Kornimate/medical-research-clean huggingface dataset:
combined lumbosacral nerve block versus spinal anesthesia for cognitive function after hip prothesis

Conditions: Cognitive Decline

Summary: hip fracture is a potentially devastating event, and serious surgical and medical complications occur frequently especially for elderly patients. delirium is one of the common complications after hip surgery. controversy exists regarding the possible impact of type of anesthesia (nerve block versus spinal) upon acute and long-term cognitive decline. the primary objective is to assess the association between type of anesthesia (nerve block vs. spinal anesthesia) and risk of cognitive decline (cd). the secondary objective is to compare intra-operative hemodynamic changes, use of vasopressor drugs, and use of post-operative analgesics with respect to the type of anesthesia. prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for cd pre- and postoperatively, using the mini mental state examination (mmse). the presence of cd will be determined at follow-up evaluation up to three months after surgery.

prospective, double blind randomized clinical trial of hip fracture patients who will be assessed for cd pre- and postoperatively, using the mini mental state examination (mmse). the presence of cd will be determined at follow-up evaluation up to three months after surgery. patients undergoing hip surgery will be randomized into two groups. group 1 will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels l3-l4 and l4-l5) as well as placebo injection (1 ml normal saline) at the spinal anesthesia level (l3-l4 or l4-l5). the sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels l3-l4 and l4-l5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg. group 2 will receive spinal anesthesia (3 ml of 0.5% bupivacaine) in addition to placebo injection at the sciatic, l3-l4 and l4-l5 levels.

Eligibility criteria:
inclusion criteria: * admitted with a hip fracture (femoral neck, trochanteric or sub-trochanteric) * 40 kg in weight and higher exclusion criteria: patients who are: * uncooperative * considered as moribund by the orthopedic surgeon at admission * alzheimer * severe cognitive impairment (mmse\<18) * absolute contraindication for spinal anesthesia (assessed preoperatively) * allergy to local anesthesia
the effect of prophylactic ketorolac on sore throat after thyroid surgery

Conditions: Anesthesia Intubation Complication; Tracheal Disease

Summary: sore throat is one of most frequent complaints related to general anesthesia with tracheal intubation. although sore throat is regarded as a minor and short-lasting discomfort after surgery, its incidence and intensity in high risk patients such as female gender, head and neck surgery and difficult laryngoscopy or intubation may attribute to prolong postoperative recovery and give patient dissatisfaction. even though the pathophysiology of post-intubation airway symptoms is not completely clarified yet, the mucosal damage related inflammation at the cuff of endotracheal tube has been thought to be an essential trigger. thus anti-inflammatory medication has been commonly used strategy to prevent postoperative airway discomfort after intubation. the preoperative administration of dexamethasone has been reported to reduce the incidence and severity of postoperative sore throat, but it is accompanied with the adverse effects such as hyperglycemia, delayed wound healing and increased infection in surgical patients. ketorolac, non-steroidal anti-inflammatory drug (nsaid), is an analgesic that commonly used for postoperative pain control and has anti-inflammatory effect. therefore, the investigator designed to evaluate the effect of ketorolac on sore throat in comparison to dexamethasone after thyroidectomy in female adult patients

ketorolac, nsaid, has not been evaluated as a pharmacologic strategy to reduce postoperative sore throat yet. the investigator will explore how the analgesic and anti-inflammatory effects of ketorolac influence airway symptoms following general anesthesia with tracheal intubation.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists(asa) physical status 1 and 2 2. 20-60 years old female 3. elective scheduled thyroidectomy exclusion criteria: surgery longer than 3 hours previous history of or expected difficult tracheal intubation laryngoscope grade (by cormack and lehane) of 3 or 4 2 more trial for intubation bmi \> 30 hypersensitivity to ketorolac history of asthma respiratory tract infection during the past 6 weeks renal dysfunction (creatinine \> 1.5 mg/dl or oligouria) hepatic dysfunction (alt :\> 50% more than normal value) use of corticosteroid, nsaids, angiotensin converting enzyme in 10 days medication for gastritis, gastric ulcer upper gastrointestinal bleeding history diabetes mellitus

Keywords: sore throat hoarseness intubation thyroidectomy ketorolac dexamethasone
group mdma-therapy for veterans with ptsd

Conditions: PTSD

Summary: this phase 2a, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of mdma-assisted group therapy for the treatment of ptsd in veterans. the study will be conducted in up to n=18 participants, recruited in three cohorts of six participants each and receive therapy sessions throughout their participation in these group cohorts.

to assess the feasibility and safety of mdma-assisted group therapy for participants with at least moderate ptsd, the sponsor-investigator is conducting a phase 2, open-label, non-randomized, 3-cohort study. this novel treatment package consists of two once-monthly open-label mdma sessions combined with non-drug preparatory and integrative therapy administered in both individual and group sessions. the primary clinical outcome measure, the clinician administered ptsd scale (caps-5), evaluates changes in ptsd symptom severity and is assessed by a blinded centralized independent rater (ir) pool. the therapeutic approach will combine manualized mdma-assisted therapy for ptsd with group therapy components.

Eligibility criteria:
inclusion criteria: * are at least 18 years old. * are a u.s. military veteran * are fluent in speaking and reading the predominantly used or recognized language of the study site. * are able to swallow pills. * agree to have study visits recorded, including mdma sessions, outcome assessments, and non-drug psychotherapy sessions. * must provide a contact who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable. * must agree to inform the investigators within 48 hours of any medical conditions and procedures. * if able to become pregnant, must have a negative pregnancy test at study entry and prior to each experimental session, and must agree to use adequate contraception through 10 days after the last experimental session. * must not participate in any other interventional clinical trials during the duration of the study. * must commit to medication dosing, therapy, and study procedures. * have a current ptsd diagnosis at the time of screening. exclusion criteria: * are not able to give adequate informed consent. * have uncontrolled hypertension. * have a marked baseline qtcf interval \>450 milliseconds \[ms\] demonstrated on repeated ecg assessments. * have a history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long qt syndrome). * have evidence or history of significant medical disorders. * have symptomatic liver or biliary disease. * have history of hyponatremia or hyperthermia. * weigh less than 48 kilograms (kg). * are pregnant or nursing, or are able to become pregnant and are not practicing an effective means of birth control. * are abusing illegal drugs or alcohol.

Keywords: mdma ptsd veterans group therapy
an efficacy and safety study of cnto 6785 in participants with active rheumatoid arthritis despite methotrexate therapy

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the efficacy and safety of cnto6785 in participants with active rheumatoid arthritis (ra) despite methotrexate (mtx) therapy.

this is a randomized (participants are assigned to treatment by chance), double-blind (participants and study personnel will not know which treatments are being given), placebo-controlled (a placebo appears identical to a study drug but has no active ingredients), multicenter study. the study will consist of 3 phases: a screening phase, a treatment phase, and a follow-up phase. approximately 250 participants with active ra despite mtx therapy will be randomly assigned to receive placebo or cnto 6785 during the double-blind treatment phase. the maximum period of active treatment will be 28 weeks. the maximum duration of study participation will be 44 weeks. participant safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * have a diagnosis of rheumatoid arthritis (ra) (according to the revised 1987 criteria of the american rheumatism association) and have had ra for at least 6 months prior to the date of signing the informed consent at screening * have active ra defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum c-reactive protein (crp) ≥ 0.8 mg/dl at screening or erythrocyte sedimentation rate (esr) ≥ 28 mm in the first hour at screening or baseline * have been treated with and tolerated methotrexate (mtx) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable mtx dose for a minimum of 6 weeks prior to the first dosing with study agent exclusion criteria: * has inflammatory diseases other than ra, that might confound the evaluation of the benefit of study agent therapy * has a diagnosis of fibromyalgia * has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant * at screening, the results of laboratory tests must meet protocol-specified criteria * has ever received any approved or investigational biologic agent for a rheumatic indication

Keywords: active rheumatoid arthritis despite methotrexate therapy cnto 6785 methotrexate
a twelve week study to investigate the efficacy of femarelle®, for the treatment of post menopausal vaginal atrophy

Conditions: Vulvo Vaginal Atrophy

Summary: based on previous data published on the serm properties of femarelle, the investigators hypothesized that femarelle could be a potential treatment for vulvo-vaginal atrophy(vva) symptoms. the current study was a pilot study to examine the effect of femarelle® on vva symptoms in symptomatic post-menopausal women.

post-menopausal women aged 54-77, with vaginal atrophy (\< 5% superficial cells on cervical cytology) with at least one moderate-to-severe vva symptom (dryness, irritation, soreness, dysuria, dyspareunia, or bleeding with coitus), will be recruited for a 12-week open-label pilot study. the study protocol was approved by schulman associates irb.femarelle will be given twice daily and subjective symptoms as well as objective measures like inspection and vaginal ph will be measured.

Eligibility criteria:
inclusion criteria: healthy post menopausal women between the ages of 40-85+yrs who complain of vaginal dryness with at least three urogenital symptoms from the following: vaginal dryness, vaginal irritation, vaginal soreness, dysuria, dyspareunia, bleeding with coitus \& one of these symptoms must be moderate to severe as determined by patient, moderate: discomforting and aware of it with activities. severe: discomforting enough to interfere with activities activities include sitting, walking, running, urinating, as well as sexual activity * bmi 18-34 (inclusive). * patients having a lmp at least one year ago, either natural or surgical. * patients with a normal mammogram within 9 months prior to enrollment. * patients able to adhere to the visit schedule and protocol requirements and be available to complete the study. * patients who provide written informed consent to participate in the study. * fsh \> 40 miu/m. * estradiol \< 20 pg/ml. * vaginal ph \> 5. * \< 5% superficial cells as assessed by vaginal cytology. * normal pelvic and breast exams by investigator. exclusion criteria: patients using hrt (cannot have used for past 3 months). * patients consuming over the last three months high soy diet or any foods or other compounds that are sold as remedies for the post menopausal symptoms. * any history of significant cancer or pre-cancer, neurological, renal, cardiovascular, respiratory (e.g. asthma, copd), hypercoagulability, hematopoietic disease, immune deficiency or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications. * patients with any clinically significant abnormality upon examination at screening visit. * patients with a known history of drug or alcohol abuse. * known hypersensitivity and/or allergy to soy or flax. * participation in another clinical trial within the past 30 days.

Keywords: vulvo vaginal atrophy femarelle
prostate cancer localization with a multiparametric magnetic resonance (mr) approach

Conditions: Prostate Cancer

Summary: the primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3t multi-modality magnetic resonance imaging (high resolution t2-weighted mri, dce-mri, mrsi and dwi techniques) in distinguishing carcinoma from other prostate tissue. the gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

goal proving that multi-parametric mr imaging in a multi-centre setting allows for localizing clinically significant (volume \> 0.5cc; gleason \> 6) prostate carcinoma in the prostate. objective 1 to determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-tesla multi-modality non-endorectal coil (erc) mr imaging in localizing prostate cancer, by correlating: 1. focal areas of low signal intensity on t2-weighted images; 2. the extent and degree of deviating metabolite ratios derived from mrsi. this can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio; 3. the extent and degree of apparent diffusion coefficient reduction on dwi; 4. the extent and degree of perfusion abnormality on dce-mri; with the presence or absence of cancer at (reconstructed) whole mount section histopathology. objective 2 proving that multi-modality mr data allows for predicting tumor grade. the parameters from the different mr methods for a tumor focus can be correlated to the local gleason grade of the corresponding lesion in the histopathological specimens.

Eligibility criteria:
inclusion criteria: * biopsy-proven diagnosis of adenocarcinoma of the prostate * subject will sign a consent form prior to study entry * radical prostatectomy and histopathological exam planned * the time interval between last biopsy and the mr exam must be at least 4 weeks * the time interval between mr exam and radical prostatectomy should not exceed 12 weeks exclusion criteria: * subjects who are unable to give valid informed consent * subjects who are unwilling or unable to undergo an mr exam, including subjects with contra-indications to mr exams * therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy). * patients under hormone deprivation therapy.

Keywords: multi-parametric mri approach
prospective constitution of database gathering data of patients suffering from glaucoma followed at university hospital of grenoble

Conditions: Glaucoma

Summary: few publications provide information on the natural history of glaucoma, outside of clinical trials do not always reflect what is observed in common situation for various reasons (specific selection criteria and sometimes restrictive, stronger motivations patients and physicians to comply with follow-up visits and prescribed treatments, etc.). therefore, much information on the natural history of glaucoma are unknown to date (degradation rate of visual field and visual function over time, risk of blindness in the years following diagnosis, effects of various treatments to reduce intraocular pressure and preserving visual field deterioration, etc.). obtaining such important data to improve the management of glaucoma patients (choice of treatment methods, identification of predictors of rapid change that can make choosing more aggressive treatment and more regular monitoring, etc.) requires the establishment of cohort of patients followed and treated with the methods usually used in current practice, and besides therapeutic trial.


Eligibility criteria:
inclusion criteria: * patients whose age is above 18 years * patients with primary or secondary glaucoma or both sides exclusion criteria: * major person under guardianship or unable to consent * patient refusal
intermittent fasting interventions on brain health in women

Conditions: Psychological Stress

Summary: adults experience high psychological stress due to many factors such as school, workplace, or personal life. adult women are known to experience higher stress levels than men. current evidence shows that fasting improves mental health outcomes in men. the research is unclear on fasting interventions and their potential impact on stress levels in women. in this study, investigators will compare two fasting diets over 8 weeks. there will be a control group, one group that fasts for two days per week, and a final group that only eats for 8 hours in the morning. mental health surveys, brain tests and a blood draw will be done during the study to see any mental or physical changes from the diets. investigators will study the motivation of women to continue the diet during and beyond the study through online surveys.


Eligibility criteria:
inclusion criteria: * english speaker * assignment of female sex at birth * bmi between 18.5-24.9 kg/m\^2 * current engagement in less than 150 minutes of physical activity per week * normal menstrual cycle length (21-40 days) for at least 3 months * non-smoker * consumption of no more than one alcoholic beverage per day * mild to higher levels of stress as indicated by a score of 15 or higher on the stress sub-set of the dass-21 questionnaire exclusion criteria: * pregnant or breastfeeding * diagnosed chronic disease (cardiovascular, metabolic, respiratory, reproductive, renal, neuromuscular, or any other disease or condition as assessed by the canadian society for exercise physiology get active questionnaire) * diagnosed eating disorder * participation in a weight-loss program in the last 3 months * loss of 5% of body weight or more in the last 3 months
whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy(hie)

Conditions: Hypoxic- Ischemic Encephalopathy; Whole-Body Hypothermia; Brain Injury

Summary: among term infants, hypoxic-ischemic encephalopathy due to acute perinatal asphyxia remains an important cause of brain injury in childhood. infants with moderate encephalopathy have a 10 percent risk of death, and those who survive have a 30 percent risk of disabilities. sixty percent of infants with severe encephalopathy die, and many, if not all, survivors are disabled. whole-body hypothermia reduces the risk of death or disability in infants with moderate or severe hypoxic-ischemic encephalopathy.

reductions in brain temperature by 2°c to 5°c provide neuroprotection in newborn and adult animal models of brain ischemia.brain cooling has a favorable effect on multiple pathways contributing to brain injury, including excitatory amino acids, the cerebral energy state, cerebral blood flow and metabolism, nitric oxide production, and apoptosis. brain cooling is effective in reducing the extent of brain injury even when it is initiated up to 5.5 hours after brain ischemia in near-term sheep fetuses.but, epidemiological data showed that, in non-developed countries and areas,whole-body hypothermia is related to the increased mortality and brain injury. the cause is unclear.

Eligibility criteria:
inclusion criteria: * ph of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical cord blood or any blood during the first hour after birth. if, during this interval,a ph was between 7.01 and 7.15, a base deficit was between 10 and 15.9 mmol per liter. or a blood gas was not available, additional criteria were required. these included an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture,uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute apgar score of 5 or less or assisted ventilation initiated at birth and continued for at least 10 minutes. * equal to or more than 36 weeks exclusion criteria: * congenital malformation * parents' refusal
hypericum vs fluoxetine for mild to moderate adolescent depression

Conditions: Depression

Summary: the study is a pilot study where adolescents 12 - 18 years of age with mild to moderate depression will be randomized to receive either hypericum 250mg twice daily or fluoxetine 10mg daily increased to 20mg daily after 1 week and the option to increase to 40mg daily after 4 weeks. patients will be treated for a total of 8 weeks. efficacy will be measured using the cdrs-r, bdi-ii and the cgi scales. safety parameters include blood tests, urinalysis and ecg.


Eligibility criteria:
inclusion criteria: * signed informed consent * adolescents aged 12 to 18 years * patients meeting the criteria for mild to moderate depression according to the dsm-iv scale * physical and laboratory examination at baseline compatible with study criteria * ecg at baseline compatible with study criteria * score of at least 40 on the children's depression rating scale - revised (cdrs-r) at baseline exclusion criteria: * patients with psychosis, bi-polar disease, schizophrenia or significant developmental disorder * patients with epilepsy * patients with a history of alcohol or substance abuse in the past year * initiation of psychotherapy or behavioral therapy in the 2 months prior to screening or during the study. * patients who have previously failed to respond to ssri's or srni's * patients who have been treated with antidepressants within 2 weeks of screening (4 weeks if fluoxetine) * patients with a contraindication to taking either remotiv or fluoxetine or taking medication contraindicated when taking remotiv or fluoxetine

Keywords: mild to moderate depression according to the dsm-iv scale