Kornimate/medical-research-clean huggingface dataset:
esophageal balloon measurements to better characterize thoraco-abdominal interrelationship mechanics.

Conditions: Surgery

Summary: esophageal pressure measurements in surgical patients requiring mechanical ventilation during abdominal laparoscopic or robotic surgeries requiring intra-abdominal insufflation.

decades of research and clinical observation in mechanical ventilation have demonstrated unequivocally that tidal volume (vt), plateau pressure (pplat) and peep (positive end-expiratory pressure) influence ventilator induced lung injury. clinicians, however, have struggled in the attempt to find a single indicator of safety and risk. recent analyses of the large multi-center randomized trials database suggest that airway driving pressure (adp) and trans pulmonary driving pressure (dtp) are the variables of greatest importance and therefore the best single parameters on which to focus. in attempting to define their optimal values and their correlation between each other in the setting of intra-abdominal hypertension, we would like to compare standard of care mechanical ventilation (control) with mechanical ventilation guided by dtp and adp (intervention) in patients undergoing abdominal laparoscopic surgery.

Eligibility criteria:
inclusion criteria: * patients requiring mechanical ventilation for abdominal laparoscopic and robotic surgeries. * patients who are passively ventilated (no respiratory efforts) as a result of the sedation plan determined entirely by the primary anesthesia team --research team will not influence or participate on the sedation protocol plan or implementation. * patients who are clinically stable and able to tolerate the changes in position that are routinely conducted as part of the standard of care in the operative room. * patient/responsible family member signing the informed consent must speak english. exclusion criteria: * patients with open abdomen prior to surgical procedures. * females of childbearing age (18-50) with the potential to become pregnant and no clinically documented negative pregnancy test. * patients with clinically evident spontaneous breathing efforts (ventilator wave forms) during surgical procedure. * patients with clinical suspicion of elevated intra-cranial pressure (requiring head elevation). * contraindication to body position change, as dictated by surgery-specific protocol. * unstable cardio-respiratory insufficiency. * age less than 18 years. * cuff leak in endotracheal / tracheostomy tube. * patient/responsible family member unable to understand the informed consent in english. * patient with contraindication for nasogastric tube placement: * severe midface trauma * recent nasopharyngeal surgery * coagulation abnormality * esophageal varices, stricture, ulcerations, or tumors * recent banding of esophageal varices * alkaline ingestion * diverticulitis, * sinusitis, epistaxis
treatment study of bipolar depression

Conditions: Bipolar Disorder

Summary: the purpose of this study is to determine whether a single intravenous administration of an n-methyl-d-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

bipolar disorder (bpd) is a common, recurrent, and disabling medical condition. although mania is the defining feature of bpd, depression represents the majority of illness burden in patients with this devastating condition. despite the high degree of morbidity and mortality associated with bipolar depression, currently available treatments are few and often inadequate. recently, a single intravenous (iv) dose of the n-methyl-d-aspartate (nmda) glutamate receptor antagonist ketamine has demonstrated rapid antidepressant effects in severe unipolar depression. therefore, the objective of the current study is to investigate the safety and efficacy of a single iv dose of ketamine in treatment-resistant bipolar depression (trbd).

Eligibility criteria:
inclusion criteria: 1. male or female patients, 21-70 years; 2. primary diagnosis of bipolar i or ii disorder as assessed by the scid-p and confirmed by a study psychiatrist; 3. current depressive episode ≥ 8 weeks duration; 4. history of a failure to respond to at least three (3) adequate pharmacotherapy trials in the current depressive episode (see above for definition for adequate trials); 5. subjects must be on a stable dose of divalproex er with serum levels greater than 55 mcg/ml prior to enrollment; 6. subjects must be free of psychotropic medication for at least 2 weeks (4 weeks for fluoxetine) prior to enrollment (with the exception of divalproex er as above); 7. subjects must have scored ≥ 32 on the ids-c30 at both screening and infusion day #1 and #2; exclusion criteria: 1. women who plan to become pregnant, are pregnant or are breast-feeding; 2. any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease; 3. clinically significant abnormal findings of laboratory parameters, physical examination, or ecg; 4. lifetime history of schizophrenia, schizoaffective disorder, ocd, mental retardation, pervasive developmental disorders, or tourette's syndrome; 5. current presence of psychotic, mixed or manic symptoms; 6. lifetime history of antidepressant-induced switch to a manic episode; 7. history of rapid cycling bipolar subtype; 8. drug or alcohol abuse within the preceding 3 months or dependence within the preceding 5 years; 9. lifetime exposure to ketamine or phencyclidine; 10. patients judged by study investigator to be at high risk for suicide.

Keywords: bipolar disorder depression treatment-resistant ketamine antidepressant glutamate
hallux limitus treated with dynamic splinting: a randomized, controlled trial

Conditions: Hallux Limitus

Summary: the purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Eligibility criteria:
inclusion criteria: * reduced flexibility in arom of extension in the great toe * pain that is worsened by walking and/or squatting * impaired gait pattern exclusion criteria: * metatarsal stress fracture * interdigital neuroma * sesamoid pathology * gout * metatarsalgia

Keywords: hallux limitus dynamic splinting dynasplint
predictors of recovery expectancy

Conditions: Pelvic Organ Prolapse; Surgery

Summary: the purpose of this study is to identify factors that influence a person's expectations regarding recovery from pelvic organ prolapse surgery. this is important because a person's expectations regarding recovery from surgery help to predict how a person will actually recover. our hypothesis is that women with multiple roles will have expectations of a longer surgical recovery time after surgery for pelvic organ prolapse after controlling for known predictors of recovery expectancies. participants will complete a preoperative online survey. additional online surveys will be send on postoperative days 14 and 42 to measure postdischarge surgical recovery.


Eligibility criteria:
inclusion criteria: * patients with greater than or equal to stage ii pelvic organ prolapse who are scheduled for reconstructive surgery. * english speaking. * over the age of 18. * use email as a form of communication. * have a reliable internet connection at home. * have a computer/smartphone/tablet at home. exclusion criteria: * non english speaking patients * patients without active email. * patients without access to reliable internet connection. * patients without access to computer/smartphone/tablet. * patients with less than stage ii prolapse.

Keywords: recovery
a study to evaluate denosumab in the treatment of postmenopausal osteoporosis

Conditions: Osteoporosis

Summary: this study will evaluate the effectiveness and safety of denosumab in treating women with postmenopausal osteoporosis.


Eligibility criteria:
inclusion criteria: * women who are 60 to 90 years of age may be eligible to participate * bone mineral density (bmd) t-score at hip or spine must be less than -2.5 exclusion criteria: * bmd t-score at the hip or the spine of less than -4.0 * patients with any severe or more than two moderate vertebral fractures on spinal x-ray at entry

Keywords: postmenopausal osteoporosis
correlation study between pest and scorad in management of atopic dermatitis with ceradan® regimen

Conditions: Atopic Dermatitis

Summary: this is a prospective, open label, single arm, and observational and multicenter study to assess the correlation between pest and scorad scores in the management of ad with the ceradan® regimen.

all eligible patients shall apply permitted topical steroid(s) according to standard local practice for the entire study period, patients should apply ceradan cream® liberally twice daily or more, if required and use a non-soap based wash once or twice daily. at the screening visit, patients will receive a diary card and will be asked to track their atopic dermatitis symptoms for 12 weeks. retrospective information on other topical treatments used will be collected at baseline.

Eligibility criteria:
inclusion criteria: * male and female children aged ≥6 months to ≤6 years * baseline pest score of 3- 4 * diagnosis of mild to moderate atopic dermatitis, with grading of 3 to11, as per the ness * diagnosis of current flare (increased dryness, itching, redness, swelling and general irritability) at baseline visit according to investigator's judgement * patients who have not visited the dermatologist before (dermatologist-naïve) * agree to participate and provide written consent by parent or guardian (and assent if applicable) exclusion criteria: * history of severe episodes of atopic dermatitis (for example: oozing, crusts) * clinical signs of skin infection (viral, bacterial or fungal) * grading of \>11 as defined by the nottingham eczema severity score (ness) within 3 months prior to study inclusion * known reaction or allergy to test drug or excipients or steroids * history of cutaneous or systemic viral (including hiv or aids), cutaneous mycotic or cutaneous bacterial disease requiring a topical or systemic therapy during the study period * patients who are receiving any investigational drug or who have taken part in a clinical study with an investigational drug within three months prior to the start of study treatment * the patient has been exposed to below therapy within the set timeframe: i. systemic administration of corticosteroid - four weeks; ii. systemic administration of immunosuppressive drugs - four weeks; iii. uv therapy four weeks * any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results * parents/guardians may be unable to complete the patient diaries or questionnaires

Keywords: children atopic dermatitis ceradan pest scorad
study to evaluate the pharmacokinetics of fidaxomicin in inflammatory bowel disease (ibd) subjects with clostridium difficile infection (cdi)

Conditions: Inflammatory Bowel Disease (IBD); Clostridium Difficile Infection (CDI)

Summary: the purpose of this study is to investigate the plasma pharmacokinetics (pk) of fidaxomicin (fdx) and primary metabolite op-1118 in subjects with inflammatory bowel disease (ibd) and c. difficile infection (cdi). this study will also compare cdi clinical response to the microbiological response in terms of magnitude of reduction of c. difficile total viable count and spore count during treatment with fdx and if achieved; the time to microbial eradication; determine time to negative cdi toxin assay in stool specimens during treatment with fdx; assess the stool concentrations of fdx and metabolite op-1118 throughout therapy; assess the length of hospital stay, readmissions and resource utilization for ibd patients receiving fdx; record the incidence and severity of adverse events (aes) and document the impact of treatment on quality of life as measured by the changes in short inflammatory bowel disease questionnaire (ibdq) score.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis or history of ibd for at least 3 months * subject has have active ibd defined by : * partial mayo score (ulcerative colitis subjects) of 2 or more, where at least 1 point has to originate from blood in stool * harvey-bradshaw index (hbi) (crohn's disease subjects) of 5 or more, excluding points for complications * cdi confirmed positive according to local standard testing for the presence of c. difficile within 48 hr prior to enrollment * female subject is not breastfeeding at screening or while participating in this study * subject agrees to practice effective birth control from screening and while participating in this study * subject agrees not to participate in another interventional study while participating in this study * male partner agrees not to donate sperm starting at screening and throughout the investigational period. exclusion criteria: * subject has received more than one day of dosing of any cdi therapy within the 48 hrs prior to enrollment * subject is unable to swallow oral study medication * presence of an ostomy or short bowel syndrome * subject has a current diagnosis of toxic megacolon * subject is not willing to adhere to the provisions of treatment and observation specified in the protocol * subject has been enrolled into this study previously, has taken any investigational drug within 28 days or 5 half-lives, whichever is longer, prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the sponsor * subject has previously participated in a cdi vaccine study * subject has hypersensitivity to fdx or any of its components * subject has a condition which, in the investigator's opinion, makes the subject unsuitable for study participation

Keywords: asp2819 par-101 opt-80 inflammatory bowel disease (ibd) clostridium difficile infection (cdi) fidaxomicin dificlir
a research study looking at new protein-based tablets in healthy male participants

Conditions: Healthy Volunteers; High Blood Cholesterol Levels; Type 2 Diabetes

Summary: in this study, four new tablet versions of two compounds will be investigated. the aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. the tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. participants will receive one treatment for 10 days in the first period. for the second period, directly following, participants will receive a different treatment for five more days. the study can last for up to approximately 10 weeks for each participant. this includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)


Eligibility criteria:
inclusion criteria: * male. * aged 18-55 years (both inclusive) at the time of signing informed consent. * body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive). * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * known or suspected hypersensitivity to study interventions or related products. * use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening. * any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. * presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator. * history (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
total motile sperm count and pregnancy rate from intrauterine insemination

Conditions: Insemination

Summary: intrauterine insemination (iui) is one of the most important infertility treatments. infertility is failure to establish pregnancy (\>12 months) with regularly unprotected sexual intercourse. post-wash total motile sperm count (tmsc) vaguely defined as a predictor of iui pregnancy rate. the minimum value required is also not clear. this study aimed to further define the relationship and determine the minimum recommended value to achieve a satisfactory iui pregnancy rate. post-wash tmsc is predictive of iui success. no optimal cut-off could be identified. in conclusion, post-wash tmsc is highly suggested as a quantitative predictor along with others in counseling and informed consent. the recommended threshold value is \>3 x 106.


Eligibility criteria:
inclusion criteria: * post-wash total motile sperm count needed to be over 5 x 10\^5 exclusion criteria: * missing data on pregnancy outcome and missing medical records

Keywords: infertility intrauterine insemination post-wash total motile sperm count
efficacy of an online self-help program for negative affect and depression

Conditions: Depressive Symptoms; Depression

Summary: the aim of the study is to test body, breath \& mind (bbm, internet-based self-help program) for its efficacy in reducing depressive symptoms and improving quality of life. bbm combines methods of value-oriented behavioral activation with exercises from the chinese healing practice qi gong,. bbm will be compared to an active control treatment (moodgym) and a waiting list control group. we expect significant differences to the waiting list control group. in comparison to the active control treatment we expect no significant differences.


Eligibility criteria:
inclusion criteria: * all persons who suffer from depressive symptoms (subthreshold and clinical depression; phq-9 ≥10) * german speaking * internet and email access exclusion criteria: * the dsm-defined criteria a9 acute suicidality and a5 psychomotor agitation in the context of a depressive disorder, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * psychotic disorders, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * major depression with psychotic features, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * eating disorders, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * current or past schizo-affective disorder, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * current substance use disorder, verified using the diagnostic interview in mental disorders in form of the mini-dips (margraf \& cwik, 2017) * inability to participate in the program due to physical, practical, or other reasons.

Keywords: depression quality of life online self-help program randomized control trial qigong
safety and efficacy of (pn-152,243)/pn-196,444 in the prevention of thrombocytopenia

Conditions: Neoplasms; Thrombocytopenia; Multiple Myeloma; Lymphoma, Malignant

Summary: intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. this investigational drug has demonstrated the ability to increase platelet counts. this study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.


Eligibility criteria:
inclusion criteria: * patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support exclusion criteria: * patients must not have active bleeding (exclusions do apply) or history of platelet disorder
peer education program for hiv/aids related sexual behaviors of secondary school students

Conditions: HIV

Summary: worldwide, about 50% of all new cases of hiv occur in youth between age 15 and 24 years. studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. peer-based interventions have become a common method to effect important health-related behavior changes and address the hiv/aids pandemic. this study therefore aimed to evaluate the effectiveness of peer education in improving hiv knowledge, attitude, and preventive practices among in-school adolescents


Eligibility criteria:
inclusion criteria: * at least 14 years of age; * non-injecting use of heroin, cocaine or crack cocaine in the last six months; * test hiv antibody negative; * agree to provide specimens for testing (hiv, hbv and pregnancy) and be willing to learn the results of these tests; * willing to return for visits at 1, 6, and 9 months post-enrollment; * willing and able to provide informed consent. exclusion criteria: * history of injection drug use in the previous 3 years; * pregnant;