Kornimate/medical-research-clean huggingface dataset:
transcutaneous electrical nerve stimulation for post-cesarean pain control

Conditions: Transcutaneous Electric Nerve Stimulation; Analgesia; Cesarean Section

Summary: purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (tens) for post-operative pain control after a cesarean delivery compared to placebo and no tens.


Eligibility criteria:
inclusion criteria: - women undergoing scheduled or non-urgent cesarean section exclusion criteria: * non-english speaking * subjects with a history of chronic pain or chronic opioid use * pre-operative use of opioids for more than 1 week in the preceding 6 months * previous exposure to the tens unit * women with an allergy or contraindication to narcotics/nsaids/acetaminophen * subjects who had a midline vertical skin incision during this operation * subjects who did not receive intrathecal opioids at the time of their cesarean delivery * adhesive allergies * subjects with a pacemaker (due to the unknown effects of the tens on the electrical activity of the heart) * intraoperative general anesthesia * inability to consent to the study * postpartum tubal ligation

Keywords: tens transcutaneous electric nerve stimulation cesarean analgesia
potassium nitrate in polycarboxylate as a direct pulp capping

Conditions: Pulp Disease, Dental

Summary: the study aimed to compare potassium nitrate in polycarboxylate cement to mineral trioxide aggregate as a direct pulp capping material of young permanent teeth in patients from 7 to 10 ears


Eligibility criteria:
inclusion criteria: * 7-10 years of children * healthy children classified as asa i or ii * asymptomatic vital immature mandibular first molar with extensive and deep caries * signs and symptoms of reversible pulpitis exclusion criteria: * necrotic teeth or teeth with irreversible pulpitis * medically compromised children
a study of alks 8700 in adults with relapsing remitting multiple sclerosis (ms) evolve-ms-1

Conditions: Multiple Sclerosis

Summary: the primary objective of this study is to evaluate the long-term safety and tolerability of alks 8700 for the treatment of relapsing remitting multiple sclerosis (rrms). the secondary objective of this study is to evaluate treatment effect over time in adult participants with rrms treated with alks 8700.


Eligibility criteria:
key inclusion criteria: * has a confirmed diagnosis of rrms * neurologically stable with no evidence of relapse within 30 days prior to visit 2 exclusion criteria: * subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration * diagnosis of primary progressive, secondary progressive, or progressive relapsing ms * history of clinically significant cardiovascular, pulmonary, gastrointestinal, dermatologic, psychiatric, neurologic (other than ms), and/or other major disease that would preclude participation in a clinical trial * history of a myocardial infarction, including a silent myocardial infarction identified on ecg, or unstable angina note: other protocol defined includison/exclusion criteria may apply.

Keywords: ms relapsing remitting multiple sclerosis rrms dimethyl fumarate dmf
utility of rapid whole genome sequencing in the nicu: a pilot study

Conditions: Genetic Disease; Genetic Syndrome

Summary: this is a pilot study involving a prospective group of 15 evaluable patients who will undergo rapid whole genome sequencing in addition to standard of care testing. subjects will be drawn from children admitted to the nicu at osf health care children's hospital of illinois who meet inclusion criteria. the aims of this study are to evaluate the turn-around time and cost of performing rapid whole genome sequencing (rwgs) compared to standard of care in the diagnosis of genetic disorders among critically ill infants in a regional children's hospital and to describe management outcomes of utilizing rwgs in acutely ill patients less than four months of age.


Eligibility criteria:
inclusion criteria: patients in the nicu less than 4 months of age with complex medical presentation of unknown etiology, who have 2 or more of the following are eligible: * critically ill\* and/or organ dysfunction * one or more major congenital anomalies * dysmorphic features and/or abnormal growth parameters * neurologic impairment (seizure, hypotonia, encephalopathy) * cardiomyopathy * features suggestive of a metabolic disorder (eg unexplained/persistent hypoglycemia or acidosis) * critically ill - cardiorespiratory insufficiency requiring ventilatory or cardiac support exclusion criteria: * previously confirmed specific genetic diagnosis (antenatal or postnatal) * obvious clinical findings for a specific condition that could be tested by targeted gene analysis * preterm less than 24 weeks post-menstrual age * ward of the state * parent/legal guardian refusal to give consent for participation in the study * patient does not meet eligibility criteria
a study of ibi3003 in subjects with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase 1/2 multicenter, open-label, first-in-human study of ibi3003. it includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(mtd)/recommended phase 2 dose(rp2d) of ibi3003, plans to enroll 23\~116 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of ibi3003 at rp2d in multiple myeloma.


Eligibility criteria:
inclusion criteria: * subjects in parts 1(dose escalation) \& 2 (dose expansion) must satisfy all of the following criteria to be enrolled into the study: 1. age ≥18 years. for part 1, age ≥18 years and ≤75 years. 2. documented initial diagnosis of multiple myeloma according to imwg diagnostic criteria. multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma-defining events in protocol 3. eastern cooperative oncology group (ecog) performance status score of 0 or 1 4. life expectancy ≥3 months. 5. subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol. exclusion criteria: 1. known active cns involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 2. have amyloidosis, plasma cell leukemia, waldenstrom macroglobulinemia, poems syndrome, or solitary plasmacytoma, or smoldering mm as defined by the international myeloma working group(imwg) criteria. 3. spinal cord compression that results in limited self-care occurs within 6 months prior to informed consent, or is expected to occur in the near future. 4. history of primary immunodeficiency. 5. current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
an open-label extension study to evaluate the safety and tolerability of perampanel (e2007) administered as an adjunctive therapy in epilepsy subjects

Conditions: Epilepsy

Summary: to evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. this study will be continued until perampanel is commercially available.


Eligibility criteria:
inclusion criteria 1. participants participating in the designated perampanel study as below, and who in the opinion of the investigator continue to benefit from treatment with perampanel designated perampanel study: e2007-g000-332 (nct01393743) (with at least 52 weeks of total exposure to perampanel). 2. provide written informed consent/assent signed by participant or legal guardian prior to entering the study or undergoing any study procedures. if the written informed consent is provided by the legal guardian because the participant is unable to do so, a written or verbal assent from the participant must also be obtained. 3. female participants of childbearing potential must agree for the duration of the study and for a period of at least 1 month following the last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (eg, a double-barrier method \[condom plus spermicide, condom plus diaphragm with spermicide\]). exclusion criteria 1. participants residing in countries where perampanel is commercially available with respect to the indication or formulation of the designated perampanel study. 2. female participants who are nursing, pregnant, or planning to become pregnant.

Keywords: epilepsy perampanel
safety and pharmacokinetic study of cabazitaxel in patients with advanced solid tumors and liver impairment

Conditions: Neoplasm Malignant

Summary: primary objectives: * to determine the maximum tolerated dose (mtd) and safety of cabazitaxel when administered to advanced solid tumor patients with varying degrees of hepatic impairment * to determine the pharmacokinetics (pks) of cabazitaxel in patients with varying degrees of hepatic impairment * to correlate pk variables with pharmacodynamic (pd) safety parameters in order to guide prescribers with regard to dosing in this patient population * to assess the effect of cabazitaxel at recommended dose of 25mg/m\^2 on cyp3a enzyme activity using midazolam as probe in an additional cohort of cancer patients with normal hepatic function.

the study consists of: * a screening phase (maximum length of 21-day). * a treatment phase with 21-day study treatment cycles. cycle lengths may be extended up to maximum of 12 additional days in case of unresolved toxicity. patients continue to receive treatment until they experience, unacceptable toxicities/aes, disease progression ,withdraw their consent, or the investigator decides to discontinue the patient, or study cut-off, whichever comes first. * a 30-day follow-up visit after the last dose of study medication. the cut off date is when the last patient treated has completed cycle 1 and the subsequent 30 days follow-up. patients may continue to be treated as long as they are benefiting from study treatment and have not met study withdrawal criteria.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of advanced, measurable or non-measurable, non-hematological cancer who have varying degrees of hepatic impairment. the cancer must be one that is either refractory to standard therapy or for which no standard therapy exists. exclusion criteria: * eastern cooperative oncology group (ecog) performance status (ps) \>2 * life expectancy \<3 months * need for a major surgical procedure or radiation therapy during the study * evidence of another active malignancy * prior chemotherapy, other investigational drug, biological therapy, targeted non-cytotoxic therapy and radiotherapy within 3 weeks prior to registration * patients with known history of gilbert's syndrome * prior treatment with cabazitaxel and a history of severe (grade ≥3) hypersensitivity to taxanes, polysorbate-80, or to compounds with similar chemical structures * prior history of bone marrow transplant * any treatment known to induce cyp isoenzymes or to inhibit cyp3a4 activities within 2 weeks before or during the test period of the pharmacokinetic sampling. moderate inhibitors within one week prior and during the pharmacokinetic sampling. * any contra-indications to midazolam, according to the applicable labeling. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
antidepressant medication for reducing hiv risk behavior in depressed intravenous drug users

Conditions: Depression; Substance-Related Disorders; HIV Infections

Summary: this study will evaluate the effectiveness of antidepressant medication treatment in reducing hiv risk behaviors in intravenous drug users with depression.

depression and injection drug use often come hand-in-hand. this is especially true in populations with limited access to mental health care and with a high risk of illness and hiv transmission. depressed injection drug users in these populations usually continue their drug use for extended periods of time, thereby further promoting the spread of hiv. this cycle has created a significant public health problem. it is necessary to explore new approaches to facilitate and maintain long-term behavior changes within this population. this study will evaluate the effectiveness of treatment with antidepressant medications in reducing hiv risk behaviors in depressed intravenous drug users. participants in this open label study will be randomly assigned to receive either antidepressant treatment or no treatment. participants in the treatment group will meet with a psychiatrist monthly for 12 months. based on psychiatric evaluations and participants' medical histories, doctors will prescribe an appropriate antidepressant medication or a combination of medications. participants in the treatment group may also receive referrals for other services if necessary. participants assigned to receive no treatment will be contacted at months 3 and 9 to verify their contact information; they will also receive any necessary referrals. all participants will partake in interviews at baseline and months 6 and 12 to assess changes in hiv risk behavior and depressive symptoms.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia * score of greater than 14 on the hamilton rating scale for depression * current opiate or cocaine use * history of injection equipment sharing * english-speaking exclusion criteria: * history of injection equipment sharing within 6 months of study entry * currently at risk for suicide * currently experiencing symptoms of psychosis * currently taking any other psychotropic medication * diagnosed with bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or paranoid disorder * informed that treatment with antidepressant medications is medically inadvisable * pregnant

Keywords: injection drug use hiv risk behavior hiv seronegativity
intravesical bcg administration to patients with invasive bladder cancer

Conditions: Bladder Cancer

Summary: patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) bcg intravesically followed by a cystectomy.

patients with muscle invasive (≥t1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical tice® bcg. bcg is an attenuated, live culture preparation of the bacillus of calmette and guerin (bcg) strain of mycobacterium bovis. after completion of bcg treatments the patient will undergo a cystectomy. a portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.

Eligibility criteria:
inclusion criteria: 1. have suspected or known invasive (≥t1) bladder cancer 2. be able to give informed consent 3. be age 18 or older 4. not be in an immunosuppressed state (e.g. hiv+, use of chronic steroids \>1 month) exclusion criteria: 1. have non-invasive (\<t1) bladder cancer 2. unable to give informed consent 3. \< 18 or older 4. is in an immunosuppressed state (e.g. hiv+, use of chronic steroids \>1 month)
efficacy and safety study of lamotrigine to treat trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the purpose of this study was to determine the efficacy and safety of lamotrigine in patients with trigeminal neuralgia (tgn).

trigeminal neuralgia (tgn) is a rare form of chronic facial pain shrouded in mystery, although not life threatening, can be excruciating painful and extraordinarily debilitating. its uniqueness and peculiarity can be ascertained by the fact that tgn may present to and be managed by dentists, neurologists, neurosurgeons, oral surgeons and ear, nose and throat surgeons. the management of tgn is initially medical, with the "gold standard" drug of carbamazepine (cbz). whilst cbz continues to be the treatment of choice, a substantial proportion of patients tolerate this drug poorly, predominantly because of side-effects that include drowsiness, accommodation disorders, hepatitis, elevation in liver enzymes, renal dysfunction, congestive heart failure, delayed multi-organ failure, leucopenia, thrombocytopenia etc. etc. if pain-relief is incomplete with cbz or it produces adverse side-effects, options include using an alternative second-line medical agent. the drugs suggested to be considered as second-line agents for the treatment of tgn, include: lamotrigine, baclofen, phenytoin, oxcarbazepine, gabapentin, clonazepam, valproate, mexiletine, and topiramate. lamotrigine (ltg), a novel anticonvulsant, which has not been adequately assessed for its antineuralgic properties. it has a bimodal mechanism of action: * inhibits the release of glutamate and aspartate by blocking voltage-sensitive sodium channels * antagonistic at neuroexcitatory n-methyl-d-aspartate receptors. it can also acts at and inhibits calcium channels to enhance the gamma- aminobutyric acid (gaba) synthesis. gaba is an inhibitory amino acid neurotransmitter that decreases neural membrane action potentials and therefore decreases nerve excitability. glutamate has been implicated in the mechanisms contributing towards phenomenon of chronic pain, such as sensitisation and wind up. ltg through its inhibition of pathological release of glutamate, has the potential towards management of chronic pain, particularly of neuropathic origin. lamotrigine, therefore has the potential to be a promising new treatment for tgn.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of trigeminal neuralgia * male; or non-pregnant/non-lactating female * must be willing to cooperate with and understands study instructions * signed informed consent prior to entering study exclusion criteria: * psychiatric illness * severe liver or cardiovascular disease * renal impairment, low white cell count * malignancy * pregnancy or lactation * alcohol or recreational drug abuse * and positive tests for human immunodeficiency virus or hepatitis b or c.

Keywords: trigeminal neuralgia lamotrigine carbamazepine lamictal® tegretol®
emg finding according to the type of lumbar disc herniation

Conditions: Intervertebral Disc Displacement; Electromyography

Summary: disc herniation is a common cause of low back pain and leg pain. electromyography is the only test that can objectively examine nerve damage caused by a lumbar disc herniation. this study aimed to compare the mri findings of disc herniation and the aspects of electromyography.


Eligibility criteria:
inclusion criteria: * radicular pain within 6 months * disc herniation confirmed by lumbar mri * undergoing electromyography exclusion criteria: * patients who refused electromyography * patients taking warfarin * lower limb amputation patient * pregnant women * patients who have undergone surgical treatment for disc herniation * patients with peripheral neuropathy ( aidp, cidp, diabetic amyotrophy, peroneal pals et al.)
climacteric therapy with applied relaxation using internet

Conditions: Hot Flashes; Menopause

Summary: the aim is to evaluate effects of internet-based applied relaxation (a simplified version of cognitive behavioral therapy) for women with menopausal symptoms mainly vasomotoric symptom (vms), i.e. hot flashes and sweating. sixty postmenopausal women with vms will be recruited and 30 randomized to applied relaxation (ar) via internet and 30 to a control group which is a non-treated waitlist group. at baseline, after 10 weeks of therapy and six, 12 and 24 months after end of therapy women will be asked to fill in diaries about hot flashes and answer questionnaires on quality of life (women's health questionnaire; whq, anxiety and depression measured with hospital anxiety and depression scale; hads and one measuring sleep, insomnia severity index; isi as well as one about knowledge of the climacteric and hormone therapy). the waiting list group will be offered internet based ar after 10 weeks with the same follow-up as the treatment group.

see above

Eligibility criteria:
inclusion criteria: * a minimum of 7 moderate or severe hot flashes per 24 h or 50 hot flashes per week in average at least during one week before randomization (mild = hot flash without sweating as recognized by the woman but not disturbing the woman, moderate = hot flash and sweating as recognized by the woman but that does not lead to disruption of ongoing activity, severe = hot flash with sweating that leads to disruption of ongoing activity) * natural menopause (at least 12 months without any menstrual bleedings at all) * at least 45 years of age during present year * access to computer with internet * ability to read and speak swedish * freely informed concent for participation exclusion criteria: * induced menopause (e.g. hysterectomy, oophorectomy, chemotherapy, radiation therapy over abdominal- and/or pelvic region) * early or premature menopause (before 45 years of age) * breastcancer disease with ongoing therapy with antiestrogen or aromatase inhibitors * ongoing usage or use during the last month of hormone therapy or other treatment aimed for hot flashes (e.g. natural remedies affecting hot flashes, acupuncture, dietary supplements aimed to treat hot flashes * treatment with psychopharmacological drugs (e.g ssri or snri) or frequent use of benzodiazepines, drugs for insomnia(\> 1 times/week) * untreated or unstable endocrinological- or metabolic disease( e.g thyroid disease) * undiagnosed vaginal bleeding after menopause

Keywords: hot flashes menopause hrqol applied relaxation insomnia women's knowledge
analytical specificity of bladder epicheck test in healthy population and urology patients without prior history or evidence of bladder cancer

Conditions: Non Muscle Invasive Bladder Cancer; Non-Muscle Invasive Bladder Urothelial Carcinoma

Summary: this is a prospective study to establish the analytical specificity of bladder epicheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.


Eligibility criteria:
inclusion criteria: * age 22 or older * able to sign the informed consent form * normal, healthy subjects or subjects with one of the following conditions: 1. benign non-genitourinary disease (e.g. heart disease) 2. non-genitourinary cancers (e.g. lung, crc, breast) 3. genitourinary disease other than bladder cancer including: 4. benign prostatic hyperplasia (bph) 5. microhematuria proven negative for bladder cancer through prior ucc evaluation 6. inflammation/infection 7. symptomatic sexually transmitted disease (std) 8. urinary tract stones 9. genitourinary trauma * subjects with native bladder exclusion criteria: * known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive) * currently in work-up due to suspicion of cancer of any kind