Kornimate/medical-research-clean huggingface dataset:
gtp regimen in the treatment of refractory/recurrent hlh

Conditions: Refractory; Recurrence; Hemophagocytic Lymphohistiocytosis

Summary: the goal of this clinical trial is to learn about efficacy and safety of gtp regimen in refractory/recurrent hemophagocytic lymphohistiocytosis. the main questions it aims to answer are: * overall remission rate of gtp regimen in r/r hlh * adverse effect of gtp regimen participants will be treated with gtp regimen

refractory/recurrent hemophagocytic lymphohistiocytosis will be treated with emapalumab combined with teniposide and methylprednisolone. observed the overall response rate and side effects.

Eligibility criteria:
inclusion criteria: 1. male and female patients ≥1 month of age with hlh 2. definitive diagnosis of hlh: meets the molecular diagnosis of phlh or has a family history of hlh, or meets at least 5 of the 8 diagnostic criteria of hlh-2004. 3. the investigators assessed the presence of refractory/recurrent hlh disease. patients must meet one of the following criteria assessed by the investigator: * previous conventional hlh treatment did not respond. * the patients were not satisfied with the efficacy of conventional hlh treatment or their condition worsened. * hlh reactivation occurs. reactivation is defined as: worsening of two or more hlh clinical and laboratory criteria (after initial remission). 4. according to the researchers, the expected survival was more than 2 weeks. 5. the informed consent is signed by the patient or his legal guardian (patients under 18 years), or by the patient's legally authorized representative. 6. women who are fertile are willing to use a highly effective contraceptive method from the start of the study until 6 months after the end of the last course of treatment. exclusion criteria: 1. there is active mycobacterium, histoplasma capsulatus, salmonella, or leishmania infection. 2. there is uncontrolled active gastrointestinal bleeding. 3. the investigator believes that there are any serious comorbidities or any other conditions that make the patient unsuitable for treatment. 4. a history of hypersensitivity or hypersensitivity to any component of the drug in the study protocol, such as polysorbate. 5. had received the bcg vaccine within 12 weeks prior to screening. 6. have received live or attenuated vaccine (except bcg) within 4 weeks prior to screening. 7. pregnancy patients. 8. within 4 weeks prior to enrollment in this study, another concurrent clinical intervention study was enrolled. 9. there is any condition or circumstance that the investigator believes may cause the patient to be unable to complete the study or to comply with study procedures or requirements.
stop ovarian cancer young; effect of the opportunistic salpingectomy on age of menopause

Conditions: Salpingectomy; Tubal Ligation; Menopause

Summary: the aim of this study is to evaluate the long-term safety of on the onset of menopause.

the aim of this study is to evaluate the long-term safety of on the onset of menopause. to investigate the effect of opportunistic salpingectomy on the age of menopause, we will compare age of menopause in women who underwent sterilization through opportunistic salpingectomy with a control group consisting of women who underwent sterilization by tubal ligation or who had no sterilization.

Eligibility criteria:
inclusion criteria: intervention group * undergoing an opportunistic salpingectomy as sterilization method * premenopausal status at enrolment * age between 30 and 45 years * will have residual ovarian tissue after surgery * able to understand the written or spoken dutch language * gives consent for participating in surveys control group * premenopausal status at enrolment * either sterilization by tubal ligation or no sterilization at all * age between 35 and 45 years * able to understand the written or spoken dutch language * gives consent for participating in surveys exclusion criteria: * postmenopausal status at enrolment * under the age of 35 or above 45 * previous salpingectomy of oophorectomy * previous hysterectomy * women with abnormal karyotype (such as turner syndrome and fragile x syndrome) * underwent chemotherapy or radiation * unable to understand the written or spoken dutch language

Keywords: salpingectomy sterilization tubal ligation opportunistic salpingectomy menopausal age
the impact of a diabetes risk prediction model in primary care.

Conditions: Type 2 Diabetes Mellitus; Primary Prevention

Summary: little evidence exists on the impact of diabetes risk scores, e.g. on physicians and patient's behavior, perceived risk of persons, shared-decision making and particularly on patient´s health. the aim of this study is to investigate the impact of a non-invasive diabetes risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.

diabetes risk scores are predictive models to estimate the probability for an individual to develop diabetes within a defined time period. in the last years, many diabetes risk prediction models were developed worldwide. it has been proposed that using diabetes risk scores as first step of diabetes screening is more practical than blood glucose tests as the latter are time consuming and costly. given the rapid development of diabetes risk scores and a simultaneous reluctance of primary care physicians (pcps) to implement diabetes risk scores in everyday practice, there is an urgent need to expand our knowledge of the impact of diabetes risk scores in the primary health care setting. thus, the aim of the study is to investigate the impact of a non-invasive risk prediction model in the primary health care setting as component of routine health checks on change in physical activity.

Eligibility criteria:
inclusion criteria for participation of medical practitioners: * general practitioners, medical practitioners and internists working as general practitioners with and without further training in diabetology according to german diabetes association standards * provide the routine health check exclusion criteria for participation of medical practitioners: * treat exclusively patients with private insurance * treat exclusively diabetes patients in a specialized medical practice inclusion criteria for participation of participants * appointment for the routine health check * insured in statutory health insurance * age \> 35 years * body mass index (bmi) of ≥ 27 kg/m2 exclusion criteria for participation of participants * type 1 or type 2 diabetes diagnosis or already abnormal blood glucose level (fasting glucose ≥ 126 mg/dl or 2 hours oral glucose tolerance test (ogtt) ≥ 200mg/dl or glycated hemoglobin (hba1c) ≥6,5%) before the routine health check * no sufficient german language skills to fill in the questionnaires * presence of an incurable disease with a prognosis of less than one year * severe mental illness or dementia * severe underlying disease, which largely impairs physical activity * pregnancy * participation in another clinical study 30 days before study inclusion

Keywords: prevention risk score behaviour physical activity
congenital naevus cohort for longitudinal evaluation

Conditions: Naevi; Neurodevelopmental Disorder; Congenital Nevus

Summary: congenital nevus (cn) is a pigmented skin lesion present at birth, which grows in size as the child grows. it can vary in appearance and is classified by its size, from small (less than 1.5 cm) to giant (greater than 40 cm). cn is associated with genetic mutations, mainly in the nras/braf genes. a large cn can lead to several clinical issues, including: risk of neurological disorders: large cn can be associated with neurological abnormalities such as neuro-meningeal melanosis, hydrocephalus, or brain malformations. these conditions may cause early neuro-developmental delays. the risk is not well understood and requires further studies. risk of melanoma: the risk of developing melanoma is higher for a large cn but remains low for smaller ones. increased monitoring is necessary during the early years for large and giant cn. psycho-social impact: parents often experience significant anxiety at birth due to the cancer risk and social stigma. as the child grows, a visible cn may impact their quality of life, particularly socially at school. management of cn remains controversial, especially for those of medium to giant size or with multiple satellites. there is an urgent need for further research to clarify best practices in monitoring and treatment, including the need for routine brain imaging and criteria for surgical intervention. ultimately, this study aims to deepen our understanding of cn, its associated neurological and melanoma risks, and the psycho-social challenges it poses, while striving to establish clear, evidence-based guidelines for monitoring and treatment to enhance patient outcomes and quality of life.


Eligibility criteria:
inclusion criteria: * patient under 2 years old. * patient with a medium, large, or giant congenital nevus (cn) according to the krengel classification, either single or multiple. * patient affiliated with social security. * patient whose legal representatives consent to their child's participation in the project. exclusion criteria: * patient with light brown spots or pigmented lesions not classified as nevi. * patient for whom it is impossible to establish annual follow-up. * patient whose parents do not speak french.

Keywords: congenital nevus neurodevelopmental disorder
combined rtms and relaxation in chronic tinnitus

Conditions: Chronic Tinnitus

Summary: repetitive transcranial magnetic stimulation in combination with relaxation therapy is used to modulate the neural pathways contributing to the perception and distress of phantom sounds.

tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. it is a frequent problem which can interfere significantly with the ability to lead a normal life. one significant modulator of tinnitus is stress. tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. also non-auditory cortical areas of attention allocation and emotional processing was shown to be involved. treatment remains difficult. the most effective treatment in chronic tinnitus is cognitive behavioral therapy including elements of relaxation therapy. repetitive transcranial magnetic stimulation (rtms) is also effective in treatment of tinnitus with moderate effect size. pilot data were positive for low-frequency rtms applied to the temporoparietal areas and high-frequency rtms applied to the left frontal cortex. newer findings indicate that exercise-combined non-invasive brain stimulation might show superior effects in contrast to rtms or exercise alone. combination of relaxation and two-sided (frontal and temporo-parietal) rtms will be examined with regard to feasibility, safety and clinical efficacy in patients suffering from chronic tinnitus in a pilot trial.

Eligibility criteria:
inclusion criteria: * diagnosis of bothersome, subjective chronic tinnitus * duration of tinnitus more than 6 months exclusion criteria: * objective tinnitus * treatable cause of the tinnitus * involvement in other treatments for tinnitus at the same time * clinically relevant psychiatric comorbidity * clinically relevant unstable internal or neurological comorbidity * history of or evidence of significant brain malformation or neoplasm, head injury * cerebral vascular events * neurodegenerative disorder affecting the brain or prior brain surgery * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse * prior treatment with tms

Keywords: repetitive transcranial magnetic stimulation chronic tinnitus relaxation
facial serum and mask and ready-to-drink jelly from thai rice

Conditions: Rice Serum; Rice Mask; Rice Jelly

Summary: this study consisted of three sub-studies including 1) development and evaluation of facial serum from thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants 2) development and evaluation of facial mask from thai rice on skin moisture, elasticity, oiliness, and melanin in healthy participants and 3) development and evaluation of ready-to-drink jelly from thai rice on controlling blood glucose and endurance time in healthy participants.

study 1: 30 male and female participants, age 30-50 years will be randomly applied with facial serum producing from either 2% alpha albutin (standard facial serum) or tubtim chumphae rice extract on either right side or left side of their face daily for 12 weeks. study 2: 60 male and female participants, age 30-50 years will be randomly assigned into 2 groups including 1) control group (n = 30): participants will not receive any facial mask for 12 weeks and 2) treatment group (n = 30): participants will be applied with home-based program facial mask with hom pathum rice extract for 30 min/day, 2 days/week for 12 weeks. study 3: this study consists of 2 sub-studies. study 3.1: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with tubtim chumphae rice, and jelly with hom pathum rice at 3.5 g/kg body weight. all participants will be measured for blood glucose levels before consumption and after consumption at 30, 60, 90, and 120 min. study 3.2: 25 male and female participants, age 18-35 years will be randomly consumed with control jelly, jelly with tubtim chumphae rice, and jelly with hom pathum rice at 3.5 g/kg body weight. after each consumption, all participants will perform walking or running on treadmill at intensity of 80% maximal heart rate to measure maximal oxygen consumption.

Eligibility criteria:
inclusion criteria: * male or female * age between 18 to 50 years * healthy * interested in facial serum with thai rice extract or facial mask with thai rice extract or jelly from with thai rice exclusion criteria: * history of adverse effects from facial serum or mask application or jelly consumption * skin allergy * skin disorders * skin wounds * history of allergy to thai rice, particularly in tubtim chumpae and hom pathum * history of allergy to facial serum or mask, i.e., serum or mask from rice * history of allergy to gelatin * signs or symptoms of fever or infection * abnormal body mass index * regular smokers or alcohol drinkers (\>2 times per week) * regular exerciser (\>2 times per week or \>150 min per week) * regular intake of dietary supplements, i.e., vitamins, antioxidants * hypertension, diabetes, cardiovascular disease, respiratory disease, endocrine disease, neuromuscular disease, musculoskeletal disease, liver disease, renal disease, immune disease, infectious disease, or cancer

Keywords: thai rice
endoscopic ultrasound (eus) guided fine needle aspiration (fna) eus-fna of solid pancreatic mass lesions using a novel corkscrew technique: a pilot study

Conditions: Pancreatic Cancer

Summary: this research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. the corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). it is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.


Eligibility criteria:
inclusion criteria: * in-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for eus-fine needle aspiration (fnta) exclusion criteria: * uncorrectable coagulopathy (inr \> 1.5) * uncorrectable thrombocytopenia (platelet \< 50,000) * uncooperative patients * pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures) * refusal to consent form * prior negative fnta * in situ metallic biliary stents * predominantly cystic lesions * inaccessible lesions to eus
three novel radiological indicators for diagnosis of adult acetabular dysplasia

Conditions: Acetabular Dysplasia

Summary: acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. these pathological changes can alter the position of the center of the femoral head. thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. herein, the investigators describe the protocol to verify three novel x-ray indicators, including offshoring index (ofi), moving up index (mui) and teardrop baseline offshoring index (tboi) of the femoral head. all data will be expressed as relative ratios, as the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.

acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation. current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior x-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. the commonly used measurement indicators include centre-edge (ce) angle, acetabular angle (sharp angle), and acetabular head index (ahi). moreover, some differences exist in the measurement results between male and female patients. acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. it is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and sharp angle.

Eligibility criteria:
inclusion criteria: * no experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery; * no marked pelvic tilt; * no hip dislocation; * no obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis; * no significant lesions in the pelvis or proximal femur; * aged over 16 years; * provision of written informed consent. exclusion criteria: * those with advanced osteoarthritis; * those with osteoarthritis secondary to acetabular dysplasia; * those with ankylosing spondylitis involving the hip joint; * those with rheumatoid arthritis; * those with inflammatory inflammation of the hip joint; * those with tumor lesions in the hip joint.
ccrc: understanding the effects of omega-3 fatty acids versus lignans in flaxseed on metabolic and inflammatory markers leading to diabetes and cardiovascular disease

Conditions: Body Weight; Lipids; Blood Glucose; Insulin

Summary: the aim of this study is to compare the effects of flaxseed on atherogenic lipids, plasma inflammatory markers, and insulin sensitivity. we hypothesize that flaxseed omega-3 fatty acids will improve the lipid profile (decrease triglyceride, total and ldl-cholesterol and increase hdl-cholesterol). flaxseed is the richest dietary source of lignan secoisolariciresinol diglucoside (sdg). lignans are estrogens found in plant sources that behave similar to endogenous estrogens and have been associated with cardiovascular benefits due to their antioxidant activity. therefore, we also hypothesize that flax-lignans will cause a significant decrease in ldl oxidation and in inflammatory markers such as c-reactive protein (crp), interleukin-6 (il-6), il-1b, serum fatty acid binding protein 4 (fabp-4), and serum amyloid attached to high density lipoprotein (hdl-saa).


Eligibility criteria:
inclusion criteria: * men or postmenopausal women in the 40-65 years age range. body mass index in the range of 25-39 exclusion criteria: * women are are premenopausal * smoking * diabetes * cancer * gout * untreated thyroid disease * kidney disease * liver disease * use of lipid lowering drugs * use of insulin sensitizing drugs * use of ace inhibitors or other blood pressure lowering medications * use of over the counter or prescription anti-obesity medications * weight loss of 10% or more within the last 12 months

Keywords: flaxseed weight loss heart health diabetes
a study of amnn107 in the treatment of metastatic and/or inoperable melanoma harboring a c-kit mutation

Conditions: Melanoma

Summary: the purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-kit mutation.

this trial began as a multi-center, randomized, phase iii, controlled trial for nilotinib vs (dtic) dacarbazine to assess the efficacy and safety of nilotinib (400 mg bid) in patients with c-kit mutated metastatic and/or inoperable melanoma. the study was open to patients with mucosal or acral melanoma. due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, phase iii study to a single-arm, simon two-stage phase ii study with protocol amendment 2 (27-jul-2011). while the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to amendment 2 were to be counted in this total, but those randomized to dacarbazine ( dtic ) dtic were not). patients randomized to dtic were allowed to cross-over to nilotinib, either immediately or at the time of progression.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed mucosal or acral 2. presence of a c-kit mutation of exon 9, 11 or 13, or mutations y822d and mutations d820y, y823d of exon 17, as confirmed by the central laboratory 3. stage iii unresectable or stage iv disease 4. the presence of one or more measurable lesions as detected by radiological or photographic methods and assessed according to recist 1.0. lesions must have a size of at least 10mm at longest diameter (using a slice thickness of 5 mm)or double the slice thickness to be considered a target lesion. target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression 5. who performance status 0 - 2 exclusion criteria: 1. c-kit mutation of exons 17(except mutations d820y, y822d or y823d) or any other exon not allowed by the inclusion criteria 2. patients with c-kit amplifications only and no mutation 3. patients with any history of brain metastases 4. patients who have had any prior treatment with tkis 5. patients receiving medications or herbal extracts which interfere with nilotinib metabolism which are not discontinued by the time of the baseline visit 6. acute or chronic liver or renal disease considered unrelated to melanoma other protocol-defined inclusion/exclusion criteria may have applied.

Keywords: melanoma amn107 c-kit c-kit mutated metastatic and/or inoperable melanoma