Kornimate/medical-research-clean huggingface dataset:
pulsed radiofrequency in chronic headaches

Conditions: Headache

Summary: pulsed radiofrequency of the occipital nerves (greater and lesser) for primary headache management.

patients participating suffered from primary headaches (migraine, cluster, and tension headache) and occipital neuralgia were enrolled in the study. they have all received in the past the standard systemic pharmacotherapy prophylaxis for headache management (with topiramate or amitriptylline) as well as tryptanes for rescue treatment, and were scheduled for a diagnostic nerve block of the occipital nerves in cases of intractable pain. inclusion criteria included: not adequate response to systemic pharmacotherapy, pain over crises of \>4/10, occipital tenderness bilaterally or unilaterally, and days with headache of more than 10/month. exclusion criteria were age\ 50% pain relief they were scheduled for pulsed radiofrequency of gon and lon bilaterally. primary outcome measure was the days with headache per month, before and after treatment. in addition, pain during headache crisis (with visual analogue scale, vas, 0-10), the analgesic consumption (number per month) and the quality of life (measured with eq6d) were studied. all measurements were performed before treatment, as well as after 1, 3, 6, and 12 months. all patients completed the brief pain inventory questionnaire in greek language and signed an informed consent prior treatment. all measurements were accomplished by an independed (blinded) researcher of the pain unit. all complications and side effects were also recorded.

Eligibility criteria:
inclusion criteria: * not adequate response to systemic pharmacotherapy * pain over crises of \>4/10 * occipital tenderness bilaterally or unilaterally, * days with headache of more than 10/month. exclusion criteria: * age\<18 years old, * pregnancy or lactation * presence of cardiac pacemaker * previous therapy with prf * severe psychiatric disorder * severe coagulopathy * patient refusal
a study to evaluate the impact of maintaining hemoglobin levels in anemic patients with carcinoma of the cervix

Conditions: Cervical Cancer; Anemia

Summary: the purpose of this study is to assess the feasibility, safety and short term effects on health related quality of life, of maintaining hemoglobin from 120 to 130 g/l versus from 100 to 110 g/l, with red cell concentrate (rcc) transfusion, in women having chemo-radiation for cancer of the cervix.


Eligibility criteria:
inclusion criteria: * previously untreated cervix cancer * figo stage ib2, ii, iiib, iva * suitable for treatment with radical intent using concurrent cisplatin and pelvic radiation exclusion criteria: * hemoglobin level above 125g/l * lower one-third vaginal involvement * para-aortic lymphadenopathy

Keywords: haemoglobin
effects of prefabricated foot orthoses with and without metatarsal pads on central metatarsalgia

Conditions: Metatarsalgia

Summary: compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity in the 2nd to 4th metatarsophalangeal joints, foot and ankle functional abilities as well as the occurrence of plantar callosities among patients with central metatarsalgia.

metatarsalgia is a common condition that affecting about 10% of the general population. central metatarsalgia involves pathology of the 2nd to 4th metatarsal and their respective metatarsophalangeal joints. this randomized control trial is designed to compare the effects of prefabricated foot orthoses with and without metatarsal pads on pain intensity, foot and ankle functional abilities as well as the occurrence of plantar callosities.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * complain of foot pain on the 2nd to 4th mtpjs during walking in shoes, rating the pain intensity as ≥ 50mm on the visual analogue scale (vas); * able to be ambulant exclusion criteria: * peripheral vascular disease (pvd) * neurological dysfunctions or neuromuscular disorders * active infection, i.e., cellulitis, osteomyelitis, shingles * cognitive impairment * history of lower limb surgery and currently undergoing rehabilitation * active ulceration on foot and ankle * current utilization of prescribed insoles
safety of the buprenorphine transdermal delivery system in subjects with mod-to-sev pain following orthopedic surgery.

Conditions: Postoperative Pain

Summary: the objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe pain after orthopedic surgery. the double-blind treatment intervention duration is 72 hours during which time supplemental analgesic medication (intravenous morphine pca) will be provided to all subjects in addition to study drug.

buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility criteria:
inclusion criteria: * underwent any major orthopedic surgical procedure requiring general anesthesia, and were expected to be hospitalized \>/=4 days postoperatively. * in moderate or greater pain post-recovery from anesthesia and were expected to be in, or greater than, moderate pain, without analgesics, for \>/=4 days post-surgery. exclusion criteria: * receiving chronic opioid therapy preoperatively for \>1 month that was at a total daily dose of \>/= 60 mg of oral morphine equivalents. * have significant concurrent pulmonary conditions. other protocol-specific exclusion/inclusion criteria may apply.

Keywords: postoperative pain opioid transdermal
propofol-remifentanyl versus dexmedetomidine in awake craniotomy: impact on electroclinical seizure activity

Conditions: Craniotomy; Seizures; Dexmedetomidine; Propofol; Remifentanil; Cerebral Tumor; Neurophysiology

Summary: awake craniotomy require a cooperative patient during resection neurosurgery phase. anesthesiologist should guarantee analgesia, sedation, nausea and vomiting prevention, while maintaining normal vital parameters. neurosurgeon could be help by intraoperative electrocorticography to maximise lesion resection and avoiding neurologic sequelae. propofol and remifentanyl have been largely used. dexmedetomidine represents an alternative. however little is known about the role of dexmedetomidine on intraoperative electrocorticography.


Eligibility criteria:
inclusion criteria: * patients undergoing awake craniotomy for tumor resection (excluded e.g. surgery of epilepsia) * intraoperative monitoring (iom) with electrocorticography * awake-awake-awake technique exclusion criteria: * age \<18 years old * non awake-awake-awake technique * absence of iom
a nutrition/hygiene education program for the prevention of child malnutrition in rural kenya

Conditions: Child Nutrition Disorders

Summary: this study will determine if an education program about hygiene and child feeding practices, taught by local village community health workers, will improve child growth and decrease the prevalence of childhood malnutrition in a rural region of kenya.


Eligibility criteria:
inclusion criteria: * child of a mother living in the catchment area of the study who delivered during the enrollment period

Keywords: infant nutrition disorder child nutrition disorders malnutrition protein-energy malnutrition
study of cabazitaxel combined with prednisone and prophylaxis of neutropenia complications in the treatment of patients with metastatic castration-resistant prostate cancer

Conditions: Prostate Cancer

Summary: primary objective: - to assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. secondary objectives: * psa response rate; * descriptive assessment of ctc (circulating tumor cells); * rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period; * description of the health quality of life of the patients; * incidence of adverse events.

screening: 15 days treatment: until disease progression post-treatment follow-up: 12 months

Eligibility criteria:
inclusion criteria : * histologically proven castration-resistant prostate cancer (stage iv only); * prior failure of treatment with docetaxel; o documentation of metastasis by imaging. * performance status 0 or 1; exclusion criteria: * previous treatment with chemotherapy, except for docetaxel; * previous use of abiraterone; * inability to maintain treatment with androgen deprivation if no previous history of orchiectomy; * presence of any other active malignancy or history of any tumor diagnosed in the last 5 years, except basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the skin, bladder or anal canal (these tumors do not prevent participation if they have been treated, even in the last 5 years); * hypersensitivity or known allergy to any of the treatments under study, including history of severe hypersensitivity reaction (≥grade 3) to docetaxel and/or to polysorbate 80 containing drugs * history of congestive heart failure or myocardial infarction within the last 6 months, or uncontrolled cardiac arrhythmias, angina pectoris or uncontrolled hypertension; * uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus) * presence of severe comorbidity, which in the opinion of the investigator, puts the patient at risk or impairs compliance to the protocol; * known seropositivity for hiv; * presence of significant psychiatric or neurological disease, in the investigator's opinion; * presence of uncontrolled hypercalcemia; * refusal to use appropriate contraception during the study period; * participation in any clinical trial in the last 12 months, unless there is benefit to the patient to be justified by the principal investigator * concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome p450 3a4/5 * inadequate organ and bone marrow function the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
the influence of blood pressure upon the clarity of surgical field in endonasal surgery

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: the work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.

the work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. a secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (nirs) and consumption of hypotensives. null hypothesis: there is no difference in the clarity of the surgical field at various levels of the mean arterial pressure. this study is being realized in accordance with the declaration of helsinki and has been approved by the ethics committee of the university hospital ostrava (849/2018). according to the statement of the state institute for drug control of 26th april 2019 (reference number sukl96964/2019), the trial is not considered a clinical trial of medicinal products. study type: single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.

Eligibility criteria:
inclusion criteria: * patients with chronic rhinosinusitis undergoing pansinusoperation * age over 18 years * concrete surgeon (petr matoušek, md, ph.d., mba) * concrete anaesthetist (michal parma, md) exclusion criteria: * coagulopathy * thrombocytopathies * vascular wall disorders * thrombophlebitis * anticoagulation or anti-aggregation therapy * history of malignancy * pregnancy

Keywords: surgical field clarity endonasal surgery intraoperative bleeding
expanding knowledge about and evaluating services for incarcerated pregnant and postpartum women in arkansas

Conditions: Health Problems in Pregnancy; Childbirth Problems; Maternal Care Patterns; Quality of Life; Emotional Stress; Health Care Acceptability; Health Risk Behaviors; Parent-Child Relations

Summary: the number of women who are incarcerated in the u.s. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. however, little is known about the population of women who have become incarcerated while pregnant in arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. this research study aims to first expand knowledge on incarcerated women in arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by arkansas from june 1, 2014 to may 31, 2019 (a five-year cohort; aim 1). then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in arkansas while pregnant (aims 2 and 3). we will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between arkansas department of corrections and uams.


Eligibility criteria:
inclusion criteria: * women incarcerated in arkansas state prison system * 18 years or older * able to give informed consent * pregnant or has given birth in past year exclusion criteria: * under 18 years of age

Keywords: incarcerated women prison
immune response analysis to influenza vaccine in elderly aged over 65 years

Conditions: Immune Response

Summary: this study is the first step in a clinical research program that aims to study the immune response to influenza vaccine in the elderly and then to propose a new method of administering the vaccine. influenza can cause severe complications in patients at risk (elderly and subjects vulnerable because of a chronic underlying disease). over 90% of deaths related to influenza occur in people aged over 65 years. vaccination is the most effective way to prevent infection. the world health organization recommends annual immunization for people at risk, including all persons aged over 65 years, to reduce the risk of morbidity and mortality related to influenza. however, the immune response to influenza vaccine appears to be lower in elderly than in young people.


Eligibility criteria:
inclusion criteria: * subject aged 65 years or over * influenza vaccination without adjuvant, within 3 weeks and 3 months before inclusion visit * legal capacity to consent * subject had given written consent before his participation exclusion criteria: * adjuvanted influenza vaccine (e.g: fluad, gripguard) * live vaccines within 3 weeks before and after influenza vaccination * inactivated vaccines within 2 weeks before and after influenza vaccination * chronic disease non-stabilized under treatment * severe malnutrition in the opinion of the investigator * congenital immunodeficiency * chemotherapy or radiotherapy over the last 6 months * immunosuppressive therapy or corticosteroid (daily dose of prednisone or equivalent \>/= 20 mg/d over 14 days) from 1 month before vaccination until the study visit * participation in another clinical study that could interfere with the present study

Keywords: influenza vaccine immune response elderly
caduet and tlc intervention in metabolic syndrome

Conditions: Metabolic Syndrome

Summary: to evaluate the effectiveness of caduet in addition to therapeutic life-style change (tlc) intervention in resolving metabolic syndrome fifty three individuals were randomized to tlc intervention study with or without caduet therapy for 12 months. the participants underwent monthly visits with investigators to obtain vital signs, and to undergo tlc counseling. metabolic parameters were measured before and after intervention.

single center, investigator driven, double blinded, randomized with caduet 5/10mg vs placebo. the participants visited with investigators on a monthly bases to evaluate the bp, weight, and obtain the waist measurements, and counseling. ogtt was performed at the beginning and the end of the study. lipid and glucose parameters were measured 5 times in duration of the study period. exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. vo2 max was measured at the beginning and end of the study. pedometers dispensed to encourage physical activity.

Eligibility criteria:
inclusion criteria: * bp ≥130/85 * metabolic syndrome per ncep-atp iii revised (3/5 criteria) * men and women age 40-65 exclusion criteria: * inability to sign a consent form. * unwillingness to complete the protocol for the duration of 15 months * unwillingness of primary care physician to participate in the program * patients already on hypercholesterolemia agent * fasting plasma glucose above 126 mg/dl or current treatment for diabetes. * if the physician believes the patient should be started on antihypertensive regimen. * creatinine clearance \<50ml/min. * therapy with anticoagulants * pregnant/lactating women (pre-menopausal women should be on birth control pill) * ast/alt \> x3 upper limit of normal * evidence of cholelithiasis * use of oral anticoagulants * cancer * recent cardiovascular event (\<6months) * substance abuse * since there is no translator, non-english speaking subjects will not be enrolled in the study.
gonadal toxicity in women with hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the gruppo italiano studio linfomi has been collecting data on patients with hodgkin lymphoma (hl) since 1988. this archive represents a homogeneous series of consecutive patients with hl. the very long follow up and the availability of clinical and treatment data make it feasible to perform a study on the gonadal toxicity related to treatment for hl.


Eligibility criteria:
inclusion criteria: * female patients in complete remission after chemotherapy for hodgkin lymphoma * age ≥ 18 e \< 40 years * previous regular menstrual cycle * no previous or concomitant gynecological diseases affecting reproducing function * no other chemo-radiotherapy for other neoplasm * written informed consent exclusion criteria: * none
absorption of transdermal vitamins in post bariatric surgery patients

Conditions: Bariatric Surgery Candidate; Vitamin Deficiency; Mineral Deficiency

Summary: patients undergoing bariatric surgery often develop new vitamin and/or mineral deficiencies or exacerbate prior deficiencies after surgery. several bariatric supplement products exist including oral tablets and transdermal patches. the purpose of this study is to observe the concentrations of serum micronutrients and determine how many deficiencies develop in patients who use a transdermal patch.

patients will undergo either a sleeve gastrectomy or gastric bypass procedure. all patients enrolled will have previously chosen to use the patch md multivitamin plus patch for vitamin and mineral supplementation versus oral or other dosage forms of vitamins after surgery. a conversation between the patient and provider will occur first during a pre operative appointment, at which time the patient will be presented with the option to use oral vitamins or the patch md multivitamin plus patch after surgery. only if the patient chooses the patch will he/she be made aware of the study and recruited. pre operative blood draws will be used to determine baseline micronutrient serum concentrations and existing deficiencies. the gastrointestinal symptom rating scale (gsrs) will be used pre operatively to determine baseline gastrointestinal symptoms. post operative blood draws and gsrs data will be collected at 3 months, 6 months, and 1 year after surgery.

Eligibility criteria:
inclusion criteria: 1. candidates for a sleeve gastrectomy or gastric bypass surgery 2. willingness and ability to provide informed consent in english 3. commitment to the 1 year study period exclusion criteria: 1. planned bariatric revision surgery 2. patients with a left ventricular assistance device 3. known end stage renal disease 4. known mutation in methylenetetrahydrofolate reductase (mthfr) gene 5. medical conditions requiring vitamin and mineral supplementation
epidural spinal cord stimulation for hypertension in patients with neuropathic pain

Conditions: Chronic Pain; Hypertension; Implanted Stimulation Electrodes

Summary: the purpose of the escape study is to determine the extent to which epidural spinal cord stimulation (scs) reduces arterial blood pressure (bp) in patients which chronic low back pain and hypertension. we also aim to determine the extent to which higher baseline bp (i.e., hypertension) predicts reductions in pain following scs implant. this is an observational study of patients undergoing an implantation of a scs device.

the broad research goal of this study is to examine the extent to which arterial blood pressure (bp) and blood markers related to hypertension and kidney function are reduced in a prospective cohort of patients undergoing implantation of an epidural spinal cord stimulator (scs) for the purpose of managing chronic pain in the lower back and/or limbs. specific aims: 1. examine the extent to which bp (primary variable), norepinephrine (marker of sympathetic nerve activity in the blood), and a vascular ultrasound scan are improved following the implant of a scs device among patients with chronic pain and hypertension. 2. examine the extent to which markers of kidney function in the blood \[serum creatinine, glomerular filtration rate (gfr), and blood urea nitrogen (bun)\] are reduced following the implant of a scs device among patients with chronic pain and hypertension. 3. determine the extent to which bp predicts reductions in pain following the implant of a scs device.

Eligibility criteria:
* planning to have an epidural spinal cord stimulation device implanted at kumc * male or female, age 30-89 * low back pain for more than 3 months * willing to visit research lab * willing to undergo a blood draw and blood pressure measures * able to provide written informed consent