Kornimate/medical-research-clean huggingface dataset:
bluewind reprieve system for the treatment of pnp

Conditions: Peripheral Neuropathic Pain

Summary: the bluewind reprieve system is a neurostimulator consisting of an implant and external components. the system is intended for home care use. the chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. the stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female aged 18 - 80. * patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires. * diagnosis of chronic neuropathic pain due to peripheral neuropathy. * documented pain attributed to neuropathy for at least 6 months. * pain intensity with an average daily vas score of at least 6, demonstrated by 3 ratings per day across 7 days. * patient refractory to conservative treatments including pain medication, for at least 6 months. * stable pain medication for at least 4 weeks prior to study enrollment. exclusion criteria: * previous participation in another study with any investigational drug or device within the past 90 days. * any active implant (cardiac or other). * any metal implant in the area of bluewind device implantation site. * current pregnancy or attempting to get pregnant (female patient). * any clinically significant neurologic disorders (except pnp).- any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study. * patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases. * severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.

Keywords: peripheral neuropathic pain pnp
school-based treatment of anxiety research study (stars)

Conditions: Anxiety Disorders

Summary: this research is being done to compare two types of talk therapy to see which is most effective in helping school children with anxiety disorders. the investigators will compare usual care (uc) with cognitive behavioral therapy (cbt). both therapies will be administered by the school mental health counselors to see if they help children with anxiety disorders to feel less scared or worried.

this four year study involves a blocked randomized controlled trial (rct) comparing the effectiveness of school-based cbt to usual care (uc) for approximately 375 students ages 7-17 diagnosed with an anxiety disorder. randomization will occur at the school level and the investigators propose to conduct the study in approximately 46 schools (23 in cbt; 23 uc). evaluations will be conducted by study staff to measure treatment progress at the end of the 12-week treatment program, at a three month follows up, and at natural termination.

Eligibility criteria:
inclusion criteria: * between the ages of 6-18 inclusively * meet dsm-iv criteria for a primary anxiety disorder exclusion criteria: * presence of a medical or psychiatric condition contraindicating study treatment (e.g., suicidal intent) * need more immediate or alternative treatment * receiving psychosocial treatment for anxiety * victim of previously undisclosed child abuse and require ongoing department of children and families (dcf) supervision

Keywords: anxiety fear worry therapy cognitive behavioral therapy
group therapy for women prisoners with comorbid substance use and depression

Conditions: Substance Abuse; Substance Dependence; Depressive Disorder

Summary: the purpose of the study is to determine whether interpersonal psychotherapy is effective for treating co-occurring depression and substance use among women prisoners.

incarcerated women are a vulnerable and rapidly expanding population with high lifetime rates of both substance use disorder (sud; abuse or dependence on alcohol, illegal drugs, or prescription drugs; 70%) and depressive disorder (dd; major depressive disorder and dysthymic disorder; 20-27%). dds tend to worsen the course of suds for incarcerated women by increasing their risk for suicide attempts, contributing to the persistence of substance abuse, and reducing the likelihood of a successful transition to an independent, sober life in the community. recent evidence indicates that dds are common in persons with suds, often do not remit with sud treatment, and should be treated. despite growing recognition that co-occurring disorders, such as dds, among substance abusing incarcerated women present an important public health concern, integrated treatments for sud-dd have not been well-developed for or systematically tested in this population. group interpersonal psychotherapy (ipt-g) has been shown to be efficacious in treating dd in other populations and may be especially pertinent to the needs of incarcerated women with sud-dd because interpersonal difficulties not only affect severity of depression, but are also strong predictors of drinking to cope, sud relapse, and prison recidivism in women. this study tests the hypotheses that as adjuncts to prison sud treatment, ipt-g, relative to psychoeducation on co-occurring disorders, will produce at least moderate effect sizes for: * reduction in the risk and severity of substance use relapse after release from prison * recovery from depressive disorder and reduction in depressive symptoms * improvement in social support and interpersonal functioning * reduction in the severity of legal problems during the 3 month follow-up period

Eligibility criteria:
inclusion criteria: * participants are recruited from prison substance use treatment programs. * current primary (non-substance-induced, as defined by the scid) depressive disorder (major depressive or dysthymic disorder) after at least 4 weeks of prison sud treatment and abstinence. * a minimum hamilton depression score of 18 or higher, indicating moderate to severe depression. * depressive disorder at any time while not incarcerated. * substance use disorder one month prior to incarceration. * between 10 and 18 weeks away from release from prison. exclusion criteria: * lifetime criteria for bipolar disorder * lifetime criteria for a psychotic disorder * actively suicidal

Keywords: drug abuse drug dependence alcohol abuse alcohol dependence major depressive disorder dysthymic disorder prisoners women
new needle for two-needle hemodialysis

Conditions: End Stage Renal Disease

Summary: our preliminary studies have demonstrated that an innovative new design of the hemodialysis venous needle (the needle that returns the cleaned blood from the hemodialysis filter to the patient) with three jets is superior to the standard venous needle because it decreases the velocity and turbulence of the blood when compared with the standard venous needle, it is more efficient in the removal of toxins from the blood, and it is safe and effective. more importantly, our preliminary studies suggested that the new needle causes less damage to the dialysis vascular access and to circulating blood cells and less inflammation and oxidative stress. these will decrease medical complications, the high cost of care and death in dialysis patients. the current study will corroborate the finding of previous studies.


Eligibility criteria:
inclusion criteria:(1) end stage renal disease receiving hemodialysis in an ambulatory outpatient dialysis facility (2) male or female, (3) ages 18-80, (4) arterio-venous graft or av fistula as vascular access, exclusion criteria:patients with fever, infection, inflammation or malignancy will be excluded

Keywords: end stage renal disease hemodialysis oxidative stress inflammation
klinefelter fertility preservation

Conditions: Klinefelter Syndrome

Summary: klinefelter syndrome occurs in 1 in 600 males and is a common cause of infertility in men. it appears scar tissue forms in these boys' testicles, leading to progressive destruction over their lifetimes. advanced reproductive technology can be used to surgically retrieve sperm from these individuals, but these methods have a 50% failure rate in adult klinefelter patients. younger men have higher success rates, suggesting that adolescence and young adulthood may be the best time to extract sperm, but these techniques have not been studied in klinefelter patients younger than 26 years of age. additionally, there is currently no way to predict which klinefelter patients will have success with these methods and which of them will not. this trial will explore sperm extraction in klinefelter syndrome in an age range (12-25 years) that has never been studied, with the ultimate hope of improving the potential for fertility in these patients. the specific goals of this study are to determine the ideal age for sperm retrieval in klinefelter patients and to establish factors that can be used to predict which of these patients will have a higher likelihood of success with advanced reproductive technology. the hypothesis is that younger klinefelter patients will have higher sperm retrieval rates.


Eligibility criteria:
inclusion criteria: * diagnosed 47,xxy (klinefelter syndrome) * 12-25 years of age exclusion criteria: * testosterone therapy within past 6 months * history of surgery, injury, or infection in the testicle * solitary testicle

Keywords: klinefelter fertility
a noninferiority study of alglucosidase alfa manufactured at the 160 l and 4000 l scales in treatment naïve patients with infantile-onset pompe disease

Conditions: Pompe Disease (Infantile-Onset); Glycogen Storage Disease Type II (GSD II); Glycogenosis 2; Acid Maltase Deficiency

Summary: a study to demonstrate comparable safety, efficacy, and pharmacokinetics (pk) of alglucosidase alfa manufactured at the 160 litre (l) and 4000 l scales in participants who had been diagnosed with infantile-onset pompe disease. participants were treated with alglucosidase alfa 160 l scale product in the united states (us) and 4000 l scale product in the regions outside the us.


Eligibility criteria:
inclusion criteria: * the participant's parent/legal guardian was willing and able to provide signed informed consent. * the participant might be less than or equal to 12 months of age. * the participant might have documented gaa enzyme deficiency from blood, skin, or muscle tissue. * the participant might be naïve to treatment with alglucosidase alfa. exclusion criteria: * the participant was cross-reactive immunologic material negative. * the participant required invasive ventilator support at the time of enrollment. * the participant had decompensated clinical heart failure. * the participant had a major congenital abnormality, excluding cardiac hypertrophy. * the participant had a clinically significant organ disease (excluding the signs and symptoms of pompe disease). * the participant was currently receiving any investigational product. * the participant was participating in another clinical study. * the participant and/or the patient's parent/legal guardian was unable to adhere to the requirements of the study.
effects of addition of magnesium sulfate in spinal anesthesia on sensory-motor blocks and postoperative pain in lumbar disk herniation surgery

Conditions: Lumbar Spine Disc Herniation

Summary: the purpose of this study is to compare three methods of intrathecal bupivacaine; bupivacaine-fentanyl; bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks and postoperative pain in patients undergoing lumbar disk herniation surgery.

* comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on sensory-motor blocks in patients undergoing lumbar disk herniation surgery * comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative pain in patients undergoing lumbar disk herniation surgery * comparison three methods of intrathecal bupivacaine;bupivacaine-fentanyl;bupivacaine-fentanyl-magnesium sulfate on postoperative side effects in patients undergoing lumbar disk herniation surgery

Eligibility criteria:
inclusion criteria: * candidate for lumbar disk herniation surgery * no contraindication to the spinal anesthesia * no history of allergy to opioids and magnesium sulfate * no peripheral or central neuropathies * no previous history of surgery on same disk level exclusion criteria: * patients with intraoperative tearing of dural suc * occuring of inadvertent intraoperative complications such as bleeding

Keywords: spinal anesthesia bupivacaine fentanyl magnesium sulfate postoperative pain
study to evaluate the immunogenicity of lr20062 compared to control when administered intramuscularly in healthy infants at 2, 4, 6 months of age

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type B Infection

Summary: this is a phase ii, randomized, double-blind, active-controlled, parallel-group, multicenter study to evaluate the immunogenicity and safety of dtap-hepb-ipv-hib hexavalent vaccine lr20062 in healthy infants as primary series at 2, 4, 6 months of age.


Eligibility criteria:
inclusion criteria: 1. is male or female aged two months (50 to 70 days inclusive) on the day of the first dose of study vaccine. 2. is born at full term of pregnancy (≥37 weeks of gestation) with a birth weight of ≥2.5 kg. exclusion criteria: medical conditions: 1. has a history of diphtheria, tetanus, pertussis, poliovirus, hep b, or hib infection. 2. has a known sars-cov-2 infection at screening. 3. was born to a mother with a known history of hep b infection based on hbsag seropositivity. 4. was born to a mother with a known history of hiv infection based on hiv antibody seropositivity. 5. had a recent febrile illness, defined as axillary temperature ≥38.0℃ \[≥100.4℉\] occurring at or within 72 hours prior to receipt of study vaccine. prior/concomitant therapy: 6. has previously received vaccination against diphtheria, tetanus, pertussis, poliovirus, and/or hib infections since birth. 7. has received or is expected to receive immunosuppressive agents or other immune-modifying drugs during the conduct of the study. 8. meets one or more of the following systemic corticosteroid exclusion criteria: 1. has received systemic corticosteroids (equivalent of ≥0.5 mg/kg total daily dose of prednisone) for ≥14 consecutive days and has not completed treatment at least 30 days prior to screening. 2. is expected to require any systemic corticosteroids during conduct of the study. note: topical, ophthalmic, and inhaled steroids are permitted at the discretion of the investigator. 9. has received any non-study vaccine within 30 days before the first dose of study vaccine or is scheduled to receive any other vaccine within one month after the third dose of study vaccine. exception: vaccines against bcg and hep b at birth, rotavirus, mmr, and pcv if received according to the routine immunization schedule, and inactivated influenza vaccine, are allowed.
the effect of emotional freedom techniques (eft) in smokers failing a smoking cessation program

Conditions: Smoking

Summary: the national health service (nhs) stop smoking service at the central lancashire nhs trust serves a diverse population of smokers, with a very good quit rate and high standards. however, clinical experience predicts that some clients are unlikely to succeed through the nhs smoking cessation program. this special population has difficulty quitting for a variety of reasons. some relapse over the course of the following two years and return repeatedly to the service. others, for instance those with health problems, may be highly motivated to quit, but unable to resist their cravings. the purpose of this study is to determine if eft makes a difference in quit rates with the most challenging population of clients.


Eligibility criteria:
inclusion criteria: * high anxiety related to the quit attempt * cravings which sabotage the quit attempt * low confidence at their ability to quit and remain quit exclusion criteria: * none, all nhs clients are eligible

Keywords: smoking eft (emotional freedom techniques) cbt (cognitive behavior therapy) cravings trauma
tailored pfannenstiel incision for caesarean delivery according to the fetal head occipitofrontal diameter

Conditions: Incision, Surgical; Cesarean Delivery Affecting Fetus; Pfannenstiel Incision Length; Fetal Occipitofrontal Diameter

Summary: the purpose of the study is whether the pfannenstiel skin incision can be adjusted according to the occipitofrontal diameter (ofd) of the fetal head.

eligable nulliparous women delivered at term by elective cesarean section in which pfannenstiel skin incision was performed according to the occipitofrontal diameter (ofd) of the fetal head were included. non-vertex presentaions, all emergency cesarean sections, severe preclampsia, women in active phase of the first stage of labor and second stage of labor, placenta pervia and low lying placenta, multiple pregnancies, uncontrolled gestational diabetes mellitus were excluded.

Eligibility criteria:
inclusion criteria: * the women older than 18 years * term nulliparous pregnancies (\>37w) * primary elective/planned cesarean delivery * fetuses with vertex presentations * underwent spinal anesthesia exclusion criteria: * all emergency cesarean sections ( fetal distress, third trimester bleeding including abruption of placenta and placenta previa bleeding, arrest of labor in the second phase) * cesarean delivery for severe preeclampsia * cesarean delivery for non-vertex fetal presentations (breech and shoulder presentation) * cesarean delivery for deflexion fetal head presentations (face and brow) * cesarean delivery during active phase of the first stage of labor * cesarean delivery for placenta previa or low-lying placenta, * cesarean delivery for multiple pregnancies * all cesarean deliveries with uncontrolled gestational or non-gestational diabetes mellitus

Keywords: cesarean delivery pfannenstiel incision length occipitofrontal diameter
investigation of novel non-ce marked catheter

Conditions: Female Stress Incontinence

Summary: hypothesis: treatment with the hydrophilic coated valved intraurethral catheter up to 16 hours per day is effective, well tolerated and seemingly safe for treatment of women with stress incontinence. test persons: ten to twenty stress incontinent women. treatment time: up to two weeks

demonstrate ease and comfort of device insertion, indwelling and removal. patient acceptability during use. other: * symptom and qol questionnaire. * drop out analysis. * is the patient motivated to continue using the valve catheter? * is the patient motivated to recommend the valve catheter to other stress incontinent women?

Eligibility criteria:
inclusion criteria: * willing to participate * adult, competent woman who understands danish. * sui as dominant symptom; daily or almost daily. * residual urine \< 150 ml. * pop-q prolapse ≤ grade 2. * negative urine stix/urine d+r. * min. 2 months local vaginal estrogen treatment if the woman is postmenopausal. * mobile and self-reliant woman. * motivated. exclusion criteria: * allergy to the silicone material * pregnancy or breastfeeding * unexplained hematuria. * current inflammatory disorders * malignant disorders of the urethra. * urethral stricture * visual diverticulum. * ak treatment. * prosthetic heart valve surgery.

Keywords: female stress incontinence
recovery housing and drug abuse treatment outcome

Conditions: Mental and Behavioral Disorders Due to Use of Cocaine: Harmful Use; Opiate Addiction

Summary: reinforcement-based therapy (rbt) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. it is meant to provide motivation for continued abstinence while enhancing social stability. in this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. previous research had shown that rbt produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. the present study compared outcomes for patients (n = 243) randomly assigned to receive abstinence-contingent recovery housing with (full rbt) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full rbt) and without additional counseling and both these treatments were superior to usual care referral. study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.

aims to conduct a randomized, controlled trial of abstinence-contingent recovery housing delivered with or without intensive day treatment among individuals exiting residential opioid detoxification. design random assignment to one of three conditions: recovery housing alone (rh), abstinence-contingent recovery housing with reinforcement-based treatment rbt (rh + rbt) or usual care (uc). rh and rh + rbt participants received 12 weeks of paid recovery housing contingent upon drug abstinence. rh + rbt participants also received 26 weeks of rbt, initiated concurrently with recovery housing. assessments were conducted at 1, 3 and 6 months after treatment enrollment. setting out-patient drug-free substance abuse treatment program in baltimore, maryland. participants patients (n = 243) who completed medication-assisted opioid detoxification. measurements primary outcome was drug abstinence (opioid- and cocaine-negative urine and no self-reported opioid or cocaine use in the previous 30 days). secondary outcomes included abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.

Eligibility criteria:
inclusion criteria: * completes residential detoxification for use of opiates and/or cocaine * willing to go to outpatient aftercare * agrees to random assignment; signs informed consent exclusion criteria: * moving out of town * primary substance use does not include opiates or cocaine

Keywords: addiction substance abuse treatment aftercare outpatient counseling opiates cocaine
enteral fish oil is superior to ursodeoxycholic acid (udca) and placebo for the treatment of cholestasis in infants

Conditions: Cholestasis; Liver Disease

Summary: to investigate the effect of enteral fish oil and udca on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.


Eligibility criteria:
inclusion criteria: neonates admitted to the neonatal intensive care unit (nicu) at university hospital (uh) in san antonio, texas, who: 1. are \>14 days old and \<24 months of age 2. have a serum direct bilirubin of ≥2 mg/dl 3. are receiving \<3 g/k/day of intralipid via tpn 4. are expected to remain hospitalized for at least an additional 21 days exclusion criteria: 1. have a congenitally lethal condition (e.g. trisomy 13) 2. have clinically severe bleeding not able to be managed with routine measures 3. have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis 4. have other health problems such that survival is extremely unlikely even if cholestasis improves 5. known allergy to eggs or fish products 6. receiving iv fish oil 7. phenobarbital therapy at enrollment

Keywords: parental nutrition associated