Kornimate/medical-research-clean huggingface dataset:
a safety study of gammagard liquid (ggl) in participants with chronic inflammatory demyelinating polyradiculoneuropathy (cidp)

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Summary: the main aim of this study is to evaluate the rates of adverse events of special interest (aesis) (thrombotic events, acute kidney injury \[aki\], and hemolytic events) among participants with cidp initiating ggl compared with rates among participants with cidp initiating comparator intravenous immunoglobulin (ivig) products. no study medicines will be provided to participants in this study.


Eligibility criteria:
inclusion criteria: * have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date. gaps in continuous enrollment less than or equal to (\<=) 31 days are permitted. * fulfill the chronic inflammatory demyelinating polyradiculoneuropathy (cidp) diagnosis algorithm on or before the index date using all available baseline data for each participant. * additionally, to be eligible for the ig-naive (new-to-class) cohort, participants will be required to meet the following inclusion criterion: * be free of any previous recorded use of any ig product at any point before ivig initiation. * to be eligible for the ig-experienced (new-to-drug) cohort, participants will be required to meet the following inclusion criterion: * have any previous recorded use of an ig product at any point before the index date. exclusion criteria: * having claims for greater than or equal to (\>=) 2 different ivig products on the index date. * recorded diagnosis of any of the following conditions where ig products are used for treatment on or before the index date 1. primary immunodeficiency disease (pid). 2. evidence of secondary immunodeficiency (sid), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab. 3. idiopathic thrombocytopenic purpura (itp). 4. dermatomyositis or polymyositis. 5. systemic sclerosis/scleroderma. 6. myasthenia gravis.
gong's mobilization and sustained natural apophyseal glide in office workers with cervical spine overload

Conditions: Cervical Spine Sprain

Summary: neck pain is a frequent and disabling complaint in the general population. one of the most common causes of neck pain is mechanical dysfunction of the cervical spine. although diverse methods have been proposed for increasing cervical range of motion (rom), joint mobilization has been confirmed as effective in several studies. typically, joint mobilization methods for increasing cervical rom include spinal manipulative therapy, the activator and diversified techniques. there are different mobilization techniques for neck pain, and mulligan's technique is one of them. it has two techniques sustain natural apophyseal glides (snags) and natural apophyseal glides (nags). gong's mobilization technique helps to heal physical pain as well as distract the mind from stress. in this study, the effectiveness of gong's mobilization and sustained natural apophyseal glides (snags) will be compared in office workers who have problems with cervical posture and range of motion (rom) in order to examine the effects of gong's mobilization on cervical pain and cervical rom. twenty office workers with problems of cervical posture, pain and rom is divided into a gong's mobilization group (n=10) and a snags group (n=10). gong's mobilization and nags will be administered three times a week for four weeks to each respective group and then changes in cervical posture, pain and cervical rom will be evaluated.


Eligibility criteria:
inclusion criteria: * • both gender * aged 25 to 45 years * participants actively working in offices and who had been diagnosed with or self-reported chronic non-specific neck pain. * nprs \>4 exclusion criteria: * • surgical treatment of cervical spine (cervical diskectomy) * tumor around the neck * rheumatoid arthritis * nervous system disorder(vestibular disorder) * whiplash injury

Keywords: mobilization, cervical spine overload, gong's mobilization, snags
evaluating trauma-informed, evidence-informed interventions for latino families experiencing domestic violence

Conditions: Interpersonal Relations

Summary: this project will evaluate the implementation and efficacy of a domestic violence intervention module for parents receiving child welfare home visitation services.

the ultimate goal of this proposed project is the provision of culturally-relevant, trauma-informed services leading to a reduction of family violence, and a resultant increase in family stability, improved communication, and a healthy home environment for children in latino families with co-occurring domestic violence (dv) and child abuse/neglect (can). the administration for children, youth and families (acyf) funded project and evaluation will be layered onto the existing uc san diego's nih-funded r01 research (nih r01 mh092950) on scale-up of safecare (sc) across the entire san diego child welfare system. in the first phase of this project, the community and academic partners will collaborate to develop a detailed evaluation plan by collecting formative qualitative data via focus groups with active cw clients with domestic violence (dv) histories and community child welfare and dv service providers. the second phase of this project will begin with the implementation of safecare+ (sc+), an evidence-based training curriculum for parents referred for child maltreatment, coupled with the healthy relationships (hr) module for latino families with co-occurring child maltreatment and domestic violence experiences. safecare® (sc) has been shown to be widely accepted among the latino community and the hr module has been specifically adapted for and successfully utilized with latino populations. as part of the expansion of the original research study, 80 clients who will be recruited into the existing study will also be randomly assigned to receive the additional hr module.

Eligibility criteria:
inclusion criteria: * service providers (cws and dv) and active cw clients with dv histories will be recruited via random selection to participate in focus groups during the planning year of the project. * latino families are eligible for the rct based on the following criteria: (a) being identified as an appropriate family for safecare; and (b) by having at least one, qualifying dv experience, which will be determined during the baseline needs assessment. exclusion criteria: * a client will be excluded if he/she indicates to the service provider that they are unable to comprehend the written questionnaire and cannot obtain outside assistance in understanding and completing the questionnaire. * clients under the age of 18 will able be excluded because they cannot provide informed consent.

Keywords: healthy relationships interpersonal relations domestic violence
comparison of a novel leuprolide with market leuprolide

Conditions: Prostate Cancer

Summary: this is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. the safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.


Eligibility criteria:
inclusion criteria: 1. males of 18-40 years old (inclusive). the age difference of subjects within and between groups should be less than 10 years, at the time of screening. 2. body weight of at least 50kg. bmi to be 19-24 kg/m2 (inclusive). 3. able to comprehend the full nature and purpose of the study, including potential risks and side effects; able to cooperate with investigators and to comply with the requirements of the study 4. signed informed consent form prior to any screening procedures exclusion criteria: 1. clinically significant and relevant history of cardiovascular, hepatic, renal, hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseases of the digestive tract. 2. history of hypersensitivity towards leuprolide, synthetic lhrh or lhrh derivatives or any excipients of the study formulation. 3. abnormal and clinically significant 12-lead ecg 4. abnormal and clinically significant laboratory assessments 5. blood donation or blood loss greater than or equal to 400ml within 3 months prior to screening 6. participation of clinical trials within 3 months prior to screening 7. use of any drugs within 2 weeks prior to screening 8. history of drug abuse within 1 year prior to screening 9. history of alcohol abuse within 1 years prior to screening 10. history of tobacco smoking (more than 5 cigarette per day) within 1 year prior to screening 11. abnormal testosterone level at screening (not in the range of 168-781ng/dl) 12. dermatitis or skin anomalies that might affect the administration area and the surroundings 13. subject or his partner not willing to adopt appropriate contraceptive measures 14. subjects have a history of depressive illness or sexual dysfunction; 15. subjects that the investigator deems unsuitable to be enrolled 16. subject not willing to cooperate with the investigators.
blended treatment for alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: blended treatment for alcohol use disorder (blend-a) is a pragmatic, cluster randomized controlled trial to assess the clinical effectiveness and cost-effectiveness of implementing a blended treatment format that aims to reduce problematic alcohol use. blended treatment is a treatment format where treatment as usual is offered as a combination of online and face-to-face sessions, integrated into one treatment protocol. the blend-a study will evaluate and implement a blended treatment program in routine alcohol addiction treatment. the trial is led by unit of clinical alcohol research, university of southern denmark (ucar) in collaboration with partners at the centre for telepsychiatry in the region of southern denmark (ctp), and sundhed.dk.

background: a major challenge to psychological treatment for alcohol use disorder (aud) is patient non-compliance. a promising new treatment approach that is hypothesized to increase treatment compliance is blended treatment, consisting of face-to-face contact with a therapist combined with modules delivered over the internet within the same protocol. while this treatment concept has been developed and proven effective for a variety of mental disorders, it has not yet been examined for aud. aims: the study described in this protocol aims to examine and evaluate patient compliance with blended aud treatment as well as the clinical and cost effectiveness of such treatment compared to face-to-face treatment only. methods: the study design is a pragmatic, stepped-wedge cluster randomized controlled trial. the included outpatient institutions (planned number of patients: n=1800) will be randomized in clusters to implement either blended aud treatment or face-to-face treatment only, i.e. treatment as usual (tau). both treatment approaches consist of motivational interviewing and cognitive behavioral therapy. data on socio-demographics, alcohol consumption, addiction severity, treatment retention, treatment duration and intensity, and type of conclusion of treatment (dropout vs. compliance), will be retrieved from the national register of alcohol treatment (nab). in addition, all patients will be assessed for alcohol consumption, consequences of drinking and quality of life at treatment entry and six months after treatment conclusion. data will be analyzed with an intention-to-treat approach by means of generalized mixed models with random effect for cluster and fixed effect for each step. also, analyses evaluating cost-effectiveness will be conducted. discussion: blended treatment may increase treatment compliance and thus improve treatment outcomes due to increased flexibility of the treatment course. since this study is conducted within an implementation framework it can easily be scaled up, and blended treatment has the potential to become an alternative offer in the majority ofmany outpatient clinics nationwide.

Eligibility criteria:
inclusion criteria: * legal person seeking public alcohol treatment in the participating municipalities. exclusion criteria: * none.
prognostic recovery observations and guidance for evaluating stroke survivors

Conditions: Acute Stroke; Functional Recovery; Prognostic Factors

Summary: this research delves into the acute prognostic factors influencing functional recovery in individuals who have experienced a stroke. the objective is to describe patterns of functional recovery after a stroke and identify new, clinically significant outcomes or metrics that can serve as predictive indicators for post-stroke functional recovery.

in this prospective observational study with additional procedures, the aim is to describe different patterns of recovery according to clinical characteristics identified during the early phases post stroke. all the additional procedure are functional and clinical tests or questionnaires validated and used for standard stroke clinical practice that pose no risk to the enrolled subject. this study, based at san raffaele hospital's stroke unit, will enrol subjects who suffer from stroke assessed in the acute phase (t0), at three-months (t1), six-month (t2) and 1-year post-stroke (t3). no intervention that can interfere with usual clinical practice will be administered between evaluations. assessments include neurological, neuropsychological and physical therapy questionnaires along with functional tests validated and used in stroke clinical practice.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * haemorrhagic or ischaemic stroke confirmed by a clinical diagnosis and by brain imaging * nihss item 5-6 ≥1 * 3 to 10 days post-stroke exclusion criteria: * transient ischaemic attack * premorbid modified rankin scale ≥ 4 * acute orthopaedic complications * inability to give informed consent
ursodeoxycholic acid in the treatment of duodenal adenomas in familial adenomatous polyposis (fap) patients

Conditions: Adenomatous Polyposis Coli, Familial

Summary: malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (fap) patients who had a restorative proctocolectomy. ursodeoxycholic acid (udca) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

we designed a randomized double blinded study to evaluate the efficiency of udca in the treatment of duodenal adenomas. one hundred patients are planned to be included. fifty will receive udca and fifty a placebo. three duodenoscopies are planned: one before inclusion, one at the end of the first year of follow-up and one after two years of follow-up at the end of the protocol. these duodenoscopies are associated to endoscopies of the ileal reservoir performed at the time of restorative proctocolectomy and are recorded numerically. severity of the duodenal adenomas are evaluated according to the spigelman score. patients are seen every 6 months. before each endoscopy, blood samples are collected for biliary acid profile analysis. moreover, during endoscopies, duodenal fluid and ileal fluid are collected for biliary acid profile analysis, also. at the end of the follow-up of the last patients included (nov 2008), biliary acid profile analysis will be performed and statistical analysis of the results will be performed.

Eligibility criteria:
inclusion criteria: * male or female patients between 18 and 65 years of age * weight less than or equal to 100 kg * restorative proctocolectomy * activated protein c (apc) mutation identified or more than 100 polyps on the colectomy specimen * spigelman score of duodenal adenoma greater than or equal to 1 * efficient contraceptive treatment for pre-menopausal women * cooperative patient * signed consent * social security insurance exclusion criteria: * spigelman score of duodenal adenoma equal to 4 with severe dysplasia * hepatic disease * intermesenteric desmoid tumour * any severe disease * daily use during the last 3 months of: * aspirin; * non-steroid anti-inflammatory drugs; * tamoxifen; * cholestyramine. * pregnancy * breast-feeding

Keywords: treatment of adenomas of the duodenum in fap patients. adenoma
resistance exercise training in children.

Conditions: Resistance Training

Summary: the purpose of this study is examine the effects of 8 weeks (3 days/week) of resistance exercise training in children 8 to 10 years of age on muscle strength, activation, and lipids of the vastus lateralis.


Eligibility criteria:
inclusion criteria: * healthy volunteer males and females ages 8 - 10 years. exclusion criteria: * no history or ongoing neuromuscular diseases, musculoskeletal injuries, or a disease that effects metabolism.

Keywords: exercise muscle cross-sectional area intramyocellular lipids extramyocellular lipids strength
study of the association between tumor microenvironment macrophages and treatment response in squamous cell carcinoma of the anal canal

Conditions: Squamous Cell Carcinoma

Summary: squamous cell carcinoma of the anal canal is a relatively rare cancer (less than 3% of digestive cancers) but its incidence has been increasing in recent decades, probably because of its association with hpv (human papillomavirus) infection. its extension is mainly locoregional pelvic by lymphatic route, rarely metastatic. the standard treatment nowadays is radiotherapy combined with chemotherapy for locally advanced tumors (t2 or more corresponding to a size of 2 cm or more, or n+): mitomycin c and 5-fu (or capecitabine). while the 5-year disease control rates are excellent in localized forms, around 80%, for locally advanced tumors, the prognosis is poorer, with only 70% progression-free survival at 3 years in patients treated with radiochemotherapy. in these patients, it seems particularly interesting to understand the mechanisms of tumor resistance to treatments, in order to increase their efficacy and to propose new therapeutic targets. the microenvironment of solid tumors, which has been extensively studied in the last two decades, is now recognized as a major factor in tumor development and invasion. immune cells, and more particularly macrophages, represent an essential component of the tumor microenvironment, and constitute a link between innate and adaptive responses. the presence of tumor-associated macrophages (tams), and in particular m2 macrophages, with an anti-inflammatory and anti-tumor action (as opposed to m1 macrophages which are on the contrary tumoricidal and pro-inflammatory), has been studied in many cancers, such as head and neck squamous cell carcinoma, hepatocellular carcinoma, cervical squamous cell carcinoma, and non-small cell lung cancer. to investigator's knowledge, it has not been studied in squamous cell carcinoma of the anal canal.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient with locally advanced squamous cell carcinoma of the anal canal for which he/she has received radiotherapy/chemotherapy: tumor \> 2cm and/or locoregional lymph node involvement * patient whose main treatment (radiotherapy and chemotherapy) was performed at the paris saint-joseph hospital * french-speaking patient exclusion criteria: * patient with missing or unanalyzable material * patient with missing data * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his data for this research
subject information and consent form f1j-us-hmcb duloxetine once-daily dosing versus placebo in patients with major depression and pain

Conditions: Depression; Pain

Summary: the purposes of this study are to determine whether an investigational drug can help patients suffering from major depression with pain symptoms, and gather data on the safety of the investigational drug including any side effects that might be associated with it.


Eligibility criteria:
inclusion criteria: * you must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy) * you must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains. * you need to be available to visit a doctor's office about once a week for 10 weeks. exclusion criteria: * you are a woman and are pregnant or breastfeeding. * you have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder. * you have had a primary diagnosis of an anxiety disorder within the past 6 months. * you have a history of alcohol or drug dependence or abuse within the past 6 months. * you have a serious medical illness.

Keywords: depression pain blues sadness aches
low glycemic index (gi) diet management for pregnant woman with overweight

Conditions: Overweight; Pregnant Women

Summary: the study is a randomized, single-blinded, controlled intervention trial to compare the effect of a low glycemic index diet versus diet recommended by the chinese dietary guide for pregnant women on maternal and neonatal insulin resistance and adverse gestational events.

overweight in pregnant women increases maternal insulin resistance and risk of adverse pregnancy outcomes. recent evidence from both animal studies and human subject studies shows that adverse environmental exposures during pregnancy result in adverse influence on offsprings. the hypothesis of the current study is that the healthy intervention during pregnancy to overweight pregnant women--low glycemic diet, may improve the maternal and neonatal insulin resistance at birth. the current study adopts randomized, single-blinded, controlled intervention trial, gives low glycemic index diet intervention based on the national diet and physical activity recommendations for pregnant women to the intervention group and only national diet recommendations to the control group. four diet consultation interviews will be done,at baseline (first prenatal examination), the end of the 1st trimester, the 2nd trimester and the 3rd trimester respectively, including diet assessment and diet consultation specifically to adopting low glycemic diet. glycemic load of diet will be calculated based on 24 hour diet recall data for each individual at every visit to help to lower their diet glycemic load by modifying some daily foods. the effect of intervention is investigated by comparing the insulin resistance levels between the two arms at birth and when infants are at age 2. for discrete traits, such as incidence of gestational diabetes and gestational hypertension, person's chi-square tests were used. for continuous traits, such as insulin resistance index, maternal weight gain and neonatal birth weight, we use t-tests for comparisons between two groups. the study expects that long-term low gi diet intervention have beneficial effects on controlling maternal and neonatal insulin resistance to overweight women and long term health.

Eligibility criteria:
inclusion * singleton pregnancy; * pregnant women with bmi≥24 kg/m2 at first antenatal examination; * aged 18 years to 45 years; * the week of first prenatal examination equal to or less than 12 weeks; * take routine prenatal examination; * willing and able to give informed consent. exclusion * artificial impregnation; * history of hypertension, diabetes, coronary heart disease or mental disorder; * with special diet habit(e.g. vegetarianism/ veganism).

Keywords: overweight pregnancy diet counselling glycemic