Kornimate/medical-research-clean huggingface dataset:
screening to obviate preterm birth

Conditions: Preterm Labor; Preterm Contractions; Abdominal Cramping; Back Pain; Vaginal Pressure; Vaginal Bleeding

Summary: our objective is to investigate the predictive value of a panel of biomarkers associated with two biologically plausible pathways of preterm birth: membrane breakdown and cervical remodeling. the investigators will obtain cervical length, cervicovaginal fetal fibronectin, and a panel of novel cervicovaginal biomarkers associated with cervical remodeling in a prospective cohort of symptomatic women with a singleton pregnancy at high risk for preterm birth in an effort to better risk stratify this cohort.

preterm birth is a complex syndrome for which several different biologically plausible pathways have been proposed, including mechanical uterine distension, abruption, inflammation, and/or activation of the fetal hypothalamic-pituitary-axis. however, despite our knowing the complexity of this syndrome and the different pathways involved, there is a paucity of clinical studies investigating whether detection of more than one of these pathways in a single patient might enhance the identification of those at greatest risk for preterm birth. we propose investigating the predictive value of a panel of biomarkers associated with two biological plausible pathways - membrane breakdown and cervical remodeling - that must be involved in the pathogenesis of preterm birth. specifically, we propose measuring cervical length and collecting cervicovaginal fetal fibronectin as well as a panel of novel cervicovaginal biomarkers that reflect molecular pathways involved in cervical remodeling in a prospectively collected cohort of symptomatic women with singleton fetuses at high risk for preterm birth. through this study we hope improve risk stratification of this high risk cohort.

Eligibility criteria:
inclusion criteria: * singleton pregnancy between 22- 33 6/7 weeks of gestational age. * must be experiencing one ore more of the following symptoms including but not limited to preterm contractions, abdominal cramping, back pain, vaginal pressure, or light vaginal bleeding. exclusion criteria: * women with a multi-fetal pregnancy * intra uterine fetal demise * preterm premature rupture of membranes * overt chorioamnionitis
prevalence of cholelithiasis with umbilical hernia

Conditions: Umbilical Hernia; Cholelithiasis

Summary: researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. umbilical hernia is defined according to the european hernia society classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. the main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. factors such as age, gender, body mass index (bmi), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.

umbilical hernia and cholelithiasis are quite common in general surgical practice. the coexistence of cholelithiasis and umbilical hernia has been previously reported in the literature. however, most of the publications on this subject are retrospective series, and the prevalence of cholelithiasis in patients with umbilical hernia and the risk factors of umbilical hernia in patients with cholelithiasis have not been investigated prospectively to date. this study aims to fill this gap by providing prospective data on the prevalence and risk factors associated with the coexistence of these conditions. researchers aim to determine the exact prevalence and risk factors for the association of gallstones and umbilical hernia. umbilical hernia is defined according to the european hernia society classification for primary and incisional abdominal wall hernias as hernias occurring from 3 cm above to 3 cm below the umbilicus. the main outcome measures are the presence of gallstones in patients presenting with umbilical hernia and the presence of umbilical hernia in patients diagnosed with gallstones. patients with umbilical hernia are examined with biliary ultrasound, while patients with cholelithiasis are evaluated for umbilical hernia by physical examination and ultrasound. factors such as age, gender, body mass index (bmi), family history, comorbidities, tobacco use, parity, and history of multiple pregnancy are analyzed as potential risk factors.

Eligibility criteria:
inclusion criteria: * patients with umbilical hernia * patients with cholelithiasis exclusion criteria: * having previously had surgery for an umbilical hernia * having undergone abdominal surgery with a median line incision * having collagen tissue disease
cold agglutinin disease real world evidence registry

Conditions: Cold Agglutinin Disease (CAD); Cold Agglutinin Syndrome (CAS)

Summary: this is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (cad) or cold agglutinin syndrome (cas). among them, a minimum of 30 patients with cad treated with sutimlimab are expected to take part in the sutimlimab cohort study. patients with cad who have been enrolled in previous sutimlimab clinical trials (e.g., bivv009-01/lts16214 \[nct02502903,cad patients\], bivv009-03/efc16215 \[nct03347396\], and bivv009-04/efc16216 \[nct03347422\]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.


Eligibility criteria:
inclusion criteria: 1. patient aged ≥18 years 2. patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations 3. patient with a diagnosis of cad or cas as per investigator judgment based on the diagnosis criteria listed in study protocol exclusion criteria: 1. patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia 2. patient actively participating in a cad or cas interventional clinical trial. after a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.
investigation of the effect of intravenous lidocaine infusion on postoperative pain treatment and bowel function in robotic bowel surgery

Conditions: Opioid Use

Summary: single center double blind randomised controlled trial. 60 subjects. giving lidocaine iv or saline to patients due to robot assisted colorectal surgery. primary outcome is cumulative morphine consumption at 24 hours.

prospective double blind randomised controlled trial. the investigators are giving lidocaine iv or saline to 60 patients undergoing robot assisted colorectal surgery. blinding and randomization is done by the hospital pharmacy. both groups get otherwise the same treatment and a iv pca (patient controlled administration) morphine pump for objectivisation of opioid consumption. other outcome measures are nrs (numerical rating score) pain score, ponv (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.

Eligibility criteria:
inclusion criteria: * all patients due to robotic laparoscopic colorectal surgery, \> 18years of age, danish speaking exclusion criteria: * allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or nsaids, pregnancy, breastfeeding women, treatment with betablockers, porphyria
single site robotic cholecystectomy in non selected patients

Conditions: Cholelithiasis

Summary: this is a study of new technology to allow gallbladder removal through a single small surgical incision. a surgical robot is utilized to help navigate the small space. in this study, patient characteristics are broad to assess how applicable the procedure is to everyone.


Eligibility criteria:
inclusion criteria: * presence of symptomatic gallstones exclusion criteria: * significant previous open abdominal surgery
pedbot ankle rehablitation

Conditions: Cerebral Palsy

Summary: the primary objective of the study is to determine engagement with use and adherence to a home exercise program with our pedbothome ankle rehabilitation device. we will place the device in the home for 90 days and consider the study a success if used for at least 30 minutes a day for at least 3 days a week during this period.

the major secondary objective is to determine if the range of motion of the ankle has improved through use of pedbothome. other secondary objectives will measure ankle strength and control. secondary outcomes will include a measurable increase in range of motion across the ankle joint (in any direction) and a measurable increase in strength in plantarflexion, dorsiflexion, inversion, and eversion. improvement in gait and speed of ambulation will also be considered secondary outcome measures as an indication of better ankle control.

Eligibility criteria:
inclusion criteria: * cerebral palsy exclusion criteria: * healthy volunteers
philos augmented - a multicenter randomized controlled trial

Conditions: Humerus Fractures; Closed Fracture of the Proximal Humerus

Summary: the primary objective is to compare the mechanical failure risks in the first year after treatment.

biomechanical tests have shown that augmentation of screws or nails with polymethylmethacrylate (pmma) leads to increased mechanical properties of the bone-implant complex, leading to the assumption that augmentation could reduce mechanical failures in patients. while a few clinical studies have already been performed with augmented trochanteric nails in proximal femur fractures, no clinical studies exist with the use of proximal humerus internal locking system (philos) and (pmma) augmentation for the treatment of fractures in the proximal humerus. in this study a new standardized technique for augmentation of screw tips using high viscous pmma cement (traumacem v+) with the philos plate will be applied. fracture treatment with philos screw augmentation will be compared with treatment with philos without augmentation.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * low energy trauma (e.g. fall from standing height) * radiologically confirmed closed fracture (≤ 10 days) of the proximal humerus * any displaced or unstable 3- or 4-part fracture of the proximal humerus (i.e. segment dis-placement \> 0.5 cm or angulated \> 45°) except isolated displaced fractures of the greater or lesser tuberosity * primary fracture treatment with a philos plate * ability to understand the content of the patient information / informed consent form * willingness and ability to participate in the clinical investigation including imaging and fol-low-up procedures * signed informed consent preoperative exclusion criteria: * bilateral or previous proximal humerus fractures on either side * splitting fracture of the humeral head or humeral head impression fracture * cuff-arthropathy of the contra- or ipsilateral proximal humerus * associated nerve or vessel injury * any known clotting disorders, severe cardiac and/or pulmonary insufficiency * known hypersensitivity or allergy to any of the components of traumacem v+ cement kit * any severe systemic disease: class 4 - 6 of the american society of anesthesiologists (asa) physical status classification * any not medically managed severe systemic disease: class 3 of the asa physical status classification * recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment * prisoner * participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study intraoperative exclusion criteria: * intraoperative decision to use implants other than philos/philos screw augmentation
isolated anti-hbc serological profile in hiv infected patients: immunological, virological characteristics and response to hepatitis b vaccination

Conditions: HIV Infection; Hepatitis B

Summary: the aim of study is to describe the clinical, immunological, serological, virological and therapeutic characteristics of hiv+ patients harboring isolated anti-hbc profile and to assess the response to vaccination in these patients.


Eligibility criteria:
inclusion criteria: * hiv+ adults patients * negative hbsag * negative a-hbs ab * positive hbc ab * without hbv - vaccination * cd4 cell above 200 /mm3 * hiv viral load below 50 copies/ml exclusion criteria: * positive hbs antigenemia in the past * transaminitis above fivefold upper normal limit * pt\<50% or platelet \<50 000/mm3 * ongoing opportunistic infection * ongoing or recent systemic corticoid or immunomodulatory therapy, splenectomy, pregnancy, contra-indication to intramuscular injection, familial history of neurological disease.
pregnancy success rates of acupuncture for in vitro fertilization

Conditions: Infertility, Female

Summary: this study evaluates the effectiveness of acupuncture on pregnancy success before embryo transfer in ivf treatment in female infertile patients. half of participants will receive acupuncture sessions before embryo transfer, while the other half will not receive.

acupuncture is used for many health problem all around the world. who reported that acupuncture can have benefit in female infertility treatment. however, there is no enough evidence about effectiveness of acupuncture treatment in the infertility.

Eligibility criteria:
inclusion criteria: * to have unexplained infertility * to go in vitro fertilization treatment * to give permission by informed consent form exclusion criteria: * below age of 18 and above age of 45 * to have secondary infertility * to reject completing informed consent form

Keywords: acupuncture infertility pregnancy
bisphenol role in the pathogenesis of pcos

Conditions: PCOS

Summary: polycystic ovary syndrome (pcos) is the most common and the most heterogeneous endocrine disorder in premenopausal women. its prevalence is estimated from 5 to 10% depending on the diagnosis' criteria . apart from signs of hyperandrogenism such as acne, hirsutism and hair loss; women with pcos usually present with menstrual irregularities and fertility problems ..

bisphenol a is formed from acetone and phenol, it is used in production of epoxy resin, polyster resins and polyvarbonate resins. epoxy resins are used in plastics, adhesives, and structural composites . humans are at the end of the food chain, thus they are exposed to the highest doses of these compounds. eds have been detected in human adipose tissue and biological fluids such as: serum, urine, milk and amniotic fluid . additionally, it has been proven that bpa can also directly stimulate androgen synthesis in the ovarian theca-interstitial cells. a correlation between increased serum testosterone levels observed in women with pcos with serum bpa concentrations has also been found .

Eligibility criteria:
inclusion criteria: * age group: 18-40 * females * diagnosed a case of polycystic ovary syndrome exclusion criteria: * • female patients with other acute or chronic illness * cardiovascular disease * neoplasms * current smoking, diabetes mellitus, * renal impairment (serum creatinine 120 mol/liter), and hypertension (blood pressure 140/85 mm hg).
a study of lorlatinib versus crizotinib in first line treatment of patients with alk-positive nsclc

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: a phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced alk-positive nsclc patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of locally advanced or metastatic alk-positive nsclc; at least 1 extracranial measurable target lesion not previously irradiated. cns metastases allowed if asymptomatic and not currently requiring corticosteroid treatment. * availability of an archival ffpe tissue specimen. * no prior systemic nsclc treatment. * ecog ps 0, 1, or 2. * age ≥18 years . * adequate bone marrow, liver, renal, pancreatic function * negative pregnancy test for females of childbearing potential exclusion criteria: * spinal cord compression unless good pain control attained * major surgery within 4 weeks prior to randomization. * radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. whole brain irradiation within 4 weeks prior to randomization * active bacterial, fungal, or viral infection * clinically significant cardiovascular disease, active or within 3 months prior to enrollment. ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long qt syndrome * predisposing characteristics for acute pancreatitis in the last month prior to randomization. * history of extensive, disseminated, bilateral or presence of grade 3 or 4 interstitial fibrosis or interstitial lung disease * active malignancy (other than nsclc, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, lcis/dcis of the breast, or localized prostate cancer) within the last 3 years prior to randomization. * concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib. 1. known strong cyp3a inhibitors . 2. known strong cyp3a inducers 3. known p gp substrates with a narrow therapeutic index * concurrent use of cyp3a substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib. * other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results * investigational site staff members directly involved in the conduct of the study and their family members, or pfizer employees, including their family members, directly involved in the conduct of the study. * participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation.

Keywords: alk; anaplastic lymphoma kinase; non-small-cell lung cancer; nsclc
cognitive and physical stimulation and promotion of social relations for the benefit of older people's quality of life

Conditions: Aging

Summary: the aim of this interventional study is thus to assess and highlight the cognitive, physical, and psychosocial benefits of a combined physical and cognitive training program in an enriched environment and to assess the factors influencing these benefits.

the number of older people worldwide is constantly increasing. however, one of the main problems associated with aging is cognitive decline, which affects essential everyday functions such as memory, attention, and executive functions. thus, maintaining autonomy and quality of life depends on physical health, and the integrity of cognitive functioning. cognitive, physical and social activities can all slow this decline but social factors and their contribution to the well-being of older people remain under-researched. the aim of the present study is to analyze how the practice environment can foster these social relations and thus enhance wellbeing and to identify the psychological dimensions that are activated by social relations.

Eligibility criteria:
inclusion criteria: * people must be at least 65 years old * people must be at independent (able to get around on their own: car, bus, walking) * people must be at living in the community (not in an institution such as a nursing home) * the persons recruited must have a score on the montreal cognitive assessment (moca) of at least 18. exclusion criteria: * people with contraindications for engaging in regular physical activity * people with severe neurological and psychological disorders.
comparison of pt-cy at a dose of 25 mg/kg/day and pt-cy at a dose of 50 mg/kg/day in gvhd prophylaxis

Conditions: Graft Versus Host Disease; Hematologic Malignancy; Cyclophosphamide Adverse Reaction

Summary: this is a two arm open label phase iii clinical trial. adult patients with hematological malignancies undergoing allogeneic hsct from any donor are eligible for the study if they meet the standard criteria defined in the investigator's institutional standard operation procedures (sops), meet all inclusion criteria, and do not satisfy any exclusion criteria. patients will receive reduced-intensity conditioning regimen of fludarabine, busulfan (treosulfan). patients will receive ptcy at different dose (25 mg/kg/day vs 50 mg/kg/day on day +3,+4 in combination with calcineurin inhibitors and mofetil mycophenolate) as gvhd prophylaxis.


Eligibility criteria:
inclusion criteria: * patients who have an indication for allogeneic hematopoietic stem cell transplantation exclusion criteria: * uncontrolled bacterial or fungal infection at the time of enrollment * requirement for vasopressor support at the time of enrollment * karnofsky index \<30% * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent

Keywords: allogeneic transplantation graft-versus-host-disease prophylaxis post-transplant cyclophosphamide
ibd registry in a sub-saharan african population

Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease

Summary: the investigators intend to establish a prospective registry of patients diagnosed with inflammatory bowel disease at parirenyatwa hospital in harare, zimbabwe. the study will periodically collect data on disease phenotype, disease course, and clinical management, and will biobank stool specimens and germline dna. one relative, and an individual from the same neighbourhood will be also be recruited for a nested case-control study into risk factors of inflammatory bowel disease in this population.

a prospective observational registry with a nested case-control study will be established at a gastrointestinal outpatient's clinic at a tertiary care hospital in harare, zimbabwe. the registry will recruit confirmed cases of inflammatory bowel disease from the clinic, other hospitals within and outside harare, and from private practitioners. two controls, a sibling or cousin, and an individual living in the same neighbourhood will also be recruited for each case. demographic and clinical data will be obtained for all cases at baseline, after 6 months and annually thereafter. a questionnaire adapted from the international organisation of ibd for risk factors of inflammatory bowel disease, and a food frequency questionnaire will be administered to all participants. stool specimens, and germline dna from peripheral blood will be biobanked in the department of medicine at the university of zimbabwe. preliminary data analysis will be carried out after at least 100 patients have been recruited. descriptive statistics will be used to summarise data on demographic and phenotypic characteristics of inflammatory bowel disease, and incidence will be estimated for harare. risk factors for inflammatory bowel disease will be analysed using conditional logistic regression.

Eligibility criteria:
inclusion criteria: * cases 1. any patient with confirmed inflammatory bowel disease 2. onset of disease ≥3 months ago. * controls 1. age ≥ 18 years (nb - cases younger than 18 will be excluded from case-control analysis 2. one sibling or cousin (2nd degree) and one neighbourhood control. exclusion criteria: * cases 1. none * controls 1. suspected inflammatory bowel disease 2. unexplained gastrointestinal symptoms including diarrhoea, vomiting, chronic abdominal pain, weight loss, rectal bleeding, and recent change in bowel habit. 3. previous unexplained gastrointestinal surgery