Kornimate/medical-research-clean huggingface dataset:
a study evaluating the efficacy of a single injection autologous adipose derived mesenchymal stromal cells in patients with knee osteoarthritis

Conditions: Osteoarthritis

Summary: ascs will be administered via intra-articular use into the knee joint affected by oa where they are expected to exert their therapeutic effects. the objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ascs versus standard of care (placebo), when administered locally into a knee joint affected by oa after in vitro cell expansion. the potential of asc to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by mri after 1 and 2 years. this will be a phase iib, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous asc with placebo.


Eligibility criteria:
inclusion criteria: * symptomatic mild to moderate osteoarthritis (oa) of the index knee as defined by the american college of rheumatology (acr) * must meet pain criteria at the time of screening/baseline visit since at least half of the days in the previous month * nsaid washout of at least 2 days before screening/baseline exclusion criteria: * previous treatments acting on cartilage or bone metabolism * received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months, * significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening. * kellgren-lawrence grade 1 or 4 in the index knee on any incidences. * osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, or contralateral knee (≥ 20 mm pain) as confirmed by a separate vas at baseline for any other painful joint concerned * history of joint replacement of the knee or hip within the previous 12 months
in-vitro myometrial contractility after oxytocin pre-exposure in women with advanced maternal age and morbid obesity

Conditions: Postpartum Hemorrhage

Summary: women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (cs), and are at a greater risk for postpartum hemorrhage (pph). oxytocin is the first line drug in the treatment of pph, however, oxytocin receptor (otr) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. it is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. further it is not known if the higher incidence of pph seen in these women is due to poor uterine contractility and/or poor response to oxytocin. the investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.

in view of the growing concern over the rising incidence of later maternal age and morbid obesity in the obstetric population, scientific evidence on pregnancy outcomes in these patients is timely and important. the investigators' previously validated in-vitro model provides a solid foundation for the study of myometrial contractility under controlled conditions, without any confounders that could be encountered in clinical settings. it is also likely to provide in-depth understanding of the parameters that the investigators feel are responsible for higher incidence of pph in these patients. the investigators' study will form a basis for future modifications in oxytocin augmentation regimens and pharmacotherapy for control of pph in these patient populations.

Eligibility criteria:
inclusion criteria: * patients who give written informed consent * patients requiring elective primary or 1st repeat cesarean section * patients with gestational age 37-41 weeks * non-labouring patients, not exposed to exogenous oxytocin * cesarean section under spinal anesthetic * patients \<30 years of age with a normal pre-pregnancy bmi (20 and 24.9 kg/m2) * patients ≥40 years of age with a normal pre-pregnancy bmi * patients with a bmi≥40 kg/m2 and age \<30 years exclusion criteria: * patients who refuse to give written informed consent * patients who require general anesthesia * patients who have had more than one previous uterine surgery/cs * patients with placental abnormalities (abruption, accreta, percreta) * patients with bleeding disorders * presence of any other risk factors for pph

Keywords: uterine contraction dose response oxytocin
mylan insulin aspart study

Conditions: Diabetes Mellitus, Type 1

Summary: the aim of this phase iii trial is to demonstrate the equivalence in the safety and efficacy profile between myl-1601d and novolog® in patients with t1dm.

this is a multicenter, open-label, randomized, parallel-group phase 3 study in subjects with t1dm comparing the safety and efficacy of myl-1601d with novolog®. after up to 3-week screening period, all subjects will be titrated on novolog® during a 4-week run-in period, and will be shifted from their current basal insulin to study insulin lantus®. after run-in period, subjects will be randomized; one group will receive myl-1601d, while the other group will receive novolog® for 24 weeks. a follow-up visit, via telephone call, will be scheduled 4 weeks after last dose of myl-1601d.

Eligibility criteria:
inclusion criteria 1. written and signed informed consent. 2. clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening. 3. subject is able and willing to comply with the requirements of the study protocol. exclusion criteria 1. history or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk from study participation. 2. history of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the study, or history of significant allergic drug reactions. 3. any clinically significant abnormality in electrocardiogram or safety laboratory tests. 4. any elective surgery requiring hospitalization planned during the study period. 5. history of a significant medical condition, such as unstable angina, myocardial infarction, stroke or transient ischemic attack in the 6 months before screening. 6. subjects with major depressive illness in the last 3 years. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
non-invasive detection of tissue oxygen deprivation in premature infants with patent ductus arteriosus.

Conditions: Premature Infant; Patent Ductus Arteriosus; Hemodynamic Instability

Summary: the proposed research evaluates tissue oxygenation (sto2) as measured by resonance raman spectroscopy (rrs) in premature infants with and without patent ductus arteriosus (pda). this is a prospective observational study of infants born at \< 30 weeks of gestation. the primary aim of this study is to determine if the difference in pre- and post-ductal sto2 as detected by rrs is more significant in premature infants with pda in comparison to infants without pda. the secondary aim of this study is to determine if the difference in pre- and post-ductal sto2 as detected by rrs is more significant in infant who develop serious adverse events.


Eligibility criteria:
inclusion criteria: * infants \< 30 weeks estimated gestational age exclusion criteria: * infants with major congenital anomalies * infants \>34 weeks post-menstrual age

Keywords: premature infant tissue oxygenation patent ductus arteriosus
study to evaluate benefits & safety of endourage formula c™ oral drops in people with post-acute covid-19 syndrome.

Conditions: Covid 19

Summary: this study will explore the contribution of cbd oral drops in persons experiencing symptoms of post acute covid syndrome or "pacs".

at present, conventional medical and rehabilitation therapies have not consistently been effective for people with pacs, and in fact some symptoms have been observed to worsen over time. this inconsistency in clinical response has created a need for alternative treatment options to be explored. cbd presents a novel approach that warrants further investigation. after review and approval by an institutional review board (irb), potential study participants will be recruited from on-line support groups who have identified themselves as persons experiencing post-acute covid-19 syndrome also known as (long-haulers syndrome). the study will be registered on the www.clincaltrials.gov website and will accept referrals from targeted clinics who refer their patients to the investigational site listed and individuals can also self-refer to the study center team. subjects will be evaluated weekly using telemedicine procedures. at completion of study, there will be a 7-day and 14-day follow up telemedicine visit to assess for continued benefit and/or re-emergence of symptoms/relapse.

Eligibility criteria:
inclusion criteria: 1. age 18 years of age or older who can provide informed consent. 2. persons who have been diagnosed with covid-19 and now in post-acute recovery phase. 3. persons who are in care with access to primary care for post covid infection or pacs. 4. ability to read and write in the english language and follow study-related procedures. 5. ability to have mail/ study drug delivered to an address and/or p.o. box in the recipient's name. 6. ability to participate in telemedicine visits/communication. 7. if a woman of childbearing age, willing to use a dual method of contraception (barrier and/or hormonal). exclusion criteria: 1. active illicit or non-prescribed drug use. 2. concomitant use of benzodiazepines. 3. concomitant use of an immune suppressant agent, e.g., prednisone. 4. documented history and active treatment for seizure disorder. 5. transaminase elevation. 6. active autoimmune disorder. 7. hepatitis c infection (currently on therapy and/or any transaminitis elevation). 8. hepatitis b infection (currently on therapy and/or any transaminitis elevation). 9. human immune deficiency virus (hiv-1 or hiv-2) infection that is newly diagnosed or untreated. 10. any form of mental impairment that will/could hinder safe participation in the study. 11. pregnancy or breast-feeding. 12. any condition that in the opinion of the investigator would be harmful or detrimental to the participant.
pegylated liposomal doxorubicin (caelyx(r)) as monotherapy in elderly patients with locally advanced and/or metastatic breast cancer (study p05059)

Conditions: Breast Neoplasms

Summary: the purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.


Eligibility criteria:
inclusion criteria: * patients meeting the following criteria will be eligible for enrollment. * female patients with histologic or cytologic diagnosis of breast cancer that is locally advanced or metastatic, and not amenable to surgery. * age \>= 65 years. * world health organization (who) performance status 0 - 2 * measurable disease in accordance with response evaluation criteria in solid tumors (recist) criteria. patients with bone metastasis can also be included but will be evaluated according to who criteria. patients with non-measurable disease can also be included. * left ventricular ejection fraction (lvef) \>= 50% verified by ultrasound cardiography (ucg); no clinical signs of heart disease. * normal organ function, except due to disease involvement, however maximum deviation: * s-creatinine \<= 1.5 x upper normal limit; * bilirubin \<= 2 x upper normal limit; * alanine aminotransferase (alat) and/or aspartate aminotransferase (asat) \<= 3 x upper normal limit. in case of liver metastases, alat and/or asat \<= 5 x upper normal limit. * adequate bone marrow function, ie: * platelets \>= 100 x 10\^9/l; * neutrophils \>= 1.5 x 10\^9/l; * white blood cell (wbc) \>= 3.0 x 10\^9/l; * hemoglobin \> 90 g/l. * life expectancy \>= 12 weeks. * patients having received oral and written information and having provided written informed consent. exclusion criteria: * patients will not be enrolled if any of the following conditions apply. * previous chemotherapy for metastatic disease. (the patient may have received previous endocrine therapy or single-drug herceptin. intrapleural or intrapericardial novantrone is allowed.) * recurrence \ 300 mg/m\^2 or epirubicin \> 540 mg/m\^2. * myocardial infarction within 6 months of planned inclusion. * symptomatic brain metastases. * human epidermal growth factor receptor 2 (her-2) positivity eligible for treatment with trastuzumab, or estrogen receptor (er) positivity eligible for hormonal therapy. * allergy to anthracyclines. * uncontrolled infection. * other not radically treated malignancy. * other disease or condition contraindicating treatment or not allowing follow-up.
percutaneous screw fixation for acute scaphoid fractures through k-wire-assisted reduction and maintenance

Conditions: Hand; Wrist; Wounds and Injuries

Summary: the scaphoid is the most common fractured carpal bone in active adults, accounting for up to 80% of all carpal fractures. the optimum treatment approach of the acute scaphoid fractures is under discussion. cast immobilization is the main treatment for non-displaced scaphoid fractures, however, about 20% of scaphoid fractures fail to heal with conservative treatment. long periods of cast immobilization may result in wrist stiffness, loss of grip strength, muscle atrophy and disuse osteopenia. operative treatment for displaced and unstable scaphoid fractures was mostly adopted, however, open fixation for scaphoid fractures have the inherent disadvantages of ligament and capsular dissection, blood vessels damage. this study introduces a novel measures of percutaneous screw fixation for acute scaphoid fractures. we used one k-wire maintaining the reduction of the scaphoid fractures throughout the entire process of drilling and screw insertion and screw fixation for acute scaphoid fractures.


Eligibility criteria:
inclusion criteria: * acute scaphoid fractures * injury to surgery less than 7 days * only one injured hand * written informed consent to undergo the surgical procedure * patients of either sex aged between 18 and 70 years exclusion criteria: * patients with vascular injuried requiring revascularization * concomitant phalanx fractures or other injuries needing immobilization * loss of skin substance requiring grafts or flaps * uncompensated diabetes, neoplasia, haemocoagulative alterations, psychic disorders * smokers
evaluation of an algorithm for identifying persistent nasal staphylococcus aureus carriage in a cohort of healthy volunteers and patients regularly monitored at the chu of saint-etienne

Conditions: Staphylococcal Infections

Summary: the nasal carriage of staphylococcus aureus is a major risk factor of s. aureus infection, notably in hemodialysis patients (hps). decolonization strategies were shown able to reduce the rate of s. aureus infection in this category of patients although the risk of emergence of antimicrobial resistance persists. approximately one quarter of the general population is colonized by s. aureus in the anterior part of the nostril (vestibulum nasi). three main categories of nasal carriers have been historically identified: persistent carriers (20%, 12-30%\]), intermittent carriers (30%, \[16-70%\]) and non-carriers (50% \[16-69%\]). by contrast to intermittent carriers and non-carriers, persistent nasal carriers have a higher risk of s. aureus infection, especially in continuous peritoneal dialysis and in orthopedic surgery. persistent carriers are characterized by a higher nasal bacterial load, a longer duration of carriage, a lower rate of exchange of s. aureus strains, and a particular affinity for the carried strain. however, there is no consensual definition of this persistent carriage state. in previous studies, 5 to 12 nasal sampling episodes were realized for a period ranging from 5 weeks to 8 years. the index of carriage, corresponding to the number of samples positive for s. aureus divided by the total number of samples, has been proposed to standardize the definition of the carriage state. according to standard tools, it is almost impossible to determine the nasal carriage state in routine practice. recently, an algorithm based on one or two quantitative cultures from nasal samples taken within 2 days that was able to distinguish accurately persistent and non-persistent nasal carriers of s. aureus has been described; only one nasal sample was needed in more than 9 cases out of 10. the aim of the present study was to assess prospectively the reliability of this algorithm in clinical practice in a cohort of healthcare workers (hcws) and hps and to check its ability for identifying patients with the highest risk of s. aureus infection


Eligibility criteria:
inclusion criteria: * healthy volunteers or hemodialysis patients * carrier state of s. aureus unknown * written consent exclusion criteria: * chronic soft skin tissue infection due to s. aureus or eczema, * ongoing or completed antibiotic treatment for less than 15 days, * nasal decolonization by mupirocin or skin decolonization by antiseptic bath for at least 5 consecutive days in the previous year, * pregnancy, * hiv infection * hemostasis disorder.

Keywords: nasal carriage staphylococcus aureus hemodialysis patients
pharmacokinetics and metabolism of [14c]bms-986165 in healthy male participants

Conditions: Psoriasis

Summary: an oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (ame) of bms-986165


Eligibility criteria:
inclusion criteria: * signed informed consent * target population: healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ecgs), physical measurements, and clinical laboratory tests * body weight of at least 50 kilograms (110 pounds); body mass index (bmi) between 18 to 32 kg/m2. * no evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination exclusion criteria: * history of any chronic or acute illness including active tb in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. * vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population. * participant with greater than grade 2 acne. * participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.
mentor integration study

Conditions: CHESS and Cancer Mentor; CHESS Only; Mentor Only; Control (Internet Only)

Summary: mentor integration project this study will investigate the benefits of chess, a human cancer mentor and the potential additional benefit of combining chess and a cancer mentor compared to internet access for women diagnosed with breast cancer. our goal is to advance interactive cancer communication systems, thus improving quality of life for patients and families facing cancer, especially underserved populations. primary aims: * determine if the internet, chess, a cancer mentor, or a combination of chess and the cancer mentor improve quality of life for women with breast cancer * determine which of the above conditions is most effective * determine which of the above conditions is most cost efficient


Eligibility criteria:
inclusion criteria: eligibility for this protocol is as follows: * all subjects must be within 2 months of their primary breast cancer diagnosis, * all subjects must be at least 18 years of age, * all subjects must be able to read and write english at the 6th-grade level * not homeless

Keywords: breast cancer internet computer support information education
trial of adjunctive vitamin d in tuberculosis treatment

Conditions: Tuberculosis, Pulmonary

Summary: the purpose of this study is to determine whether vitamin d enhances response to standard antibiotic treatment for pulmonary tuberculosis.


Eligibility criteria:
inclusion criteria: * suspected smear positive pulmonary tuberculosis. * age 18 years or older. * written informed consent to participate. exclusion criteria: * known intolerance of vitamin d or first-line anti-tuberculous therapy. * taking antituberculous therapy for more than six days in the six months preceding enrolment. * taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy. * taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol. * diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, hiv infection, liver failure, renal failure or malignancy * infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing) * biochemical disturbance at enrolment: serum corrected calcium \>2.66 mmol/l, serum ast \>120 iu/l, total serum bilirubin \> 40 micromol/l or serum creatinine \> 250 micromol/l * breastfeeding or pregnancy