Kornimate/medical-research-clean huggingface dataset:
an open-label, single dose safety study of quadrivalent hpv vaccine in chinese female subjects (v501-035)

Conditions: HPV Infections

Summary: to prove that quadrivalent hpv (types 6, 11, 16, 18) l1 virus-like particle (vlp) vaccine is generally safe and well tolerated in the chinese population.


Eligibility criteria:
inclusion criteria: * subject is female, between the ages of 9 years and 0 days and 26 years and 364 days on the day of enrollment * subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent * subject is able to read, understand, and complete the vaccination report card exclusion criteria: * subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use * subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention * subject has known allergy to any vaccine component, including aluminum, yeast, or benzonase (nuclease, nycomed \[used to remove residual nucleic acids from this and other vaccines\])
effects of habit-ile in adults with bilateral cerebral palsy

Conditions: Cerebral Palsy; Bilateral Cerebral Palsy

Summary: this randomized controlled trial (rct) aims to evaluate the effects of intensive hand and arm bimanual intensive therapy including lower extremities (habit-ile) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.

this randomized controlled trial (rct) will investigate the impact of two weeks of habit-ile therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (cp). key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via emg and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. this study aims to provide a comprehensive analysis of habit-ile's effects especially on motor function, daily life activities and participation across a wide range of age.

Eligibility criteria:
inclusion criteria: * diagnosed bilateral cerebral palsy, * adults aged 18 to 50 years old, * level of manual ability : level i to v of macs * level of gross motor function : level i to iv of gmfcs * ability to follow instructions and complete testing, * ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted). exclusion criteria: * unstable seizure * programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time * alcohol/drug abuse * pregnancy * severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion * uncontrolled health issues (cardiac, metabolic...)

Keywords: cerebral palsy motor skill learning intensive therapy body function body structure muscle structure pain activities quality of life adults
treatment strategies for igg4-rd patients with superficial organ involvement

Conditions: Autoimmune Diseases

Summary: this study has been designed as a 12-month, open-label randomized controlled clinical trial. the study aims to compare the efficacy and safety of three treatment strategies in igg4-rd patients with superficial organ involvement: diprospan plus iguratimod, diprospan plus leflunomide and prednisone plus leflunomide.

90 igg4-rd patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group i are treated with diprospan (1ml im) and then with iguratimod (25mg bid); patients in group ⅱ are treated with diprospan (1ml im) and then with leflunomide (10-20mg qd); and patients in group ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd). all patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and igg4-rd responder index (ri) will be recorded during follow up. the primary endpoint is the difference of relapse rate between two groups at 12 months. the secondary endpoints are relapse time, response rate and side effects.

Eligibility criteria:
inclusion criteria: * 1. fulfillment of the 2019 american college of rheumatology/european league against rheumatology (acr/eular) igg4-related disease classification criteria; 2. newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. the addition of glucocorticoids was started at lower than 10 mg/d. exclusion criteria: * 1. patients who were diagnosed as other autoimmune diseases; 2. patients who were diagnosed as malignant diseases; 3. pregnant and lactating women； 4. active infection: hiv, hcv, hbv, tb； 5. severe irreversible damage of organ function; 6. receipt of any biologic therapy or immunosuppressive agent other than gcs.

Keywords: immunoglobulin g4-related disease treatment strategies iguratimod leflunomide relapse
development of novel gastric cancer screening and diagnosis technologies using tongue imaging and study of tongue image changes mechanisms

Conditions: Gastric Cancer; Tongue Images; Diagnosis

Summary: in this study, the investigators will prospectively recruit 100,000 individuals, including gastric cancer patients who have not undergone any anti-tumor treatment and non-gastric cancer participants. the investigators will construct a diagnostic model for malignant tumors based on the combination of tongue imaging, tongue coating, saliva, gastric juice, and fecal multi-omics data (including metagenomics, proteomics, metabolomics, etc.). additionally, the study will explore the relationship between oral, gastric, and intestinal microbiota and the development of malignant tumors.

patients with gastric cancer were recruited through outpatient clinics, endoscopy units, and inpatient departments of various centers, with all patients requiring a histopathological diagnosis. non-gastric cancer participants were sourced from community health check-ups, outpatient clinics, and endoscopy units affiliated with these centers.

Eligibility criteria:
inclusion criteria for gastric cancer patients: * 18≤age≤90 * histologically or cytologically confirmed gastric cancer * no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for gastric cancer * subject volunteers to join the study, signs informed consent, has good compliance and can cooperate with follow-up exclusion criteria for gastric cancer patients: * two or more kinds of malignant tumors at the same time * gastric cancer that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy * the use of glucocorticoids and antibiotics in the past three months * history of long-term medication * presence of oral diseases such as tooth and gum diseases * subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers inclusion criteria for healthy participants: * 18≤age≤90 * willingness to participate in the study, signing an informed consent form, and demonstrating good compliance exclusion criteria for healthy participants: * history of malignant tumors * the use of glucocorticoids and antibiotics in the past three months * history of long-term medication * presence of oral diseases such as tooth and gum diseases * subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers
a safety and efficacy study of msi-1256f (squalamine lactate) to treat "wet" age-related macular degeneration

Conditions: Macular Degeneration

Summary: age-related macular degeneration (amd) is a degenerative eye disease of the retina that causes a progressive loss of central vision. amd is the leading cause of legal blindness among adults age 50 or older in the western world. amd presents in two different types - "dry" and the more severe "wet" form. wet amd is caused by the growth of abnormal blood vessels in the macula. squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. this study will test the safety and efficacy of squalamine in the treatment of amd.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of "wet" age-related macular degeneration exclusion criteria: * prior treatment of "wet" age-related macular degeneration in the affected eye in the past 3 months

Keywords: subfoveal choroidal neovascularization squalamine lactate
tissue procurement substudy for participants in study cp-mga271-01

Conditions: Melanoma

Summary: the purpose of this study is to gain a better understanding about how the study drug mga271 works. no test drug will be given in this study. patients with easily accessible tumors at the screening visit for participation in study cp-mga271-01 will be asked to participate in this substudy. patients will undergo two excisional biopsies, punch biopsies, or core needle biopsies.

patients with easily accessible tumors (generally, metastatic deposits involving skin, subcutaneous tissues, or peripheral lymph node whose excision would not require general anaesthesia or the invasion of a body cavity) at the screening visit for participation in study cp-mga271-01 (the main study) will be asked to participate in this substudy. after providing appropriate informed consent, patients will undergo excisional biopsy, punch biopsy, or core needle biopsy of the accessible tumor prior to receiving study drug in the main study and then again after the first cycle of study drug is completed. some of the biopsy tissue will be sent to a central laboratory for research purposes. the central lab will analyze the tissue to see what effects that the study drug might have on tumors.

Eligibility criteria:
inclusion criteria: * qualified, by meeting all inclusion and exclusion criteria, for participation in study cp-mga271-01. * must have provided informed consent to participate in study cp-mga271-01. * must have accessible tumors (generally speaking, metastatic deposits involving skin, subcutaneous tissue, or peripheral lymph node whose excision, punch biopsy, or core needle biopsy would not require general anaesthesia or the invasion of a body cavity). * willing to undergo two minor surgical procedures with no expectation of personal benefit * have provided informed consent for this substudy as indicated by a signature on an approved consent document obtained from the patient or his/her legally authorized representative exclusion criteria: * any medical condition that would contraindicate the use of local or locoregional anaesthesia, or conscious sedation for the intended minor surgical procedure. * any medical condition (eg. skin disease or bleeding diathesis) that would hinder wound healing following a minor surgical procedure. * dementia or altered mental status that would preclude understanding and rendering of informed consent.

Keywords: melanoma accessible tumors b7-h3 positive tumors
change of urinary metabolic profile secondary to a congenital urine flow impairment (ufi) by nuclear magnetic resonance (nmr) and metabolomics analysis

Conditions: Congenital Urine Flow Impairment

Summary: for the new-born, diagnosis and prognosis of congenital urine flow impairment (ufi) are difficult to confirm only with morphological examination (ultrasonography, intravenous pyelography) and functional examination (dynamic renal scan mag3). only the test of time allows the post confirmation of a significant ufi requiring a surgery. this meant that the actual therapeutic indications are imperfect by the absence of an "absolute" endpoint for ufi. the objective of the study is to characterize the urinary metabolomics profile of new born with renal pelvis and/or ureters tract dilatation (suspicion of pelvi-ureteric junction anomalies, primary megaureter and vesico-ureteric reflux), detected by prenatal ultrasonography, by nuclear magnetic resonance (nmr) and metabolomics analysis. this characterization will allow the identification of statistically significant metabolomics markers for the diagnosis and prognosis of a favourable evolution of the anomaly. the evolution with time of these metabolomics profiles will also considered.


Eligibility criteria:
* inclusion criteria - ufi group: * newborns or infants between 1 and 3 months of age, * who present an upper urinary tract dilatation detected on prenatal ultrasound scanning, and confirmed with a postnatal sonographic investigation between d4 and d10 of life showing a renal pelvis with an anteroposterior diameter \> 10 mm and/or an ureters \> 6 mm, * written, informed consent obtained from the 2 parents * inclusion criteria - control group: * newborns or infants between 1 and 3 months of age, * written, informed consent obtained from the 2 parents * non-inclusion criteria - ufi group: * urological associated anomaly: bladder dysfunction, solitary kidney, bilateral pathology, * absence of parents consent * non-inclusion criteria - control group: * nephrologic or urological anomaly * previous medical conditions or prior surgery; except minor surgery (inguinal hernia, umbilical hernia, hypertrophic pyloric stenosis.....) * absence of parents consent

Keywords: congenital urine flow impairment urinary metabolomics profile nuclear magnetic resonance
gut microbiome studies in patients with poems syndrome and other plasma cell disorders

Conditions: Plasma Cell Disorders

Summary: a study to evaluate gut microbiome with poems syndrome and other plasma cell disorders

the characteristics and role of gut microbiome rare plasma cell disorders- poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (al) amyloidosis, have not been explored; and their pathophysiology is quite elusive. to help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed poems patients and al amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. moreover, gut microbiome in newly diagnosed poems patients will be compared to poems patients in remission. it is the overall hypothesis that in poems patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in poems patients will be different from patients with other plasma cell disorders and healthy controls.

Eligibility criteria:
inclusion criteria: * diagnosed with poems syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (mm), monoclonal gammopathy of undetermined significance (mgus), amyloid light chain (al) amyloidosis or healthy controls from their households exclusion criteria: * age under 18 years * pregnancy * substance abuse * antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation * chronic gastrointestinal disorder * gastrointestinal surgeries in the past 2 years * chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)
tobacco use in pregnancy intervention for cessation

Conditions: Pregnancy

Summary: the proposed project will test the effectiveness of the novel delivery of an established tobacco cessation treatment among pregnant women in kentucky. tobacco use during pregnancy is one of the most modifiable risk factors associated with poor birth and maternal outcomes and yet smoking prevalence among pregnant women in kentucky is among the highest in the county and estimated to be twice that of the national average, with no meaningful declines observed in twenty years.

the purpose of this pilot project is to test effectiveness of a tobacco-treatment cessation intervention (american college of obstetricians and gynecologists (acog) 5 a's) through use of a non-physician healthcare champion from within the clinic's existing infrastructure. this tobacco use in pregnancy intervention for cessation (topic) will involve training the identified healthcare provider to become a certified tobacco treatment specialist (ctts) and to administer the 5 a's to pregnant medicaid patients receiving prenatal care through two high-volume kentucky obstetrics clinics. this trial will provide evidence to evaluate this approach to delivering an established intervention in clinical practice. the investigators propose to test the effectiveness of the clinical intervention by using a two-armed cluster randomized controlled design. eligible participants will be randomized to the intervention (topic) or standard of care for smoking cessation in pregnancy. this pilot project will gather quantitative and qualitative data for a mixed-method, multi-stakeholder process evaluation of intervention training and delivery. furthermore, the investigators' use of medicaid claims data to examine healthcare utilization outside of maternal and infant well-care visits will enhance understanding of the strengths and limitations of these data for future evaluations. this study has the potential to significantly impact the most vulnerable in kentucky, where rates of tobacco use among pregnant women are among the highest in the nation.

Eligibility criteria:
inclusion criteria: * pregnant * tobacco user * able to read and write english * medicaid eligible exclusion criteria: * male

Keywords: pregnancy, smoking cessation, tobacco, preterm birth, topic
evaluation of oncoxin-viusid® in cutaneous melanoma

Conditions: Cutaneous Melanoma, Stage II; Malignant Cutaneous Melanoma; Cutaneous Melanoma, Stage III

Summary: malignant melanoma, responsible for 75% of deaths from skin cancer. current therapeutic options have poor response, many adverse events and high costs. for this reason, a study with nutritional supplement oncoxin-viusid was carried out. according to previous studies, it has an antitumor, immunomodulatory effect and to potentiate the antiproliferative effect of standard chemotherapeutic agents in different locations and stages of cancer.

performed at manuel fajardo surgical clinical university hospital in havana, cuba from september 2014 to april 2018, following a proof of concept open label study, with no control group in 20 patients diagnosed histologically in fajardo hospital or oncology institute, as melanoma, primary cutaneous stage iib-iiia. all received conventional surgical treatment and oral oncoxin-viusid (25 ml 2 times a day for one year), where it was also indicated adjuvant treatment or chemotherapy. all were evaluated monthly the first year and semesterly the second year. complying with the provisions of the helsinki act.

Eligibility criteria:
inclusion criteria: * patients with histological diagnosis of malignant cutaneous melanoma in stage iib-iic-iiia * subjects of 18 years and over of both sexes. * general health status according to the karnofsky index ≥ 70. * laboratory parameters within the normal limits defined as: hematopoietic: hemoglobin ≥ 9 g / l, total leukocytes ≥ 3 x 109 cells / l, neutrophils ≥ 1.5 x 109 cells / l, platelets ≥ 100 x 109 / l hepatic: liver function within 2.5 times upper normal limit and without liver disease demonstrated by tgp, ogt and alkaline phosphatase. * patients who express written voluntariness to enter the study with their signature of the informed consent document. * women of childbearing age should have a negative pregnancy test and use effective contraceptive methods such as intrauterine devices, hormonal contraceptives, barrier method or tubal ligation. exclusion criteria: * pregnancy or lactation. * patients with a second concomitant tumor. * present an associated chronic disease in the decompensation phase (heart disease, diabetes, hypertension). * history of hypersensitivity to another similar product. * severe acute allergic states. * severe septic processes. * non-operated patients, in whom the surgery was contraindicated. * patients at potential risk of not completing the study (those who will travel during the period of the investigation or distance in their residence, outside the city). * subjects who are participating in another clinical trial. * patients with cognitive disorders or a mental disorder that hinders their follow-up.

Keywords: cutaneous malignant melanoma nutritional supplement survival green tea
the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers

Conditions: Laughter Yoga

Summary: this study aims to evaluate the effect of laughter yoga on pain, fatigue, and general well-being in cancer patients and their caregivers. participants will be randomly assigned to either a laughter yoga intervention group or a control group. the intervention group will receive six sessions of laughter yoga over two weeks. outcomes will be measured before and after the intervention.

laughter yoga is a complementary mind-body practice that combines unconditional laughter with breathing techniques. it has been shown to reduce stress, improve mood, and promote psychological and physiological well-being. this randomized controlled trial will assess the effectiveness of a 6-session laughter yoga program on reducing pain and fatigue and enhancing general well-being in cancer patients and their caregivers. participants in the experimental group will attend three sessions per week for two weeks, each lasting approximately 30-40 minutes. outcomes will be measured before and after the intervention using validated scales. pain will be assessed using the visual analog scale (vas), which measures pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). fatigue will be measured using the visual analogue scale for fatigue (vas-f), a validated instrument that evaluates the intensity of fatigue and its impact on daily activities. the general well-being scale is a self-report instrument used to assess an individual's overall psychological well-being.he scale includes items related to mood, emotional state, and general life satisfaction. it is typically measured using a likert-type format, where participants rate the frequency and intensity of their feelings or experiences on a scale (e.g., from "strongly disagree" to "strongly agree"). these validated scales will be administered at baseline (before the intervention) and at the end of the intervention (after the 6 sessions) to assess changes in the primary outcomes of pain, fatigue, and general well-being.

Eligibility criteria:
inclusion criteria: * individuals who volunteer to participate in the study exclusion criteria: * having asthma or copd * being under 18 or over 65 years of age, and having any health condition or disability that impairs communication (such as visual or hearing impairments, or neurological or psychiatric disorders).

Keywords: pain caregives fatigue laughter therapy cancer patients