Kornimate/medical-research-clean huggingface dataset:
a study evaluating b cell levels in infants potentially exposed to ocrelizumab during pregnancy

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Summary: this study will evaluate the potential placental transfer of ocrelizumab in pregnant women with clinically isolated syndrome (cis) or multiple sclerosis (ms) \[in line with the locally approved indications\] whose last dose of ocrelizumab was administered any time from 6 months before the last menstrual period (lmp) through to the first trimester (up to gestational week 13) of pregnancy, and the corresponding pharmacodynamic effects (b cell levels) in the infant.


Eligibility criteria:
inclusion criteria: * diagnosis of ms or cis (in line with the locally approved indications) * currently pregnant with singleton pregnancy at gestational week ≤30 at enrolment * documentation that first and second obstetric ultrasound has been conducted before enrolment during the screening period * documentation that the last exposure to ocrelizumab occurred up to 6 months before the lmp before the woman became pregnant or during the first trimester of pregnancy exclusion criteria: * last exposure to ocrelizumab \>6 months before the woman's lmp or later than the first trimester of pregnancy * gestational age at enrolment \>30 weeks * non-singleton pregnancy * received the last dose of ocrelizumab at a different posology other than per the local prescribing information * lack of access to ultrasound pre-natal care as part of standard clinical practice * prior or current obstetric/gynecological conditions associated with adverse pregnancy outcomes * pre-pregnancy body mass index \>35 kg/m2 * any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state * significant and uncontrolled disease that may preclude a woman from participating in the study * women with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies * prior or current history of alcohol or drug abuse, or current use of tobacco * positive screening tests for hepatitis b * treatment with drugs known to have teratogenic effects * planned treatment with interferons, glatiramer acetate, or pulsed corticosteroids as a bridging therapy after the last ocrelizumab dose and throughout pregnancy * treatment with disease-modifying therapies for ms within their respective half-lives prior to the last ocrelizumab dose or prior to the lmp * treatment with natalizumab within 12 weeks prior to the lmp * treatment with teriflunomide within the last two years, unless measured plasma concentrations are \ 0.02 mg/l or not known, an accelerated elimination procedure is required * treatment with any investigational agent within 6 months or five half-lives of the investigational drug prior to the last ocrelizumab dose or prior to the lmp

Keywords: ocrelizumab, ocrevus, placental transfer, pregnancy
evaluation of hepatic pharmacokinetics for grazoprevir (mk-5172) in participants with chronic hepatitis c (mk-5172-022)

Conditions: Chronic Hepatitis C

Summary: this study is divided into 2 segments, and proposes to qualify fine needle aspiration (fna) as a platform to evaluate the hepatic pharmacokinetics of low and high oral doses of grazoprevir (mk-5172) in non-cirrhotic participants chronically infected with hepatitis c virus (hcv). the first segment, is a procedural pilot conducted prior to the main study, that is aimed at ensuring optimal execution of the fna procedure. during the procedural pilot, core needle biopsy (cnb) will be performed on participants as part of their standard of care, but no study drugs will be administered, nor will any procedures other than fna be conducted. the second segment, the main study, is designed to evaluate the feasibility of measuring grazoprevir by fna. during the main study, drugs will be administered, and other additional procedures will be conducted.


Eligibility criteria:
inclusion criteria: * has chronic compensated hcv infection. * no contraindications to cnb or fna procedures. * pilot study only: all comers with chronic hcv already scheduled to undergo cnb for fibrosis staging. * pilot study only: requires a diagnostic liver biopsy to monitor progression of liver disease. * pilot study only: does not have cirrhosis. * main study only: males or non-pregnant and postmenopausal females willing to use medically acceptable contraception during, and for 6 months or longer after study. * main study only: body mass index of 18.5 - 32.0 kg/m\^2. * main study only: can avoid aspirin, anticoagulants, and non steroidal inflammatory agents. * main study only: has undergone prior treatment or is treatment naive for chronic hcv infection. exclusion criteria for main study only: * history of any of the following: stroke, chronic seizures, major neurological disorders, gastric bypass surgery or bowel resection. * no viral response to prior interferon based therapy. * prior treatment for hcv with an ns3/4a protease inhibitor. * history of either clinically significant, uncontrolled endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities/diseases. * history of neoplastic or myeloproliferative disease. * has any of the following : cirrhosis, decompensated liver disease, or other advanced liver disease, hepatocellular carcinoma, infection with human immunodeficiency virus (hiv), or hepatitis b. * evidence of high grade bridging fibrosis from prior liver biopsy or chronic hepatitis not caused by hcv. * history of illicit drug use or alcohol abuse. * had surgery, donated at least one unit of blood, or participated in any other investigational study within 4 weeks prior to screening visit. * history of multiple and/or severe allergies.
deep repetitive transcranial magnetic stimulation for cannabis use disorder

Conditions: Cannabis Use Disorder

Summary: there is a credible basis for lateral prefrontal cortex and insula deep repetitive transcranial magnetic stimulation (dtms) stimulation as a treatment for cannabis use disorder (cud), but no studies to date have examined this. evidence of benefit could expand the treatment options available for cud but require randomized controlled trials (rcts) to evaluate its efficacy. toward an rct of this intervention, the proposed study is a phase 1 open-label pilot trial of dtms for adults with cud. this study will establish the viability of an h4 protocol constituting an active arm of a future double-blind rct.

deep repetitive transcranial magnetic stimulation (dtms) is a technique that stimulates areas of the brain using magnetic pulses and is an approved treatment for several mental health and substance use disorders. the treatment uses head coils to deliver the magnetic pulses. a dtms coil called the h4 coil stimulates the lateral prefrontal cortex and insula, and has been approved for the treatment of tobacco use disorder. no studies have been conducted on the h4 coil for treat cannabis use disorder. the purpose of this pilot study is to determine feasibility and tolerability of a dtms h4 protocol. the goal is to lay the foundation for randomized controlled trials of dtms as a treatment for adults with moderate-to-severe cannabis use disorder.

Eligibility criteria:
inclusion criteria: * adult, age 25-65 * dsm-5 cud, moderate or higher (4+ dsm-5 symptoms) * 4 or more days of cannabis use per week * reports inhalation as one route of administration * treatment-seeking (i.e., self-reported readiness to change of 5 or greater on a 0-10 readiness ruler) * stable domicile and reliable transportation, and willingness to attend in-person visits at sjhh hamilton. exclusion criteria: * current psychotic symptoms, history of schizophrenia-spectrum disorders or bipolar disorder, or current ptsd * active suicidality (past 3 months) or history of severe suicidality (i.e., requiring hospitalization) * any other mental health condition deemed incompatible by the team * high risk alcohol involvement and/or 4+ symptoms of alcohol use disorder * unstable management of an existing mental health condition or anticipation of a change to the treatment over the next 3 months * current unstable medical condition (e.g., diabetes) * rtms contraindications: intracranial or metal implants in the head or nearby regions that cannot be safely removed; history of epilepsy or seizures; pregnancy (female participants only); pacemaker and/or implantable cardioverter-defibrillators). * medication contraindications (e.g., bupropion \>300 mg/day due to risk of seizures, benzodiazepine equivalent dose to lorazepam \>2 mg/day). * history of recurrent headache or migraine (past year) * significant literacy, visual, or hearing problems * co-enrollment in a clinical drug trial

Keywords: transcranial magnetic stimulation h4 coil
comparison of 4 cp-690,550 doses vs. placebo, each combined with methotrexate, for the treatment of rheumatoid arthritis in japan

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of cp-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis * inadequate response to stably dosed methotrexate exclusion criteria: * current therapy with any dmard or biologic other than methotrexate

Keywords: phase ii mtx add-on study in japan
study to investigate the long-term efficacy and safety of human-cl rhfviii in previously treated patients (ptps)

Conditions: Severe Hemophilia A

Summary: the purpose of the study is to study the long-term efficacy, safety and tolerability of human-cl rhfviii in previously treated patients with severe hemophilia a.


Eligibility criteria:
inclusion criteria: * completion of gena-01 study with at least 50 exposure days (eds) and at least 6 months study participation and immediate enrollment into gena-11 exclusion criteria: * development of fviii inhibitors (\<=0.6 bu), during the course of the gena-01 study * development of any severe liver or kidney disease (alt and ast level \> 5 times of upper limit of normal, creatine \>120 micro mol/l) during the course of the gena-01 study
combination regimen with sodium valproate for severe hemophilia: a single-arm, phase 1, pilot trial.

Conditions: Hemophilia

Summary: the goal of this clinical trial is to determine the clinical efficacy and toxic effects of sodium valproate, sirolimus and calcitriol in the treatment of severe haemophilia in participants with severe haemophilia . the main questions it aims to answer are the possibility of adding a combination regimen to primary treatment for severe haemophilia . patients will receive oral sodium valproate extended-release tablets 0.5g/day, sirolimus tablets 1mg/day and osteopontin capsules 0.25μg/day.


Eligibility criteria:
inclusion criteria: 1. patients with clinically confirmed severe haemophilia; 2. expected survival of ≥ 24 weeks with an ecog score of 0-2; 3. not having participated in another clinical trial within four weeks; 4. informed consent signed by the patient or an immediate family member. exclusion criteria: 1. those with other types of blood disorders diagnosed at the morphological or molecular level of the bone marrow; 2. significantly abnormal cardiopulmonary function; 3. hepatic or renal insufficiency; 4. pregnancy or lactation, or inability to use contraception during the trial and for three months before the test and one year after administration 5. persons who are allergic to the drugs likely to be used or where there is a contraindication to their use; 6. those with severe uncontrollable infectious diseases or uncontrolled hypertension, malignancy, etc.; 7. inability to cooperate with a regular follow-up due to psychological, social, family and other geographical circumstances; 8. any other condition that, in the investigator's opinion, makes participation in this trial inappropriate.

Keywords: hemophilia sodium valproate sirolimus calcitriol
hativ® electrocardiogram monitoring on patients with suspected arrhythmia

Conditions: Arrhythmia

Summary: help-a study is a single-center, randomized, controlled trial. a total of 588 patients enrolled during the 2 years of enrollment period and followed for 1 month of follow-up period. this study aims to compare diagnostic yield between continuous ecg patch and intermittent handheld ecg in patients with arrhythmia symptoms.

help-a study is a single-center, randomized, controlled trial designed to compare diagnostic yield, arrhythmia detection rate, user convenience, and cost-effectiveness between continuous ecg patch and intermittent handheld ecg in patients with arrhythmia symptoms. patients who have symptoms of arrhythmia but are not diagnosed on a 12-lead ecg and require additional tests. a total of 588 patients enrolled during the 2 years of enrollment period and followed for 3 month of follow-up period. patients will be assigned to continuous patch ecg or intermittent handheld ecg and will be examined for one month. if there is no diagnosis after a month, the patient will be crossed over to another device and examined for another month.

Eligibility criteria:
inclusion criteria: * patients who have arrhythmia symptoms but are not diagnosed on a 12-lead electrocardiogram and require additional tests. * patients who can use a smartphone exclusion criteria: * patients who have cardiac implantable electronic devices(cieds) * patients who can't use handheld ecg

Keywords: palpitation dizziness arrhythmia
patient removal of catheters after urogynecologic surgery

Conditions: Urinary Retention Postoperative; Patient Satisfaction

Summary: management of postoperative urinary retention often requires the use of indwelling catheters. the purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

voiding trials are a routine part of urogynecologic surgery. management of postoperative urinary retention often requires the use of indwelling catheters. however, patients often view the need for catheters as the worst part of their surgical experience, and follow-up voiding trials in the office utilize excess healthcare resources. many urology practices allow patient removal of catheters after procedures, though this has not been formally studied. the purpose of this study is to see if patient removal of catheters at home is non-inferior to standard office removal.

Eligibility criteria:
inclusion criteria: * all women undergoing prolapse or anti-incontinence surgery who fail their voiding trials prior to discharge * 18+ years old exclusion criteria: * non-english speaking * pregnant * elevated pvr (\>150 ml) or dependent upon catheterization to void pre-operatively * urethral bulking injection surgery * intra-operative complication requiring prolonged catheterization * unable or unwilling to remove catheter at home
nilotinib pharmacokinetics (pk) in gastrointestinal stromal tumor (gist): nilotinib pk

Conditions: Gastrointestinal Stromal Tumors

Summary: in patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. the relationship between surgery type and nilotinib pharmakokinetic properties will be investigated in this study.


Eligibility criteria:
inclusion criteria: * patients with metastatic or unresectable gastrointestinal stromal tumor * patients receiving nilotinib after failure to imatinib and sunitinib

Keywords: gastrointestinal stromal tumor pharmacokinetics nilotinib
chemotherapy combined with targeted therapy for high-risk her2 positive and lymph node negative early breast cancer

Conditions: HER2-positive Breast Cancer

Summary: human epidermal growth factor receptor 2 (her2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. the emergence of her2 targeted drugs has greatly improved the prognosis and survival of such patients. at present, for her2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. it is planned to explore the efficacy and safety of t1-t2, her2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.


Eligibility criteria:
inclusion criteria: * 1) treated in peking university people's hospital and underwent radical resection with hospitalization records; * 2) postoperative pathology confirmed invasive breast cancer, pathological staging was t2, n0, her2 positive, and accompanied by one of the high-risk factors (g3, or hormone receptor negative); * 3) has signed and agreed to participate in the pkuph breast disease cohort study. exclusion criteria: * 1) lack of clinical and pathological data (such as imaging data and pathological data); * 2) preoperative neoadjuvant therapy; * 3) patients with metastatic breast cancer or bilateral breast cancer; * 4) failure to perform radical surgery.

Keywords: taxane target therapy carboplatin
faah availability in psychiatric disorders: a pet study

Conditions: Post Traumatic Stress Disorder; Alcohol Use Disorder; Psychosis

Summary: the aim of the present study is to examine fatty acid amide hydrolase (faah) availability in humans, including healthy individuals and across a spectrum of psychiatric disorders in which alterations in the endocannabinoid system are observed.

this study involves in vivo examination of faah availability, implicated both in the pathophysiology and therapeutics of disorders including ptsd, substance use disorders (e.g., alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic disorders including schizophrenia, and mood disorders. the endocannabinoid system is a neuromodulatory system that has been implicated across a wide range of psychiatric disorders and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition. thus, alterations in the ecs have wide ranging implications. finally, the ecs is being explored as a novel therapeutic target for several psychiatric disorders. additionally, the test/retest reliability of the radiotracer, \[11c\]mk-3168, will be studied in up to 10 healthy control individuals.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 65 years, inclusive * good physical health as determined by history, physical and laboratory examinations, ecg, and vital signs ptsd inclusion criteria: * diagnosis of post-traumatic stress disorder aud inclusion criteria: * diagnosis of alcohol use disorder psychosis inclusion criteria: * diagnosis of psychotic disorder such as schizophrenia, schizoaffective disorder exclusion criteria: * presence of ferromagnetic metal in the body or heart pacemaker * women with a positive pregnancy test or women who are lactating
use of frequency compression in severe-profound hearing loss adults

Conditions: Frequency Compression; Severe-profound Hearing Impairment

Summary: the purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.

frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. it works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.

Eligibility criteria:
inclusion criteria: 1. participants must be over 18 years of age- this study is looking at the use of frequency compression \& its effects of speech perception in adults. 2. no ear surgery that would make it impossible to fit a hearing aid- to ensure limited confounding variables. 3. no history of ear surgery within the last 12 months- to ensure limited confounding variables. 4. no history of ear infection(s) within the last 6 months- to ensure no contraindications and limited confounding variables to testing. 5. no otoscopic abnormality making it impossible to fit a hearing aid- to ensure no contraindications to testing. 6. bilateral severe-profound hearing impairment with air conduction thresholds \>71dbhl within the frequency range of 250hz to 4 khz- to analyse the effects of frequency compression on speech perception within this patient population. 7. post lingual deafness, with good spoken english- to ensure reliability of speech testing. 8. previous bilateral digital hearing aid experience (6+ months)- to ensure limited confounding variables. 9. written consent required. exclusion criteria: 1. participants under the age of 18 years. 2. history of ear surgery making it impossible to fit a hearing aid. 3. history of ear surgery within the last 12 months.
placebo-controlled pilot trial of mecamylamine for treatment of autism spectrum disorders

Conditions: Autistic Disorder; Pervasive Developmental Disorder

Summary: the purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.

this is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children. this pharmacotherapeutic trial will be conducted as a direct result of findings of a nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from autism. a pharmacological agent, mecamylamine, with specificity for the nicotinic receptors implicated in autism, will be tested in children with autism spectrum disorder. twenty children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks of either matched placebo (n=8) or mecamylamine (n=12). children randomized to placebo who do not respond will be given the opportunity to enroll in a ten week open label extension. the trial has been completed and published in j. of child \& adolescent psychopharmacology.

Eligibility criteria:
inclusion criteria: * autistic disorder or pervasive developmental disorder-not otherwise specified * age 4-12 * general good health * iq of \>=36 or mental age of \>=18 months * parent/caregiver willingness to accompany child to clinic and monitor for side effects exclusion criteria: * unstable seizure disorder * psychoactive medication in the process of adjustment * antipsychotic medication in previous 3 months before baseline * systemic corticoids (inhalers allowed) * planned beginning of major behavioral intervention in 3 months of study or the 2 months prior to the study.

Keywords: autistic disorder autism mecamylamine pervasive developmental disorder-not otherwise specified