Kornimate/medical-research-clean huggingface dataset:
a study of adjuvant atezolizumab or atezolizumab plus tiragolumab in solid tumors with resectable disease with intermediate-high risk of recurrence and high tumor mutational burden (tmb-h) or microsatellite instability (msi-h)

Conditions: Solid Tumors

Summary: this study is being conducted to evaluate efficacy parameters (disease free survival \[dfs\] and overall survival \[os\]) of atezolizumab and atezolizumab in combination with tiragolumab in tmb-h or msi-h as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 to 1 * any of the following solid tumors considered to be resectable with a curative intent: non-small cell lung cancer, skin melanoma, skin squamous cell carcinoma, urothelial carcinoma, colorectal cancer, gastric cancer, endometrial cancer, cervix cancer, head and neck cancer and any other tumor type with known high tmb (≥ 13 mut/mb) or msi-h * participants must undergo standard treatment according to the stage of their disease and investigator´s choice * all participants must be disease free after standard therapy to be included in this study * having tmb ≥ 13 mut/mb or msi-h in tumor tissue biopsy obtained prior to starting standard treatment or from surgical specimens and analyzed using f1 cdx * participants must be at intermediate/high risk of recurrence * adequate hematologic and organ function * female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy * women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug. exclusion criteria: * previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * prior cancer immunotherapy * women who are pregnant, lactating, or intending to become pregnant during the study * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (ct) scan * significant cardiovascular disease * treatment with systemic immunosuppressive medications within 2 weeks prior to inclusion * treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization.
improving survival of colorectal liver metastases by rfa-mediated immunostimulation

Conditions: Liver Metastasis Colon Cancer

Summary: to examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.

purpose: to investigate the impact of immunostimulation using radio frequency ablation (rfa) on survival in patients undergoing curative-intent surgery for colorectal liver metastases (crlm). hypothesis: rfa-mediated partial destruction of crlm will stimulate the immune system to recognize otherwise hidden cancer antigens, which in turn will improve survival by inhibiting micrometastases and recurrence. background: crlm affects around 1,600 individuals in denmark each year. state-of-the-art treatment includes liver resection, rfa treatment, radiation therapy, and chemotherapy. of all individuals undergoing surgery, 50% will experience local or distant recurrence of the disease within five years. although liver resection is the gold standard, rfa treatment has evolved considerably in recent years. rfa is a parenchymal-sparing treatment for hepatic malignancies, inducing a localized coagulation necrosis of the tumor. this leads to release of tumor antigens, which activates the patients' immune system. however, many cancer cells, including those from crlm, have the ability to hide their antigens to the patients' immune systems. using rfa as immunostimulation prior to surgery, these antigens may become visible to the immune system, which in turn can help eradicating all tumor cells and decrease the risk of tumor recurrence. combined, this likely improves survival. methods: 220 patients with crlm planned for surgery will be enrolled in this study. patients will be randomized to +/- rfa treatment before surgery. under guidance of ultrasonography, a single-electrode rfa-needle is placed in a crlm with a diameter of at least 3 cm, which is later going to be resected. in 20 of the patients, we will draw blood samples for determination of immune status both pre- and postoperatively. all patients will be part of a work-up with regular ct-scans. endpoints: disease free survival and overall survival. secondarily, we will examine the effect of rfa treatment of tumors on the innate and adaptive immune system in 20 patients

Eligibility criteria:
inclusion criteria: * patients with colorectal liver metastases planned for resection * at least one tumor size \>=3cm * performance status 0-1 exclusion criteria: * liver cirrhosis * extrahepatic metastases that can not be addressed curatively * other malignant diseases within 5 years prior to diagnosis * prior rfa treatment
clinical study evaluating outcomes of reverse shoulder arthroplasty with smr stemless

Conditions: Rotator Cuff Tear Arthropathy; Osteo Arthritis Shoulders

Summary: the objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of smr stemless reverse shoulder arthroplasty (limacorporate s.p.a.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.

the focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of smr stemless reverse shoulder arthroplasty. there is a retrospective and prospective study population. the follow up time-points are (as of standard of care and not different for this study): * baseline * 6 weeks postop * 6 months postop * 12 months postop * 24 months postop

Eligibility criteria:
inclusion criteria: * rotator-cuff arthropathy, osteoarthritis * approving written informed consent exclusion criteria: * female patients who are pregnant, nursing, or planning a pregnancy. * all adult patients with any of the smr stemless contraindication for use for the reverse configuration as reported in the current local instruction for use. * not consenting in participating in this study

Keywords: stemless reverse shoulder arthroplasty
sickle cell children's exercise study (success)

Conditions: Sickle Cell Disease

Summary: the sickle cell children's exercise study (success) will explore the feasibility and effects of a moderate intensity strengthening, balance, speed, and agility intervention program in children with sickle cell disease.

participants will perform the baseline assessment and after six weeks of performing the success program the participants will perform a post-intervention assessment. participants will be asked to attend a total of six physical therapy in-person sessions (1x/week) at the university of maryland department of physical therapy and rehabilitation science and to perform 12 home program sessions.

Eligibility criteria:
inclusion criteria: * children 6-17 years of age diagnosed with sickle cell disease exclusion criteria: * diagnosis of neurological disorder, not related to sickle cell disease * lower extremity injury such as a fracture with a cast

Keywords: physical therapy neuromotor performance functional capacity
memantine and intensive speech-language therapy in aphasia

Conditions: Aphasia; Stroke

Summary: * aphasia, the loss or impairment of language caused by brain damage, is one of the most devastating cognitive impairments of stroke. aphasia can be treated with combination of speech-language therapy and drugs. conventional speech-language therapy in chronic aphasic subjects is of little help and several drugs have been studied with limited success. therefore other therapeutic strategies are warranted. * recent data suggest that drugs (memantine) acting on the brain chemical glutamate may help the recovery of cognitive deficits, included language, in subjects with vascular dementia. the present study examines the safety profile and efficacy of memantine paired with intensive language therapy in subjects with stroke-related chronic aphasia (more than 1 yr. of evolution).

* the efficacy of drugs that act on glutamate such as the n-methyl-d-aspartic acid (nmda) receptor antagonist memantine requires to be explored in this population. the rationale for using memantine in post-stroke aphasia comes from recent studies on vascular dementia. data extracted from a recent cochrane review of randomized controlled trials of memantine in different types of dementia (vascular dementia, alzheimer's disease, mixed dementia) reveal, after 6 weeks of treatment, beneficial effects on cognition (including language), activities of daily living, behavior and global scales as well as in the global impression of change. * recovery from aphasia is possible even in severe cases. while speech-language therapy remains as the mainstay treatment of aphasia, its effectiveness has not been conclusively proved. this has motivated the planning of more rational therapies (e.g., constraint-induced language therapy \[pulvermüller et al., 2001; 32: 1621-1626\]). * in addition, the neural correlates of improvement of language function can now be readily detectable with event-related potentials. this is a noninvasive technique that can detect in real time functional brain changes during recovery promoted by the combined action of memantine and constraint-induced language therapy. * the aim of the present study is to assess the efficacy, safety profile, and functional correlates of memantine paired with massed language therapy in a sample of patients with chronic poststroke aphasia.

Eligibility criteria:
inclusion criteria: * chronic aphasia of more than one year duration * must be able to complete protocol exclusion criteria: * dementia * major psychiatric illness * severe global aphasia (precludes participation in constraint-induced language therapy)

Keywords: aphasia memantine constraint-induced language therapy event-related potentials
ridge preservation comparing simultaneous vs. delayed grafting

Conditions: Tooth Loss

Summary: comparison of the clinical healing of simultaneous vs. delayed grafting for dental implant placement.

the primary aims of this study are to compare the clinical and histologic results of a traditional ridge preservation with implant placement at 16 weeks (control group) with early implant placement (8 weeks) with simultaneous contour augmentation as described by buser (test group).

Eligibility criteria:
inclusion criteria: * have one non-molar maxillary tooth requiring extraction that will be replaced by a dental implant. the site must be bordered by 2 teeth. * healthy persons at least 18 years old. * patients must sign an informed consent approved by the university of louisville human studies committee. exclusion criteria: * patients with debilitating systemic disease, or diseases that have a clinically significant effect on the periodontium. * exclude any molar tooth. * presence of or history of osteonecrosis of jaws. * patients with current or previous history of iv bisphosphonates, irrespective of duration. * patients taking oral bisphosphonates for ≥ 3 years. * pregnant women. * allergy to any material or medication used in the study. * patients who need prophylactic antibiotics prior to dental procedures. * previous head and neck radiation therapy. * chemotherapy in the previous 12 months.
observational registry for basal insulin treatment study (orbit)

Conditions: Diabetes

Summary: the scientific use of basal insulin is of great help to individuals and the government. however, there are few studies to investigate the real world use, effect, safety and influence factors of basal insulin in china. this study is to evaluate the use of first basal insulin in china patients with type 2 diabetes with inadequate glycemic control on oral antidiabetic agents (oads) from the naturalistic clinical practice.

this is a 6-month multicentre, observational, prospective, registry study. about 200 hospitals from different parts of china will take part in this study, and about 20,000 patients with type 2 diabetes mellitus (t2dm) who are inadequately controlled with oads and willing to accept basal insulin (bi) treatment will be consecutively enrolled during a 12 months period. the study participants will include at baseline (0 month), 3 month and end point (6 month) to collect the study information. the project will probably last for about 18 months.

Eligibility criteria:
inclusion criteria: * 18-80 years old * type 2 diabetic patients * taking oads before inclusion * recently tested hba1c \>=7% at the same site within 3 months * being suggested by physician to start basal insulin (bi) treatment * willing to start and having been prescribed bi treatment * willing to join the registry study and sign the informed consent exclusion criteria: * diagnosed with type 1 diabetes * received any type of insulin in the last 2 years (except for the intermittent use of insulin of less than 1 month each time) * with any severe health problem, or any other situation judged by the investigator, that is difficult for the 6 months follow-up * current or planned pregnant, lactating women * involved in other clinical trial simultaneously or at most 1 month before

Keywords: diabetes basal insulin effectiveness and safety oral antidiabetic drugs real world clinical practice
parasitic infection in anemic pregnant women

Conditions: Anemia of Pregnancy

Summary: women included between 18 and 45 years old, pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) with hemoglobin level below 10.5 mg /dl.

all patients in the study were subjected to: 1. detailed history was recorded. a proper history concerning age, sex, residence, socioeconomic status, onset, progression, and previous treatment of anemia was taken. participants' socio-demographic characteristics including gravida and parity were documented, level of education, occupation, diet, and information useful to determine the socioeconomic level was recorded. information on previous pregnancies and children and history of chronic diseases were also recorded. 2. general examination; patients were clinically examined and gestational age (assessed by measuring the fundal height), weight was calculated for each participant. 3. diagnosis of anemia by complete blood count (cbc), hb level and measuring hematocrit concentration. 4. diagnosis of parasitic infection by stool analysis using suitable techniques. 5. imaging including obstetric ultrasound (u/s) to assess fetal development. 6. women with helminthic infections will be divided into groups group (a): received iron + antiparasitic treatment as follows: * patients who have sth received alzental 200mg tab 2 tabs single oral dose. * patients who have entamoeba or giardia received flagyl 500mg tab twice daily for 5 days. * (b): received iron only.

Eligibility criteria:
inclusion criteria: * pregnant during their second or third trimester of pregnancy (calculated by a sure menstrual date and confirmed by a 1st trimesteric ultrasound) * hemoglobin level below 10.5 mg /dl exclusion criteria: * women with chronic diseases as diabetes, heart, renal, hepatic or endocrinological disorders * women diagnosed with blood diseases as hemoglobinopathy or vascular diseases as vasculitis. * women with autoimmune diseases and those allergic to iron or antihelminsic treatment were also excluded
intra-abdominal pressure effect on intra-abdominal volume and airway pressures during laparoscopy

Conditions: Surgery; Pneumoperitoneum; Intra Abdominal Pressure

Summary: during pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure. the generated pressure can lead to a different increase in volume depending on the abdominal cavity and patients' characteristics. the primary objective is to determine the relationship between intraabdominal pressure (iap) and intraabdominal volume (iav) during pneumoperitoneum insufflation. the secondary objective is to determine the rate of abdominal-thoracic transmission (att) assessing the correlation between iap and respiratory driving pressure (δprs).


Eligibility criteria:
inclusion criteria: * enrolled one of the three studies (ippcollapse i, ii or iii). * underwent an initial insufflation procedure with a stepwise change in intraabdominal pressure to record intraabdominal volume * data from insufflation at 5 cmh2o of peep
clinical study on the effectiveness and safety evaluation of directional atherectomy combined with drug-coated balloons

Conditions: Peripheral Vascular Diseases

Summary: dcb can maximize the patency rate of blood vessels on the basis of intraluminal da. da+dcb treatment is effective and safe \[8\], and the advantages of da and dcb in the treatment of severe calcification and occlusive disease across joints and lower extremities have been confirmed. the combined application of da and dcb in the treatment of peripheral arterial disease has a good early and mid-term effect. konstantinos et al. reported that darrt has a higher first-phase patency rate compared with dcb. a retrospective study by sebastian et al. showed that compared with pta after da, the combination of da and dcb has a better event-free survival rate after 12 months of follow-up. therefore, da combined with dcb therapy may be one of the best and most promising methods for the treatment of lower extremity aso.


Eligibility criteria:
inclusion criteria: * age over 18 years old * ruthford grade 2-5 patients * for patients whose arteries in both lower extremities meet the enrollment criteria, both lower extremities can be included * at least one outflow tract over 10 cm at the distal end of the knee is continuous with a healthy back of the foot or internal and external arteries of the plantar * the guide wire clearly passed through the lesion and the follow-up treatment was performed. in the case of failed anterograde passage, reverse puncture to achieve the guide wire through the lesion can also be included in the group * after the failure of the first intracavitary treatment, the blood vessel can be recanalized by the intracavitary treatment again, and it can still be included in the group * patients with aortic iliac artery disease can be included in the group after the aortic artery is opened * patients who are willing to participate in this study and sign informed consent * for severely infected r6 patients, if the infection is effectively controlled, they can be considered for inclusion exclusion criteria: * patients who refuse to participate in this observational study * femoral popliteal artery disease with acute and subacute thrombosis * patients with thromboangiitis * patients who have failed endovascular treatment and transferred to surgical treatment * for patients who have received plaque exfoliation on the femoral artery * patients who are allergic to heparin, low molecular weight heparin and contrast agents * patients enrolled in other clinical studies in the past 3 months * pregnant women * patients who have a life span of less than 2 years due to serious diseases
non-endoscopic tracking of disease activity in eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: to prospectively determine the natural history of inflammation resolution following initiation of diet treatment and to optimize the diet treatment of patients with eoe through the use of a non-endoscopic tracking device, the esophageal string test (est).

this is an adult and pediatric prospective, longitudinal study in which we will measure symptoms, qol and inflammation at baseline and again at 2, 4 and 6 weeks after starting stand of care (soc) four food elimination diet (ffed) (aim 1). newly or previously diagnosed patients with eoe with active disease who will be undergoing soc ffed will be offered entry into the study by the pi's or their local co-investigators at each of their institutions. eoe patients who are in remission on soc ffed from aim 1 will be recruited to participate in this food reintroduction trial in aim 2. eligible subjects will undergo soc sequential food reintroductions and during the food introduction, ests will be performed at 2 and 4 week intervals during a clinic visit. if inflammation is detected by the est, this food will be eliminated from the diet for six weeks and a repeat est will be administered at this time to assess inflammation. if inflammation has resolved based on est results, food reintroduction will resume. if no inflammation is detected by the est at the 4 week interval, a new food will be added. est will be performed after each food reintroduction as outlined above. based on known allergenic properties of these foods, the order of food reintroduction will be soy, eggs, wheat and milk.

Eligibility criteria:
inclusion criteria: * participant must be able to understand and provide informed consent * males and females ≥7 years of age to 65 years of age * have diagnosis of eoe * have histologically confirmed active disease ≥15 eosinophils/hpf * symptomatic (have experienced symptoms within the last one months prior to enrollment). * female subjects of childbearing potential must have a negative pregnancy test upon study entry * female (and male) subjects with reproductive potential, must agree to use fda approved methods of birth control for the duration of the study exclusion criteria: * inability or unwillingness of a participant to give written informed consent or comply with study protocol * secondary causes of eosinophilia * pregnancy * immunodeficiency states * have participated in any investigative drug study within 6 weeks prior to study entry * unable to complete study procedures including endoscopy * luminal stricture identified \<13mm which would prevent passage of the est and prevent assessment of mucosal inflammation * past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
inflammation markers in fluid aspirate from a scarred uterine vs. a normal uterine cavity

Conditions: Infertility Due to Nonimplantation; Infertility Secondary; Cesarean Section Complications

Summary: a prospective study that will take place in the hydrosonography clinic, comparing patients with an intact uterus to those who had a caesarean section. eligible patients will preform a transvaginal ultrasound for evaluation of presence of a niche. after fixation of the transcervical catheter, we will flush 2 ml sterile nacl 0.9% into the uterine cavity and aspirate the fluid. after collecting all samples, the samples will be snap frozen and stored at -80o c, until they undergo an immunological analysis.


Eligibility criteria:
inclusion criteria: - patients suffering from infertility and assigned for a hydrosonography exam for assessment of the integrity of the uterus and fallopian tubes. exclusion criteria: 1. patients with hydrosalpinx/pyosalpinx/sactosalpinx 2. patients who went through surgical correction of a niche 3. hormonal treatment- estrogens or progestins. 4. immunosuppressive/immunomodulating medication