Kornimate/medical-research-clean huggingface dataset:
corneal biomechanics and continuous iop monitoring using soft contact lenses in glaucomatous patients

Conditions: Open Angle Glaucoma With a Progressive Visual Field

Summary: ocular hypertension and its fluctuations is a major risk factor of glaucoma onset and progression. in normal eyes, iop presents a circadian rhythm, but in glaucomatous eyes iop circadian rhythm is altered and varied widely between patients. to date, the only way to evaluate 24 hour iop fluctuations is a regular gat-iop measurement during a 24-hour hospitalization. this method is expensive and does not reflect physiological conditions because it requires iop measurements during sleeping periods that may potentially produce artifacts. sensimed ag has developed a new medical device sensimed triggerfish® that enables a 24-hour continuous monitoring of iop fluctuations. as any iop measurements methods, this medical device might be influenced by corneal properties of the cornea as central corneal thickness, keratometry or biomechanics. we, therefore, investigate the corneal lens tolerance, potential modifications of corneal parameters after a 24-hour wear of the lens, and its influence on data collected during the whole period of analysis. then we will also analyze the influence of corneal parameters on continuous iop fluctuations measured with the contact sensor and finally the correlation between data collected and the rate of progression (severity) of glaucoma evaluated with visual field test or optic nerve head damages.


Eligibility criteria:
inclusion criteria: * at least 40 year-old * signed informed consent * visual field defect : at least 2 visual field already done, only the second one is considered for the visual field defect diagnosis, using theses criterion: * 3 adjacent points with at least 5db loss * or 1 point with at least 10 db loss * or a 10db difference between two adjacent points on either sides of the nasal horizontal meridian * open angle glaucoma patients with a progressive visual field * for women of childbearing potential, adequate contraception exclusion criteria: * corneal dystrophy, scars or corneal surgery * iridocorneal angle opening less than 3 using shaeffer classification * history of glaucoma surgery * any contraindications with the sensimed triggerfish® device, as written in the user manual (active eye disease, severe dry eye, contraindications for silicone contact lens wear...) * diabetes * sleep apnea syndromes * cataract surgery * high myopia * pregnancy and lactation * patients not able to understand the character and individual consequences of the investigation

Keywords: open angle glaucoma corneal biomechanics intra ocular pressure iop iop fluctuation continuous iop monitoring sensimed triggerfish®
pharmacokinetics and tolerability of minodronic acid and food and age effects on the pharmacokinetics

Conditions: Osteoporosis

Summary: the primary objective of the the study was to evaluate the pharmacokinetic properties of minodronic acid tablets following single and multiple oral administration in healthy chinese subjects. additionally, the effects of age and food on minodronic acid pharmacokinetics was also explored.

this was a single-center, phase i study in healthy young (19-30 years) and elderly (60-65 years) volunteers, which was conducted in four parts. in part 1, minodronic acid tablets were administered to young volunteers at doses of 1, 2, and 4 mg. in part 2, after a single dose, young volunteers in the 1-mg dose group received repeated oral doses of minodronic acid once daily for 7 days. in part 3, a single oral dose of minodronic acid 1 mg was administered to elderly volunteers. in part 4, after a washout period of 8 days, volunteers in the 4-mg dose group received a single dose of 4 mg minodronic acid under fed conditions (administrated 30 minutes before high-fat breakfast). plasma samples were collected and plasma concentrations of minodronic acid were analyzed by lc-ms/ms. tolerability was assessed throughout the study by physical examinations, vital signs measurement, laboratory analyses, and monitoring of adverse effects.

Eligibility criteria:
inclusion criteria: * subjects were included based on the following criteria: * males or females aged 19 to 35 years for young subjects or aged 60 to 65 years for elderly subjects * body mass index between 19 and 24 kg/m2 * thorax radiography and ecg with no abnormalities * normal blood pressure values * heart rate * laboratory test results (hematology, blood biochemistry, hepatic function, and urinalysis) * negative test results for hiv and hepatitis b. exclusion criteria: * subjects were excluded if they had a heart disease or disorder * a hepatic, renal, respiratory, immune system, or nervous system disorder * any of the following conditions: * pregnancy * breast-feeding * hypocalcemia * prescription or over-the-counter medication use (including herbal products) within 2 weeks before the initiation of the study * blood donation or participation in other clinical trials within 3 months before enrollment in the study * alcohol or drug abuse * smoking more than 10 a day * clinically significant allergies to drugs or foods * sitting blood pressure \ 140/100 mm hg * a ventricular rate \ 100 beats/min at rest.

Keywords: minodronic acid pharmacokinetics tolerability food age chinese subjects
using cumulase for denudation of cycles with ≤ 8 cumulus-oocytes complexes

Conditions: Infertility

Summary: the cumulus-corona-oocyte complex (cocs) surrounds each oocyte and must be removed prior to intracytoplasmic sperm injection (icsi). this is traditionally achieved with a bovine-derived hyaluronidase followed by mechanical denudation through pipetting. a human recombinant hyaluronidase (cumulase) has been developed to circumvent the problems and concerns associated with the animal origin and lack of purity of the bovine-derived form of the enzyme. whether cumulase offers a higher chance for success after icsi for women with 8 cocs or lower remains an open question.


Eligibility criteria:
inclusion criteria: * icsi indicated partcipants exclusion criteria: * severe medical disease
study of allogeneic adipose-derived mesenchymal stem cells for treatment of covid-19 acute respiratory distress

Conditions: Covid19

Summary: this is a phase 2 study to assess covi-msc in the setting of current standard of care in hospitalized subjects with rt-pcr confirmed sars-cov-2 (covid-19) infection and acute respiratory distress / acute respiratory distress syndrome.

this is a phase 2 multicenter (united states and mexico) study to assess the safety and preliminary efficacy of covi-msc in the setting of current standard of care in hospitalized subjects with rt-pcr confirmed sars-cov-2 (covid-19) infection and acute respiratory stress (ard) / acute respiratory distress syndrome (ards). subjects will be randomized 1:1 covi-msc to placebo. covi-msc or placebo will be administered intravenously on day 0, day 2, and day 4.

Eligibility criteria:
inclusion criteria: * laboratory-confirmed sars-cov-2 infection as determined by an approved polymerase chain reaction (pcr) or an approved antigen test of any specimen (can be documented from inpatient medical record) * hospitalized with at least "severe" covid-19-induced ard or ards as defined per fda guidance; covid-19: developing drugs and biological products for treatment or prevention * requires oxygen supplementation at screening * willing to follow contraception guidelines exclusion criteria: * current standard of care treatments for covid-19 appear to be working and the subject is clinically improving * has severe ards with a pao2/fio2 (pf ratio) ≤ 100 mmhg or spo2/fio2 ratio \< 150 mmhg with peep ≥ 5cm h2o * a previous stem cell infusion unrelated to this trial * pregnant or breast feeding or planning for either during the study * suspected uncontrolled active bacterial, fungal, viral, or other infection (aside from infection with covid-19) * history of a splenectomy, lung transplant or lung lobectomy * concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable) * expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days * has an existing "do not intubate" order * has undergone home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for continuous positive airway pressure or bi-level positive airway pressure (cpap/bipap) used solely for sleep-disordered breathing (eg, obstructive sleep apnea) * has any significant medical condition, laboratory abnormality or psychiatric illness that in the investigator's opinion would interfere or prevent the subject from safely participating in the study

Keywords: covid-19
tumor: breast ratio study

Conditions: Breast Cancer; LCIS; DCIS

Summary: this is an observational study of 3 arms: breast conservation therapy, mastectomy and reconstruction, and mastectomy only.


Eligibility criteria:
inclusion criteria: * patient must be scheduled to undergo breast conservation therapy (bct), mastectomy or mastectomy with immediate reconstruction (defined as initiating the reconstructive process at time of mastectomy) for ductal carcinoma in situ (dcis), lobular carcinoma in situ (lcis), and early stage breast cancer (clinical stages ia-iib). stage iib tumors are 2-5 cm with micrometastases 0.2 to 2.0 cm in lymph nodes; or 2-5 cm tumor with 1-3 positive axillary or internal mammary lymph nodes, or \>5 cm with no lymph node involvement. clinical staging, based on imaging and physical exam will be used for enrollment. patients that are upstaged due to unexpected findings at the time of surgery/assessment of surgical pathology will be excluded at that time. for staging reference please see http://www.cancer.gov/cancertopics/pdq/treatment/breast/patient/page2#keypoint13 * if multifocal/multicentric disease of the ipsilateral breast is encountered and patients are still deemed eligible for bct or mastectomy per standard of care, then the tumor area will be calculated as the total volumes of the identified foci. * patient must be between 18-72 years old * patient must be able to understand and willing to sign a written informed consent document exclusion criteria: * cognitive impairment * history of radiation to the chest wall or breasts * patients unable to undergo mri due to metallic implant or claustrophobia * patients that are pregnant since breast mri is contraindicated * history of previous breast surgery other than primary cosmetic augmentation or breast reduction * identification of a concurrent or synchronous contralateral cancer during the enrollment period * any patient that would not have been considered for bct or reconstruction * bct patients planning to proceed with reconstruction during their study participation timeline

Keywords: mastectomy breast cancer reconstruction lumpectomy breast conservation therapy
a study of the l-ppds with adjunctive xalatan® eye drops in subjects with oh or oag

Conditions: Ocular Hypertension; Open-Angle Glaucoma

Summary: the objective of this study is to investigate how the intraocular pressure (iop)-lowering effect of the l-ppds is altered by adjunctive xalatan therapy.


Eligibility criteria:
inclusion criteria: * over 18 years * diagnosed with bilateral open-angle glaucoma or ocular hypertension * currently on prostaglandin therapy exclusion criteria: * uncontrolled medical conditions * subjects who wear contact lenses * subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Keywords: ocular hypertension open-angle glaucoma xalatan iop
a chw intervention to identify and decrease barriers to covid 19 testing & vaccination

Conditions: Vaccine Hesitancy; COVID-19 Testing; Community Health Workers

Summary: the objective of this study is to compare the results of a covid-19 specific curriculum led by lacdhs community health workers (chws) from these same communities of safety-net patients to effectively increase covid-19 testing and vaccination for individual patients, and to facilitate needed healthcare in a timely manner for the safety net health system, and to develop a sustained public health presence in these communities to build trust and preparedness for critical covid-19 related future needs.

this study represents the third aim of a grant with three aims. the study used unsupervised machine learning and qualitative interviews to develop a chw intervention for this aim. the aim will compare and evaluate a community health worker-led curriculum aimed to identify and address barriers to covid-19 testing and vaccination among lacdhs safety-net patients. for the study, the investigators will recruit 66 eligible safety-net patients for a covid-19 specific curriculum, provided by community health workers at los angeles county department of health services. the study will take place remotely over the course of 6-weeks. utilizing a randomized control design among african american and latinx safety net patients, will assess the effect of the chw hypothesis-driven intervention on trust, self-efficacy, and intent to participate in covid-19 testing and vaccination. the remote chw intervention that the study participants will participate in and be compensated for is a pilot program intended to provide additional chw training. monthly calls from lacdhs to remind them of covid-19 vaccination are standard of care for all empaneled lacdhs patients.

Eligibility criteria:
inclusion criteria: * age 16 years and older * self-identify as african american or latinx * english speaking * receives primary or specialty care treatment at an lacdhs facility * has either not completed lab orders for covid-19 testing and/or vaccination at an lacdhs facility * have reliable internet access exclusion criteria: * not meeting the inclusion criteria listed above

Keywords: covid-19 vaccine hesitancy covid-19 testing community health workers safety-net patients
effects of combined high intensity interval training and resistance training

Conditions: Hypertension

Summary: background: hypertension has long been considered as a major risk factor for cardiovascular disease representing a high public health concern. objectives: the purpose of this study is to evaluate the effects of combined hiit and resistance training on body composition, blood pressure, and cardiorespiratory fitness in obese hypertensive men. methods: this study will make use of sixty obese hypertensive men aged 40 to 60 years. all participants meeting the eligibility criteria will be assigned to one of three groups; combined hiit and resistance group, hiit only group or control group. combined exercise group subjects will undergo weekly three sessions of both hiit and resistance training for sixteen weeks. the hiit session will involve four four-minute high-intensity intervals with an intensity of at 80-95% of the hrmax interspersed with two-minute active recovery intervals with intensity of 40% to 60% of the hrmax. the resistance training session will be composed of eight exercises perform 3 sets of 8-12 repetitions with an intensity of 80% of the subject's estimated 1-rm. the hiit only group perform 12 weeks of hiit only. the control group subjects will be instructed not to change their usual daily physical activities routine and instructed to abstain from practicing any exercise regimens during the 12-week study period. body composition measures, blood pressure and vo2peak will be assessed at baseline and at the end of the study period. results: all the outcome variables will be assessed at baseline and 12 weeks following the treatment period.


Eligibility criteria:
inclusion criteria: * men aged between 40 and 60 years old, * have been diagnosed with clinical stage 1 or 2 hypertension, * being obese with body mass index more than 30 kg/m2 * physically inactive exclusion criteria: * musculoskeletal problems that may limit their ability to participate in resistance or hiit programs * diabetes mellitus * a history of respiratory or chronic heart disease

Keywords: hypertension. obesity high intensity interval training resistance training blood pressure
mini stem dexa (dual energy x-ray absorptiometry)

Conditions: Osteoarthritis, Hip

Summary: the objective of this study is to evaluate the bone ingrowth after implantation of the study device. this study will also document any device-related surgical complications or adverse radiographic observations. improvement in pain, function, and health economic data will be compared with improvements documented with other joint systems.

the purpose of the current investigation is to assess the bone ingrowth after implantation with a modular, short hip stem using dual energy x-ray absorptiometry (dexa). the intended use of this product is for patients with non-inflammatory and inflammatory degenerative joint disease who require a primary total hip replacement.

Eligibility criteria:
inclusion criteria: * patient has hip disease that requires a total hip arthroplasty. * patient is willing to consent to participate in the study. * patient plans to be available for the study duration. * patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk. exclusion criteria: * patient known to have insufficient bone stock. * patient has had major non-arthroscopic surgery to the study hip. * patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up. * patient has a known sensitivity to materials in the device.
a phase i/ii study of cp-4055 in patients with platinum resistant ovarian cancer

Conditions: Ovarian Cancer

Summary: this is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage iii and iv) ovarian cancer it will be conducted in two successive phases. phase ii has a two-step design

phase i * three eligible patients will be enrolled at each dose level (dl), according to standard dose escalation decision rules * patients will receive cp-4055 at increasing dls until the maximum tolerated dose and the recommended dose (rd) have been established phase ii * step 1 (the patient inclusion may stop after this step): * patients will be enrolled at the rd until there are maximum 16 evaluable patients at this dl * step 2: * depending on the response rate at step 1, up to 26 patients will be included and treated at step 2

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented advanced epithelial ovarian cancer measurable with ct and/or mri * received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (pbt) * evidence of platinum resistant or refractory disease * ecog performance status 0 - 1 * life expectancy \> 3 months * signed informed consent (ic) * women of child-bearing potential must have a negative serum or urine pregnancy test. nursing patients are excluded. * women of child-bearing potential must not become pregnant while participating in the study * adequate haematological and biological functions exclusion criteria: * patients with mixed mullerian tumours (mmt) (carcinosarcomas) * known brain metastases * another known active cancer within the last 5 years * radiotherapy to more than 30 % of bone marrow * participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study * concomitant treatment with a non-permitted medication * a history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to cp-4055, i.e., ara-c and/or egg * any serious concomitant systemic disorders incompatible with the clinical study * any significant cns or psychiatric disorder(s) that would hamper the patient's compliance * pregnancy or breastfeeding * known positive status for hiv and/or hepatitis b or c * drug and/or alcohol abuse * any reason why, in the investigator's opinion, the patient should not participate

Keywords: cp-4055 cancer metastatic solid tumors advanced ovarian cancer stage iii and iv ovarian cancer advanced epithelian ovarian cancer
a study to evaluate efficacy and safety of an investigational drug named volixibat in patients with itching caused by primary biliary cholangitis

Conditions: Primary Biliary Cholangitis; PBC

Summary: the purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with primary biliary cholangitis (pbc), and to assess the possible impact on the disease progression of pbc.


Eligibility criteria:
inclusion criteria: * provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study * male or female, age ≥18 years at the screening visit * confirmed diagnosis of pbc in line with the aasld guidelines * udca and anti-pruritic medication use will be allowed if meeting additional criteria * qualified pruritus associated with pbc as assessed by adult itchro exclusion criteria: * pruritus associated with an etiology other than pbc * evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events * current symptomatic cholelithiasis or inflammatory gallbladder disease * history of small bowel surgery/resection impacting the terminal ileum that may disrupt the enterohepatic circulation. * evidence, history, or suspicion of other liver diseases; pbc patients with aih are not excluded * history of liver transplantation

Keywords: pruritus pbc itching cholangitis primary biliary cholangitis hepatobiliary disorders
carnival study: gut flora dependent metabolism of dietary carnitine and phosphatidylcholine and cardiovascular disease

Conditions: Dietary Modification

Summary: the principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary carnitine and choline in humans.

the principal goal for the study is to examine the role gut flora plays in modulating metabolism of dietary trimethylamine nutrients in humans. we have recently shown that dietary intake of two trimethylamines abundant in animal products, carnitine and the choline group of phosphatidylcholine (pc), are mechanistically linked to cardiovascular disease risk. we wish to further explore the metabolism of these nutrients in humans, and to test the hypothesis that the intestinal micro flora (gut flora) plays a critical role in generation of metabolites from dietary carnitine and choline/pc linked to cardiometabolic disease. we further hypothesize that the production of specific metabolites of carnitine and choline/pc are influenced by the composition of gut flora, and these may be altered by the preceding dietary patterns of the subjects. we therefore wish to test whether dietary supplementation with carnitine and/or choline alters the metabolism of carnitine and choline/pc in subjects. we also hypothesize that transient suppression or modulation of gut flora via short-term broad spectrum antibiotic therapy, or by reconstitution of micro flora composition via probiotic therapy, in healthy subjects, can alter the metabolism of carnitine and choline/pc. we will also examine the impact of low dose aspirin on these pathways by examining subjects before versus after taking aspirin.

Eligibility criteria:
inclusion criteria: * men and women age 18 years or above. * able to provide informed consent and comply with study protocol exclusion criteria: * significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, hematologic diseases or pregnancy. * active infection or received antibiotics within 2 months of study enrollment * use of over-the-counter (otc) probiotic within past 2 months, or ingestion of yogurt within past 7 days * chronic gastrointestinal disorders, or intolerance to probiotic therapy * having undergone bariatric procedures or surgeries such as gastric banding or bypass

Keywords: carnitine metabolism gut flora phosphatidylcholine