Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the effect of food on how tasocitinib (cp-690,550) is absorbed and moves through the body following oral administration of tasocitinib (cp-690,550) tablets to healthy subjects

Conditions: Rheumatoid Arthritis

Summary: in this study, a 10 mg tasocitinib (cp-690,550) tablet will be administered to healthy subjects on two separate dosing occasions. on one occasion the tasocitinib (cp-690,550) tablet will be administered in a fasting condition; on the other occasion the tasocitinib (cp-690,550) tablet will be administered in a fed condition following a standard breakfast meal. the amount of tasocitinib (cp-690,550) in the blood will be measured at various times over 24 hours following each dosing occasion and compared to evaluate for any differences.

to evaluate the effect of food on the pharmacokinetics of tasocitinib (cp-690,550).

Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight for males\>50 kg (110 lbs). for females, total body weight \>45 kg (99 lbs). * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) exclusion criteria: * evidence or history of any clinically significant illness, medical condition, or disease. * evidence or history of any clinically significant infections within the past 3 months. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Keywords: healthy subjects food effect study
hyperekplexia : adaptative skills and neurodevelopmental trajectory

Conditions: Hyperekplexia

Summary: hereditary hyperekplexia is a rare neuronal disorder, caused by genetic defects leading to dysfunction of glycinergic neurotransmission. the clinical presentation is characterized by stiffness and exaggerated startle responses to unexpected stimuli, that appear shortly after birth. the generalised stiffness can lead to apnea and sudden infant death syndrome. several genes are known to be associated with hereditary hyperekplexia. the most frequent are glycine receptor alpha 1 (glra1), glycine receptor beta (glrb) and solute carrier family 6 member 5 (slc6a5). they encode for the postsynaptic glycine receptor (glra1, glrb) and the presynaptic glycine transport (slc6a5). genetic mutations in these genes lead to dysfunction in the glycinergic inhibitory neurotransmission. the neurodevelopment was initially described as normal, or as delayed due to the motor difficulties. global development delay and intellectual disability are reported as well, in the most recent studies. nevertheless, the degree of severity of the learning difficulties and the adaptive faculties of the patients is not specified. similarly, the efficacy of clonazepam in hyperekplexia is well known, but the evolution of dosage over time and the frequency of complete withdrawal have never been studied. the primary endpoint of this study is to describe adaptive skills using a standardized questionnaire, vineland adaptive behavior scale (vabs2). secondary endpoints are: * neurodevelopmental course study * description of the evolution of the clinical manifestations over the years * evaluation of the efficacity of the treatment clonazepam, initially and over time, and evolution of the dosage * comparison of clinical and therapeutical characteristics according to the genotype


Eligibility criteria:
inclusion criteria: * clinical diagnostic criteria for hyperekplexia (see thomas et al. brain, 2013): * the presence of hypertonia (either hypertonia on examination, axial or segmental, or access of stiffness) * exaggerated reflex startles, to auditory, tactile or visual stimuli * the presence of reflex bursts on percussion of the midline * children \>2 years and adults * no opposition of one of the two parents (or legal representative) or of the adult patient exclusion criteria: * the presence of a cause secondary to the hyperekplexia (traumatic, autoimmune, etc.) * the presence of another cause for a delay in psychomotor development (other neurological pathology, serious head trauma, etc.) * pregnant or breastfeeding women * person deprived of liberty by judicial or administrative decision

Keywords: hyperekplexia neurodevelopment trajectory adaptative skills
long-term patient-reported maternal outcomes following abdominal cerclage for the prevention of preterm birth

Conditions: Cerclage, Cervical; Cervical Insufficiency

Summary: this study aims to explore the maternal patient reported outcomes on pelvic pain sexual health anxiety and depression bladder discomfort foreign body sensation trust in the cerclage, and how these parameters affect the general health perception in the quality of life of women treated with abdominal cerclages in denmark since 2004.


Eligibility criteria:
inclusion criteria: * transabdominal cerclage exclusion criteria: * most recent birth within 6 months

Keywords: patient reported outcomes (pro) quality of life preterm birth abdominal cerclage
premedication for non-emergency endotracheal intubation in the nicu

Conditions: Respiratory Distress Syndrome

Summary: those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. the objectives of the study include: 1.) does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.

the investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. the study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. the investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study. the response of paralysis, onset and duration will be assessed clinically. onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone

Eligibility criteria:
inclusion criteria: 1. infants admitted to the nicu at beaumont children's hospital royal oak and troy. 2. gestational age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher 3. infants who require endotracheal intubation on a non-emergent basis 4. signed informed consent by parents exclusion criteria: 1. intubations that occurred in the delivery room or for other emergent basis, 2. absence of intravenous access 3. abnormality of the airway 4. known or family history of neuromuscular disorder 5. renal insufficiency (urine output \ 1.7 mg/dl if \> 1 day of age) 6. known hepatic insufficiency (abnormal liver function or coagulation laboratory results) 7. current diagnosis of pulmonary hypertension 8. any infant deemed by the attending neonatologist as unstable or unfit for the study
special investigation in patients with rheumatoid arthritis (hopeful iii study), a follow-up survey of study p12-069

Conditions: Rheumatoid Arthritis

Summary: the main objective of this study was to determine the ability to maintain response after discontinuation of adalimumab treatment and the secondary objective was to determine radiographic progression in participants participating in the study, including the percentage who displayed minimal progression.

this was a two-arm, multi-center, post marketing observational study (pmos) conducted in japanese participants with rheumatoid arthritis (ra) who continued the one year observational period of study p12-069 (hopeful ii study; nct01163292) and provided informed consent to participate in study p12-707 (hopeful iii study; nct01346501), after completion of study m06-859 (hopeful i study; nct00870467). the study p12-707 provided an additional two years of observation for those participants who participated in study p12-069.

Eligibility criteria:
inclusion criteria: participants with ra who continued the one year observational period of study p12-069 and provided informed consent to participate in study p12-707. exclusion criteria: participants with ra who used biological agents other than adalimumab in the one year observational period of study p12-069.

Keywords: rheumatoid arthritis
lymphocyte profiles and activation status in patients with graft-versus-host disease

Conditions: Graft Versus Host Disease; Hematopoietic/Lymphoid Cancer

Summary: this research trial studies lymphocyte profiles and activation status in patients with graft-versus-host disease. studying samples of blood in the laboratory from patients with cancer may help doctors identify and learn more about biomarkers related to graft-versus-host disease.

primary objectives: i. to explore and assess changes in subsets and activation status of b-, t,-, and natural killer (nk) lymphocytes in peripheral blood following allogeneic stem cell transplant and how they may be associated with clinical events with an ultimate future goal of conducting a larger successor study to identify potential therapeutic targets based on its findings. secondary objectives: i. to assess the feasibility of obtaining and comparing patients with chronic graft-versus-host disease (cgvhd) with time-matched stem cell transplant (sct) patients without cgvhd and identify logistical challenges with obtaining and processing samples in each of the subgroups of interest for these analyses. ii. to assess and explore differences in lymphocyte subsets (b-, t-, and nk) between those with vs. without cgvhd. iii. to assess and explore differences in cytokines in patients with cgvhd vs. those without. iv. to describe lymphocyte subsets and activation and explore how these may be related to specific clinical manifestations of cgvhd. outline: blood samples are analyzed for activation status of b lymphocytes, t lymphocytes, and nk lymphocytes via flow cytometry, enzyme-linked immunosorbent assay (elisa), enzyme-linked immunosorbent spot (elispot), immunoblot, and microarray assays.

Eligibility criteria:
inclusion criteria: * allogeneic sct groups: patients who have received stem cell transplantation at the ohio state university are eligible and who are at or beyond day +75 following allogeneic sct regardless of previous diagnosis of acute or chronic graft-versus-host disease (gvhd) * autologous sct group: patients who have received an autologous stem cell transplant at the ohio state university and who have achieved platelet and neutrophil engraftment

Keywords: gvhd chronic graft versus host disease
antiretroviral regime for viral eradication in newborns

Conditions: HIV/AIDS and Infections

Summary: this is a multi-center, randomized, controlled, open clinical trial. the trial will be carried out in five provinces in china. pregnant women with hiv infection and at high risk of mother-to-child transmission of hiv will be identified. their newborn babies who are at high risk hiv infection will be recruited and randomized into intervention and control groups. children in intervention groups will receive art and intensive hiv testing after birth. children in control group will receive routine prevention of mother-to-child transmission services. all the included children will be followed up and their development and infection status will be recorded and compared.


Eligibility criteria:
inclusion criteria: * children whose mother with hiv infection * children whose mother received antiretroviral drugs after 36 gestational weeks or received no drugs before delivery * live birth exclusion criteria: * birth weight is less than 2000g * apgar score is less than 3 at 1 minute after birth or less than 6 at 5 minute after birth .

Keywords: hiv antiretroviral treatment child testing
cbt versus cbt with virtual reality exposure for social anxiety disorder and agoraphobia

Conditions: Social Anxiety Disorder; Agoraphobia

Summary: introduction: anxiety disorders have a high lifetime prevalence, early-onset, and long duration or chronicity. exposure therapy is considered one of the most effective elements in cognitive behavioral therapy (cbt) for anxiety, but in vivo exposure can be challenging to access and control, and is sometimes rejected by patients because they consider it too aversive. virtual reality allows flexible and controlled exposure to challenging situations in an immersive and protected environment. aim: the soreal-trial aims to investigate the effect of group cognitive-behavioral therapy (cbt-in vivo) versus group cognitive behavioral therapy with virtual reality exposure (cbt-in virtuo) for patients diagnosed with social anxiety disorder and/or agoraphobia, in mixed groups. methods \& analysis: the design is an investigator-initiated randomized, assessor-blinded, parallel-group and superiority-designed clinical trial. three hundred two patients diagnosed with social anxiety disorder and/or agoraphobia will be included from the regional mental health centers of copenhagen and north sealand and the northern region of denmark. all patients will be offered a manual-based 14-week cognitive behavioral group treatment program, including eight sessions with exposure therapy. therapy groups will be centrally randomized with concealed allocation sequence to either cbt-in virtuo or cbt-in vivo. patients will be assessed at baseline, post-treatment and one-year follow-up by treatment blinded researchers and research assistants. the primary outcome will be diagnosis-specific symptoms measured with the liebowitz social anxiety scale for patients with social anxiety disorder and the mobility inventory for agoraphobia for patients with agoraphobia. secondary outcome measures will include depression symptoms, social functioning, and patient satisfaction. exploratory outcomes will be substance and alcohol use, working alliance and quality of life. ethics and dissemination: the trial has been approved by the research ethics committee in the capital region of denmark. all results, positive, negative as well as inconclusive, will be published as quickly as possible and still in concordance with danish law on the protection of confidentially and personal information. results will be presented at national and international scientific conferences.


Eligibility criteria:
inclusion criteria: * fulfilling diagnostic criteria for social anxiety disorder (icd-code: f40.1) and/or agoraphobia (icd-code: 40.0) * age 18-75 years * sufficient knowledge of the danish language * informed consent exclusion criteria: * alcohol or drug dependence (icd-code: f10-19.20-26).

Keywords: social anxiety virtual reality virtual reality exposure therapy rct social phobia agoraphobia
a study of ixekizumab (ly2439821) in participants with moderate-to-severe plaque psoriasis naive to systemic treatment

Conditions: Plaque Psoriasis

Summary: the main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (fae) and methotrexate (mtx) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.


Eligibility criteria:
inclusion criteria: * present with moderate-to-severe chronic plaque psoriasis based on a diagnosis of chronic psoriasis for at least 6 months before baseline. * participants who are candidates for systemic therapy and who are naive to systemic treatment for psoriasis. * have a (pasi score \>10 or bsa \>10) and dlqi \>10 at screening and at baseline. exclusion criteria: * have predominant pattern of pustular, erythrodermic, and/or guttate forms of psoriasis. * have received systemic nonbiologic psoriasis therapy. * have prior, concurrent, or recent use of ixekizumab or any other biological psoriasis therapy. * have any condition or contraindication as addressed in the local labeling for mtx or fae. * presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic, or neuropsychiatric disorders or abnormal laboratory values at screening. * have severe gastrointestinal disease, oral ulcer, or known, active gastrointestinal ulcer. * have had a serious infection or are immunocompromised. * at screening, participants with significant, present, or early liver disease, e.g., explained by alcohol consumption or hepatic insufficiency.

Keywords: fumaderm
mesh alone vs combined mesh and darn in the management of primary inguinal hernia in adult males

Conditions: Inguinal Hernia

Summary: a prospective randomized study involved 228 individuals with primary inguinal hernia, operated in our departments, between january 2015 to february 2018. the duration of hospital stay, operative time, duration of returning to routine activities, postsurgical sequels and recurrence rates estimated. we randomly allocated it into two groups: mesh repair was applied to 166 patients (group 1) and combined both mesh, and darn repair applied to 162 patients (group 2).

background in spite of the era of laparoscopy still, open repair in primary inguinal hernia is currently the most commonly performed general surgical operation. to evaluate whether the combined darn repair plus lichtenstein compare lichtenstein repair alone in the treatment of inguinal hernias regarding postoperative complication and recurrence. materials and methods: a prospective randomized study involved with 218 patients with primary inguinal hernia, operated in our departments, between 2015 and 2018. the duration of the operation time, hospitalization, and time to return to daily activities and postoperative complication and recurrence rates were evaluated. we randomly allocated into two groups: lichtenstein repair was applied to 169 patients (group 1), and combined both modified darn repair plus lichtenstein repair was applied to 160 patients (group 2). results: the average follow-up period was 48 months. for the alone lichtenstein procedure, the average duration of operation was 62 min; the average time to return to routine activities was 21 days. the number of patients with postoperative complications was 12 (11.3 %), and the number of patients with recurrence was 1 (0. 9%). for darn repair plus lichtenstein procedure, the average duration of operation was 72 min; the time to return to daily activities was 21days. the number of patients with postoperative complication was 13 (11.6%), and no recurrences were noted. the hospitalization time of the groups was similar. conclusion: two-year follow-up, combined mesh and darn better than mesh alone in recurrence rate, both had the same postoperative complication, hospitalization time and return to routine activity.

Eligibility criteria:
inclusion criteria: * primary hernia * male exclusion criteria: * female * bilateral * recurrent hernia

Keywords: adult inguinal hernia mesh darn repair hernia repair techinques primary inguinal hernia
effect of over-the-counter dietary supplements on kidney stone risk

Conditions: Hyperoxaluria

Summary: the purpose of this study is to ascertain whether certain supplements promote excessive urinary oxalate excretion and increase the risk for calcium oxalate kidney stones. supplements that enhance urinary oxalate excretion, as a result of their oxalate concentration or from some other mechanism (e.g., providing substrate for oxalate biosynthesis) will be identified by the investigators.

the investigators hypothesize that certain over-the-counter dietary supplements will increase urinary excretion of oxalate as measured in 24-h urine collections. the investigators further hypothesize that the concentration of oxalate in dietary supplements may not be associated with urinary oxalate excretion, suggesting that other nutritional components of the supplements may be exerting an influence over oxalate biosynthesis, oxalate absorption in the gastrointestinal tract, and/or renal oxalate handling. these other factors include the form of oxalate in the supplement (water- vs. non water-soluble) and the supplement's concentration of ascorbic acid.

Eligibility criteria:
inclusion criteria: * at least 18 years of age, no prior personal history of kidney stones exclusion criteria: * personal history of kidney stones (by subjects' report); known allergy to any of the dietary supplements to be used in the study (by subjects' report); short bowel; active ulcerative colitis or irritable bowel disease; crohns or celiac disease; renal tubular acidosis; current use of topiramate or other carbonic anhydrase inhibitor, steroids, allopurinol, thiazide diuretics, or supplemental ascorbic acid \>250 mg/day.
pragmatic assessment and treatment for the health system

Conditions: Stroke; Traumatic Brain Injury; Schizophrenia

Summary: the project goal is to promote a feasible and effective approach to communicative disorders in neurological and psychiatric populations, focused on the pragmatics of language. pragmatics allows speakers to use and interpret language in context and to engage in successful communication. pragmatic language disorder is widespread in clinical conditions and causes reduced social interactions and lower quality of life for both patients and their family. yet it is seldom considered in assessment and rehabilitation.

the project aims at developing a comprehensive approach for the assessment and treatment of pragmatic impairment in neurological disease. it consists of three work packages: * the aim of wp1 is to develop a short test of pragmatic abilities. 200 healthy participants will be enrolled for this wp, and the same test will be administered to 40 patients with right hemisphere damage, 40 with traumatic brain injury, and 50 with schizophrenia. * the aim of wp2 is to test the efficacy of a novel treatment for pragmatic disorder. 32 patients will be enrolled (16 for each patient group) and allocated (via randomized control trial) to a standard treatment or to a novel treatment for pragmatic disorders. only rhd and tbi will take part to this wp. * the aim of wp3 is to better clarify the neural correlates of pragmatic abilities. all patients will undergo an high density eeg recording session, and their brain activity will be correlated with performance on neuropsychological tests and on pragmatic impairment. the rhd and tbi patients enrolled for wp2 will undergo a session of hd-eeg also at the end of rehabilitation to monitor brain changes after treatment.

Eligibility criteria:
inclusion criteria: healthy participants * no neurological disorder * written informed consent right hemisphere damage (rhd) * unilateral stroke * first stroke * no comorbidities with psychiatric disorders * written informed consent tbi * traumatic brain injury * written informed consent schizophrenia: * diagnosis of schizophrenia * written informed consent exclusion criteria: * important comorbidities that may affect results