Kornimate/medical-research-clean huggingface dataset:
bronchoscopic icg injection and percutaneous hook-wire techniques for preoperative lung nodule localization in vats

Conditions: Lung Cancer

Summary: the purpose of the study is to evaluate the efficacy and safety of transbronchial icg and percutaneous hook-wire assisted video-assisted thoracoscopic sublobar resection. in the control group, ct-guided percutaneous hook-wire preoperative localization will be used for surgical resection; in the experimental group, electromagnetic navigation bronchoscopy guided transbronchial icg injection will be performed for localization before vats.

this is a single-center, prospective, randomized trial initiated by the investigator. subjects with pulmonary nodules who will undergo video-assisted thoracoscopic sublobar resection will be randomly divided into two groups. in the experimental group, before the vats operation, transbronchial icg injection will be guided by electromagnetic navigation bronchoscopy to locate the nodule. in the control group, the subject will undergo ct guided hook-wire placement for nodule localization before vats. the study is expected to enroll 188 patients. finally, the effectiveness and safety of the two methods will be compared.

Eligibility criteria:
inclusion criteria: * above 18 years old; * with lung nodule diameter ≤2cm and distance from pleura ≥1cm, and vats sublobar resection is arranged; * located difficultly by intraoperative visual inspection and palpation, a preoperative location is needed. exclusion criteria: * cardiopulmonary function cannot tolerate general anesthesia, or other contraindications, such as uncorrectable coagulopathy; * more than one pulmonary nodule requires preoperative localization; * subject underwent thoracic surgery in the past and was suspected of having severe chest adhesions; * the nodule puncture path has bony structure block; * others conditions that the investigator considers not appropriate for this trial.

Keywords: electromagnetic navigation bronchoscopy (enb) localization lung cancer video-associated thoracic surgery indocyanine green (icg)
a study of arry-520 in patients with advanced myeloid leukemia

Conditions: Advanced MDS; Acute Myeloid Leukemia

Summary: this is a 2-phase study during which patients with select myeloid leukemias or advanced myelodysplastic syndrome (mds), who have failed, refused or are not eligible for standard treatment, will receive investigational study drug arry-520. the study has 3 parts. the first phase of the study, phase 1, has 2 parts. in the first part of phase 1, patients with select myeloid leukemias or advanced mds will receive increasing doses of study drug on different schedules in order to achieve the highest dose possible that will not cause unacceptable side effects. approximately 30 patients (per schedule) from the us will be enrolled in part 1 (completed). in the second part of phase 1, patients with advanced mds will receive the best dose of study drug and schedule determined from the first part of the study. approximately 10 patients from the us will be enrolled in part 2 (completed). in the third part of the study, phase 2, patients with acute myeloid leukemia (aml) or advanced mds will receive the best dose of study drug and schedule determined from the first part of the study and will be followed to see what side effects the study drug causes and to see what effectiveness it has, if any, in treating the cancer. approximately 40 patients from the us will be enrolled in part 3 (withdrawn).


Eligibility criteria:
key inclusion criteria (part 2): * patients with either intermediate-2 or high risk mds or with aml (\>20% bone marrow blasts) with stable low or normal white blood cell count (wbc). patients should have failed one prior chemotherapy regimen which should have included a hypomethylating agent. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * discontinuation of prior treatment at least 2 weeks prior to the start of the study. * adequate hepatic and renal function. * additional criteria exist. key exclusion criteria (part 2): * concurrent cytotoxic therapy, or biological, endocrine and immunological response modifiers. * previous radiation to \>25% of bone marrow. * other active malignancies. * known positive serology for the human immunodeficiency virus (hiv). * central nervous system involvement as documented by spinal fluid cytology. * active, uncontrolled infection. * additional criteria exist

Keywords: preleukemia dysplasia of myeloid blood cells
nuevo amanecer ii: translating a stress management program for latinas

Conditions: Breast Neoplasms; Psychology, Social

Summary: the primary aim is to assess the effectiveness of the nuevo amanecer-ii (na-ii) cognitive-behavioral stress management program through a 6-month rct with 150 spanish-speaking latinas with breast cancer in three rural settings in terms of improving quality of life (qol) and reducing distress, compared to a usual care control group (that is offered the program at the end of the 6 months). the investigators will also test the effects of the program on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). trained latinas, called compañeras (companions), who have had breast cancer deliver the stress management program in-person to spanish-speaking latinas with breast cancer.

the purpose of this study is to adapt nuevo amanecer (na-i) for use in rural populations and test the effects of the new adapted program, na-ii, in a 6-month rct among 150 rural, low literacy latinas with non-metastatic breast cancer. primary outcomes will consist of quality of life and distress. in an ancillary study, the investigators will compare the intervention and wait-list control groups on biomarkers of stress (hair and saliva cortisol) and aging (telomere length from saliva). finally, to facilitate statewide dissemination of nuevo amanecer-ii (na-ii), the investigators will develop a guide to implementation for community-based organizations. the investigators will adapt na-i to be appropriate for rural and low-literacy latinas with breast cancer. needed program adaptations will be identified through a formative evaluation consisting of semi-structured interviews with key informants (e.g., rural latina breast cancer survivors, advocates, health care providers) and iterative consultations with community representatives in three rural areas with large latino populations. results will be applied by the study team and community advisors to adapt na-i to create na-ii and create the implementation guide. the investigators will identify key individual, organizational, and community factors that facilitate implementation and support scalability and statewide dissemination through a process evaluation where the investigators will track key implementation activities and debrief program participants, interventionists, and advocates. products will include na-ii interventionist and participant manuals and a guide to implementation for organizations seeking to replicate the program.

Eligibility criteria:
inclusion criteria: * self-identifies as latina * diagnosed with stage 0, i, ii, or iii (non-metastatic) breast cancer * primarily spanish-speaking, or spanish monolingual * aged 18 or older * living in surrounding areas of tulare (visalia, dinuba), santa cruz (eastside santa cruz, watsonville, freedom), or imperial valley (el centro) counties, california. exclusion criteria: * terminal illness * stage iv breast cancer (distant metastasis)

Keywords: breast cancer latinas peer support counselor spanish speaking community based rural
type 2 diabetes mellitus and chronic kidney disease

Conditions: Renal Disorder Associated With Type II Diabetes Mellitus

Summary: to investigate the effect of co existance of diabetes mellitus and chronic kidney disease on basic coagulation profile in comparison with diabetic patients with normal kidney function and non diabetic patients with chronic kidney disease

we will study impact of type 2 diabetes mellitus on basic coagulation profile and platelet indices among patients with chronic kidney disease

Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus with and without chronic kidney disease patients with chronic kidney disease without diabetes mellitus exclusion criteria: * any situation influence on basic coagulation profile and platelet indices other than diabetes mellitus and chronic kidney disease
prospectic italian laparoscopic hybrid mesh hernia repair in obese patients trials

Conditions: Uncomplicated Ventral Incisional Hernia; Obesity

Summary: the aim of this study is to evaluate safety and effectiveness of a hybrid mesh (gore® synecor intraperitoneal biomaterial) in patients with a bmi of 30 kg/m2 or more undergoing laparoscopic ventral hernia repair (lvhr) with intraperitoneal position of the mesh.

a prospective italian multicenter observational trial will be conducted in 8 different italian centers to compare the effectiveness and feasibility of treatment of incisional hernia with gore® synecor intraperitoneal biomaterial mesh in patients with bmi \>30 kg/m2. this study was reviewed and approved by the local regional ethics committee. the study adhered to the consort guidelines in reporting this trial's results

Eligibility criteria:
inclusion criteria: * age \> 18 years * clean wounds * informed consent * patients affected by incisional and ventral hernia * elective surgery * hernia size between 3 e 7 cm * bmi \> 30 kg/m2 exclusion criteria: * age \< 18 years; * life expectancy \< 24 months (as estimated by the operating surgeon), - * pregnancy * immunosuppressant therapy within 2 weeks before surgery * clean-contaminated and contaminated, dirty wounds * cirrhosis

Keywords: ipom plus, incisional hernia ventral hernia obesity
heart failure worsens muscle strength in copd

Conditions: COPD; CHF; Muscle Weakness

Summary: the combination of heart failure (hf) and chronic obstructive pulmonary disease (copd) is highly prevalent, but underdiagnosed and poorly recognized. it has been suggested that the decline in functional capacity is associated with musculoskeletal and systemic changes than primary organ (heart and/or lung) failure. in addition, it is recognized that both diseases have several mechanisms that are responsible for musculoskeletal impairment. however, the association of reduced systemic perfusion with low oxygen content observed in the association of hf and copd may contribute to the worsening of the components of the muscle impairment cascade. thus, muscle strength and fatigue may not only be even more altered but may also be the main determinants of functional capacity in patients with coexistence of hf and copd. although many studies have evaluated the muscle performance of patients with hf or copd, the literature did not show data on worsening due to the association of the diseases. particularities identification of the muscle impairment in the coexistence of hf and copd is fundamental for the development of rehabilitation strategies, mainly through physical exercise. in this line, the present study tested the hypothesis that the coexistence of hf and copd could present lower values of strength and greater fatigue. similarly, the muscle dysfunction degree could strongly correlate with the performance markers of the incremental or functional tests in patients with hf associated with copd. the study protocol was reviewed and approved by the institutional research board. all subjects gave written informed consent before participating in the study.


Eligibility criteria:
inclusion criteria: * non-cachectic sedentary patients * moderate-to-severe copd according to gold classification (fev1/ fvc \<0.7 and predicted post-bronchodilator fev1 between 30% and 80%) * no clinical or echocardiographic evidence of hf for the copd group * echocardiographic evidence of hf with reduced left ventricular ejection fraction (\<40%) for the overlap group * chronic dyspnoea (mrc scale score 2-4) * nyha class 2 or 3. exclusion criteria: * long-term o2 therapy * recent (within a year) rehabilitation program * osteomuscular limitation * type i or non-controlled type ii diabetes mellitus * peripheral arterial disease associated with claudication * patients with preserved ejection fraction hf
pneumocystis jirovecii pneumonia in non-hiv-infected immunocompromised patients

Conditions: Pneumocystis Jirovecii Infection

Summary: pneumocystis jirovecii pneumonia (pjp) is a rare infectiouse disease with a high level of mortality. pjp is a classical opportunistic infection which concern hiv infected and immunocompromised patients. during the past decade, several therapeutic's progresses have been done in oncology, immunology and hematology. as a consequence, patients benefited of greater treatment efficacy but are exposed to a higher risk of opportunistic infections as pjp. the investigators hypothesis is that pjp incidence increase and its form is depending of underlying immune conditions. the investigators aim to describe its incidence, the pjp forms depending on comorbidities and to identifiy pronostics factors.


Eligibility criteria:
inclusion criteria: * underlying immune condition at risk of pneumocystis jirovecii pneumonia excluding hiv infection * clinical, biological and radiological presentation which evoke pneumocystis jirovecii pneumonia * microbiological confirmation by respiratory specimen analyses ( specific coloration and/or ifi and/or prc) exclusion criteria: * no microbiological confirmation by respiratory specimen analyses * proved hiv infection * patient denied to particpate

Keywords: pneumocystis jirovecii pneumonia hiv-free patients
far infrared radiation treatment for osteoarthritis

Conditions: Osteoarthritis

Summary: a study to evaluate the possibility of using far infrared radiation to manage pain due to osteoarthritis.

arthritis consists of more than 100 different conditions. these conditions range from relatively mild forms such as tendonitis and bursitis to crippling forms as rheumatoid arthritis. pain syndromes include fibromyalgia and arthritis-related disorders as lupus erythematosus that involve every part of the body. there are forms of the disease, such as gout that almost nobody connects with arthritis. osteoarthritis is the most common form of arthritis. the objective for the study is to access the possibility of using far infrared radiation for pain management.

Eligibility criteria:
inclusion criteria: * 1 year old and above exclusion criteria: * none

Keywords: arthritis, degenerative osteoarthrosis osteoarthrosis deformans
surgical vs endoscopic treatments as immunomodulating interventions in high-risk acute calculous cholecystitis

Conditions: High-risk Patients With Acute Calculous Cholecystitis (ACC)

Summary: randomized controlled trial on high-risk patients with acc. consecutive patients with a diagnosis of acc, if they meet the inclusion and exclusion criteria, will be randomized to receive laparoscopic cholecystectomy (lc) or transmural ultrasound-guided gallbladder drainage (tugd) with lumen-apposing self-expandable metal stents (lamss) within 10 days from onset of symptoms. blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. bile samples will be taken during the procedure for microbiological exam and culture. blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. the follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.


Eligibility criteria:
inclusion criteria: * have a diagnosis of acc as defined by 2018 tokyo guidelines criteria * be ≥ 18 years old * have a possum ps ≥ 25 * onset of symptoms \<= 7 days before emergency department (ed) admission * provide signed and dated informed consent form * willing to comply with all study procedures and be available for the duration of the study * have an israelian score (is) (table 3) for the risk of main bile duct stones \<2 or an is =2 and an eus or a mrcp negative for main bile duct stones exclusion criteria: * pregnancy * patients unwilling to undergo follow-up assessments * patients diagnosed with concomitant pancreatitis * acute cholecystitis not related to a gallstone etiology * onset of symptoms \>7 days before ed admission * altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum * previous drainage of the gallbladder * biliary peritonitis
prevalence and outcome of brachial artery endothelial function in morbidly obese patients undergoing bariatric surgery

Conditions: Obesity, Morbid; Ischemic Heart Disease

Summary: the relation between obesity and ischemic heart disease (ihd) is under considerable debate. the reduction in all-cause mortality and, more specifically, the reduction in cardiac-related mortality seen after weight-loss surgery, may be due to regression or slowing developement of subclinical ihd. function of cells lining the arteries (endothelium) is closely related to the state of ihd and its measurement can serve as a surrogate marker for the existence and severity of ihd. the investigators hypothesize that the prevalence of undiagnosed ihd in the morbidly obese population is high and that following surgery for weight reduction there is a halt in the progression, or even a regression in its severity. the study includes measurement of endothelial function before and after weight-reducing surgery.


Eligibility criteria:
inclusion criteria: * morbidly obese patients who fulfill the nih criteria for surgical intervention. exclusion criteria: * patients deemed unfit for surgery * pregnant women, or who are attempting conception. * subjects with any history of myocardial infarction, coronary artery bypass grafting surgery, coronary angiography with angioplasty and/or stenting, or any lesion \> 50% of the coronary artery luminal diameter, cerebrovascular accident, or peripheral vascular disease with abnormal electrocardiograms and/or echocardiography. * history of drug or alcohol abuse. * chronic liver disease.
assessing a risk model for g6pd deficiency

Conditions: Malaria, Vivax; G6PD Deficiency

Summary: a clinical study designed to develop and inform an individual risk of hemolysis model based on individual red blood cell g6pd levels. volunteers who are eligible to treatment with primaquine as per national guidelines and with confirmed normal g6pd levels as per the fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14 days or 3 day chloroquine with concomitant primaquine for 14 days. the volunteers will be followed intensively during treatment and for 14 days after treatment for haematologic measures, g6pd quantification, and drug level assays.

open label, randomized trial with 72 total participants assigned to one of two treatment arms. each arm will have 36 participants comprised of 12 males hemizygous for wildtype g6pd, 12 females homozygous for wildtype g6pd, and 12 females heterozygous for g6pd with a normal fluorescent spot test (fst) (g6pd genotype abnormal with g6pd activity ≥40% and ≤80% of normal). arm 1a will receive primaquine for 14 days, and arm 1b will receive chloroquine for 3 days and concomitant primaquine for 14 days. all participants will be healthy volunteers without severe g6pd deficiency who will be followed for two weeks after completing their study drug dosing. pregnant women and those breastfeeding will be excluded. venous blood samples will be taken at regular intervals for haematologic measures, g6pd quantification, and drug level assays. g6pd levels will be measured both by spectrophotometry to provide whole blood g6pd levels normalized for hemoglobin, as well by flow cytometry to to provide red blood cell g6pd distributions throughout the treatment and post treatment. changes in the g6pd distributions will be modeled, incorporating other critical haematological indicators collected throughout the study too.

Eligibility criteria:
inclusion criteria: * previous g6pd test at shoklo malaria research unit (smru) clinic with one of following results: 1) g6pd homozygous wildtype females (g6pd genotype normal) 2) g6pd heterozygous females with a normal fst (g6pd genotype abnormal with g6pd activity ≥40% and ≤80% of normal ) 3) g6pd hemizygous wildtype males (g6pd genotype normal) * willing to participate and sign informed consent form * willing to allow donated samples to be used in future research * aged ≥18 years * ability (in the investigators' opinion) and willing to comply with all study requirements exclusion criteria: all participants: * malaria or other illness * recent history (within 20 days) of anti-malarial treatment * history of allergy or adverse reaction to chloroquine or primaquine * blood transfusion in the past 3 months * g6pd activity less than 40% normal activity or 3.00 iu/ghb by the quantitative g6pd spectrophotometric assay * haemoglobin ≤10 g/dl * presence of any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study female participants only: * pregnancy at the time of screening * breastfeeding
a study on the effects of mastiha oil in adults with hypertriglyceridemia

Conditions: Hypertriglyceridemia

Summary: mastiha oil is a 100% natural product of the mediterranean, extracted from the resin of mastiha. its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. the aim of this study is to determine the effect of mastiha oil in adults with hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. both groups will receive standard nutritional counselling. the intervention will last 3 months. the effects of the intervention will be evaluated via clinical and laboratory markers.


Eligibility criteria:
inclusion criteria: * 30 years \< age \< 75 years hypetriglyceridemia a stable weight for ≥ 3 months pre-intervention an unchanged treatment regimen for ≥ 6 months pre-intervention exclusion criteria: hepatotoxic medication untreated diabetes mellitus dysthyroidism, hypopituitarism, cushing syndrome / disease pregnancy, lactation psychiatric or mental disorder any use of antioxidant-phytochemical rich supplement, vitamin d supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
expanded access to everolimus, for an individual patient with gist (gastrointestinal stromal tumors)(ctms#18-0019)

Conditions: Gastrointestinal Stromal Tumor

Summary: single patient treatment with everolimus.


Eligibility criteria:
clinical trial to evaluate ant-1207 in subjects with acne

Conditions: Acne Vulgaris

Summary: the purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ant-1207 in the treatment of acne.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe facial acne * 15 to 40 papules and pustules, and 5 to 50 open and/or closed comedones * no presence of nodules * female subjects must be not pregnant and non-lactating exclusion criteria: * presence of 1 or more nodules * use of topical steroids on the face 4 weeks prior and during the study * use of systemic corticosteroids 6 weeks prior and during the study * topical or systemic acne treatment in the 4 weeks prior to baseline