Kornimate/medical-research-clean huggingface dataset:
breast, omega 3 free fatty acid, ph 0

Conditions: Breastcancer

Summary: assess the impact of dietary omega 3 free fatty acids breast cancer patients.

prospective, single arm, short term study with correlative biomarker endpoints. two hundred (200) newly diagnosed breast cancer patients will be recruited to participate in a short term (30 day) phase 0 biomarker evaluation study prior to surgical resection. patients will be receive fish oil (omega-3 ffas, 2700 mg by mouth twice daily).

Eligibility criteria:
inclusion criteria: * at least 18 years of age * ecog ≤2 * ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's irb/ethics committee * consented for tissue collection on ctrc repository 07-32 exclusion criteria: * active systemic illness (infection including viral illnesses such as hepatitis and hiv) * chronic use of nsaids or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days) * any nsaids or omega-3 free fatty acid supplementation within the last 14 days * history of medical noncompliance * scheduled date of surgical resection that would limit the amount of time taking the intervention to less than 21 days
effect of weight and/or obesity on dapsone drug concentrations

Conditions: Obesity; Leprosy; Tuberculosis

Summary: this study will find how weight affects the dosing of a drug called dapsone. currently, the amount of dapsone a patient receives is the same regardless of the patient's weight.


Eligibility criteria:
inclusion criteria: * male and female subjects, age \>18 years, of all racial and ethnic origins. * non-english speaking spanish speakers will be included in the study. * we are recruiting 12 normal or underweight (bmi \ 40 kg/m2) for this study. this index is calculated using the volunteer's height and weight (formula: weight (lb) / \[height (in)\]2 x 703). half of each group will be male; the other half will be female. exclusion criteria: * pregnant or nursing or unwilling to use a reliable contraception method during the study. the effects of dapsone on pregnancy are unknown. in addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable. * abnormal liver function tests: transaminases\>10 times upper limit of normal, alkaline phosphatase\>5 times upper limit of normal, total bilirubin\>5 times upper limit of normal. * history of allergies to dapsone, sulfones, or sulfonamides. * dapsone, sulfones, or sulfonamides are contraindicated for any reason. * volunteers unwilling to comply with study procedures. * current suspected or documented infection of any kind. * volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug. * current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by pi. * donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by pi. * current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir. * creatinine clearance \< 70 ml/minute (min) as estimated by the cockcroft-gault equation.

Keywords: obesity pharmacokinetics dapsone leprosy tuberculosis
safety, immunogenicity and reactogenicity of recombinant hepatitis b vaccine (adjuvanted & new formulation) and engerix™-b

Conditions: Hepatitis B

Summary: the purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis b vaccine, engerix™-b and hepatitis b vaccine new formulation when administered at 0, 6 months

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years old. * written informed consent will have been obtained from the subjects. * good physical condition as established by physical examination and history taking at the time of entry. * female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry exclusion criteria: * pregnancy or lactation. * positive titres for anti hbs antibody. * any vaccination against hepatitis b in the past. * any previous administration of mpl. * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * axillary temperature \> 37.5°c at the time of injection. * any acute disease at the moment of entry. * chronic alcohol consumption. * any treatment with immunosuppressive or immunostimulant therapy. * any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * simultaneous administration of any other vaccine(s). * administration of any immunoglobulin during the study period. * simultaneous participation in any other clinical trial.

Keywords: hepatitis b engerix™-b recombinant hepatitis b vaccine adjuvant
influence of testosterone administration on drug-induced qt interval prolongation and torsades de pointes

Conditions: Long QT Syndrome

Summary: torsades de pointes (tdp) is a potentially fatal ventricular arrhythmia associated with corrected qt (qtc) interval prolongation. more than 50 commonly used drugs available on the us market may cause qtc interval prolongation and tdp. while tdp occurs more commonly in women, 33-45% of all cases of tdp have occurred in men. older age is a risk factor for drug-induced tdp in men, possibly due to declining serum testosterone concentrations. available evidence shows an inverse relationship between qtc intervals and serum testosterone concentrations. in addition, experimental data, including those from the investigators' laboratory, suggest that both exogenous testosterone or progesterone administration may be protective against prolongation of ventricular repolarization and tdp. specific aim: establish the influence of transdermal testosterone administration and oral progesterone administration as preventive methods by which to diminish the degree of drug-induced qt interval prolongation in men 65 years of age or older. hypothesis: transdermal testosterone administration and oral progesterone administration both effectively attenuate drug-induced qt interval response in older men. to test this hypothesis, transdermal testosterone, oral progesterone or placebo will be administered in a 3-way crossover study to men 65 years of age or older. qtc interval response to low-dose ibutilide will be assessed. the primary endpoints will be fridericia-corrected qt interval (qtf) response to ibutilide, in the presence and absence of testosterone, and in the presence or absence of progesterone: 1) effect on pre-ibutilide qtf, 2) effect on maximum post-ibutilide qtf, 3) effect on % change in post-ibutilide qtf, and 2) area under the qtf interval-time curves.


Eligibility criteria:
inclusion criteria: * men ≥ 65 years of age exclusion criteria: * prostate cancer; history of prostate cancer; * history of breast cancer; benign prostatic hypertrophy; * weight \< 60 kg * weight \> 135 kg * serum k+ \< 3.6 meq/l; * serum mg2+ \< 1.8 mg/dl; * hemoglobin \< 9.0 mg/dl; * hematocrit \< 26%; * hepatic transaminases \> 3x upper limit of normal; * baseline bazett's-corrected qt interval \> 450 ms * heart failure due to reduced ejection fraction (left ventricular ejection fraction \< 40%) * family or personal history of long-qt syndrome, arrhythmias or sudden cardiac death; * concomitant use of any qt interval-prolonging drug.

Keywords: torsades de pointes testosterone progesterone clinical trial risk reduction electrocardiography
the effect of addıtıonal surgery on muscle strength, proprıoceptıon and balance in anterıor crucıate lıgament surgery

Conditions: Anterior Cruciate Ligament Injuries; Meniscus Lesion

Summary: meniscal tears and ramp lesions are frequently seen together with acl injuries. the aim of this study was to evaluate the effects of meniscus repair and ramp lesion repair acl reconstruction surgery in terms of muscle strength, proprioception, and balance. in our study, the clinical outcomes of both anterior cruciate ligament reconstruction (aclr), medial meniscus repair (mr) and ramp lesion repair (rr) have been compared with those of isolated aclr.

methods: fifteen patients of isolated aclr performed, 15 patients of aclr with mr or rr performed, and 15 healthy participants were included in our study. besides, patients to whom aclr and additional interventions performed divide into subgroups: 7 patients with rr and 8 patients with mr. isokinetic muscle strength, proprioception, balance, fall risk, lysholm knee scoring and tegner activity level scale of patients were evaluated preoperatively and at the postoperative 6th week. the data obtained in the research were analyzed using the spss (statistical package for social sciences) for windows 22.0 program. number, percentage, mean, and standard deviation were used as descriptive statistical methods in the evaluation of the data. the relationship between grouped variables was tested by chi-square analysis. one-way anova test was used to compare quantitative continuous data between more than two independent groups. scheffe test was used as a complementary post-hoc analysis to determine the differences after the anova test. the difference between within-group measurements was analyzed with the paired-group t-test.

Eligibility criteria:
inclusion criteria: * being between 18 and 40 years of age, not having had any previous knee surgery and not having any diagnosis of knee pathology, not having any musculoskeletal injury, cardiopulmonary or vestibular dysfunction that would prevent performing the tests in the study were the inclusion criteria for control group. exclusion criteria: * in addition to acl injury, the patients with cartilage damage, knee arthrosis, misalignment in the lower extremity and additional ligament pathologies, history of previous knee surgery, any pathology in the opposite lower extremity, and additional neuromuscular diseases were excluded.

Keywords: ramp lesion muscle strength balance proprioception acl
effects of tens on pain threshold and brain activities in healthy adults

Conditions: Transcutaneous Electrical Nerve Stimulation; Electroencephalography; Pressure Pain Threshold

Summary: the purpose of this study was to understand the effects of conventional versus acupuncture-like tens on pain threshold, brain activities, and their relationships.

transcutaneous electrical nerve stimulation (tens) is a pain modulation tool which is commonly used clinically. tens has 2 major modes: "conventional tens'' and "acupuncture like tens". conventional tens induces a local pain modulation, whereas acupuncture like tens induces central pain modulation mechanism. the pain threshold at treatment area and outside of area is regarded as local pain modulation and central pain modulation respectively. however, the effect of acupuncture like tens on pain threshold was remained unclear. tens also induces cortical activities changed in the central nervous system. recent electroencephalography (eeg) studies suggested that tens induces event-related potential and power spectrum changes, however, the time and frequency bands of eeg changes and its relationship with pain threshold were still unclear. therefore, the purpose of this study was to understand the effects of conventional versus acupuncture-like tens on pain threshold, brain activities, and their relationships.

Eligibility criteria:
inclusion criteria: * 20\~65 y adults * no cognitive function problem * without taking any type of pain medication or substances that could affect the cognitive functions exclusion criteria: * peripheral or central nervous system disease * sensory lose * tens application is contraindication * cardiac pacemaker * any type of pain

Keywords: transcutaneous electrical nerve stimulation electroencephalography pressure pain threshold pressure pain tolerance
learning and executive function disorders in children and psychosis risk at adult-age

Conditions: Schizophrenia; Learning Disorders; Executive Function Disorders

Summary: the primary objective of the study aims to study transition toward schizophrenia in patients with learning disorders, and to compare the risk between patients with specific learning disorders, and patients with complexed learning disorders (by two types: patients with other neuro-developmental disorders including executive function disorders, and patients with anxiety).

as secondary objectives, the study aims to: * argue the clinical predicted markers (neuropsychological) transition toward psychosis. * test the feasibility and the acceptability of a early diagnosis for a potential applicable guidance for different referent centers of learning in french territory. * have a better classification of patients with learning disorders in order to target a prospective primary prevention of risk of psychosis via the questionnaires (aq of baron-cohen: autism-spectrum quotient auto-questionnaire; inventory of beck anxiety inventory, auto-questionnaire for panic disorder and general anxiety; liebowitz social anxiety scale). * improve identification of the early signs and the early emerging psychological diseases intervention management (schizophrenia). * psychic disability: prevent and reduce non-seeking care and accompaniment situations, and risk of rupture of care. * permitting better care of psychosocial rehabilitation with cognitive evaluation. this study will be conducted in centre de référence des troubles du langage et des apprentissages, hôpital raymond poincaré, aphp, in france.

Eligibility criteria:
inclusion criteria: * patients born between 1990 and 2005, have been cared by dr schlumberger in 2014 in the center of language and learning disorders at raymond poincaré hospital; * with severe learning disorders: deficiency in school work, need at least one medical appointment and long-term rehabilitation in the center of language and learning disorders at raymond poincaré hospital; * affiliated to a social protection schema; * written informed consent signed. exclusion criteria: * absence of learning disorder; * intellectual deficiency; * epilepsia; * patients who will performed follow-up at chartres city; * patients under guardianship or curatorship; * foreign patients under ame schema, a medical help from the state in france.

Keywords: learning disorders executive function disorders psychosis children adult-age
the application of invivo microscopy imaging in the early diagnosis of cervical cancer

Conditions: Cervical Cancer; Cervical Precancer

Summary: this study intends to carry out a prospective, randomized controlled trial to research and development a new invivo microscopy based on the technology which is combined with high-definition microscopy and colposcopy，so as to diagnose cervical lesion directly and non-invasively by observing cervical tissues and cells, which makes it possible to diagnose cervical cancer without wounds.


Eligibility criteria:
inclusion criteria: 1. cervical cytologic test result is hsil 2. persistent infection with high-risk hpv 3. cervical pathological diagnosis is lsil or hsil exclusion criteria: 1. acute infection of lower genital tract 2. the wound in lower genital tract 3. active bleeding in lower genital tract

Keywords: invivo microscopy colposcopy cervical precancer and cancer
a comparison between internet therapy and group therapy for social phobia - a trial using cognitive behavioural therapy

Conditions: Social Phobia

Summary: social phobia is one of the most prevalent anxiety disorders in the western world. cognitive behavioural therapy (cbt) is the psychological treatment that has the largest empirical support. however, the availability to cbt is very limited in sweden due to lack of therapists with proper training. therefore it is important to evaluate alternative forms of treatment that are more time efficient. one of these methods is internet based self-help therapy, which has proven to be an effective treatment for social phobia. to the investigator´s knowledge, no study has yet directly compared live-cbt to internet therapy. the aim of the present study is to compare the effect of live cbt vs cbt delivered via the internet. the study is considered to be an equivalence trial. 128 patients will be randomly assigned to one of the two treatment conditions. the primary outcome measure is liebowitz social anxiety scale (lsas).


Eligibility criteria:
inclusion criteria: * must have a primary diagnosis of social phobia exclusion criteria: * substance abuse during the last 6 months * other dominating diagnosis (not phobic personality disorder) * a history of bipolar disorder or psychosis * major depression according to dsm-iv and \>20 on madrs-s * risk of suicide * start of medication or change of dosis during the last 2 months * other parallel psychological treatment * previous cbt (last 3 years) for social phobia
combination of qls31905, ql2107 and chemotherapy as first-line therapy in cldn18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma

Conditions: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Summary: this is an open-label, multicenter phase ii clinical study aimed at evaluating the tolerability, safety, efficacy, pk profile, and immunogenicity of qls31905 for injection combined with ql2107 injection and xelox regimen in the first-line treatment of cldn18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma.

qls31905 is a bispecific antibody targeting cd3 and cldn18.2 independently developed by qilu pharmaceutical co., ltd. ql2107 is a biosimilar of pembrolizumab (keytruda®) developed by qilu pharmaceutical co., ltd. this is an open-label, multicenter phase ii clinical study aimed at evaluating the tolerability, safety, efficacy, pk profile, and immunogenicity of qls31905 for injection combined with ql2107 injection and xelox regimen in the first-line treatment of cldn18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma.

Eligibility criteria:
inclusion criteria: * subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma confirmed by histopathological or cytological examination; * subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to recist v1.1. lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging pd; * no prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma. exclusion criteria: * subjects with a known history of severe or repeated allergy, intolerance, or contraindication to qls31905, ql2107, or other large molecule protein preparations, as well as oxaliplatin injection or capecitabine tablets and any components in their preparations; * subjects had other second primary malignancies within 5 years prior to the first dose; * subjects with clinically significant hemorrhage within 3 months before the first dose

Keywords: cldn18.2, gastric or gastroesophageal junction (gej) adenocarcinoma
study on the carcinogenesis of sox-9 in oral cancer, and chemopreventive possibility for the treatment of oral cancer.

Conditions: Carcinogenesis; Oral Cancer

Summary: study on the carcinogenesis of sox-9 in oral cancer, and chemopreventive possibility for the treatment of oral cancer using sox-9 inhibitor.

to find out if there is prognostic value which to the performance of sox-9 of oral cancer in taiwan and provide some reference for future treatment. we anticipate to enroll 40 persons with normal oral mucosa, 65 persons with oral dysplasia and 150 persons with oral cancer and collect the tissue which was stained for pathological sections over a 3 year period. we also collect the blood and saliva samples from patients and the results along with patient-specific information such as tumor phases, tumor size, lymph node metastasis, cancer metastasis, prognosis and betel nut chewing, smoking and drinking habits and other parameters are statistically analyzed.

Eligibility criteria:
inclusion criteria: * dysplasia or cancer of the oral cavity. exclusion criteria: * pregnant woman

Keywords: sox-9 oral cancer arecoline
study of bms-936558 (nivolumab) compared to docetaxel in previously treated metastatic non-squamous nsclc

Conditions: Non-Squamous Cell Non-small Cell Lung Cancer

Summary: the purpose of the study is to compare the overall survival of bms-936558 (nivolumab) as compared with docetaxel in subjects with non-squamous cell non-small cell lung cancer (nsclc) after failure of prior platinum-based chemotherapy

checkmate 057: checkpoint pathway and nivolumab clinical trial evaluation 057

Eligibility criteria:
inclusion criteria: * men \& women ≥18 years of age * subjects with histologically or cytologically-documented non-squamous cell nsclc who present with stage iiib/iv disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second or third line of treatment for advanced disease * disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease * measurable disease by computed tomography (ct)/magnetic resonance imaging (mri) per recist 1.1 criteria * eastern cooperative oncology group (ecog) performance status ≤1 * a formalin fixed, paraffin-embedded (ffpe) tumor tissue block or unstained slides of tumor sample (archival or recent) must be available for biomarker evaluation. specimens must be received by the central lab prior to randomization. biopsy should be excisional, incisional or core needle. fine needle aspiration is insufficient exclusion criteria: * subjects with untreated central nervous system (cns) metastases are excluded. subjects are eligible if cns metastases are asymptomatic or treated and subjects are neurologically returned to baseline for at least 2 weeks prior to enrollment. in addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤10mg daily prednisone (or equivalent) * subjects with carcinomatous meningitis * subjects with active or recent history of known or suspected autoimmune disease. subjects with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll * subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization * prior therapy with anti-programmed death-1 (anti-pd-1), anti-programmed cell death ligand 1 (anti-pd-l1), anti-programmed cell death ligand 2 (anti-pd-l2), anti-cluster of differentiation 137 (anti-cd137), or anti-cytotoxic t lymphocyte-associated antigen 4 (anti-ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) * prior treatment with docetaxel * treatment with any investigational agent within 14 days of first administration of study treatment other protocol-defined inclusion/exclusion criteria apply