Kornimate/medical-research-clean huggingface dataset:
phenylephrine and noradrenaline for post spinal anesthesia hypotension

Conditions: Adverse Anesthesia Outcome

Summary: hypotension following spinal anesthesia for cesarean section is a serious problem. in this study we investigated the effect of the vasopressors phenylephrine and noradrenaline on postspinal hypotension.

on arrival to the operating room, an 18g cannula will be inserted and monitors will be applied (electrocardiography - pulse oximetry - non-invasive blood pressure monitor). patients will receive spinal anesthesia with 500 ml rapid crystalloid co-load. ten milligrams heavy bupivacaine in addition to 20 mcg fentanyl will be injected in l3-l4 or l4-l5 interspace using 25 g spinal needle in the sitting position. after spinal block, patients will be randomly allocated into one of two groups: * phenylephrine group (n=100) * norepinephrine group (n=100) patients who shows sbp above 140 mmhg or heart rate below 55 bpm after the first vasopressor dose will not receive the infusion. the infusion will stop if the sbp was above 140 mmhg or if the heart rate was below 55 bpm. patients will be positioned in the supine position with left lateral tilt. block success will be assessed using pinprick, patients with failed block will be excluded from the study. the highest sensory block level will be assessed after 5 minutes from intrathecal injection. co-hydration will be continued till maximum of 1.5 litres.

Eligibility criteria:
inclusion criteria: * full term singleton parturients * elective cesarean sections exclusion criteria: * cardiac morbidities * hypertensive disorders of pregnancy * peripartum bleeding * body mass index \> 35 will be excluded from the study
viome nutritional programs to improve clinical outcomes for mental health conditions

Conditions: Mental Health; Depression; Anxiety

Summary: us residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. participants who are enrolled complete a survey upon enrollment and are randomized into one of three arms. this study is direct to participant and will not utilize clinical sites.

participants who meet the eligibility criteria are randomized into any of the three arms including: the control arm, viome's condition-based supplements (vcs) arm or the viome precision nutrition program (vpnp) arm. placebo, viome-designed condition-based supplements and viome's precision nutrition program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. the trial will last approximately 4 months for each participant.

Eligibility criteria:
inclusion criteria: * resident of the united states * females and males ages 25-75 (inclusive) * able to speak and read english * no unexplained weight loss, fevers, anemia, or blood in stool * willing and able to follow the trial instructions, as described in the recruitment letter * signed and dated informed consent prior to any trial-specific procedures. * phq9 score of 5-24 (inclusive) exclusion criteria * unwilling to change their current diet * prior use of viome products or services * antibiotic use in the previous 4 weeks * pregnancy (current or planned in the next 4 months) * \< 90 days postpartum * breast feeding * active infection * unable or unwilling to use viome's app on an iphone or android smartphone * significant diet or lifestyle change in the previous 1 month * ibd diagnosis -major psychiatric/dsm-4 disease diagnosis (e.g. schizophrenia, bipolar disorder, post- traumatic stress disorder, obsessive compulsive disorder) * use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial * cancer therapy within the previous 1 year * major surgery in the last 6 months or planned in the next 4 months * allergies to any supplement ingredients listed in the screening survey * currently on a specific diet: fodmap, keto, paleo * answered yes to the question, "in the past few weeks, have you wished you were dead or had thoughts about killing yourself?" * gastrointestinal disease including: * gi surgery except: * appendectomy and benign polypectomy * esophagitis * celiac disease * gi malignancy or obstruction * peptic ulcer disease * duodenal or gastric ulcer disease

Keywords: mental health diet supplements vitamins stress
efficacy and safety of growth hormone treatment in spinal cord injury

Conditions: Spinal Cord Injury

Summary: objectives: to evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (gh) in patients with traumatic spinal cord injury. the first six months the pharmacological treatment will be associated to rehabilitation treatment. the main hypothesis is that gh can improve motor function of patients with traumatic spinal cord injury below the lesion level. the hypothesis is based on possible effects of gh at muscle and synaptic level. gh can also promote axonal growth and regeneration. design: clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design). duration of intervention and monitoring: 364 days. primary outcome measures. changes of the american spinal injury association (asia) scale (motor score)


Eligibility criteria:
inclusion criteria: * traumatic spinal cord injury * incomplete (asia scale b or c) * level of injury: between c4 and d12 * more than 18 months from the sci injury. exclusion criteria: * non traumatic spinal cord injury * complete sci (asia a) * incomplete (asia d or e) * less than 18 months from the sci * intensive care unit (icu) staying for a period of 2 months or more * more than 3 urological infections in the last year * pneumonia in the 6 months prior to the study * severe respiratory failure * history of head trauma * severe psychiatric disorder * a history of heart disease, diabetes or hypertension * concomitant neurological diseases * regular use of substances of abuse * patients with severe kidney and / or liver failure. * patients who can not be included in an intensive rehabilitation program * patients who are pregnant or breast-feeding * history of malignancy * impossibility to obtain informed consent

Keywords: spinal cord injury growth hormone trauma incomplete asia
severe proliferative diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to examine and compare, prospectively, best corrected visual acuity (bcva) outcomes and complications of a cohort of patients with proliferative diabetic retinopathy and tractional retinal detachment not involving macula undergoing pars plana vitrectomy (ppv) or conventional management (panretinal photocoagulation).

the utility and practice of panretinalphotocoagualtion (prp) in patients with high-risk proliferative diabetic retinopathy (pdr) have not changed since the etdrs reported guidelines in 1987. a meta-analysis of the drs and etdrs two large u.s. rct of laser therapy for pdr confirmed the effectiveness of prp (level i evidence). both trials had large sample sizes, excellent compliance and adequate follow-up. these studies established that prp reduces the risk of severe visual loss in patients with high-risk pdr by 50% to 60%20. with the arrival of the vitrectomy, this surgery was often used to treat eyes with severe complications from pdr. the most common indications for vitrectomy were nonclearing vitreous hemorrhage, tractional retinal detachment(trd) with macular involvement, and combined traction and rhegmatogenous retinal detachment. with the addition of new indications to the known indications vitrectomy has been performed in earlier stages(severe pdr). a large number of case series reports have assessed the effect of pars plana vitrectomy on diabetic trd with or without macular detachment but the level of evidence was low and they included patients not homogeneous. these studies have generally shown benefit, with improved vision seen in many patients (ranging from 22% to 65%) but they have also indicated a high rate of operative and postoperative complications. these numerous intra and post-operative complications could lead to satisfying anatomical results but poor vision.the purpose of this study is to examine and compare, prospectively, best corrected visual acuity (bcva) outcomes and complications of a cohort of patients with proliferative diabetic retinopathy and tractional retinal detachment not involving macula undergoing pars plana vitrectomy (ppv) or conventional management (panretinal photocoagulation)

Eligibility criteria:
inclusion criteria: * eyes with advanced proliferative diabetic retinopathy some with trd not involving the macula. the definition of severe pdr included eyes with extensive, active neovascular and fibrovascular proliferation graded using modified airlie house classification exclusion criteria: * eyes with fibrovascular tractional detachment involving the macula were excluded. eyes with a combined tractional and rhegmatogenous retinal detachment and eyes with a history of uveitis or trauma, with previous vitrectomy and neovascular glaucoma were also excluded.

Keywords: severe proliferative diabetic retinopathy vitrectomy panretinalphotocoagulation
prevalence, risk factors, and prognostic factors of intraabdominal hypertension and abdominal compartment syndrome in critically ill surgical patients in ramathibodi hospital

Conditions: Intraabdominal Hypertension; Abdominal Compartment Syndrome

Summary: to identified prevalence, risk factors, and prognostic factors of iah and acs in surgical critically ill patients in institutional hospital

every postoperative patients admitted to surgical icu who meet inclusion criteria will be asked for informed consent. after obtained, intraabdominal pressure (iap) will be measured through already placed foley's catheter simultaneously with patients's data record. if patients don't have iah or ics, iap will be measured daily until discharge from icu or removal of foley's catheter. if patients have iah or acs, iap will be measured every 6-8 hours until iap is less than 12 mmhg then it will be measures daily until discharge from icu or removal of foley's catheter. after completion of data collection, data will be analyzed accordingly.

Eligibility criteria:
inclusion criteria: * postoperative patient admitted to surgical icu * age \>/= 18 * foley's catheter in place exclusion criteria: * patient refusal * underwent neo-bladder procedure * need continuous bladder irrigation

Keywords: intraabdominal hypertension abdominal compartment syndrome prevalence risk factors icu surgical
effect of the use of specific oral hygiene devices on gingival health among patients with systemic sclerosis

Conditions: Scleroderma Systemic

Summary: systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. this condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life. the aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to "standard" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.


Eligibility criteria:
inclusion criteria: * adult male or female ≥ 18 years (18th birthday completed) * affiliation to a social welfare system * signed informed consent form * more than 12 natural teeth suitable for evaluation * systemic sclerosis with cutaneous involvement with a diagnosis based on american college of rheumatology (acr) and leroy and metzger criteria exclusion criteria: * localized scleroderma or systemic sclerosis without cutaneous involvement ("sine scleroderma" limited form) * less than 12 natural teeth suitable for evaluation and/or mandibular/maxillary complete denture(s) * other progressive chronic illness /autoimmune disease other than systemic sclerosis (e.g. diabetes) * another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region) * current use of sonic toothbrush and/or dental water flosser * severe manual handicap preventing the patient from holding a toothbrush with a large handle * oral antiseptics (e.g. chlorhexidin mouthwashes) * ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs) * smoking (≥ 10 cigarettes per day) * impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties) * individual under guardianship, curatorship or judicial protection
the effect of continuous versus enteral pump feeding in aspiration in tube fed patients

Conditions: Aspiration Pneumonia

Summary: background: tube feeding had been found to be a cause of aspiration pneumonia. continuous pump feeding at slower rates as compared to bolus feeding may be less associated with aspiration pneumonia. methods: randomized controlled trial subjects: patients expected to remain on tube feeding for 4 or more weeks outcomes: 1) pneumonia, 2) mortality

eligible subjects are randomized into 2 groups by random numbers generated by a computer programme: intermittent bolus feeding versus continuous feeding via a delivery pump. baseline assessment: clinical details including background medical diagnoses, indications for enteral feeding, functional status and baseline cxr findings are recorded. tube feeding regime: the choice of feeding formula and feeding volume will be guided by 2 dietitians collaborating in this study. giving sets for continuous pump feeding are changed everyday. pump feeding is defined at delivery rate \<60ml/hr. in order to avoid interfering with rehabilitative activities, pump feeding can be discontinued for no more than eight hours during the day. bolus feeding is defined as no more than 400ml/hr, 4 to 5 times per day. all subjects are reviewed to monitor complications arising from enteral feeding. free pump feeding sets will be provided for an extra 2 weeks for pump feeding group subjects discharged before the end of the trial. all subjects discharged prior to the end of trial will be contacted regularly by a research assistant until completion or outcome is reached. outcome pneumonia is diagnosed in the presence of 2 major clinical signs: increased sputum production and pneumonic changes in the cxr (according to radiologist report), or in the presence of one major sign and 2 of the following minor clinical signs: raised or depressed white cell count, hypoxia at room air (pao2 \<92%) and body temperature greater than 38%. when the criteria for pneumonia are fulfilled, the trial will be terminated. all the subjects are followed up for four weeks or until outcome is reached (i.e. pneumonia). mode of tube feeding on discharge will be decided by the attending physicians, patients and family members.

Eligibility criteria:
inclusion criteria: * patients likely to need tube feeding for another 4 weeks exclusion criteria: * patients already on pump feeding. * active sepsis: fever, abnormal white cell count * cxr shadowing * chronic hypoxia (o2 saturation \<92% on room air) * patients who have a history of recurrent self-extubation. * short life expectancy (within weeks)
pemetrexed and cisplatin as treatment in small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to determine if cisplatin and pemetrexed are effective in the treatment of patients with small cell lung cancer, extended disease.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of small cell lung cancer (sclc). * functional stage from 0 to 2 of the ecog functional scale * no previous systemic chemotherapy, immunotherapy or biologic therapy for sclc. * previous bone marrow radiotherapy less than 25% is allowed. * there must be at least one measurable lesion that complies with the solid tumor response evaluation criteria. * appropriate organic function. * life expectancy estimated at 12 weeks minimum. * females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment. * the patient must be compliant and located close to the trial area for appropriate follow-up. * the patient or his/her legal representative must sign an informed consent document. * patients must be at least 18 years of age. exclusion criteria: * having received treatment for the last 30 days with a drug that has not obtained regulatory approval. * having participated in a previous pemetrexed trial. * mixed histologic diagnosis of sclc and nsclc. * concurrent illness. * having an active infection. * severe cardiac disease. * having received recently or concurrently a vaccine against yellow fever. * having suffered a previous malignant process other than sclc. * central nervous system (cns) metastases require concurrent corticoid therapy. treated and stable cns metastases are allowed. * clinically relevant fluid accumulation in the third space. * significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion. * concurrent administration of any other anti-tumor treatment. * severe renal failure. * unable to discontinue administration of non-steroidal anti-inflammatory (nsaids) agents. * inability or unwillingness to take folic acid and vitamin b12 supplements. * inability to take corticoids.
gene therapy follow-up protocol for people previously enrolled in car-t cell studies

Conditions: Lyphoma, B-Cell; Leukemia, B-cell; Multiple Myeloma; Hematologic Malignancies

Summary: background: - gene therapy is a way to treat or prevent disease using genes. it is monitored very closely by regulators because there can be long-term, unexpected side effects. nih is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. this is to see if they have had any bad side effects. this trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the nci surgery branch who are no longer enrolled on their original gene therapy clinical trial. objective: - to collect of long-term follow-up data on people who have been in gene transfer studies. this follow-up is required by regulators. eligibility: - people age 18 and older who have been in a previous nci surgery branch gene therapy research study. design: * after they get the genetically modified cells, participants will: * have blood drawn 3, 6, and 12 months later. * have an annual clinic visit for the next 4 years. they will have a physical exam. they will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. blood may be drawn. * be called or emailed annually for the next 10 years. they will answer health questions. blood samples may need to be taken. * participants will be asked for their current address and phone number. they will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. one of these should be a family member if possible, * at the time of the participant s death, researchers will request permission from their family for an autopsy.

background: -the national cancer institute surgery branch (nci-sb) branch investigator conducts clinical trials utilizing gene transfer. the current u.s. food and drug administration (fda) requirements for long term follow up may be up to fifteen years for some products. as this time period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow up of these subjects objectives: -to facilitate collection of long term, follow up information on subjects who have participated in gene transfer studies as required by the u.s. food and drug administration and other regulatory groups eligibility: -enrollment on a car t-cell treatment protocol for gene therapy. design: -patients will undergo physical exams; laboratory evaluation or phone follow up as required by the treatment protocol and/or as clinically indicated.

Eligibility criteria:
* inclusion criteria: * subjects who have received treatment on a car t-cell gene therapy protocol. age \>= 18 years as children are generally excluded from car t-cell gene therapy studies.

Keywords: recombinant dna product laboratory evaluation nih office of biotechnology activities gamma-retroviral vectors natural history
a comparison study of uhe-103 cream in subjects with moccasin type tinea pedis

Conditions: Tinea Pedis

Summary: the study is being done to determine and compare the safety and effectiveness of an investigational combination therapy (low and high concentrations) versus mono-therapy (low and high concentrations) or mono-therapy (fixed concentration) in subjects with moccasin type tinea pedis.

uhe-103 cream is an investigational combination drug to treat moccasin type tinea pedis, a fungal infection that affects the feet and toes. eligible subjects will be assigned to one of the 5 possible treatment groups and participate for a total of 6 weeks. subjects will apply their assigned test drug twice daily for 2 weeks. each subject will then be assessed for safety and efficacy at week 4 and week 6. there will be a total of 5 clinic visits: 1 screening/baseline visit (day 1), 2 treatment visits (days 8 and 15), and 2 follow-up visits (days 29 and 43).

Eligibility criteria:
inclusion criteria: * male or non-pregnant female, 16 years of age or older. * clinical diagnosis of moccasin type tinea pedis * microscopic evidence (positive koh) of the presence of fungi * provided written informed consent/assent * in general good health exclusion criteria: * pregnant or lactating or planning to get pregnant while on the study * has concurrent tinea infection (e.g., tinea versicolor, tinea cruris) * other skin disease which might interfere with the evaluation of tinea pedis * history of diabetes mellitus or is immunocompromised * currently enrolled in an investigational drug or device study * used an investigational drug or investigational device treatment within 30 days prior to visit 1 (study day 1)/baseline other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
the temporo-spatial dynamics of genital tract microbiota - an observational study in oocyte donors

Conditions: Bacterial Vaginoses

Summary: the investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. the endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. these results will be compared to equivalent samples of ivf patients.


Eligibility criteria:
inclusion criteria: oocyte donors meeting local criteria for donation. written informed consent. regular cycle exclusion criteria: antibiotics within 1 month vaginal products other than for menstrual hygiene within 1 month uterine malformations(septum, polyps, adenomyosis, fibroids) hiv, hepatitis b or c positivity. hpv cin 2 or higher. chlamydia trachomatis positivity. any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)