Kornimate/medical-research-clean huggingface dataset:
the effect of perioperative pregabalin on the incidence of chronic post-thoracotomy pain syndrome

Conditions: Chronic Pain

Summary: pregabalin, administered prior to and following lateral thoracotomy surgery will reduce the likelihood of chronic post-thoracotomy pain syndrome (cptps).

a total of 200 patients scheduled for lateral thoracotomy will be randomly assigned to receive either placebo or 150 mg pregabalin (lyrica)1 hour prior to surgery, 12 hr after surgery and then every 12 hr for an additional 10 days. while in the hospital, patients will be assessed for pain intensity, satisfaction and side effects. patients will be re-assessed at 2, 4 and 6 months following surgery.

Eligibility criteria:
inclusion criteria: * elective open thoracotomy for primary thoracic surgery, understanding and provision of written informed consent, asa class i ii or iii exclusion criteria: * inability ot adhere to study protocol: * intolerance or hypersensitivity to any agents to be used in the study, contraindication to thoracic epidural placement * inability to respond to the study questionnaire * renal insufficiency(serum creatinine \> 1.5 upper limit of normal) * body mass index \> 40 * planned post-operative ventilation. * confounding procedural factors which might affect validity of data: * previous ipsilateral thoracotomy * surgery for tumor extending into the chest wall * rest pain in proposed surgical area pre-operatively * chest tube in situ at time of surgery * requirement for second thoracotomy or re-occurrence of disease after surgery \*isolated pleuroscopy or pleurodesis procedures. * potential interaction with study medications and patient's current medications: * current alcohol or other substance abuse * chronic steroid use * pre-existing chronic pain requiring chronic analgesic use * history of seizure disorder requiring treatment with an anticonvulsant * current therapy with thiazolidinedione class oral hypoglycemic agents (eg, actos, avandia or avandamet) * history of congestive heart failure * major psychiatric disorder * any contraindication to use of nsaids. * insufficient safety data in the patient population: * patients requiring preoperative assistance or assistive device for ambulation, pregnant or breastfeeding * weight \<50 kg * dizziness while inpatient.

Keywords: thoracotomy chronic pain pregabalin lyrica
anecortave acetate risk-reduction trial (aart)

Conditions: AMD

Summary: the purpose of this study was to demonstrate that anecortave acetate for depot suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * dry amd in study eye, wet amd in non-study eye; * other protocol-defined inclusion criteria may apply. exclusion criteria: * under 50; * other protocol-defined exclusion criteria may apply.
study on serum metabolomics of gdm

Conditions: GDM; Pathogenesis; Diagnosis

Summary: this study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without gestational diabetes mellitus (gdm). we will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. this study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of gdm.


Eligibility criteria:
inclusion criteria: * no obvious abnormalities in all inspection items * no history of diabetes * no particular dietary habits * no previous history of other mental illnesses * no history of drug abuse or allergies * no history of smoking or drinking exclusion criteria: * pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome * critical illnesses such as cardiovascular disease or abnormal liver/kidney function * personal history of syphilis, hiv positive, and other infectious diseases * artificial insemination or ivf pregnancy * multiple pregnancy (twins or more) * patients participating in other clinical studies * other reasons that researchers think are inappropriate

Keywords: metabolomics
coexisting thyroid disease and hyperparathyroidism

Conditions: Hyperthyroidism

Summary: purpose: prospective studies of patients with hyperparathyroidism are warranted to determine the prevalence of concurrent thyroid disease applying the current standard of pre-operative radioscintigraphic and sonographic imaging of the neck. timely diagnosis and treatment of co-existing thyroid disease is advantageous given the well-established increased morbidity associated with a second neck exploration. the purpose of this study is to determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. research design: this will be a prospective single arm observational study of up to 200 military health care beneficiaries over the age of 18 years with primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection. methodology: patients will undergo standard pre-operative imaging of the neck including ultrasonography and 99mtc-sestamibi scintigraphy. an operative plan will be developed based on the information obtained from history, physical examination, laboratory studies, and imaging studies. the number and type of thyroid disease in these patients will be determined based on these non-invasive studies (objective a). a change in the otherwise standard treatment will include those patients having partial or complete resections of their thyroid glands because: a) the patients would have undergone minimally invasive surgery if not for the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland parathyroidectomy if not for the results of the imaging studies (objective b).


Eligibility criteria:
inclusion criteria: patients with hyperparathyroidism and appropriate indications for operation * patients over 18 years of age and capable of providing informed consent * each patient must provide written informed consent prior to entering the study. exclusion criteria: * patients who have previously undergone thyroid or parathyroid operation * patients with medullary thyroid carcinoma and hyperparathyroidism or suspected multiple endocrine neoplasm syndrome

Keywords: thyroid disease, hyperthyroidism
development and relationship between resilience and anxiety and depression in elderly gastric cancer survivors

Conditions: Resilience; Anxiety; Depression

Summary: this study will explore the dynamic interaction between mental resilience, anxiety and depression in elderly patients with gastric cancer 1 year after surgery, in order to better understand the role of these two factors in patients' mental health, and provide accurate insights for clinical practice and targeted psychological support strategies.


Eligibility criteria:
inclusion criteria: * diagnosed with gastric cancer by endoscopy or pathology * age ≥60 years old * radical gastrectomy was proposed * be able to communicate simply in writing and verbal exclusion criteria: * received preoperative radiotherapy or chemotherapy; * combined with other sites of malignant tumors; * combined with severe heart, liver, lung and renal insufficiency; * recent using hormones, immunosuppressants; * with physical disabilities.

Keywords: gastric cancer resilience anxiety depression trajectory
pennsylvania abusive head trauma prevention program

Conditions: Injury; Traumatic Brain Injury; Child Abuse

Summary: this project is designed to evaluate a statewide, hospital-based parent education program to prevent abusive head trauma (aht) in pennsylvania, and investigate the additional effectiveness and cost-effectiveness of "booster" sessions of parent education delivered to parents at primary care provider offices in central pennsylvania. specific aims: 1. assess the effectiveness of an established statewide program of hospital-based postnatal parent education about violent infant shaking, provided at a single consistent point in time between the infant's birth and hospital discharge, in reducing the incidence of aht. 2. identify which component(s) are the most important mediators of the intervention's effectiveness; determine whether the intervention effect is more directly related to changes in perpetrator or caregiver behavior; and determine the effectiveness of the intervention among various socioeconomic groups. 3. determine the cost effectiveness of the hospital-based program. 4. establish the feasibility, additional costs, and effectiveness of a combined program of repeated exposure delivered both post-natally in the hospital and during follow up 2-, 4- and 6-month outpatient health maintenance visits with the pediatric care provider.

upon the birth of the child, all parents (mothers, and whenever possible, fathers or father figures) will be asked to read written materials and view an 8-minute video on the dangers of violent infant shaking. parents will be asked to voluntarily sign a commitment statement affirming their receipt and understanding of the materials; these commitment statements will be sent to the principal investigator. a random subset of parent participants will be asked to voluntarily answer a short questionnaire about their impressions of the materials. in addition, 31 counties in central pennsylvania will be randomly divided into two groups. in 15 counties, the hospital-based intervention will remain as described above. in the other 16 counties, all primary care providers having offices in those counties will be asked to provide all parents of newborns at the 2-, 4-, and 6-month immunization visits another set of written materials about violent infant shaking and voluntarily sign a response form that they read and understood the materials. participating parents in this group will also be asked if they would be willing to complete a short telephone survey when the infant is 7 months old (and if so, asked to provide a telephone number). the telephone survey asks questions about the intervention materials and parents' perception of the information, and seeks to determine the mediators of a program effect. an invitation letter will be sent to a control group of parents who do not receive the office-based intervention to ask if they would be willing to complete the short telephone survey when their infant is 7 months old.

Eligibility criteria:
inclusion criteria: * parents giving birth in a pa hospital
conotruncal cardiac defects and nutrigenetic etiopathogeny

Conditions: Conotruncal Cardiac Defects

Summary: the investigators planned to study the etiopathogenic factors of conotruncal cardiac defects regarding the relations between the metabolic, the genetic and the environmental factors which lead to these cardiopathy.


Eligibility criteria:
inclusion criteria: * conotruncal cardiac defects patients and theirs mothers * weight: \> 3750 g exclusion criteria: * syndromic conotruncal cardiac defects * 22q11 deletion holder's * patients whose mother's took anti-folates before and during first pregnancy semester

Keywords: conotruncal cardiac defects methylation genotype cobalamin folates nutrition
optic neuropathy in 10 patients with glioblastoma receiving bevacizumab

Conditions: Glioblastoma; Optic Neuropathy

Summary: does treatment with bevacizumab (avastin) in combination with prior or current radiotherapy lead to optic neuropathy?

the investigators research will focus on patients prior to them beginning treatment with bevacizumab (avastin), by undergoing a baseline visual examination with visual evoked potentials testing. this will allow testing of the patient's optic nerve function bilaterally. patients will then begin their normally scheduled treatment with avastin, and other chemotherapeutic agents, as well any radiation treatments scheduled. once patients have completed their treatment with avastin for 6-8 weeks, they will then undergo their second visual evoked potential testing, with both studies then being compared for any changes within the optic nerves. patients will also be recommended to have stringent follow up with an ophthalmologist to include confrontational visual field testing, external and anterior segment examination, and dilated fundus examination. the investigators main objective is to assess whether or not bevacizumab causes a direct toxic effect on patient's optic nerves leading to an acute/subacute optic neuropathy.

Eligibility criteria:
inclusion criteria: * diagnosed w glioblastoma grade iv, and scheduled to begin chemo radiotherapy with avastin exclusion criteria: * no diagnosis of gbm, not scheduled to begin treatment with avastin in combination with radiotherapy.

Keywords: prospective study glioblastoma avastin visual evoked potential optic neuropathy chemo-radiotherapy
peroperative use of positive end-expiratory pressure prevents formation of atelectasis as studied by computerised tomography at end of surgery

Conditions: Atelectasis

Summary: atelectasis is common during and after general anaesthesia and a number of interventions have been suggested in order to prevent their formation. the use of positive end expiratory pressure (peep) during general anaesthesia has in recent years been questioned. the investigators hypothesize that the use of peep as a single intervention improves oxygenation and prevents atelectasis as investigated by computed tomography compared to a control group with zero peep.


Eligibility criteria:
inclusion criteria: * healthy subjects, american society of anesthesiology (asa) i-ii. * patients scheduled for non-abdominal day case surgery under general anaesthesia. exclusion criteria: * asa class iii or higher. * body mass index (bmi) 30 or higher. * arterial oxygen saturation (spo2) \<96% breathing air. * chronic obstructive pulmonary disease (copd). * ischaemic heart disease. * known or anticipated difficult airway. * active smokers and ex-smokers with a history of more than 6 pack years. * need for interscalene or supraclavicular plexus block for postoperative pain relief (risk of phrenic nerve paralysis).

Keywords: atelectasis positive end-expiratory pressure oxygenation anaesthesia computed tomography
perspectives on spinal manipulative therapy for low back pain

Conditions: Low Back Pain

Summary: the goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.


Eligibility criteria:
inclusion criteria: * pain between 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region. * meets nih task force criteria for chronic low back pain exclusion criteria: * prior surgery to the lumbosacral spine * currently pregnant * not currently receiving spinal manipulative therapy or exercise interventions from another healthcare provider such as a chiropractor or massage therapist. * no neurogenic signs indicating radiculopathy * no "red flags" of a potentially serious condition (e.g., cauda equina syndrome, fracture, cancer, infection, etc.)
performance comparison of a new fetal/maternal monitor with an fda-cleared method

Conditions: Labor Fetal Anoxia

Summary: this is a prospective clinical trial involving the use of the fda-cleared fetal ecg tracing in labor with the an24 (fetal monitoring device marketed by monica healthcare) to the novii (a newer device also created by monica healthcare) using the same technology with different monitor placement.

this study has one arm, in which both the fda - approved an24 (fetal monitoring device marketed by monica healthcare) and the new device (novii, being investigated in this clinical trial) will be placed on the patient's abdomen. after delivery of the patient's infant, the data will be abstracted from the second device. this data will be compared to the data from the first device for accuracy.

Eligibility criteria:
inclusion criteria: * term laboring patients exclusion criteria: * preterm labor * fetal anomaly * imminent cesarean

Keywords: fetal monitoring ecg
heart to heart: testing a sexual health training for foster and kinship caregivers

Conditions: Sexual Behavior; Conflict, Family; Pregnancy Related; Sexually Transmitted Diseases; Family and Household

Summary: heart to heart is a brief pregnancy prevention training program delivered to foster and kinship caregivers to prevent unintended pregnancy in foster youth. the training delivers easy to understand information on sexual health, contraception, and adolescent development. it also includes a brief behavioral training, and information on effective communication, monitoring strategies, and social support. the curriculum was piloted in los angeles. investigators will test the intervention in a randomized control trial.

dr. ahrens and her team will evaluate the effectiveness of this training using a randomized stepped wedge study design with a target enrollment of 100 foster and kinship caregivers. recruitment will be carried out in collaboration with the los angeles department of child and family services, foster family agencies and support groups. after completing a baseline survey, participants will be randomly assigned to either the intervention group or the waitlist control group. (with a target 1:1 ratio of controls to intervention subjects, but in consideration of greater levels of attrition in the waitlist control group due to the 6-month wait before being offered the training, participants will be randomized in a ratio of 4:3 to control vs intervention group). the intervention group will receive the training soon after enrollment, and will then complete 3 follow-up surveys over the following 6 months. participants assigned to the waitlist control group will first complete 3 surveys over 6 months, receive the intervention at the 6 month mark, then take 3 follow-up surveys over the following 6-month period. dr. ahrens and team will use these survey data to measure the effectiveness of the training based on the outcome measures. participants will be surveyed at multiple timepoints both because the different outcomes are expected to occur within different time intervals (e.g. knowledge may change right away, while behaviors will take longer), and to assess whether these outcomes change over time (e.g. whether knowledge gained in the training is lasting).

Eligibility criteria:
inclusion criteria: * is a foster or kinship caregiver in los angeles county. * has a youth age 11-21 who has lived with them for at least 3 months in the past year. * anticipates that at least one youth age 11-21 will continue to live with them for the next 12 months. * is available for either training group (immediate or in 6 months). exclusion criteria: * does not anticipate youth will stay in their home for 12 months * does not have a youth age 11-21 in their home * cannot commit to being randomized to either training group.

Keywords: foster caregiver kinship caregiver foster youth unintended pregnancy curriculum intervention sexually transmitted infections behaviorism monitoring communication adolescent development sexually transmitted diseases
effects of a classic high-frequency rtms treatment versus a deep rtms treatment

Conditions: Depressive Disorder, Treatment-Resistant

Summary: the main objective is to demonstrate that dtms is more efficient than high frequency rtms with a conventional coil. the patient will receive treatment arm a or b : arm a : classic rtms treatment (use of the 8-shaped coil) and standard therapy arm b: treatment with deep rtms (use of the h-shaped coil (helmet)) and standard therapies. 20 rtms sessions are planned (5 sessions per week) and 3 follow-up visits : at day 30, day 60 and day 90.


Eligibility criteria:
inclusion criteria: * volunteer subjects over 18 years old * having signed a free and informed consent * having a diagnostic of caracterised depressive episod recurrent or isolated according to dsm iv criteria (a.p.a 1994). * having an antidepressant treatment not modified since 3 weeks * score to madrs scale ≥ 21 * subject affiliated to a social security regimen exclusion criteria: * depression with psychotic caracteristics * co-morbid diagnosis according to axis i (dsm iv) of schizophrenia, dependence (or abuse) on alcohol and / or another substance (lifetime) * patient who has already undergone seismotherapy for current episode and non-responder to this treatment * patient hospitalized under duress or under legal protection (guardianship, curatorship) * patient with a high risk of suicide (item 10 of madrs \> 4) in the absence of hospitalization. * contra-indication for irm exam or rtms : personnal history of comitial crisis, of neurological or neurochirurgical pathologies, metallic prosthetic material or foreign body (pacemaker, intraoculare ferromagnetic material, implanted cardiac defibrillator, cochlear implant, metal clip * pregnancy * simultaneous participation to another interventionnal study
nutricovid30 : nutritional evaluation for covid-19 infection at d30

Conditions: COVID-19

Summary: describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

the recent covid-19 outbreak has brought usa, european, british and french nutrition learned societies to publish recommendations for the nutritional management of patients infected with the sars-cov-2. they reminded that there is a risk of malnutrition for that population. the emergency and rapid evolution in the situation have led to severe cases of anosmia, ageusia, diarrhea, odynophagia, anorexia etc.. some of the first patients cured from covid-19 have lost up to 10 kgs. to this day, there is no available information regarding either nutritional characteristics or nutritional interventions (enteral or parenteral nutrition, oral nutritional supplements, dietary supplementations) for covid-19 patients. the objective of this study is to describe nutritional consequences of the covid-19 infection for adults, 30 days after their discharge from hospital, as well as the nutritional care they received. type and proportion of chronic diseases will be assessed in this trial.

Eligibility criteria:
inclusion criteria: * 30 days or more after discharge from hospital for covid-19 * patient received information about the trial and gave his/her consent * patient capable of answering the phone (alone or with some help) exclusion criteria: * patient diseased * impossibility to collect information from the patient or one of his/her relatives * patient protected by the french public health code (art. l1121-5 à l1121-8)