Kornimate/medical-research-clean huggingface dataset:
long-term outcomes of open versus laparoscopic distal gastrectomy for t4a gastric cancer

Conditions: Gastric Cancer

Summary: there are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in vietnam, most of cases in t4a. the purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical t4a stage.

gastric cancer is one of the most common cancers in vietnam . despite recent advances in multimodality treatment and targeted therapy, surgery remains the first option of treament for this disease. for resectable gastric cancer, complete removal of macroscopic and microscopic lesions and/or combined resections and also regional or extended lymphadenectomy should represent worldwide now. laparoscopic gastrectomy for locally advanced gastric cancer agc have commonly used for treatment of agc, especially in japan, korea and china. however, the real role of laparoscop for treament of (agc) is still controversial in term of technical feasibility, safety and oncologic aspect for t4a stage. paragastric inflammatory strands may occur in t4a tumor so that laparoscopic technique is difficult to radically perform. peritoneal seeding of malignant cells, intra- and postoperative complications, trocarts metastasis may risk during procedures. despite, some studies have demonstrated the safety and the short-term benefits of lg for t4a gastric cancer, the number of these studies and sample sizes have been still inadequate to give good evidence for applying it. and long-term oncologic outcomes there are more than 75% of patients with gastric cancer who are diagnosed in advanced stage in vietnam, most of cases in t4a. the purpose of this study was to compare short- and long- term outcomes of open and laparoscopic distal gastrectomy for gastric adenocarcinoma in surgical t4a stage.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed adenocarcinoma of the stomach, surgical staging of st4an0-3m0 according to the 7th edition of the american joint committee on cancer/union internationale contre le cancer (ajcc/uicc) staging system exclusion criteria: * intraoperatively detected bulky lymph nodes * inadequate lymphadenectomy (d0, d1, d1+) * macroscopic residual tumor (r2) * an american society of anaesthesiology (asa) score of \> iv * concurrent cancer or history of previous other cancers * previous gastrectomy * neoadjuvant chemotherapy * complications such as bleeding or perforation required emergency gastrectomy.
antidepressant effect of theta-burst rtms

Conditions: Major Depression

Summary: the aim of this study is to evaluate the safety and efficacy of theta-burst rtms in patients with major depression. patients will be randomized to receive ether left-sided intermittent theta-burst rtms or rigt-sided continuous theta-burst rtms or sham theta-burst rtms over two weeks period with an option for an additional two weeks period, depending on treatment response. clinical assessments will be performed weekly by the hamilton depression rating scale. in addition, standard neurophysiological assessment of cortical excitability will be done.


Eligibility criteria:
inclusion criteria: * major depressive episode (dsm iv criteria). * informed consent. * age: 18-70. exclusion criteria: * suicidality * psychosis * pacemaker * cardiac arrythmia * seizure disorder * implantable metal devices * pns and cns disorders * any other contraindications as specified in safety guidelines for rtms (wassermenn, 1998).

Keywords: major depression theta-burst rtms cortical excitability hamilton depression rating scale
a close examination of patient experiences in cluster headache clinical research

Conditions: Cluster Headache

Summary: historically, participation in clinical studies is highly skewed towards particular demographic groups of people. this research will invite several participants to gather a wide range of information on clinical trial experiences for cluster headache patients. the aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of cluster headache. the data collected from this study will help improve future outcomes for all cluster headache patients as well as those in under-represented demographic groups.


Eligibility criteria:
inclusion criteria: * patient has been diagnosed with cluster headache * patient has access to a home internet connection in order to provide regular updates through the course of the study * participant must be 18 years of age or older exclusion criteria: * patient has an ecog score of 4 or higher * patient is not able to provide consistent digital updates as per study requirements * patient does not complete or agree to terms outlined in the informed consent form

Keywords: cluster headache
biological markers for post-traumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: the current study aims to evaluate the sensitivity and specificity of a combination of various objective biomarkers for the diagnosis of ptsd.

ptsd affects a major fraction of military combatants and is also very common in the general population. like other psychiatric conditions, the diagnosis of ptsd is currently based on an interview and questionnaires. however, the validity of these tools is limited since it depends on the evaluator's skills, and on patient compliance and mental status; and may be prone to exaggeration or minimization of symptoms. this prompts an urgent need for evaluation that will combine biomarkers for objective diagnosis, and follow up of individuals with ptsd. knowledge has grown in recent years regarding the biologic pathophysiological cascade responsible for the development of a "non-healing wound in the brain" that characterizes ptsd. shortly after the traumatic experience, fundamental changes in autonomic nervous and endocrine activity are evident, together with changes in brain function; these can become chronic in those with long-standing unremitting ptsd. several studies indicate good correlations of the diagnosis and severity of ptsd, with objective biological measures such as heart rate variability (hrv), brain connectivity and endocrine activity. however, the currently available data on these biological variables are still not sufficient to be used for diagnosis of ptsd. the aim of the current study is to characterize the biological fingerprint of ptsd, by using a combination of biological measures, for an objective diagnosis.

Eligibility criteria:
inclusion criteria: 1. the willingness and ability to read, understand and sign an informed consent form. 2. age 20-60 years. 3. a history of more than 2 years of combat service, and of at least one potentially life-threatening combat experience. 4. one year or more after the last combat experience. exclusion criteria: 1. inability to attend scheduled clinic visits or comply with the study protocol 2. a history of traumatic brain injury or any other known brain pathology. 3. substance use, except for prescribed cannabis, if it can be withheld for at least 24 hours prior to the study evaluation. 4. a current psychiatric disorder other than ptsd. 5. the inability to perform an awake brain mri.
cortical bone trajectory with patient guide

Conditions: Degenerative Disc Disease

Summary: the use of patient specific guides with proper preoperative planning, following a cortical bone trajectory technique, should guarantee a successful surgery and benefit of less invasive technique. this study intends to measure the safety and efficacity of myspine mc patient-specific guide system, when used according to its general indication of use and following the surgical technique suggested by the manufacturer

adult patients affected by degenerative disc disease, meeting all inclusion/exclusion criteria, will be proposed to take part to the current post-marketing surveillance study during their pre-operative visit. they will be provided with an information letter and, in case of acceptance to participate to the study, asked to sign a consent form. after enrolment, each patient will be monitored for 13 months. data concerning demography, preoperative clinical conditions, surgical details including device implanted and complications occurred, postoperative clinical and/or radiological assessments (as per standard routine at 5 weeks, 3, 7 and 13 months) will be prospectively collected. the level of bone fusion will be evaluated with a postoperative ct scan at 7 ±2 months follow-up

Eligibility criteria:
inclusion criteria: 1. those affected by degenerative disc disease needing a surgical treatment one/two levels with posterior approach to screw fixation 2. those who need a surgical procedure of lumbar spine stabilization according to medacta device instruction for use from level l2 to level s1 3. those who signed consent form to participate to the study 4. normal healthy patients or with mild systematic disease identified as patients with asa score 1 or 2 5. patients with bmi ≤ 35 kg/m2 6. non responsive or unsufficient resposive to non -invasive treatment such as analgesics exclusion criteria: 1. patients affected by lytic lystesis and degenerative lystesis with grade≥2 will be excluded 2. patients \<18 years 3. patient who is pregnant or intends to become pregnant during the study 4. known substance or alcohol abuse
amplification of zinc finger protein 217 gene in multiple myeloma

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (pcs) mainly in the bone marrow (bm) .the zinc-finger protein 217 (znf217) is an oncogenic protein that plays deleterious functions in various human cancers. the znf217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors .

multiple myeloma (mm) is blood disorder characterized by the detection of a monoclonal paraprotein in serum or urine, which is often associated with the presence of clonal plasma cells (pcs) mainly in the bone marrow (bm) . mm is the second most common hematologic malignancy and is expected to cause ∼13 000 new cases and 30 000 deaths in 2018. myeloma is a genetically complex disorder characterized by multiple genetic changes, affecting different pathways, that have the ability to deregulate plasma cell biology leading to a broadly similar phenotypic manifestation of disease. from a genetic perspective, myeloma can be divided into those with and without a hyperdiploid karyotype .the zinc-finger protein 217 (znf217) is an oncogenic protein that plays deleterious functions in various human cancers. the znf217 gene is located at the 20q13 chromosomal region, which is frequently amplified in human tumors . this region also contains several oncogenes thought to confer selective advantages to cancer cells. increased copy numbers of znf217 have been reported in various tumors and linked to poor outcome in some studies . znf217 can attenuate apoptotic signals resulting from telomere dysfunction and may promote neoplastic transformation and later stages of malignancy. znf217 was shown to be a prognostic biomarker and therapeutic target during breast cancer progression. in our best knowledge, no studies were done to detect znf217 in multiple myeloma.

Eligibility criteria:
inclusion criteria: * newly diagnosed multiple myeloma patients, who fulfill the who criteria of myeloma diagnosis. exclusion criteria: * patients with any other type of malignant or benign tumors should be excluded from our study.

Keywords: zinc finger 217 protein gene . multiple myeloma
second-line treatment with cadonilimab and lenvatinib for unresectable hcc

Conditions: Hepatocellular Carcinoma

Summary: this is an open-label, multi-center, single-arm, phase ii study to evaluate the efficacy and safety of lenvatinib in combination with cadonilimab as second-line therapy in subjects with advanced hepatocellular carcinoma (hcc) who failed first-line standard therapy of immunotheray and antiangiogenic therapy.


Eligibility criteria:
inclusion criteria: * sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol * age 18-75 years old, male of female * ecog ps 0-1 * histologically/cytologically or clinically (according to chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of hcc * not suitable for radical surgery and/or local treatment, bclc stage c or stage b who failed local treatment * patients who progressed on first-line standard system therapy (atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or camrelizumab and apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance) * child pugh a-b7 * expected survival time≥12 weeks * at least one measurable lesion (recist 1.1) * enough organ and bone marrow function exclusion criteria: * fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma. * other anti-tumor therapies have been received after first-line systemic anti-tumor therapy. * have history of hepatic encephalopathy, or a history of liver transplantation. * there are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion. * people with acute or chronic active hepatitis b or hepatitis c, hepatitis b virus (hbv) dna \> 2000iu/ml or 10\^4 copies /ml; hepatitis c virus (hcv) rna \> 10\^3 copies /ml; hepatitis b surface antigen (hbsag) and anti-hcv antibodies were both positive. * central nervous system metastasis. * previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months. * autoimmune immune disease. * hiv infection. * pregnant women. * the presence of any serious or uncontrolled systemic disease. * other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. the investigator considers that there are other potential risks that are not suitable for participation in the study.

Keywords: cadonilimab (anti pd-1/ctla-4 bispecific antibody)
abbv-085, an antibody drug conjugate, in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors; Undifferentiated Pleomorphic Sarcoma; Squamous Cell Carcinoma of the Head and Neck; Carcinoma of the Breast

Summary: this is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of abbv-085 and determine the recommended phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options. 2. eastern cooperative oncology group (ecog) performance status of 0 to 2. 3. participants must have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1 or disease evaluable by assessment of tumor antigens: - participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens \>=2 x upper limit of normal (uln). 4. all participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (ffpe) tumor tissue and on study biopsies. 5. participant has adequate bone marrow, renal, hepatic and cardiac function. 6. women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. exclusion criteria: 1. participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of abbv-085. 2. uncontrolled metastases to the central nervous system (cns). participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of abbv-085. 3. unresolved adverse events \>= grade 2 from prior anticancer therapy, except for alopecia. 4. participant has ongoing hemolysis. 5. major surgery within \<=28 days prior to the first dose of abbv-085. 6. clinically significant uncontrolled condition(s). 7. participant has history of major immunologic reaction to any auristatin-based and /or immunoglobulin g (igg) containing agent.

Keywords: cancer advanced solid tumors neoplasm undifferentiated pleomorphic sarcoma squamous cell carcinoma of the head and neck carcinoma of the breast antibody drug conjugate
study of ve800 and nivolumab in patients with selected types of advanced or metastatic cancer

Conditions: Metastatic Cancer; Melanoma; Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Colorectal Cancer

Summary: this study evaluated the safety and efficacy of ve800 in combination with nivolumab in patients with selected types of advanced or metastatic cancer

consortium-io was the first-in-human multicenter, open-label study; the main objectives were to evaluate: * safety and tolerability of ve800 in combination with nivolumab * efficacy as measured by objective response rate the study planned to enroll approximately 111 patients with melanoma, gastric/gastroesophageal junction (gej) adenocarcinoma, or microsatellite-stable (mss) colorectal cancer (crc). nivolumab is already approved by the u.s. food and drug administration (fda), however, it is not approved for the study cancer indications. ve800 was the investigational product, which was designed to enhance the immune response to the tumor.

Eligibility criteria:
partial inclusion criteria: * patients with advanced or metastatic cancer who had received no more than 3 lines of prior systemic therapy for advanced/metastatic disease. * histologically diagnosed advanced (unresectable) or metastatic cancer with at least one measurable lesion as per recist 1.1 * tumor lesions amenable for biopsy, if deemed safe by the investigator * toxicity from prior cancer therapy should have resolved to common terminology criteria for adverse events (ctcae) grade ≤ 1 (excluding alopecia and neuropathy, where up to grade 2 residual was allowed) partial exclusion criteria: * prior treatment with immune checkpoint inhibitor (icpi) (note: this criterion did not apply to patients with melanoma) * receipt of any conventional or investigational systemic anti-cancer therapy within 21 days prior to the first dose of vancomycin * concurrent chemotherapy, immunotherapy, biologic, or hormonal anti-cancer therapy. agents such as bisphosphonates or denosumab were acceptable as prophylaxis for bone metastasis. * patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment * patients with an active, known or suspected autoimmune disease. patients with type i diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment were permitted to enroll. * patients with known active hepatitis (e.g., hepatitis b or c) note: patients with previously treated hepatitis b or c were permitted to enroll if there was evidence of documented resolution of infection. * received a fecal transplant, spore or other preparation of fecal material, isolated bacterial products, genetically modified bacteria, or ve800

Keywords: metastatic cancer ve800 nivolumab opdivo melanoma gastric cancer gastroesophageal junction adenocarcinoma gej adenocarcinoma colorectal cancer crc-mss vedanta bms
study assessing safety and tolerability of azd8931 alone or in combination with paclitaxel in japanese patients.

Conditions: Neoplasms; Metastatic Cancer; Breast Cancer

Summary: the main purpose of this study is to determine if azd8931 can be safely administered in japanese patients alone and in combination with weekly paclitaxel. the study will be conducted in two parts: a monotherapy and a combination part, where safe doses of study treatment will be determined.


Eligibility criteria:
inclusion criteria: * cancer that is refractory to standard therapies, or for which no standard therapies exist (monotherapy part) * patients suitable for paclitaxel chemotherapy, who are not candidates for hormonal and anthracycline therapy (combination part) * life expectancy more than 12 weeks exclusion criteria: * inadequate kidney, liver, heart, gastric, lung or eye function * brain metastases * hypersensitive to paclitaxel (combination part)

Keywords: cancer tumour metastatic breast cancer
pain during chest tube withdrawal: evaluation using pan monitor

Conditions: Chest Pain

Summary: pain evaluation remains a clinical problem. pain monitor allows pain evaluation using the measurement of skin conductance. withdrawal of chest tube can be painful and the purpose of the study was to compare auto-evaluation of pain (visual analogic scale) and the index measured by the pain monitor.


Eligibility criteria:
inclusion criteria: * patients undergoing removal of a chest tube after lung surgery, * patients able to indicate the pain score. exclusion criteria: * pregnancy, lactation , * insulin-dependent diabetes with dysautonomia, * central or peripheral neurological disease, agitation, * inability to understand the protocol, * inability to use the pain monitor: skin abnormalities at the site of measurement, pacemaker or implantable defibrillator, condition affecting the sympathetic nervous system, tremor of the extremities, * contra-indication to oral morphine , * respiratory failure, severe hepatic insufficiency, intracranial hypertension, epilepsy associations * recent administration of neostigmine or of atropine.
alternatives to hand therapy for hand surgery patients

Conditions: Carpal Tunnel Syndrome; Trigger Finger; Ganglion Cysts; Distal Radius Fracture; Finger Fracture; De Quervain Syndrome

Summary: patients will be asked to use a mobile phone app to conduct their hand therapy after having hand surgery.

patients who are undergoing the included procedures will be informed of the study \& consented. they will be given information on how to download the app \& input their surgery date. the app will guide the patient through various hand therapy exercises and ask them to record their quickdash, psfs and vas pain weekly.

Eligibility criteria:
inclusion criteria: * patients undergoing the following procedures: carpal tunnel release, trigger finger release, distal radius fracture fixation, de quervains release, cyst excision, finger fracture fixation * smart phone that is compatible with the app exclusion criteria: -
study evaluating etanercept plus methotrexate in early rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis; Arthritis, Rheumatoid; Rheumatoid Arthritis

Summary: study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of early rheumatoid arthritis. * methotrexate (mtx) naive. * active early rheumatoid arthritis at the time of enrollment. exclusion criteria: * previous or current treatment with etanercept, other tumor necrosis factor-alpha (tnf) inhibitors, or other biologic agents. * concurrent treatment with any disease-modifying anti-rheumatoid drugs (dmard), within 4 weeks before baseline. * concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (nsaid) at baseline.