Kornimate/medical-research-clean huggingface dataset:
a study of sc-006 and in combination with abbv-181 in subjects with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: this is a multicenter, open-label, phase 1 study of sc-006 given as a single agent and in combination with abbv-181 in participants with advanced colorectal cancer (crc), and consists of part a (single agent sc-006 dose regimen finding), followed by part b (single agent sc-006 dose expansion), and part c (sc-006 and abbv-181 combination escalation and expansion). part a (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (mtd) and/or recommended part b dose and schedule. part b (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the mtd determined in part a. part c is dose escalation of sc-006 and fixed dose of abbv-181 in combination. recommended dose cohort of sc-006 with abbv-181 will be expanded.


Eligibility criteria:
inclusion criteria: * participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (crc) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting. * participants with an eastern cooperative oncology group (ecog) of 0 - 1. * participants with adequate hematologic, hepatic, and renal function. exclusion criteria: * participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug. additional exclusion criteria for the sc-006 and abbv-181 combination treatment regimen: * history of inflammatory bowel disease * active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism * history of primary immunodeficiency, allogenic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis * history of immune-mediated pneumonitis * current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment

Keywords: advanced colorectal cancer cancer metastatic colorectal cancer unresectable colorectal cancer maximum tolerated dose pharmacokinetics
prenatal carrier screening for spinal muscular atrophy among thai pregnant women

Conditions: Spinal Muscular Atrophy

Summary: spinal muscular atrophy (sma) prenatal carrier screening is recommended by american college of medical genetics (acmg) and american college of obstetrics and gynecology (acog). however, in thailand, there are no standard protocol for sma prenatal carrier screening.

spinal muscular atrophy (sma) is one of the most common neuromuscular autosomal recessive disorders. the incidence is about 1:10,000 livebirths. there are 5 subgroups base on onset of symptoms and clinical severity. type 1 is the most severe type which age of onset is 6 months old and life expectancy is less than 1-2 years. sma carrier frequency is approximately 1/40-1/60. molecular genetic testing to detect copies number of smn1 gene is possible with as high as 95% detection rate. since 2008, american college of medical genetics (acmg) and american college of obstetrics and gynecology (acog) recommended sma preconceptional and prenatal carrier screening in general population. in thailand, there are no standard protocol for sma prenatal carrier screening.

Eligibility criteria:
inclusion criteria: * maternal age \> 18 years * singleton pregnancy * gestational age ≤ 14 weeks exclusion criteria: * refuse to participate the research trial

Keywords: spinal muscular atrophy prenatal screening
hygirelief procedure and hygisample evaluation for functional constipation

Conditions: Rome IV Functional Constipation

Summary: this study has a single center, prospective, open label design. the population will include patients diagnosed with rome iv functional constipation who are at the time of study enrollment being managed with a stable dose of linzess. they will stop taking their linzess, undergo monitoring of bowel habits for 2 weeks, have a hygirelief procedure and then undergo an additional 2 weeks of bowel habit monitoring.

after undergoing a 5-7 day linzess washout period, patients will record their bowel habits in a daily diary for 2 weeks. patients will have the hygirelief procedure with a hygisample evaluation, then they will record their bowel habits in a daily diary for 2 weeks following the hygirelief procedure. hygisamples (stool samples) will be collected throughout the hygirelief procedure and the samples will be sent for microbiome evaluation. patients will complete multiple questionnaires - happiness scale, hospital anxiety and depression scale (hads), and a personal assessment which includes the constipation symptom score and adverse event screening. these will be completed at baseline, after the 2 week pre-hygirelief period, and after the 2 week post-hygirelief period.

Eligibility criteria:
inclusion criteria: 1. patient's age is between 18 and 80 years old 2. patient diagnosed with rome iv functional constipation (attachment c2) 3. patient is currently managed with linzess and willing to stop taking it for study duration exclusion criteria: 1. patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation) 2. patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study 3. patient has any of the contraindications listed below: 1. cardiac: congestive heart failure (nyha class iii or iv or ef \<50%) 2. gi: intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon, rectal, or abdominal surgery 3. gu: renal insufficiency (cc \< 60 ml/min/173m2), cirrhosis with ascites 4. abdominal surgery within the last 6 months 5. pregnancy 4. patient took antibiotics within two months of starting the study
effects of qigong sensory training on sensory modulation and behavior in children with autism

Conditions: Autism

Summary: autism spectrum disorder (asd) is a complex neurodevelopmental condition characterized by challenges in social interaction, communication, and a range of repetitive behaviors. among these challenges, sensory processing abnormalities are highly prevalent, manifesting as hyper- or hypo-sensitivity to sensory stimuli, and can significantly impact daily functioning and quality of life. in sensory modulation there are difficulties in regulating and responding appropriately to sensory input from the environment. sensory modulation can have a significant impact on the daily lives of individuals with autism, affecting their ability to engage in various activities and navigate social interactions. autistic children also have repetitive behaviors, such as repetitive actions like self-stimulation behavior, or stimming. these behaviors can involve one part of the body, the entire body or an object. qst in which deep pressure with thumb apply on head, neck, trunk and limbs along deep breathing which give relaxation to body and have effect on sensory modulation and behavior in children with autism. the intended project aims to evaluate the sensory modulation and behavior in children with autism spectrum disorder (asd) through qigong sensory training (qst). a quasi-experimental study will be conduct to evaluate the effect of qst on the sensory modulation and behavior of autistic children. 21 participants will be included in the study with age of 4-12 years diagnosed with asd. participants will be received 15 mints massage therapy 2 times in a day and 5 days a week for 8 weeks. before and after 8 week of intervention, assessment of sensory modulation scale (asms) will be used to check the sensory modulation level and strength and difficulties questionnaire (sdq) will be used to check the behavior. data will be collected from nishtar hospital multan. the pre and post intervention assessments will be done. the reliability and validity of tools are mentioned. the duration of study will be 10-months. data will be analyzed with the help of spss 25.


Eligibility criteria:
inclusion criteria: * children aged 4 to12 years diagnosed with autism spectrum disorder. * male and female will be included in study. * parental/guardian consent to participate in the study. * children do not receive any other intervention therapy during study exclusion criteria: * children with severe physical disabilities that significantly impair their ability to participate in touch-based interventions, as determined by a qualified healthcare provider. * children diagnosed with severe psychiatric conditions other than autism spectrum disorder (asd), including but not limited to schizophrenia, bipolar disorder, and severe anxiety disorders.

Keywords: qigong sensory training autism sensory modulation strength behavior
tacrolimus toothpaste for management of oral chronic graft vs. host disease (cgvhd)

Conditions: Chronic Graft Versus Host Disease Oral

Summary: this study aims to investigate the use of a novel formulation of tacrolimus, as a toothpaste, in a population of patients with oral chronic graft vs. host disease (cgvhd) as an adjunctive therapy in addition to standard-of-care systemic therapy. the investigators plan to summarize our findings to add to the current body of literature regarding managing cgvhd, specifically those with oral involvement. additionally, establishing effective topical application of tacrolimus in the oral cavity will allow for future prospective studies comparing outcomes for these patients with a more traditional standard of care.


Eligibility criteria:
inclusion criteria: * patients with oral chronic graft vs. host disease (cgvhd) * stable immune suppression within two weeks of enrollment * ages \> 1 year and \< 40 years exclusion criteria: * clinically confirmed or suspected herpes simplex virus (hsv) stomatitis * a recent (within 2 weeks of enrollment) escalation in immune suppression or change in systemic immune suppression of ongoing chronic graft vs. host disease (cgvhd)
minimal inflation tourniquet pressure using induced hypotension

Conditions: Vascular Diseases

Summary: limb occlusion pressure (lop) and arterial occlusion pressure (aop) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. lop can be determined manually or automatically by slow cuff inflation until disapper of pulsation with doppler flow-meter or pulse oximeter

the advantages of the tourniquet during upper or lower limb procedures are providing bloodless operative field and so less intra-operative blood lossit has been reported that using the lowest effective inflation pressure minimize tourniquet induced nerve injury .). limb occlusion pressure (lop) and arterial occlusion pressure (aop) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. lop can be determined manually or automatically by slow cuff inflation until disapper of pulsation with doppler flowmeter or pulse oximeter .aop can be estimated by a formula (aop = \[sbp + 10\]/ktp) using patient's systolic blood pressure (sbp) and tissue padding coefficient (ktp) values. in both methods, addition of a safety margin to lop or aop is recommended for potential hemodynamic fluctuations during surgery

Eligibility criteria:
inclusion criteria: * • asa physical status i and ii. * male and female patient * age group 20-50 years old exclusion criteria: * • patient who refuse to participate in the study * patients with contraindication of using the tourniquet (e.g. peripheral vascular disease or coronary artery disease sickle cell anemia neuromuscular disorders,) * contraindications of using induced hypotensive anesthesia (cerebrovascular disease, impaired kidney function , chronic liver disease, pregnancy). * patients on medications inﬂuencing blood ﬂow such as nitrogycerine * surgery extends more than 90 minutes. * hypertensive patients
duration of analgesic effect for ultrasound guided supraclavicular blocks with the addition of buprenorphine to local anesthetic solution

Conditions: Regional Block for Pain Control; Supraclavicular Block; Ultrasound Guided Block; Block Additive

Summary: the patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. a flip of the coin will decide who gets and additive called buprenorphine in their block or not. they will both contain the same amount and type of numbing medicine. the goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status 1-3 2. age 18-79, inclusive 3. bmi \<36 kg/m\^2 4. patient consenting to single injection brachial plexus nerve block as primary anesthetic for a procedure exclusion criteria: 1. patients with coagulation disorders 2. clinically significant pulmonary disease 3. clinically significant cardiac disease 4. neurologic deficit in surgical extremity 5. allergy to bupivacaine or buprenorphine 6. intolerance of narcotics 7. local infection over intended area of needle insertion 8. hepatic failure or renal failure 9. significant psychiatric disease, including drug abuse 10. seizure disorder 11. possible pregnancy or lactation by patient report 12. use of narcotic medication greater than 2 times a week for greater than 1 week. 13. patients for whom the surgeon requests a shorter-acting block

Keywords: nerve block outpatient surgery
investigation of immune amnesia following measles infection in select african regions

Conditions: Measles Infection

Summary: the goal of this observational study is to investigate the effects of measles virus (mev) infection on pre-existing immunity, vaccine response, and susceptibility to subsequent illness in children aged 1-15 either with or without acute mev infection.

this is a prospective, observational, longitudinal study to be conducted in west africa. eligible children will be enrolled into 1 of 2 arms: acute mev infection (cases) or no acute mev infection (controls) as assessed using upper respiratory specimens and blood samples. blood samples will be collected at screening/enrollment (day 0) and follow-up visits on day 14, week 13, and week 52, and tested for humoral and cellular immune responses to endemic pathogens to determine changes in antibody diversity and antibody secreting cells (ascs). all children in each arm will receive rabies vaccination (standard 3-dose series given as pre-exposure prophylaxis \[prep\]), with the first dose randomized to either week 8 or week 47 after enrollment. biological samples will be collected after vaccination to assess if the immune stimulus (rabies vaccine) response differs: 1) between children with and without mev infection, and 2) based on the timing of the receipt of the rabies vaccine.

Eligibility criteria:
inclusion criteria: * aged 1 to 15 years. * ability of the participant's legal or culturally acceptable representative to provide informed consent. * ability to give assent, as appropriate. * stated willingness of parent/guardian and participant as appropriate, to comply with all study procedures. * willingness to receive rabies vaccine. * meet the criteria for assignment to group 1 or group 2, as follows: * group 1, cases (acute mev infection): * clinical signs and symptoms suggestive of acute mev infection (koplik spots or skin rash) and * laboratory confirmed measles: * upper respiratory specimen (swab) pcr for measles positive, or * serum igm for measles positive. * group 2, controls (no acute mev infection): * no clinical signs and symptoms suggestive of acute mev infection (koplik spots or skin rash) and * upper respiratory specimen (swab) pcr negative for mev and * serum measles igm negative and * serum measles igg positive and previously vaccinated for measles (2nd dose will be offered if appropriate). if serum measles igg is negative, participant must be willing to be vaccinated regardless of prior measles vaccine history to meet this criterion. exclusion criteria: * hiv infection or any other immunosuppressive condition or medications. * pregnant or lactating. * history of prior measles or immunologic evidence of prior measles in the absence of prior measles vaccination. * severe anemia, defined as hemoglobin less than 8 g/dl. * any acute or chronic condition which, in the opinion of the investigator, constitutes a contraindication to participation in this study.
use of sterile water feeds for treatment of hypernatremia in extremely low birth weight infants

Conditions: Extremely Low Birth Weight Infants; Hypernatremia

Summary: the improved survival rate of extremely low birth weight(elbw)infants has resulted in new fluid and electrolyte problems that have not been encountered previously,in particular electrolyte imbalance. elbw infants are especially vulnerable to hypernatremia(serum sodium value \>150 meq/l). hypernatremia may be due to rapid dehydration or excessive administration of intravenous fluids(iv)that contain sodium. the current treatment modality for hypernatremia is to increase iv fluids above daily requirements.enteral sterile water feeds(eswf)are theorized as an endogenous source of fluids that may decrease elevated electrolytes such as sodium and potassium in premature infants. by giving eswf to decrease elevated electrolytes, there would be less need for large volumes of ivf that contribute to the co-morbidities of prematurity: bronchopulmonary dysplasia (bpd),intraventricular hemorrhage(ivh)and patent ductus arteriosus(pda). the purpose of this proposed study is to determine whether enteral sterile water feedings is effective in decreasing the incidence, duration and severity of hypernatremia in elbw infants.


Eligibility criteria:
inclusion criteria: * infants less than or equal to 1,100 grams birth weight * less than or equal to 28 weeks gestational age exclusion criteria: * \* congenital heart disease, other than a pda * major congenital anomalies * a surgical condition (gastroschisis,omphalocele) * renal disease * hypotension treated with pressor support * reverse end diastolic flow on doppler study prior to delivery * emergency medication received in the delivery room,except fluid boluses * apgar scores recorded at 10 minutes of life \< or up to 5 and/or ph less than 7.0 on the first blood gas upon admission to the nicu

Keywords: extremely low birth weight infants hypernatremia enteral sterile water feeds
efficacy and safety of toronto association in the treatment of erectile dysfunction and premature ejaculation

Conditions: Erectile Dysfunction; Premature Ejaculation

Summary: the purpose of this study is to evaluate the efficacy and safety of toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * male participants, with age greater than or equal to 18 years; * heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period; * participants with erectile dysfunction, in stable and effective treatment with pde-5 inhibitors; * participants diagnosed with premature ejaculation; * participants with ielt ≤ 2 minutes; * participants with score ≥ 25 points in the erectile function questionnaire; * participants (or partners) who use at least one contraceptive method. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participation in a clinical trial in the year prior to this study; * known hypersensitivity to any of the formula compounds; * participants with cardiovascular disease for whom sexual activity is inadvisable * history or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation; * diagnosis of other diseases or conditions in the urinary tract; * participants with conditions that may predispose them to priapism; * history of severe psychiatric or psychosocial disorders; * participant whose partner has clinically important sexual dysfunctions.

Keywords: erectile dysfunction premature ejaculation
the comparison of anterior knee pain in patella with or without denervation in medial unicompartmental knee arthroplasty

Conditions: Osteoarthritis, Knee

Summary: the present study will conduct to assess anterior knee pain and complications after medial uka with or without patella denervation in medial compartment arthritis and severe lateral facet patellofemoral arthritis patients.

in this prospective cohort study, the investigators will conduct to compare the clinical result of 70 patients of unicompartment knee arthroplasty with and without patella denervation between april, 2018 and april, 2019 for the patients with osteoarthritis.

Eligibility criteria:
inclusion criteria: * patients who diagnose with medial osteoarthritis (oa) of the knee with an alhback score of 2, 3 and 4 (ahlback 1968) and with any kujala score for pre-operative anterior knee pain. * older than 40 years of age. * pain on the medial joint line. * primary medial compartment osteoarthritis with a well preserved lateral compartment with competent cruciate ligaments with correctable intraarticular varus deformity. * rom flexion up to 110° under anesthesia. exclusion criteria: * patients with fixed varus deformity \> 15° * inflammatory arthritis * previous high tibial osteotomy or acl reconstruction
cobalamin supplementation during infancy; effect on b-vitamin status, growth and psychomotor development

Conditions: Vitamin B 12 Deficiency

Summary: adequate levels of vitamin b12 (cobalamin) is necessary for normal growth and development in infants. we have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life. the purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

during fetal life and infancy, an adequate cobalamin status is important for normal growth and central nervous system development. a metabolic profile consistent with impaired cobalamin status is prevalent in breast-fed infants. whether this profile reflects immature organ systems or cobalamin deficiency has not been clarified. low levels of cobalamin, elevated levels of total homocysteine (thcy), cystathionine and/or methylmalonic acid (mma) in the blood are measures of impaired cobalamin status. the purpose of this randomized, controlled study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants. six weeks old infants will be randomly assigned to receive either an intramuscular injection with 400 µg cobalamin or no intervention. concentrations of cobalamin and folate in serum, and total homocysteine (thcy), methylmalonic acid (mma) and cystathionine in plasma will be determined at inclusion and at the age of 4 months. a questionnaire on infant and maternal nutrition, vitamin supplementation, growth parameters, parity and maternal use of tobacco will be completed.

Eligibility criteria:
inclusion criteria: * 6 weeks old infants * the infant should be healthy and not have any serious malformations * the mother should be healthy and not have any serious disorders or use any daily medications * the mother should have an ordinary omnivorous diet exclusion criteria: * if there are evidence of serious infant disease during the study period, the infant should be excluded from the study

Keywords: cobalamin methylmalonic acid homocysteine folate newborns infants deficiency disease breastfeeding infant