a solid tumor cancer * patient is willing to release previously collected tissue sample * patient is willing to provide research blood samples * patient must be at least 18 years of age exclusion criteria: * patient is unable to consent. * patient with hematologic malignancy