Kornimate/medical-research-clean huggingface dataset:
treatment of severe asherman syndrome by collagen scaffold loaded with autologous bone marrow mononuclear cells

Conditions: Infertility; Asherman Syndrome

Summary: this study evaluates the addition of collagen scaffold loaded with autologous bone marrow mononuclear cells(abmnc) to foley catheter balloon after hysteroscopic adhesiolysis in the treatment of severe asherman syndrome. half of participants will receive collagen/abmnc scaffold after hysteroscopic adhesiolysis, while the other half will receive foley catheter balloon.

severe asherman syndrome will lead to infertility, and the most common method to treat asherman syndrome is operating to dissect adhesions. in order to prevent the postoperative re-adhesion, many physical isolation measures have been tried. however, they don't improve the microenvironment of endometrial regeneration. it's reported that bone marrow mononuclear cells have good effects on the functional recovery of injured uterus. this study will determine whether collagen scaffolds loaded with autologous bone marrow mononuclear cells will be more effective than foley balloon catheters at treating infertile women with severe intrauterine adhesions who have taken hysteroscopic adhesiolysis. in addition, the study will be carried out in 2 centers, one is the affiliated nanjing drum tower hospital of nanjing university medical school, the other is changzhou maternal and child health care hospital that is in jiangsu province.

Eligibility criteria:
inclusion criteria: * having a clear desire to fertility; * infertility that is defined as a women fails to become pregnant after having a normal sex life for two years without contraception. * hysteroscopy examination confirmed intrauterine adhesions(patients who has at least one of the three symptoms which are amenorrhea, hypomenorrhea or infertility, and hysteroscopy or histologic diagnosis of intrauterine adhesions), meeting american fertility society diagnostic criteria ⅱ-iii; * normal ovarian function; * regular menstrual cycles and menstruation is normal before abortion or curettage; * bmi\< 30 kg/m2; * sign a consent form; * follow the test plan and follow-up process. exclusion criteria: * hereditary diseases; * simple thin endometrium with no uterine cavity adhesion; * simple uterine scar formation with no uterine cavity adhesion after hysteroscopic adhesiolysis; * contraindications to bone marrow collection or assisted reproductive technology; * history of malignant tumor; * other diseases associated with the uterus: uterine fibroids, severe adenomyosis, severe malformations of the uterus; * abnormal blood coagulation, liver and kidney dysfunction, or other diseases which the researchers think may affect the study(such as: uncontrolled hypertension, diabetes, sexually transmitted diseases); * with a positive urine pregnancy test； * participating in other clinical studies at the same time; * hysteroscopic adhesiolysis more than 3 times in the past.
forearm shaft fractures: plating of radius and ulna versus plating of radius and nailing of ulna

Conditions: Fractures of Radius and Ulna

Summary: the hypothesis is that intramedullary nailing of the ulna and plating of the radius will result in a superior outcome as evidenced by two primary end points: 1. a lower rate of implant pain 2. a lower re-operation rate to remove painful hardware.

this is a prospective, randomized study to determine if intramedullary nailing of the ulna and plating of the radius is equal to, or superior to plating of both the radius and ulna for the treatment of both bone forearm fractures.

Eligibility criteria:
inclusion criteria: * diaphyseal fractures of both radius and ulna * ulna fractures that are oblique or transverse * fractures may be closed or grade i-iiia open * patients must be over 18 and skeletally mature exclusion criteria: * children under the age of 18 * pregnancy * comminuted ulna fractures * those with associated bony elbow or wrist trauma * elbow dislocation * subjects with bone pathology (osteoporosis, oi, paget's disease, bone cancer)

Keywords: fractures of both radius and ulna
trunkstability: a predisposition for armfunction

Conditions: Trunk Stability

Summary: trunk stability is supposed to be an important predisposition for arm function. to the investors knowledge this is never been demonstrated.

fifty healthy subjects will execute a reaching movement in sitting. they will reach to a cone at a distance of little more than armlength. electromyogram (emg) and kinematics will be the outcome measures. secondary outcome measures are: sex, dexterity, skillfulness, fifty first time stroke patients will execute the same movements. primery outcome is emg and kinematics; secundary outcome measures are: side of hemiplegia, arm recuperation.

Eligibility criteria:
inclusion criteria: * bmi \< 30 * no orthopedic, neurologic disorder that can influence the reaching * age between 18 and 70 yrs exclusion criteria: * bmi\>30 * orthopedic, neurologic disorder that can influence the reaching * \< 18 yrs of age * \>70 yrs of age

Keywords: stroke reaching adl
multimodal magnetoencephalography and electroencephalography exploration of the acute effects of thc exposure on neural noise and information transmission within working memory networks

Conditions: THC

Summary: the purpose of this study is to use non-invasive brain imaging methods (meg and eeg) to characterize the effects of thc on brain activity during learning.

the goal of this study is to use multimodal meg/eeg to gain novel insight into the acute effects of thc on neural noise and its interaction with the fast information processing dynamics of the brain's cognition-related functional neural networks.

Eligibility criteria:
inclusion criteria: * cannabis use at least once in the past 12 months * no cannabis use during the course of the study confirmed with negative urine toxicology at screening and on each test day * good physical and mental health exclusion criteria: * cannabis naïve individuals * lifetime or current medical, psychiatric or psychosocial disorders or history that is deemed unsuitable for participation in the study per pi discretion. * positive pregnancy test, lactation, or refusal to practice birth control for the duration of the study and for two weeks following completion * major current or recent stressors * positive urine drug test * contraindication for magnetic resonance imaging * treatment with psychotropic medication as per discretion of the pi * iq less than 80 * weight exceeding 166kg * diagnosis of major psychotic or manic disorder in first-degree relatives.

Keywords: meg eeg thc placebo working memory neural noise cognitive process
study to assess the safety & tolerability of a parp inhibitor in combination with gemcitabine in pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: the purpose of this study is to identify a safe and tolerable dose of the drug ku-0059436 that can be given in combination with gemcitabine chemotherapy for the treatment of pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of pancreas * locally advanced or metastatic unresectable disease exclusion criteria: * no prior anti cancer chemotherapy, radiotherapy (except palliative \>4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

Keywords: advanced pancreatic cancer poly (adp ribose) polymerases advanced solid tumours
risk of failed epidural in patients with and without chronic pain and opioid use

Conditions: Chronic Pain; Postoperative Pain; Central Sensitisation

Summary: patients with chronic pain syndrome (cps) may develop central sensitization wich may lead to increased pain intensity and lower pain threshold sometimes to the extend of hyperalgesia and allodynia. furthermore, patients with daily use of opioids may develop opioid tolerance, and to a lesser extent opioid induced hyperalgesia. these factors may lead to a higher pain intensity in the perioperative setting resulting in the observed increased opioid dosage needed to treat the acute pain. furthermore opioid titration may be difficult with higher levels of pain and a higher risk of opioid related adverse effects incl. respiratory depression and sedation. the factors above advocate for utilizing opioid sparing analgesic techniques. in our department as in many others we use an multimodal opioid sparing approach for surgical procedures including epidural anesthesia (ea) as a standard part of the perioperative analgesia strategy after upper laparotomy, as a sufficient epidural anesthesia has shown to provide a stable and often better pain relief than systemic opioids in these patients. clinically, there is a suspicion that patients with cps on fixed opioid treatment have a higher frequency of need for epidural optimization, despite the lack of an anatomical reason for this. one potential explanation could be an altered nociception, requesting another ea strategy than in non-opioid patients. purpose and hypothesis this study will explore the frequency of failed ea, defined as ea with insufficient analgesic effect to the extent were replacements of the epidural is needed within the first 5 postoperative days (pods), testing the hypothesis that failed epidural occurs more frequent in patients with cps on fixed opioid treatment than in non-opioid patients without cps.


Eligibility criteria:
inclusion criteria: * patients undergoing elective laparotomy with epidural anesthesia as a part of the postoperative pain treatment * for the intervention group - patients with chronic pain disorder defined as pain for more than 3 months and a daily use of opioids regardless of dosage. * for the control group - no chronic pain disorder defined as no daily use of opioid or other medicine with strong analgetic effect. a daily use of acetaminophen and nsaids were deemed acceptable. exclusion criteria: * patients with substance abuse * suspected withdrawal due to opioid deficiency - noted in the medical chart

Keywords: failed epidural chronic pain syndrome central sensitization opioid use opioid naive
transversus abdominis plane block plus quadratus lumborum block or retrolaminar block of multiple injections for postoperative analgesia following laparoscopic colorectal surgery

Conditions: Quadratus Lumborum Block; Analgesia; Laparoscopic; Colorectal

Summary: our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-ii class * colorectal cancer patients * 18 and 80 years old * elective laparoscopic colorectal surgery exclusion criteria: * serious complications associated with other systems: * severe cardiac insufficiency * renal failure * hepatic encephalopathy * infection in the block injection area * coagulopathy * a known allergy to local anesthetics * a previous history of tranquilizer or opioid abuse, * body mass index (bmi) greater than 30 kg/m2 or less than 18 kg/m2, * inability to cooperate with the assessment of visual analogue scale (vas) pain scores * refusal to participate in the study
efficacy of kinesio taping in musculoskeletal neck pain

Conditions: Musculoskeletal Neck Pain

Summary: the aim of this study is to compare efficacy of kinesio taping against a conventional tape in a patient with cervical musculoskeletal pain. for this, a double-blind controlled clinical trial be carried out in patients with musculoskeletal neck pain.

during the months of may to july 2021, a research assistant will contact potential participants who will be invited to participate in this study. once they agree to participate, it will schedule for a face-to-face consultation at the university, where the main researcher will inform the study participants. once the information sheet and informed consent will be a sign, an investigator will carry out the measurements of the variables for initial data collection in the first session. in another room, an expertise physiotherapist with experience in applying kinesio taping will perform interventions on patients on the same day as the initial evaluation. it this way, the investigator that will assess outcomes will be blind to the treatment that each patient will receive. at the second consultation, 4 days after the first, the same physiotherapist who applied the bandage will remove it from the patients who received it and any remains of the bandage on the skin were cleaned. for patients in the control group (nothing apply), it will be the same protocol to alter, not the double-blind. the principal investigator will perform the evaluations and data collection without knowing the intervention the patient will receive. in a third consultation, as a follow-up (30 days after the second consultation), the collection of the same measurements and clinical variables from the patients who completed the process will repeat by the same investigator that did the outcomes' assessment.

Eligibility criteria:
inclusion criteria: * presence of myofascial pain syndrome (mps) and myofascial trigger point (mtp) in the upper trapezius muscle, according to the diagnostic criteria proposed by the american academy of pain medicine(2) and the scientific community (3) a) tender point on palpation, with or without referred pain b) patient recognizes pain during tender point palpation c) at least three of the following: muscle stiffness or muscle spasm, limited range of motion in an associated joint, increase of pain with stress, palpation of tight band and / or nodule, associated with a tender point * understand written spanish. exclusion criteria: * neck pain of traumatic origin, due to recent surgery or causing radiculopathy * have been diagnosed with chronic pathology, as well as neoplastic or suspicion of it * have received some type of pharmacological or non-pharmacological analgesic treatment in the last 30 days. * pregnant or menstrual women

Keywords: musculoskeletal neck pain; kinesio taping
prospective study investigating the role of occupational exposure on sinus surgery outcome

Conditions: Rhinosinusitis

Summary: the pathophysiology of chronic rhinosinusitis (crs) is complex and involves several immune, infectious and anatomic factors. when medical therapy fails, functional endoscopic sinus surgery (fess) is the therapy of choice. from literature it is known that 10% of patients that undergo fess, need revision surgery within the 3 years following initial surgery. causes of failure are multiple and not fully understood. as is the case in patients suffering from occupational rhinitis (or), a subgroup of patients with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced by occupational factors as well. no data are currently available on how these factors may contribute to the disease manifestation, whereas negligence of these factors as potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal condition and even give rise to the induction of bronchial symptoms. there exists no documentation on the role of the occupational agents on chronic sinus disease. this prospective study aims at providing data about the exposure levels of patients that undergo sinus surgery and correlate them with both subjective and objective postoperative parameters. this will be done by providing a questionnaire that was developed at our department to all patients that are planned for sinus surgery at the participating centers. this questionnaire asks for medical history, current sinonasal symptoms, professional history and recreational occupation. an extensive list of occupational agents is given and patients are asked to indicate those that they encounter at work or during recreational activities. this will be followed by an extensive clinical investigation including nasal endoscopy. these investigations (questionnaire and clinical examination) will be repeated at 3 months and 12 months after surgery.


Eligibility criteria:
inclusion criteria: 1. patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps. 2. age \> 18 and \< 65 years 3. signed informed consent 4. willingness and capability to fill in questionnaire. exclusion criteria: 1. patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome 2. patients that undergo fess for antrochoanal polyp 3. patient that undergo fess for a malignant process 4. patient that are diagnosed with sarcoidosis or any type of vasculitis

Keywords: chronic rhinosinusitis
efficacy and safety of vildagliptin compared to metformin in drug naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Eligibility criteria:
inclusion criteria: * not currently on durg therapy for type 2 diabetes * body mass index (bmi) in the range 22-45 * blood glucose criteria must be met exclusion criteria: * type 1 diabetes * pregnancy or lactation * evidence of serious diabetic complications * evidence of serious cardiovascular conditions * laboratory value abnormalities as defined by the protocol * other protocol-defined exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin
a pragmatic randomized trial to evaluate the comparative effectiveness between dapagliflozin and standard of care in type 2 diabetes patients

Conditions: Type 2 Diabetes Mellitus

Summary: a trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and standard of care (soc)

a longitudinal, open labelled, pragmatic randomized 104 week multicentre trial of patients with type 2 diabetes mellitus to evaluate the comparative effectiveness between dapagliflozin and standard of care (soc)

Eligibility criteria:
inclusion criteria: for inclusion in the study patients should fulfil the following criteria at the time of screening: 1. provision of informed consent prior to any study specific procedures 2. females and males aged ≥18 years up to ≤ 75 years 3. diagnosed with type 2 diabetes mellitus. 4. uncontrolled on first-line metformin treatment, defined as ≥8 weeks on maximum tolerated dose of metformin and hba1c \> 6.5%. 5. ability to read and write as judged by the investigator. exclusion criteria: patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. involvement in the planning and/or conduct of the study (applies to both astrazeneca staff and/or staff at the study site) 2. previous enrolment or randomization in the present study 3. age \> 75 years 4. pregnancy/active breast feeding at the time of inclusion 5. known moderate to severe renal impairment (egfr\<60ml/min). 6. participation in an interventional clinical trial ≤ 3 months before enrolment. 7. unsuitable to participate on mental health grounds, as judged by the investigator. 8. physician decision to use, as second line treatment, insulin, a glp1 agonist compound or a sglt2 inhibitor different from dapagliflozin. 9. presence of any of the characteristics in which the products in study are contraindicated, as per current labels.

Keywords: type 2 diabetes mellitus randomised pragmatic standard of care dapagliflozin forxiga
eeg@home (phase 1 of the project)

Conditions: Epilepsy

Summary: the goal of this project is the development of an eeg-cap (min. 21 electrodes) with user-friendly active dry electrodes that meets the expectations of the users regarding comfort and esthetics, without losing sight of the functional and technical demands for recording high quality eeg signals. the purpose is to use the eeg-cap to investigate clinical neurological disorders (e.g. epilepsy). the eeg-cap could also be used at home so that hospital admission in the emu can be avoided for some patients and an increasing number of patients can be examined. in phase 1 of the project epilepsy patients and their family will be interviewed about their personal experiences with the condition, eeg registrations, daily life, ... . in addition eeg-technologists and neurologists will be interviewed about their experience with eeg registrations and what features their dream eeg-cap would have. the purpose is to gain insight in the wishes and expectations of the end users so we can take this into account when designing of the eeg-cap. this interview is anticipated to take approximately 1 hour. minimum 5 - maximum 50 patients and their family will be interviewed. minimum 5 - maximum 50 eeg-technologists or neurologists will be interviewed. the results of the interviews will be analysed by the design company pilipili nv.


Eligibility criteria:
inclusion criteria: * epilepsy patient or eeg-technologist or neurologist exclusion criteria: * no experience with eeg
effect of extensively hydrolyzed liquid human milk fortifier on growth and tolerance in moderately premature infants

Conditions: Complication of Prematurity

Summary: the purpose of this study is for the researchers to examine the safety and efficacy of liquid human milk fortifier (hmf) in moderately preterm infants compared to powdered human milk fortifier.

this is a prospective, randomize, double-blinded study in preterm infants born between 28-34 weeks gestation admitted to the nicu at the university of kansas hospital. after obtaining informed consent, babies will be randomized to either liquid or powdered hmf using opaque, sealed envelopes with preassigned randomization. the feeding protocol as established in the ku nicu will be followed, beginning with initiation of trophic feeds, and advancement of enteral feeds depending on the gestational age and preceding illnesses. once infants reach 80ml/kg/day of enteral feeds, human milk will be fortified to 22 kilocalories by adding either liquid or powdered fortifier. the beginning of the study(study day 1) will be defined as reaching and tolerating 100ml/kg/day of 24 kilocalorie human milk fortified with either liquid or powdered fortifier. enteral feeds will be advanced per unit protocol until they reach 150-160ml/kg/day and 110-120 kcal/kg/day. the volume of feeds will be adjusted based on the documented weight to provide energy and protein requirements as recommended by the espghan guidelines. babies will be followed up until the time of nicu discharge.

Eligibility criteria:
inclusion criteria: * inborn preterm infants born between 28 0/7 and 34 0/7 weeks gestation and fed either mother's own milk or donor human milk exclusion criteria: * newborn infants \ 34 weeks gestation, those with life threatening illness, congenital and chromosomal anomalies, gastrointestinal anomalies or necrotizing enterocolitis and fed premature formula

Keywords: prematurity growth nutrition human milk fortifier