Kornimate/medical-research-clean huggingface dataset:
first-line treatment for locally advanced or metastatic mesenchymal epithelial transition factor (met) - positive gastric, lower esophageal, or gastroesophageal junction (gej) adenocarcinoma

Conditions: Gastric Cancer

Summary: this is a phase 3, multicenter, randomized, double-blind, placebo controlled study of epirubicin, cisplatin \& capecitabine (ecx) with rilotumumab or placebo for untreated advanced met-positive gastric or gastroesophageal junction (gej) adenocarcinoma


Eligibility criteria:
key inclusion criteria: * pathologically confirmed unresectable locally advanced or metastatic gastric or gej adenocarcinoma •eastern cooperative oncology group (ecog) performance status (0 or 1) * tumor met-positive by immunohistochemistry (ihc) * evaluable (measurable or non-measurable) disease by response evaluation criteria in solid tumors (recist) 1.1 criteria key exclusion criteria: * human epidermal growth factor receptor 2 (her2) -overexpressing locally advanced or metastatic gastric or gej adenocarcinoma •previous systemic therapy for locally advanced or metastatic gastric or gej adenocarcinoma * less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy to randomization * previous treatment with anthracyclines must not exceed total cumulative dose of epirubicin of 400 mg/m2 * squamous cell histology * left ventricular ejection fraction (lvef) \< 50%

Keywords: gastric cancer first line treatment gastroesophageal junction (gej) gastroesophageal junction cancer (gej) gej cancer
trial of prompt mental health care

Conditions: Anxiety; Mild to Moderate Depression

Summary: anxiety and depression are among the most common mental disorders in the population. anxiety and depression have significant consequences at the individual, family and community level, and mental illness is estimated to cost the norwegian society 180 billion norwegian kroner annually. the majority of this amount is accounted for by anxiety and depression disorders. meanwhile, access to mental health services to treat these disorders is limited. the proportion of people who do not receive treatment of those who are in need of treatment is estimated to be over 50%. prompt mental health care (pmhc) is a pilot project initiated in 2012 by the directorate of health commissioned by the ministry of health, with the goal of increasing access to evidence-based treatment for adults with anxiety disorders and mild-to-moderate levels of depression. the treatment offered is cognitive behavioural therapy and should lead to reduced levels of symptoms of anxiety and depression, improved quality of life and better employability. pmhc is based on the english program "improving access to psychological therapy (iapt)", which is established in virtually all health communities in england. the evaluations of iapt and pmhc have until now been based on relatively weak research designs which make it difficult to know to what extent the initiative really has the desired effect. in this study, pmhc is compared with a control group that receives treatment as usual (often provided by the general practioner) in two pmhc pilot sites (kristiansand and sandnes). participants are randomly assigned to either the pmhc or the control group. the investigators aim to include 1100 clients in the study. the key objectives of this study are to investigate whether pmhc treatment is more effective as compared to treatment in the control group with regard to symptoms of anxiety and depression, work participation, functional status, and mental well-being. cost-effectiveness of pmhc is also examined.


Eligibility criteria:
inclusion criteria: * phq-9/gad-7 scores above cut off level * being above 18 years of age and a resident in the pilot sites * basic verbal and oral norwegian proficiency exclusion criteria: * entitled to secondary care services due to eating disorder, suicide risk, bipolar disorder, severe depression, invaliding anxiety, psychotic symptoms, severe substance abuse, and personality disorder. * two or more previous treatment attempts without effect. * serious physical health problem as prime problem

Keywords: anxiety depression cbt outcome monitoring dissemination routine services
interventional study of incb 99280 with ipilimumab in participants with select solid tumors

Conditions: Melanoma; Hepatocellular Carcinoma (HCC); Renal Cell Carcinoma (RCC); Microsatellite Instability - High (MSI-H); Mismatch Repair Deficient (dMMR); Colorectal Carcinoma (CRC)

Summary: the purpose of this study is to characterize the safety, tolerability, pk, and efficacy of incb 99280 in combination with ipilimumab in participants with select solid tumors.


Eligibility criteria:
inclusion criteria: * prior systemic therapy, diagnoses and disease setting as follows: * for part 1 (dose escalation), and no history of treatment with anti-ctla-4 or anti-pd-(l)1 therapy and one of the following, * unresectable or metastatic cutaneous melanoma, or * unresectable of metastatic child-pugh class a ndd not eligible for surgical and/or locoregional therapy, or * intermediate or poor-risk advanced clear cell rcc, or * msi-h or dmmr metastatic crc and able to provide fresh or archival tumor tissue for central confirmation of msi-h or dmmr. * for part 2 (dose expansion), io treatment -naïve, e.g., no prior receipt of an anti pd-1, anti-pd-l1 or pd-l1, anti-ctla-4, gitr, lag3, tim3, ox-40, il-2, 4-1bb or other immune modulator, and have not received prior systemic therapy and one of the following, * unresectable or metastatic child-pugh class a hcc not eligible for surgical and/or locoregional therapy, or * intermediate - or poor-risk advanced clear cell rcc. * ecog performance score of 0 or 1. * life expectancy \> 3 months, in the opinion of the investigator. * histologically confirmed solid tumors with measurable disease per recist v1.1. * exception: hcc may be diagnoses based on cross-sectional multiphasic imagining using the aasld criteria. * willingness to avoid pregnancy or fathering children. exclusion criteria: * known history of an additional malignancy. * central nervous system (cns) metastases requiring treatment and/or leptomeningeal disease. * toxicity from prior therapy that has not recovered. * received thoracic radiation within 6 months of the first dose of study treatment. * participation in another interventional clinical study while receiving incb099280. * impaired cardiac function of clinically significant cardiac disease. * history of evidence of interstitial lung disease including non-infections pneumonitis. * presence of gastrointestinal condition that may affect drug absorption * any autoimmune disease requiring systemic treatment in the past 5 years. * diagnosis of immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent * active infection requiring systemic therapy. * history of organ transplantation, including allogeneic stem cell transplantation. * receipt of system antibiotics within 28 days of first dose of study treatment. * probiotic usage is prohibited during the screening and throughout the study treatment period. * received a live vaccine within 28 days of planned start of study drug. * laboratory values outside the protocol-defined ranges. other protocol-defined inclusion/exclusion criteria may apply.
research study to investigate how well semaglutide tablets taken once daily work in people who are overweight or living with obesity (oasis 1)

Conditions: Obesity; Overweight

Summary: this study is being conducted to see if semaglutide tablets can be used as a treatment to help people living with overweight or obesity lose weight. this study will look at the change in participants body weight. participants will either get semaglutide tablets (new medicine) or placebo tablets ('dummy' medicine that looks like semaglutide but has no effect on the body). for a fair comparison, people are divided into two groups at random by a computer. this process is called randomisation. semaglutide tablets are new medicine being tested to treat overweight and obesity. doctors in many countries can already prescribe semaglutide tablets at lower doses to treat type 2 diabetes. participants will get semaglutide or placebo tablets for 68 weeks and will need to take 1 tablet every morning in addition to taking the medicine, participants will have talks with study staff about: * healthy food choices * how to be more physically active * what participants can do to lose weight the study will last for about 1½ year.participants will have 14 clinic visits and 7 phone calls with the study doctor. blood samples will be taken at 10 visits. participants will have a test to check their heart done at 3 visits. women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. if participant is a woman and is able to become pregnant, participant will be checked for pregnancy via urine tests.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * body mass index (bmi): greater than or equal to 27.0 kg/m\^2 with the presence of at least one of the following weight-related complications (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or greater than or equal to 30.0 kg/m\^2 * history of at least one self-reported unsuccessful dietary effort to lose body weight exclusion criteria: * hba1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening * a self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
a phase 3 study to evaluate the efficacy of xw003 in adults with overweight or obesity

Conditions: Weight Management

Summary: the aim of the study is to evaluate the efficacy and safety of xw003 versus placebo in adults with overweight or obesity

in this phase 3 study, eligible participants will be randomized into three cohorts in a 3:1:3:1:3:1 ratio to receive once-weekly subcutaneous xw003 (low, medium, or high dosage) or volume-matching placebo for 48 weeks, including a dose-escalation period.

Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 years old, inclusive; 2. bmi between 24.0 to 28.0 kg/m2 with at least one comorbidity, including prediabetes, hypertension, hyperlipidemia, fatty liver , obstructive sleep apnea syndrome, etc.; or bmi ≥ 28 kg/m2 with or without comorbidities. 3. weight change of no more than 5% (based on self-report), with diet and exercise alone, within 3 months before screening. 4. willing and able to maintain stable diet and exercise during the study period. exclusion criteria: 1. obesity induced by endocrine diseases such as hypothyroidism, cushing syndrome, etc. 2. history of bariatric surgery (except liposuction \>1 year ago) or planned bariatric surgery during the study period. 3. within 3 months before screening, history of using the following drugs or treatments: 1. any approved or unapproved weight-loss drugs or chinese herbs or health products that affect body weight. 2. any hypoglycemic medication. 3. any medication that may cause significant weight gain, including systemic glucocorticoid treatment, tricyclic anti-depressants, anti-epileptic and antipsychotics. 4. any investigational drug, vaccine, or medical device.

Keywords: weight management overweight obesity glucagon-like peptide-1 (glp-1) ecnoglutide xw003
adjuvant radiotherapy for pt1b esophageal cancer after submucosal endoscopic resection

Conditions: Esophageal Cancer

Summary: endoscopic resection (er) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. however, lymph node metastasis rate in pt1b patients is relatively high. although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over esd alone. this study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after esd.

the incidence of early-stage esophageal cancer (ec) is increasing rapidly and even accounting for approximately 40% of esophageal squamous cell carcinoma. endoscopic resection (er) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. however, lymph node metastasis rate in pt1b patients is relatively high, and additional treatment is recommended after er. adjuvant chemoradiotherapy is a treatment option and has already been proven to be equivalent to radical surgery. however, limited studies, with relatively small sample size and nature of low-level evidence, consistently showed that additional adjuvant radiotherapy failed to improve survival. hence, adjuvant radiotherapy should not be applied without selection. t1b ec patients are a heterogeneous population, with reported regional metastasis or recurrence rates varying considerably from 0-53% in sm1 disease, 19-31% in sm2, and 36-61% in sm3. the risk factors of regional metastasis or recurrence were also reported, generally including lymphovascular invasion (lvi) and pt1b disease. in view of the aforementioned evidence, we hypothesized that selective adjuvant radiotherapy based on risk factors might significantly improve survival. the aim of this study was to evaluate the efficacy of adjuvant radiotherapy after esd for pt1b ec and further explore the potential population who could benefit.

Eligibility criteria:
inclusion criteria: (1) ecog score \< 2; (2) pathologically confirmed squamous or adenosquamous cell cancer; (3) clinical stage ctis-1bn0m0; (4) multiple primary t1 lesions were allowed; (5) no lymph nodes and distant metastases confirmed by chest ct, neck ct or neck ultrasound, and abdominal ct or abdominal ultrasound; (6) underwent esd between january 2010 and december 2019; (7) pt1b disease confirmed by endoscopically resected specimen; (8) underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after esd. exclusion criteria: (1) diagnosed with other locally-advanced or advanced malignancies within 3 years before esd; (2) underwent radical surgery after esd; (3) upfront radiotherapy, chemotherapy or chemoradiotherapy before esd; (4) lost to follow-up or insufficient clinical information.

Keywords: early-stage submucosal endoscopic resection adjuvant radiotherapy
phase 2 study of can008 in subjects with gbm

Conditions: Newly-diagnosed Glioblastoma

Summary: this is a multi-center, randomized, double-blind, placebo-controlled phase 2 study whose objectives are to evaluate the clinical efficacy and safety of can008 plus tmz during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.

this study plans to enroll approximately 117 subjects. subjects determined as having met inclusion criteria through screening will be randomized into treatment groups (can008 + rt + tmz, 78 subjects) and the control group (placebo + rt + tmz, 39 subjects) in a ratio of 2:1.

Eligibility criteria:
inclusion criteria: * age 18 to 70. * newly diagnosed glioblastoma. * tumor excision rate ≥80%. * karnofsky performance score ≥70. exclusion criteria: * medical history of brain radiation therapy or electric field treatment of tumor. * primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis. * any malignant tumor (excluding who grade i-ii low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ). * receiving high-dose hormone therapy.

Keywords: glioblastoma can008 apg101
arthroereisis versus lateral column lengthening in the treatment of planovalgus feet

Conditions: Flatfeet

Summary: there is no consensus on the surgical treatment of unremitting, painful flatfeet in children. subtalar arthroereisis has gained notoriety although there is a paucity of literature on its biomechanical effects. the goal of the investigators was to compare a group treated with subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening. the investigators hypothesis was that the results of arthroereisis would be equivalent to the more established method of calcaneal lengthening.

the purpose of this prospective, non-randomized study was to evaluate two different surgical treatments for symptomatic planovalgus feet: lateral column lengthening osteotomy and subtalar arthroereisis. the goal of the investigators was to compare the outcomes of these two surgeries and determine whether both treatments resulted in clinical improvement. this was accomplished through the use of pre- and post-operative kinematics, pedobarography, radiographic measurements, and validated outcome measures. the investigators were particularly interested in analyzing the kinematic changes to quantify the changes in the foot mobility and alignment during ambulation, as it has not been previously studied to our knowledge. the investigators hypothesis was that both procedures would show significant improvement and be equivalent in their results. a prospective trial was conducted. the investigators enrolled fifteen patients (mean age 12.8y, 24 feet) with painful, planovalgus feet refractory to conservative treatment. seven patients (13 feet) were enrolled in the arthroereisis group, and eight patients (11 feet) were enrolled in the calcaneal lengthening group. though not specifically excluded, none of the enrolled patients had an underlying neuromuscular diagnosis. kinematic motion analysis was performed on each patient prior to surgery and at one year of follow-up. pedobarometry studies, radiographs, and validated outcome questionnaires (oxford ankle-foot questionnaire for children) were also performed to evaluate the outcomes of both groups.

Eligibility criteria:
inclusion criteria: * planovalgus foot deformity * patient normally ambulates without use of assistive devices * patient is between the ages of 7 and 17 at the initial evaluation exclusion criteria: * hip flexion contractures greater than 15 deg. * knee flexion contractures greater than 10 deg. * ankle dorsiflexion less than 0 deg. (plantarflexion contracture) * taking medication which effects motor control * inability to follow instructions to perform study

Keywords: painful flatfeet planovagus feet subtalar arthroeresis lateral column lengthening kinematic motion analysis
evaluation of laparoscopic peritoneal lavage for perforated diverticulitis: a national registry - based study

Conditions: Diverticular Disease of Colon; Diverticulitis, Colonic; Peritonitis; Gastrointestinal Diseases; Digestive System Disease

Summary: the goal of this observational study is to study the emergency surgical treatment of diverticular disease in sweden outside clinical trials. the main questions it aims to answer are: * which is the preferred surgical method of acute diverticular disease in sweden? * which are the short and long-term outcomes of the different surgical methods? researchers will compare the different methods to see if there is a surgical operation that is superior for the treatment of acute diverticulitis.

a retrospective study of patients who were admitted to a swedish hospital between 1st july 2014 and 31st december 2020 with an icd-10 code for diverticular disease of the large intestine (k57.2- k57.9) will be included. patients who underwent procedures relevant to diverticulitis will be identified and therefore will be included. procedures will be grouped into two categories: laparoscopic peritoneal lavage (group i), and sigmoid resection with or without stoma (group ii). the cohort will be studied from 1st january 1997 until the index date aiming to assess comorbidities, previous abdominal surgeries, and admissions for diverticular disease. a charlson comorbidity index (cci) system adjusted for swedish icd-10 version will be used to calculate a composite score to reflect comorbidity.

Eligibility criteria:
inclusion criteria: * all patients aged 18 years or older who were admitted to a swedish hospital between 1st july 2014 and 31st december 2020 with an icd-10 code for diverticular disease of the large intestine (k57.2- k57.9). * emergency admissions. * patients who underwent procedures relevant to diverticulitis. exclusion criteria: * patients who were diagnosed with colorectal cancer before the index date. * patients with synchronous operations that are supposed to be irrelevant to acute diverticulitis.

Keywords: perforated diverticulitis purulent peritonitis laparoscopic peritoneal lavage
prevalence of attention deficit hyperactivity disorder and its comorbidities

Conditions: ADHD

Summary: estimate the prevalence of attention deficit hyperactivity disorder and comorbid psychiatric disorder among primary school students in new valley governorate.

adhd (attention deficit hyperactivity disorder) is a common neurodevelopmental disorder characterized by hyperactivity, impulsivity, and inattention. its prevalence ranges between 5.9 and 7.1% worldwide. etiology of adhd included combinations of genetic, neurological, and environmental factors. adhd is more often a complex disorder with a high rate of associated comorbid conditions. comorbid conditions are prevalent among people with adhd and increase its burden and complexity of management. children with adhd are at a higher risk than children without adhd for developing other psychiatric disorders. most children with adhd also have at least one comorbid condition, the presence of which contributes to poorer long-term outcomes. the pattern of comorbidities is influenced by age and sex; externalizing disorders are more common in younger ages and male participants, in contrast, internalizing disorders are more prevalent among older ages and female participants. comorbidity involving adhd and learning disorders is frequent, ranging from 25 to 40%. other disorders likely to co-occur with adhd are: bipolar disorders (11-75%), tic disorders (20%), obsessive compulsive disorders (6-15%). children with adhd may show several motor problems: longer and more variable reaction times, increased variability in speed and less accurate response reengagement, and impaired orienting responses, and increased number of responses with very long reaction times. neurological soft sign have been associated with inattention and behavior difficulties for decades. some researchers argue that these signs should be included in the diagnosis of adhd.

Eligibility criteria:
inclusion criteria: age: 6-17 years. sex: both sexes will be included in the study. exclusion criteria: age: less than 6 years or more than 17 years. patients with major neurological deficits, cerebral palsy. patient who refusing to participate in the study or their caregiver refusing to give informed consent. mentally retarded children.