Kornimate/medical-research-clean huggingface dataset:
an investigation for the optimal timing of a cleft palate repair

Conditions: Cleft Palate

Summary: the effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. the objective of this study is to determine the effectiveness of early palatal repair versus the hospital for sick children (sickkids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. the null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and sickkids routine palatal repair in isolated cleft palate patients.

the goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. two major criteria by which the success of cleft palate surgery is determined are subsequent speech development and facial growth. therefore, the debate about timing of cleft palate surgery is focused on the need for early palatoplasty for speech purposes versus later palatoplasty to ensure undisturbed facial growth. a compromise solution to this controversy was proposed by schweckendiek; the soft palate is repaired at an early age leaving the hard palate cleft unrepaired until later in life. the premise is that primary veloplasty will result in a functioning velopharyngeal mechanism for early speech development, while the unrepaired hard palate will allow unrestricted maxillary growth. the speech outcomes of patients who have undergone delayed stage palate repair have been addressed in several studies and case series. however, there is little evidence to support the benefits of delayed stage repair with respect to facial growth and speech development. results from published studies have shown the speech results to be relatively poor and fistula rates as unacceptably high. these results have lead a vast majority of north american surgeons to favour primary one-stage repair. yet, the optimum timing of primary palate repair remains unknown. no randomized control trials or prospective cohort studies have been conducted to address this question.

Eligibility criteria:
inclusion criteria: * infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate. * between newborn and 5 months of age (pre-palate surgical assessment/ consultation. * treated at sickkids. exclusion criteria: * if they are non-ontario residents; * if they have clinical features suggestive of an associated syndrome and/or an associated syndrome; * if they have pierre robin sequence; * if the palate repair cannot be performed before 15 months of age; * if the extent of clefting is limited to the primary palate or submucous cleft of the soft palate; * if the child have a combined cleft lip and palate diagnosis

Keywords: pediatric cleft palate plastic surgery palatoplasty pharyngoplasty
heart rate variability and anxiety during urinary bladder catheterization

Conditions: Spinal Cord Injuries; Urinary Bladder, Neurogenic; Anxiety State; Catheter Complications; Autonomic Dysreflexia

Summary: this is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (sci).

given that intermittent catheterization is the recommended method of bladder management in individuals with sci, it is crucial that the potentially negative cardiovascular and psychological responses to this procedure are examined. individuals will undergo self-catheterization, then two standard of care catheterization procedures performed by an experienced urology nurse, while either blinded to or aware of time of catheterization. continuous cardiovascular monitoring will be in place throughout all three procedures. assessment of anxiety will be administered pre- and post- each procedure.

Eligibility criteria:
inclusion criteria: * male or female, 18-70 years of age * any chronic traumatic sci with either motor sensory complete injury (ais a/b, n=10) or motor sensory incomplete injury (ais b/d, n=10). * at least 1 year post injury, and at least 6 months from any spinal surgery * hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage * must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak english or have access to an appropriate interpreter as judged by the investigator) * willing and able to comply with clinic visit and study-related procedures exclusion criteria: * signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra * currently taking beta blockers or other medications that may affect heart rate * history of ureteral injury * history of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, mitrofanoff appendicovesicostomy * for women of childbearing potential, currently pregnant * a member of the investigational team or his/her immediate family presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study

Keywords: intermittent catheterization
randomized study in the prevention of pain shoulders after laparoscopic surgery

Conditions: Shoulder Pain

Summary: the purpose of this study is to assess shoulder pain at rest (average over the last 24 hours) assessed by visual analogue scale from 0 to 100mm on day 1.

this is an interventional, comparative, controlled, randomized, single-blind study (the patient will be blinded to the result of the randomization, unlike the investigator) and single-center. comparative prospective cohort study of laparoscopic surgery with the addition of specific non-surgical interventions aimed at preventing postoperative shoulder pain (use of local intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver abdominal) versus without specific interventions aimed at preventing post-operative shoulder pain. all patients will benefit from transversus abdominis plane block with multimodal analgesia provided in the usual setting of laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * celiosurgery including a transversus abdominis plane block with multimodal analgesia; * planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia, incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation; * affiliation to the social security scheme; * signed informed consent exclusion criteria: * celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy, nephrectomy; * surgical emergency; * history of chronic obstructive pulmonary disease; * weight less than 50 kg; * consumption of preoperative opioids; * antidepressant treatment and/or anxiolytic treatment; * conversion by laparotomy; * intraperitoneal sepsis; * major intraoperative complication (hemorrhage, anaphylaxis, etc.); * other surgical or medical interventions planned during the study; * patient participating in another clinical trial, or during a period of exclusion from another clinical trial; * inability to understand information related to the study; * woman who is pregnant or likely to be pregnant (of childbearing age, without effective contraception) or currently breastfeeding; * patient deprived of liberty or under guardianship or curatorship or unable to give consent.
sub-study for the validation and calibration of data regarding physical activity, anthropometry and diet

Conditions: Chronic Disease

Summary: this study was an update and amplification of exposure measurements of the epic-potsdam study, which started in 1994-1998.

the sub-study was conducted in the german institute of human nutrition according to an approved study protocol. the study program included comprehensive surveys on diet and lifestyle (smoking, physical activity, and anthropometry). the aim was to achieve repeated measurements in a sub-cohort of about 600 people to validate (measurement error correction) and calibrate (adjustment of insufficient data collected to the actual data location) existing baseline data in the entire cohort (epic-potsdam cohort). to this end, within age groups and by gender, active epic participants were then randomly selected in the years 2009 to 2012 from the cohort, contacted and invited to re-visit the respective study center. 816 subjects were acquired for re-examination, participation rate was 56.4%. each participant gave informed consent. the study protocol has been approved by the ethics committee of the medical association of the state of brandenburg, cottbus, on 18/12/2009. the information in this section are study hypothesis and contains no results or conclusions.

Eligibility criteria:
inclusion criteria: * participants in the epic study who meet the following three conditions were eligible for invitation to the re-examination: 1. actively participating in the epic-potsdam follow-up 2. current address in brandenburg or berlin 3. phone number known exclusion criteria: * not meeting the above stated criteria
comparison of activator manipulation versus manual side posture manipulation in patients with low back pain

Conditions: Back Pain

Summary: this study compared the treatment effect of activator methods chiropractic technique (amct) and manual diversified type spinal manipulative therapy in a sample of patients with acute and sub-acute low back pain.

the purpose of this study is to compare the effects of (mfma) activator instrument adjusting to manual side posture (hvl) adjustments in patients with acute low back pain. primary outcomes measured include pain measurement with a vas scale, the use of the oswestry pain scale questionnaire, and the bournemouth back pain scale questionnaire. an additional aim of this study is to evaluate feasibility of recruitment, data collection, and other procedures which can lead to additional studies with larger number of subjects including a control group.

Eligibility criteria:
inclusion criteria: 1. being 18 years or older; 2. having current acute or sub-acute low back pain defined as pain that has not lasted more than 16 weeks; 3. minimum score of 30mm on a 100mm visual analog pain scale. exclusion criteria: exclusion criteria consisted of the following: 1. have any of six possible un underlying causes of low back symptoms in their history (spinal osteomyletisosteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome, or cancer, excluding nonmalignant skin cancer); 2. have undergone surgery involving the low back; ( 3. have received workers'compensation benefits within the preceding year or were potentially involved in litigation relating to back problems; 4. pregnancy, because of possible need for exposure to diagnostic x-rays; 5. have participated as a subject in research previously at the trial clinic site; 6. have received spinal manipulation within the preceding 3 months or on more than three occasions during the preceding year. 7. subjects with sciatica were excluded if they had any one of the following: * ankle dorsiflexion / plantar flexion weakness; * great toe extensor weakness; * absence of knee or ankle reflexes; * loss of light touch sensation in the medial, dorsal, and lateral aspects of the foot; * ipsilateral straight-leg-raising test (positive result: leg pain at \<60°); * crossed straight-leg-raising test (positive result: reproduction of contralateral pain). these six neurologic tests allow detection of most clinically significant nerve root compromises resulting from l4-l5 or l5-s1 disc herniations, which together make up more than 90% of all clinically significant radiculopathies attributable to lumbar disc herniations (21-25). because approximately 12% of ambulatory patients with back pain h 8. have symptoms of sciatica or leg pain without neurologic compromise related to lumbar disc herniation,\[5\] investigators attempted to include such subjects in the trial. the criteria described above were intended to minimize the likelihood of including subjects with a lumbar disc herniation.

Keywords: low back pain chiropractic spinal manipulation activator methods chiropractic technique
efficacy and safety of ql1706 plus lenvatinib as 2nd line theapy in patients with metastatic esophageal carcinoma after disease progression on icis therapy

Conditions: Esophageal Squamous Cell Carcinoma (ESCC)

Summary: the purpose of this study is to assess the efficacy and safety of ql1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy


Eligibility criteria:
inclusion criteria: 1. subjects participate voluntarily and sign informed consent. 2. 18-75 years, male or female. 3. histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma 4. patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-pd-1/pd-l1 antibodies 5. at least 1 measurable target lesion according to response evaluation in solid tumors (recist 1.1). 6. ecog ps 0-1 exclusion criteria: 1. presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism) 2. those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment 3. severe allergic reaction to other monoclonal antibodies 4. those who terminated treatment due to related toxicity during anti-pd-1/pd-l1 antibody treatment 5. prior treatment with bispecific anti-pd-1/ctla-4 checkpoint blockades or vegfr inhibitors

Keywords: ql1706 lenvatinib immune checkpoint blockades esophageal squamous cell carcinoma escc
the impact of m1/m2 tumor associated macrophage (tam) polarization on cancer progression and prognosis prediction

Conditions: Tumor; Lung Cancer

Summary: the purpose of this study is to evaluate the correlation between m1/m2 phenotype of tumor associated macrophage (tam) in lung cancer patients and clinical outcome.

inflammatory response in the tumor micro-environment may facilitate the metastatic process (1). macrophages are pivotal members of the inflammatory cells and the innate immune system within the tumor stroma. tumor-associated macrophages can release growth factors, cytokines and inflammatory mediators that may facilitate cancer cell invasion, migration, angiogenesis, tumor progression or metastasis (1-5). a lot of studies showed tam encounter factors that most frequently polarize them toward m2 type macrophage (1,4-5). it is interesting that in vitro studies macrophages have the potential to kill tumor by appropriate stimulation but these macrophage belonged to m1 and were not present in most tumor tissue (6). some drugs target to suppress tam have the promising results in animal models (7-9). switching the tam phenotype from m2 to m1 may promote anti-tumor activity (10). in this study we will correlate tam m1/m2 ratio and patients' prognosis, the gene expression pattern of tam. references 1. coussens lm, werb z. inflammation and cancer. nature 2002;420(6917):860-867. 2. crowther m, brown nj, bishop et, lewis ce. microenvironmental influence on macrophage regulation of angiogenesis in wounds and malignant tumors. j leukoc biol 2001;70(4):478-490. 3. lin ey, nguyen av, russell rg, pollard jw. colony-stimulating factor 1 promotes progression of mammary tumors to malignancy. j. exp. med. 2001;193(6):727-740. 4. mantovani a. cancer inflammation by remote control. nature 2005;435(7043):752-753. 5. pollard jw. tumor-educated macrophages promote tumour progression and metastasis. nature reviews cancer 2004;4(1):71-78. 6. sica a, schippa t, mantovani a, allavena p. tumor-associated macrophage are distinct m2 polarized population promoting tumor progression: potential targets of anti-tumor therapy. eur j of cancer 2006;42:717-27 7. sessa c, de braud f, perotti a, et al. trabectedin for women with ovarian carcinoma after treatment with platinum and taxanes fails. j clin oncol 2005;23:1867-74. 8. wahl l, kleinman hk. tumor-associated macrophages as targets for cancer therapy. j natl cancer inst 1998;90:1583-4. 9. giraudo e, inoue m, hanahan d. an amino-bisphosphonate targets mmp-9-expressing macrophages and angiogenesis to impair cervical carcinogenesis. j clin invest 2004;114:623-33. 10. guiducci c, vicari ap, sangaletti s, trinchieri g, colombo mp. redirecting in vivo elicited tumor infiltrating macrophages and dendritic cells towards tumor rejection. cancer res 2005;65:3437-46.

Eligibility criteria:
inclusion criteria: * lung cancer with malignant pleural effusions exclusion criteria: * none

Keywords: tumor associated macrophage lung cancer outcome
androgens and nafld longitudinal cohort study

Conditions: PCOS; NAFLD; NASH

Summary: the researchers want to learn how androgens, a type of sex hormone, might affect nonalcoholic fatty liver (nafld) in young women over time. nafld happens when fat builds up in the liver which can cause damage to the liver such as inflammation or scarring. young women with a condition called polycystic ovary syndrome (pcos) have a high risk for nafld, and they often have high androgen levels too. so the researchers are recruiting young women with pcos as well as those without pcos, and will compare changes in nafld over time between young women with and without pcos. this study is funded by the national institutes of health

the studies central hypothesis is that androgens promote liver injury and nafld/nash progression in pcos, which occurs through aberrant lipid activity (including lipotoxicity and dysregulated de novo lipogenesis), in part from androgenic effects on visceral adipose tissue (vat). data in young women taking exogenous testosterone show redistribution of fat from subcutaneous to visceral stores in the general population, vat promotes nash through several established pathways, including production of tissue injurious or "lipotoxic" lipids such as some phospholipid, sphingomyelin, and ceramide species. recent data show androgen- associated increase in serum glycerophospholipids in women with pcos, a lipid class that is associated with nash in women. additionally, androgen-associated de novo lipogenesis (dnl) may contribute to nash in women. hepatic dnl is a key source of lipid accumulation, and co-investigators at duke university recently discovered an enzymatic balance that regulates hepatic dnl with dysregulation of this pathway (reflected by branched-chain keto and amino acids) predictive of prevalent nash in humans. androgen-induced de novo lipogenesis also occurs in cultured hepatocytes from women (but not men) supporting the researchers focused evaluation of the relationship between androgens, dysregulated hepatic dnl, and nash in pcos. as existing data support androgenic effects on hepatic and visceral fat in women, the researchers will now determine the relationship of androgens with liver injury and progression in pcos and the potential mechanistic contributions of vat and aberrant lipid metabolism to this process. the team includes clinical and translational researchers at two centers (ucsf and duke) with expertise in nafld, pcos, obesity, and lipid metabolism, with a track record of collaboration. the study team will leverage an existing well-characterized pcos cohort29 to follow 150 reproductive-aged women with nash (125 pcos and 25 non-pcos controls) to accomplish this.

Eligibility criteria:
inclusion criteria: * metabolic associated steatohepatitis (mash) (formerly nash) * pcos * non-pcos exclusion criteria: * high levels of alcohol use (more than 7 drinks a week) * current pregnancy * other causes of hepatic steatosis * weight loss of more than 10% body weight in the last 6 months

Keywords: androgen
effectiveness of a family-based treatment for preventing anxiety disorders in at-risk children

Conditions: Anxiety Disorders

Summary: this study will test the effectiveness of a family-based, cognitive behavioral therapy (cbt)-based program for preventing anxiety disorders in at-risk children.

anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. the children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapeutic interventions. in children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. this study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders. participation in this study will last 1 year. first, interested participants will be asked to perform a screening assessment. this will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. if, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour intervention visits, during which participants will learn skills to reduce anxiety. after completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. in addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks, 6 months, and 12 months after entering the study. all participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.

Eligibility criteria:
inclusion criteria: * parents of child participant have a current, primary anxiety disorder exclusion criteria: * child has an anxiety disorder or is currently in treatment for anxiety

Keywords: anxiety