Kornimate/medical-research-clean huggingface dataset:
study of aro-hsd in healthy volunteers and patients with non-alcoholic steatohepatitis (nash) or suspected nash

Conditions: Non-alcoholic Steatohepatitis

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics of single and multiple doses of aro-hsd in healthy adult volunteers and in patients with nash or suspected nash.


Eligibility criteria:
inclusion criteria: * women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * on a stable diet for at least 4 weeks with no plans to significantly alter diet or weight over course of study * normal electrocardiogram (ecg) at screening * no abnormal finding of clinical relevance (other than nash, suspected nash in patients) at screening that could adversely impact subject safety during the study or adversely impact study results. exclusion criteria: * clinically significant health concerns (other than nash, suspected nash in patients) * human immunodeficiency virus (hiv) infection, seropositive for hepatitis b virus (hbv), seropositive for hepatitis c virus (hcv) * uncontrolled hypertension * excessive use of alcohol within three months prior to screening * use of illicit drugs within 1 year prior to screening, or positive urine drug screen at screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study note: additional inclusion/exclusion criteria may apply, per protocol - -
investigation into optimal fes training characteristics after spinal cord injury

Conditions: Spinal Cord Injury

Summary: the aim of this study is to investigate two different modalities of functional electrical stimulation (fes) leg exercise in patients with spinal cord injury (sci). the primary outcomes being compared are 1. fes-induced leg aerobic fitness, and 2. fes-induced leg strength. there will be two fes-leg training groups, and sub-acute patients with sci will be randomised between the groups - high-short \[hi-short\] and low-long \[lo-long\]. both groups (n=10 per group) will exercise on the hasomed rehastim™ exercise ergometer for 6-8 weeks, three-four times per week (24 therapy sessions). \[hi-short\] will perform 10 x 2-min of high-intensity interval training with a recovery of 1-2 min between exercise bouts. \[lo-long\] will perform 20+ min of continuous exercise at a low-moderate exercise intensity. exercise intensity for \[hi-short\] and \[lo-long\] will be titrated by neuromuscular stimulation characteristics. the primary outcomes will be assessed before training commences and after 6-8 weeks of training has been completed.


Eligibility criteria:
inclusion criteria: * greater than 6-weeks post-trauma after sci. * traumatic and atraumatic spinal cord injuries between c7 and t10 * participants diagnosed with "motor complete' spinal cord injury american spinal injury association impairment scale a and b. * age between 18-75 years old. * both male and female. * have at least 90º bilateral knee flexion. * able to perform fes muscle contractions (not fes intolerant). * able to follow verbal instructions. exclusion criteria: * a recent history of trauma to the lower limb. * severe or infected pressure sore on weight-bearing skin areas. * illness caused by acute urinary tract infection. * uncontrolled spasticity or pain. * history of cardiovascular / cardiorespiratory disease contraindicating exercise. * uncontrolled orthostatic hypotension. * unhealed decubiti at electrode placement area. * recurrent and uncontrolled autonomic dysreflexia. * active heterotopic ossification. * other peripheral or central neurologic injury.

Keywords: functional electrical stimulation exercise training aerobic fitness muscle strength
antidepressant treatment for premenstrual syndrome and premenstrual dysphoric disorder

Conditions: Premenstrual Syndrome

Summary: this study will determine whether characteristics of women with premenstrual syndrome influence response to treatment with serotonin reuptake inhibitors and whether sris can alleviate premenstrual symptoms.

moderate to severe premenstrual disturbances afflict up to 20 percent of women. studies have shown the use of serotonin reuptake inhibitors (sris) during the luteal phase of the menstrual cycle to be effective in improving symptoms in women with premenstrual dysphoric disorder (pmdd). unfortunately, sri treatment has only been evaluated in controlled clinical trials, and evidence suggests that patients in these clinical trials are not representative of women commonly seen in clinical practice. thus, the real-world feasibility of intermittent dosing is questionable. patients in this study receive sertraline (zoloft) during the luteal phase of their menstrual cycle every month for 6 months. the dose may be modified based on structured interviews with the patients. assessments include questionnaires and interviews which take place at study start, at midpoint, and at the end of the study.

Eligibility criteria:
inclusion criteria: * dsm-iv criteria for premenstrual syndrome (pms) or premenstrual dysphoric disorder (pmdd) * for a diagnosis of pms but not pmdd, patients must have 3 to 4 symptoms, complain of functional impairment as a result of their symptoms, and identify symptoms as problematic enough to warrant treatment * symptoms of pms/pmdd in at least 9 of 12 menstrual cycles during the year prior to screening * symptom-free during the follicular phase and impairment during the luteal phase * regular menstrual cycles * adequate methods of birth control exclusion criteria: * major depression, bipolar disorder, or psychotic disorders * hepatitis or hepatic failure * amenorrhea, oligomenorrhea, blood dyscrasias, or illnesses for which monoamine oxidase inhibitors must be prescribed * follicular phase symptoms consistent with a diagnosis of major depression, bipolar disorder, or psychotic disorders * co-existing condition that renders the patient unsuitable for the study * risk of suicide * antidepressants or other psychotropic medication * hypersensitivity or adverse reaction to sertraline * pregnancy, breast-feeding, or plans to become pregnant during the course of the study * depot hormonal preparation or any other medication that would lead to lack of menses or markedly irregular menses
a pilot efficacy evaluation of bli-801 as a laxative in constipated adults

Conditions: Constipation

Summary: to compare the safety and efficacy of bli-801 administered at 4 dose levels in constipated adults.


Eligibility criteria:
inclusion criteria: * male or female subjects at least 18 years of age * constipated according to rome i criteria * otherwise in good health, as determined by physical exam and medical history * if female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, iud, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse) * negative urine pregnancy test at screening, if applicable * in the investigator's judgment, subject is mentally competent to provide informed consent to participate in the study exclusion criteria: * subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon * subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study * subjects who are pregnant or lactating, or intending to become pregnant during the study * subjects of childbearing potential who refuse a pregnancy test * subjects who are allergic to any bli-801 component. * subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures * subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days

Keywords: constipation laxative
genetics of differences of sex development and hypospadias

Conditions: Disorders of Sex Development; Hypospadias

Summary: this study seeks to identify genetic causes of conditions that affect the gonads and genitals, and to study the impact on families of receiving genetic results.

this study seeks to understand the genetic causes of conditions that affect the development of the genitals, such as differences of sex development (dsd) and hypospadias, and the impact on families of receiving genetic results. the investigators are recruiting individuals with dsd and/or hypospadias without a clear genetic cause along with their family members for our research study. the investigators will collect samples for genetic studies. the investigators will review the clinical record for history, labs and physical exam information. the investigators will return results of genetic testing to parents/guardians of children with dsd/hypospadias and have them complete questionnaires to assess the impact of receiving these results.

Eligibility criteria:
inclusion criteria: * genital or gonadal abnormalities as evidenced by physical examination or imaging (including but not limited to hypospadias, microphallus, clitoromegaly, ambiguous genitalia), with no cause identified by standard clinical evaluation exclusion criteria: * inability to provide informed consent

Keywords: exome sequencing
the impact of sage extract on gts b and d gene expression in s. mutans

Conditions: Caries,Dental; Dental Caries; Dental Diseases

Summary: glucosyltransferases (gtfs) play a crucial role in the pathogenesis of dental caries caused by streptococcus mutans. gtfs is recognized as an attractive target for effective therapeutic interventions aimed at inhibiting cariogenic biofilms. objective: this study evaluates the antibacterial effects of sage extract compared to chlorhexidine mouthwashes on the expression of gtf genes in s. mutans from salivary samples of high caries risk patients over a one-month follow-up, utilizing real-time polymerase chain reaction. methodology: this clinical trial involves 42 participants with a high risk for caries, who are randomly divided into two groups of 21 subjects each.

glucosyltransferases (gtfs) are essential in the development of dental caries caused by streptococcus mutans. they are currently recognized as promising targets for effective therapeutic strategies aimed at disrupting cariogenic biofilms. objective: this study investigates the antibacterial effects of sage extract in comparison to chlorhexidine mouthwashes on the expression of gtf genes in s. mutans from the saliva of patients at high risk for caries, over a one-month follow-up period, using real-time polymerase chain reaction. methodology: this clinical trial includes 42 high caries risk participants, who are randomly assigned to two groups, each consisting of 21 subjects.

Eligibility criteria:
inclusion criteria: * medically free, high caries patient with dmft exclusion criteria: * pregnant and smokers

Keywords: high caries risk chlorohexidine real-time pcr
a dose escalation and expansion study of tac-001 in patients with select advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: incline-101 is an open label, multicenter phase 1/2 study designed to evaluate safety, pharmacokinetics (pk), and preliminary anti-tumor activity of tac-001 administered intravenously.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically-documented solid tumors. 2. eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. 3. demonstrate adequate organ function. exclusion criteria: 1. prior history of or active malignant disease other than that being treated in this study. 2. known brain metastases or cranial epidural disease. 3. a known hypersensitivity to the components of the study therapy or its' analogs.
effect of calcium/vitamin d supplementation on body weight and fat loss.

Conditions: Obesity; Overweight

Summary: the aim of this study was to assess the effect of calcium/vitamin d supplementation (caltrate 600 +d®) on body weight loss during a weight-reducing program

the effect of a calcium supplementation on body weight loss is inconclusive and some studies have suggested that adequate calcium intake can have a favourable effect on some metabolic variables. the objectives of this study were to evaluate the impact of (caltrate 600 + d ®) on body composition and various indicators of metabolic health in overweight and obese females characterised by a usual low daily calcium intake, on a weight-reducing program. the main hypotheses of this study were: * caltrate 600 +d® increases body weight and fat mass losses of individuals on a weight-reducing program. * caltrate 600 +d® improves the metabolic profile of these subjects, independently of variations promoted by body fat loss.

Eligibility criteria:
inclusion criteria: * daily calcium intake below 800mg/day * stable body weight * body mass index (bmi) between 27-40kg/m2 * less than 3 periods of 20 minutes of physical exercise/week * general good health * normal blood pressure values * normal cholesterol levels * normal thyroid hormone levels * no participation in another clinical trial within 6 months of screening * coffee consumption ≤ 5 cups/day. exclusion criteria: * breast feeding, pregnant or menopaused women * use of calcium supplements within 30 days of screening * cholesterol levels requiring pharmaceutical treatment * smoking * use of medication that could affect body weight

Keywords: caltrate lipoproteins glucose insulin blood pressure body fat body weight women diet macronutrients
lys228 pk, clinical response, safety and tolerability in patients with complicated intra-abdominal infection (ciai)

Conditions: Intra-abdominal Infections

Summary: the purpose of the study was to evaluate whether lys228 can be developed for the treatment of complicated intra-abdominal infections. it was planned that lys228 exposure across patients with varying renal function would be evaluated during the study to confirm that lys228 concentrations are predicted to be adequate to treat the patient population. it was planned that the pk exposure of the initial 8 patients would be analyzed. pk analysis was not conducted as per protocol the first analysis required 8 patients.


Eligibility criteria:
inclusion criteria: * male and female patients 18 to 85 years of age with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis including at least one inclusionary diagnosis during surgical intervention. exclusion criteria * any of the excluded diagnoses: abdominal wall abscess, small bowel obstruction, traumatic bowel perforation undergoing surgery within 12 hours, perforation of gastroduodenal ulcer with surgery within 24 hours, an intra-abdominal process that is not likely caused by infection. * pre-operative treatment of any duration with non-study drug systemic antibiotic therapy for peritonitis or abscess is not allowed unless certain criteria are met. * concomitant bacterial infection at time of enrollment requiring non-study drug antibiotics and that may interfere with the evaluation of clinical response to the study antibiotic. * known non-abdominal source of infection, including endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to enrollment. * patient has an acute physiology and chronic health evaluation ii (apache ii) score \> 30 or is considered, in the judgement of the investigator, unlikely to survive 4 weeks (e.g. rapidly progressive terminal illness, including septic shock). * patients that meet sepsis criteria as defined by the quick sequential sepsis-related organ failure assessment (qsofa). * women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 7 days after stopping study treatment.

Keywords: intra-abdominal infection lys228 beta-lactam antibiotics creatinine clearance enterobacteriaceae
efficacy study of fk-506 and cyclosporine in vernal keratoconjunctivits (vkc)

Conditions: Keratoconjunctivitis, Vernal

Summary: the study was a double-blind, parallel study to compare efficacy of 0.1% tacrolimus ophthalmic ointment vs 2% cyclosporine eye drops in children with vernal keratoconjunctivitis. the duration of the blinded period was 8 weeks followed with 4 weeks of open-period of tacrolimus ointment. the hypothesis was that tacrolimus was as effective as cyclosporine for the treatment of this condition.

background: vernal keratoconjunctivitis (vkc) is a serious, sight-threatening ocular disease, occurring mainly in children. prolonged use of ophthalmic corticosteroids is usually required in severe cases which could lead to serious complications such as glaucoma and cataract. cyclosporine and tacrolimus are among newer treatments for vkc. objective: to compare the efficacy of 0.1% tacrolimus (fk-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of vkc. methods: twenty-four patients with vkc were recruited. after a 2 week-washout period, they were randomized into 2 groups in a double-blinded, parallel fashion. the first group received 0.1% fk-506 eye ointment with placebo eye drops and the second group received 2% cyclosporine eye drops with placebo ointment for 8 weeks. thereafter, all patients received an open-treatment with 0.1% fk-506 eye ointment for another 4 weeks. subjective ocular symptoms and side effects were scored by patients at the entry, and at the end of the 1st, 4th, 8th and 12th weeks. objective ocular signs were evaluated by an ophthalmologist (pk) at all follow up visits.

Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of vernal keratoconjunctivitis exclusion criteria: * coexisting ocular diseases such as glaucoma, other corneal disease, ocular infections, other coexisting systemic diseases

Keywords: vernal keratoconjunctivitis fk-506 tacrolimus cyclosporine children
double-masked study of pg324 ophthalmic solution in patients with open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: to evaluate ocular hypotensive efficacy and safety of pg324 ophthalmic solution compared to netarsudil (ar-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older (19 years of age or older in canada) 2. diagnosis of open angle glaucoma (oag) or ocular hypertension(oht) in both eyes 3. unmedicated intraocular pressure \>20mmhg and \<36mmhg in both eyes at 2 qualification visits 4. best corrected visual acuity (bcva) equivalent to 20/200 snellen or better 5. able to give informed consent and follow study instructions exclusion criteria: ophthalmic: 1. clinically significant ocular disease 2. pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles 3. unmedicated intraocular pressure ≥36mmhg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening 4. known hypersensitivity to any component of the formulation or latanoprost 5. previous glaucoma surgery or refractive surgery 6. ocular trauma within 6 months prior to screening 7. any ocular surgery or non-refractive laser treatment within 3 months prior to screening 8. recent or current ocular infection or inflammation in either eye 9. use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study 10. mean central corneal thickness \>620µm at screening in either eye 11. any abnormality preventing reliable applanation tonometry of either eye systemic: 12. clinically significant abnormalities in lab tests at screening 13. clinically significant systemic disease 14. participation in any investigational study within 60 days prior to screening 15. systemic medication that could have had a substantial effect on iop within 30 days prior to screening, or anticipated to be used during the study 16. women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
hephospital: a hepatology home hospital intervention for patients with advanced liver disease

Conditions: Cirrhosis; End Stage Liver DIsease; Liver Cirrhosis; Liver Disease Chronic

Summary: this research study is evaluating a program that entails home-based care for people with advanced liver disease.


Eligibility criteria:
inclusion criteria: 1. adult patients ≥ 18 years old with a diagnosis of cirrhosis based on histology, radiology, and/or elastography 2. admitted for symptomatic ascites 3. receiving their outpatient hepatology and/or primary care at mgh 4. hemodynamically stable during the first 24 hours of hospital admission 5. must have telephone or internet/wifi access 6. residing within the designated geographic area for mgh home hospital service exclusion criteria: 1. have \> grade 1 hepatic encephalopathy 2. the presence of asterixis 3. have a current diagnosis of hepatic encephalopathy on medical therapy and do not have a caregiver at home 4. have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent 5. are admitted to the intensive care unit 6. have refractory ascites or are on dialysis 7. current admission for acute portal vein thrombosis, gi bleeding, or alcohol-related hepatitis 8. have a history of solid organ transplantation of any organ 9. reside within a long-term care or rehabilitation facility 10. undomiciled 11. in police custody 12. require more than the assistance of one person to reach a bedside commode 13. require routine administration of controlled substances 14. those deemed ineligible based on the mgh home hospital, inpatient medicine or hepatology clinician evaluation
long-term follow-up of incisional hernia repaired with intraperitoneal mesh

Conditions: Incisional Hernia

Summary: the intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. however no studies have convincingly proven that this approach is better than the on-lay repair. the authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.


Eligibility criteria:
inclusion criteria: * patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2) * first repair * older than 35 years of age and younger than 75 years of age * both genders * any bmi * only upper abdominal midline incisional hernias (supraumbilical) * patients submitted only to elective repair exclusion criteria: * recurrent incisional hernia * emergency surgery * hernias with a diameter higher than 5 cm or more than 25 cm2 of area * lower midline abdominal incisional hernias * other hernias rather than midline incisional hernias * non-incisional hernias

Keywords: incisional hernia intraperitoneal mesh repair on-lay repair prosthetic mesh first repair (no recurrent hernia will be included) recurrence complications