Kornimate/medical-research-clean huggingface dataset:
evaluating the impact of a novel cannabinoid product for endometriosis

Conditions: Endometriosis

Summary: despite the proliferation of cannabis and cannabinoid products in recent years, little research has been done to determine the impact of these products on womens health conditions, including endometriosis. this study is designed to assess the impact of a custom-formulated, hemp-derived, full-spectrum, high-cbd product vs. placebo on clinical symptoms and biomarkers over the course of 12 weeks of treatment in patients with endometriosis. this project will provide information that does not currently exist on the potential efficacy of a cannabinoid-based sublingual product for endometriosis.

despite recent increases in both medical and recreational cannabis use in the united states and globally, little research has been conducted to determine the potential applications for womens health. endometriosis impacts approximately 10% of women of reproductive age, an estimated 176 million individuals, and is characterized by endometrial cells growing outside of the uterus, resulting in severe pain, chronic inflammation, gastrointestinal symptoms, infertility, and often, depression and anxiety (who, 2023). existing treatment options are often limited in efficacy and may result in a variety of negative side effects. previous research has indicated that cannabinoids including cannabidiol (cbd), delta-9 tetrahydrocannabinol (thc), and a number of other cannabinoids may hold potential for treating the symptoms of endometriosis, especially the chronic pain associated with the condition. this study is a double-blind crossover clinical trial of a high-cbd product compared to placebo over a total of 12 weeks of treatment in patients with endometriosis. participants will complete 7 visits over 12 weeks; 4 visits will be conducted in-person at mclean hospital in belmont, ma, and 3 visits will be conducted remotely. visits consist of clinical ratings, assessments of conventional medication use, quality of life measures, and providing saliva, urine, and blood samples.

Eligibility criteria:
inclusion criteria: 1. subject has provided informed consent 2. sex assigned female at birth 3. subject is 21 or older 4. subject is fluent in english 5. subject endorses at least moderate levels of pain at the baseline visit 6. subject endorses having endometriosis exclusion criteria: 1. non-fluent english speakers 2. endorsement of current substance use disorder, psychotic disorder, or an eating disorder 3. currently uses cannabis or cannabinoid products regularly 4. patients will be excluded if they have a positive urine pregnancy test, are trying to become pregnant, or are currently breastfeeding 5. presence of a serious or unstable medical illness, including liver, kidney, or cardiovascular disease (hyper/hypotension, cardiac disorders), or neurological disorder (including seizure disorder) 6. neuropathic pain or cancer-related pain 7. disclosure of a genetic polymorphism affecting cyp2c9 function
neuromuscular electrical stimulation during immobilization due to ankle fractures

Conditions: Immobilization; Muscle Disuse Atrophy

Summary: rationale: situations such as fractures of the lower extremity can necessitate a prolonged period of immobilization in otherwise healthy individuals. long-term immobilization of the lower extremity has shown to cause significant reductions in skeletal muscle mass, already occurring during the early stages of disuse. accordingly, feasible strategies for attenuating this loss of muscle during disuse need to be pursued. local neuromuscular electrical stimulation (nmes) offers such a potential strategy but, as yet, remains untested during prolonged muscle disuse in a clinical setting. objective: to investigate whether twice daily local (gastrocnemius/soleus) nmes attenuates muscle loss during 2 weeks of unilateral ankle immobilization. study design: randomized, parallel (two groups) study design. study population: 30 adults (18-65 y) with any form of closed ankle fractures needing surgical treatment. intervention: twice daily neuromuscular electrical stimulation (nmes) or no intervention. main study parameters/endpoints: primary: calf muscle (gastrocnemius) cross sectional area (csa) as determined by ct scan. secondary: type i and ii muscle fiber csa and sc content, intramuscular triglyceride content and mrna and protein expression of anabolic signaling proteins.


Eligibility criteria:
inclusion criteria: * unilateral closed ankle fracture (weber type a, b or c) * aged from 18-65 years * 18.5 \< bmi \< 30 kg/m2 * undergoing surgical treatment exclusion criteria: * additional fractures beside ankle fracture (e.g. multi-trauma following a car accident) * use of oral anticoagulants such as vitamin k-antagonists (e.g. acenocoumarol and fenprocoumon) and direct-acting or new oral anticoagulants (e.g. apixaban, dabigatran and rivaroxaban). * any family history of thrombosis * all co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis). * myocardial infarction within the last 3 years
stanford cardiac invasive electrophysiology novel computer experience

Conditions: Atrial Fibrillation; Atrial Tachycardia; Atrial Flutter; Arrhythmias, Cardiac

Summary: this study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.

patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (af) or atrial tachycardias (at) which may be reentrant or focal. each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. the research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.

Eligibility criteria:
inclusion criteria: * patients undergoing catheter ablation for atrial arrhythmias exclusion criteria: * inability to sign informed consent * expected survival \< 1 year * extreme comorbidity, such as advanced nyha class iii/iv heart failure, dialysis, series stroke.

Keywords: atrium, tachyarrhythmias
pain and hysteroscopy

Conditions: Hysteroscopy Surgery

Summary: the purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.


Eligibility criteria:
inclusion criteria: 1. adults 18 years of age and older 2. scheduled for in office hysteroscopy 3. able to consent for the study in english or spanish exclusion criteria: 1. persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions) 2. previous in-office hysteroscopy 3. hysteroscopy for foreign body/ intrauterine device (iud) removal 4. minors, prisoners, or other members of vulnerable populations 5. patients who cannot communicate in english or spanish
the efficacy and mechanisms of oral probiotics in preventing necrotizing enterocolitis

Conditions: Necrotizing Enterocolitis; Death

Summary: the purpose of this study is to investigate the efficacy and its mechanisms of oral mixture probiotics in preventing necrotizing enterocolitis among the preterm very low birth weight infants.

necrotizing enterocolitis (nec) remains the most catastrophic gastrointestinal emergencies in preterm very low birth weight (vlbw) infants.although study showed it is a multifactorial disease, its pathogenesis is still not yet unclear currently. prematurity and formula feeding is considered as the main risk factors.gut microbiota disturbance and immature immune system is associated with nec. a lot of studies had showed that oral probiotics can alter gut microbiota flora colonization and reduce the incidence of nec,but the exact mechanism remains unclear.the aim of this study is to elucidate the clinical efficacy and possible molecular mechanism of oral mixture probiotics in preventing nec among preterm vlbw infants. patient registry procedures: first,randomized numbers was generated by the computer and sent to the principal investigator(pi) at each center when an infant was eligible for enrollment.second, patient will be assigned randomly to experimental group or control group by pi.finally,the pi at each center will be responsible for the accuracy,completeness or representativeness of medical records, registry forms,data collection. sample size determination: the incidence of death and nec was around 20% recently.to reduce the incidence of nec and death to 10% at discharge would require a 50% improvement.at 80% power at p = 0.05 (two-sided),the loss rate of 0.2, this would require 135 subjects per arm. statistical analysis:the two groups were compared by a χ2-test for categorical variables,mann-whitney u test were used when reporting medians.a p value of \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * preterm infants ≦ 34 weeks gestational age and birth weight below 1500 gm and who survive to nicu are eligible for the trial. exclusion criteria: * severe asphyxia (stage iii), * fetal chromosomal anomalies, * cyanotic congenital heart disease, * congenital intestinal atresia, gastroschisis, omphalocele, active upper gastric intestinal bleeding, * lacking/refused of parental consent, * those who are fasted for \>3 weeks during the study period.

Keywords: probiotics preterm very low birth weight infants necrotizing enterocolitis gut microflora tlr nf-kb inflammatory factors
a phase ii clinical trial to evaluate hlx208 in advanced solid tumor patients with braf v600 mutation

Conditions: Solid Tumor

Summary: an open-label, multicenter phase ii clinical study to evaluate safety, efficacy and pk of hlx208 (braf v600e inhibitor) in advanced solid tumor with braf v600 mutation


Eligibility criteria:
inclusion criteria: * age\>=18y * good organ function * expected survival time ≥ 3 months * advanced solid tumors with braf v600 mutation that have been diagnosed * previous failure to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage. * ecog score 0-1; exclusion criteria: * previous treatment with braf inhibitors or mek inhibitors * symptomatic brain or meningeal metastases (unless the patient has beenon \> treatment for 6 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable) * a history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin * patient with non-small cell lung cancer, anaplastic thyroid cancer, malignant primary intracranial tumor, melanoma, colorectal cancer or hematological tumor（vulva and vaginal melanoma are excluded.） * severe active infections requiring systemic anti-infective therapy
paravertebral block versus thoracic epidural analgesia

Conditions: Lung Cancer; Postoperative Pain

Summary: thoracic epidural analgesia (tea) is the basic method of analgesia in patients undergoing pulmonary lobectomy. tea is considered to be a safe and thoroughly investigated method of pain relief that rarely causes serious complications. however, blocking the nerves as they emerge from the spinal column (paravertebral block, pvb) may represent an alternative method with some potential benefits. in this study, tea and pvb will be compared for patients undergoing pulmonary lobectomy by video assisted thoracoscopic surgery. the aim of the study is to test the hypothesis, that pvb is a time-saving procedure compared with tea on the day of surgery and that pvb is as efficient in postoperative pain reduction as tea.


Eligibility criteria:
inclusion criteria: patients with lung cancer in stage 1 or 2 who are accepted for vats-lobectomy exclusion criteria, preoperative: patients who do not wish to participate patients with: * suspicion of ingrowth in the thoracic wall. * marginal lung function. * kidney failure. * chronic pains and/ or daily use of opioids. * cognitive, visual and / or linguistic dysfunction. * allergies to drugs used in the paravertebral block or the thoracic epidural analgesia. exclusion criteria, per- and postoperative * conversion from vats to thoractomy. * unsuccessful admission of thoracic epidural analgesia * unsuccessful admission of paravertebral block * postoperative respiratory treatment * postoperative delirium patients who for various reasons are not able to self-report pain after surgery. patients who wish to withdraw from the study

Keywords: epidural analgesia pneumonectomy
health and nutrition status of chinese elderly

Conditions: Malnutrition; Sarcopenia

Summary: this study is aiming to understand the prevalence and risk factors related to malnutrition and sarcopenia in chinese elderly.

the study objective is to understand the prevalence of malnutrition and sarcopenia in chinese elderly with the cut-off points from the normal range of muscle mass and function in chinese adults; to understand the risk factors related to malnutrition and sarcopenia in chinese elderly; to set up a screening tool on malnutrition and sarcopenia risks in chinese elderly.

Eligibility criteria:
inclusion criteria: 1. male or female chinese ages \>= 60 years. 2. subject lives in the community for more than 12 months. 3. subject has voluntarily signed and dated an informed consent form, approved by an independent ethics committee/institutional review board (iec/irb) prior to any participation in the study. exclusion criteria: 1. subject who did/does heavy manual labor 2. subject who was a professional or semi-professional athlete or game player 3. subject who has physical disabilities such as loss of hand or foot or limbs or any other physical disability which may affect the muscle mass by the opinion of the study physician. 4. subject has an implanted electronic device or orthopedic metal implantations, such as pacemaker, cardiac defibrillator, subcutaneous injection pump, or metal hip, metal knee joint, metal fracture internal fixation, etc. 5. subject who has active hyperthyroidism or hypothyroidism and needs medication treatment as by self-report. 6. subject who has severe heart dysfunction or renal dysfunction with significant sodium water retention or edema by the opinion of study physicians. 7. subject who takes hormones except for external application of glucocorticoids. 8. subject who takes diuretics except for using a stable dose for at least 3 weeks as a part of hypertension treatment. 9. subject who has later stage of malignancies with cachexia by the opinion of study physicians. 10. subject has any other disease or situation who should not to participate in the study by the opinion of study physicians. 11. subject had hand/wrist or foot/leg surgery/injury within the past 3 months and the surgery/injury may affect the hand grip or gait speed test by study physician's opinion. 12. subject is too frail by study physician's opinion 13. subject is drug addicted or alcohol addicted 14. subject is participating in other clinical trials which are not approved by an
comparison of the effects of phenylephrine and norepinephrine on cardiac function during carotid artery surgery

Conditions: Vasopressor Agents; Endarterectomy, Carotid; Echocardiography, Transesophageal

Summary: this will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. the effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin i intraoperatively and postoperatively. we will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. we hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.


Eligibility criteria:
inclusion criteria: * elective carotid endarterectomy under general anesthesia * \> 18 years old * written informed consent exclusion criteria: * contraindication to general anesthesia * contraindication to transesophageal anesthesia * esophageal disease * esophageal stricture * history of esophageal or gastric bleeding * esophageal anatomic abnormality * past esophageal or gastric surgery * severe dysphagia

Keywords: vasopressor agents carotid endarterectomy cardiac function transesophageal echocardiography wall motion abnormalities
second stage:open-label study of therapeutic hepatitis b vaccine (mimogen-based) for chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the purpose is to evaluate efficacy and safety of therapeutic hbv vaccine (mimogen-based) treatment in chronic hepatitis b patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

second stage(76-144 weeks): in this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks) 1. subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εpa-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128. 2. subjects with both virological and serological response, will be followed-up to 144 weeks with no adefovir dipivoxil or εpa-44 900 μg treatment. the definition of response as below: 1. virological response: hbv dna\<2.93×10∧3iu/ml at 76 weeks; 2. serological response: serological conversion of hbeag at 76 weeks.

Eligibility criteria:
inclusion criteria: 1. the subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial 2. uses effective contraception for subject with child-bearing potential (including females and female partners of males) 3. understands and signs icf approved by ec 4. willing to comply with the study procedures and complete the study exclusion criteria: 1.any other factors inappropriate for enrollment in the study or study completion in the view of the investigator

Keywords: chronic hepatitis b hbeag positive therapeutic hbv vaccine hbv-specific cytotoxic t lymphocyte
a clinical trial to study the safety and efficacy of chandrakanthi choornam in patients with low sperm count

Conditions: Oligospermia

Summary: this is an open clinical trial to study the safety and efficacy of chandrakanthi choornam in 40 patients with oligospermia. chandrakanthi choornam is a formulation consisting of 25 ingredients. they are curculigo orchioides -rhizome, madhuca longifolia - flower, cinnamomum verum -bark,cinnamomum tamala-leaf, syzygium aromaticum - flower bud,coscinium fenestratum-stem bark,mesua ferrea-flower, maerua arenaria-tuber, adhatoda vasica- seed, moringa oleifera-seed, lawsonia inermis-seed, vitis vinifera- fruit, bombax ceiba- gum, bambusa aurundinaceae-salt,phoenix dactilifera- fruit,ilicium verum- flower, mucuna prurita-seed, cyperus rotundus- rhizome, glycyrrhiza glabra-root, tribulus terrestris-fruit, cuminum cyminum-seed,costus speciosus-root,myrsitica fragrans-seed, alternanthera sessilis-seed and asphaltum-mineral. treatment duration is three months.study is conducted in india (chennai). primary outcome measure is to see the changes in sperm count, motility and morphology. secondary outcome measure is to see the impact on the harmone level.

methodology of proposed research: i. preclinical study ii. clinical study i. preclinical study: standardization of the study drug 1. botanical identification 2. chemical identification 3. preparation of the study drugs: formulation: chandrakanthi choornam source : chikicharathna deepam part ii. pg-168 (approved sastric book as per drugs \& cosmetic act 1940. 4. chemical methods of testing 5. pharmacological study : a. spermotogenic activity 6. toxicological study : a. acute toxicity b. long term toxicity ii. clinical study conducted as per the guidelines of gcp accepted by ayush adapted from the ich. a. pilot study b. main study

Eligibility criteria:
inclusion criteria: * male infertile patients with age between 21-45 yrs * marriage history for \>1 year * abnormal sperm count 1-15 million/ml * patients with normal liver \& renal function test * willing to give specimen of semen before \& at the end of the clinical trial * informed patients giving written consent exclusion criteria: * azoospermia - complete absence of sperm cells in the ejaculate * aspermia - complete lack of semen * necrospermia- spermatozoa in semen are either immobile or dead. * clinical diagnosis of varicocele \& hydrocele * history of undescended testis * inguinal hernia on physical examination * male accessory gland infection * history of dm, hypertension and cardiac disease * any recent medical or surgical illness * underwent treatment for promoting spermatogenic fertility in last 3 months * other systemic disease requiring specific therapies * known thyroid disease * past history of renal, hepatic or any other chronic illness in the patient

Keywords: hypospermatogenesis, low sperm count, oligozoospermia