Kornimate/medical-research-clean huggingface dataset:
fruquintinib in the cross-line treatment of refractory mcrc

Conditions: Fruquintinib; Metastatic Colorectal Cancer

Summary: this is a real-world study. patients with metastatic colorectal cancer who have progressed (pd) after third-line treatment with fruquintinib combined with pd-1 inhibitors will receive fruquintinib combined with tas-102 as fourth-line therapy. the objective of this study was to observe the efficacy and safety of cross-line（from third to fourth line）treatment with fruquinitinib.

this is a real-world study. patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-vegf, anti-egfr (ras and braf wild type) (treatment with anti-vegf-tki is not allowed), and had received fruquinitinib combined with pd-1 inhibitors for third-line treatment. after progression (pd) (confirmed by recist 1.1 ), fruquinitinib combined with tas-102 as fourth-line therapy was received. the primary endpoint was observation the overall survival (os) of fourth-line treatment of mcrc with fruquinitinib and tas-102. the study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.

Eligibility criteria:
inclusion criteria: - to be enrolled in this study, patients must meet all of the following criteria: 1. age ≥18 years, ≤75 years; 2. no gender limitation; 3. patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-vegf, anti-egfr (ras and braf wild type) (treatment with anti-vegf-tki is not allowed), and had received fruquinitinib combined with pd-1 inhibitors for third-line treatment. after progression (pd) (confirmed by recist 1.1 ), fruquinitinib combined with tas-102 as fourth-line therapy was received. 4. expected survival ≥12 weeks 5. must have at least one measurable lesion (recist1.1). 6. full organ and bone marrow function. exclusion criteria: - patients will not be admitted to the study if they meet any of the following criteria: 1. patients with contraindications to study drugs (fruquinitinib, pd-1 inhibitor, tas-102); 2. allergic to the investigational drug or any of its adjuncts; 3. there are other non-investigational drugs during third-line and fourth-line treatment; 4. pregnant or lactating female subjects; 5. patients with a large number of pleural effusion or ascites requiring drainage; 6. patients considered unsuitable for inclusion in this study by the investigators.
minimally invasive endoscopic treatment of zenker's diverticulum comparing ligasuretm vs sb-knife.

Conditions: Zenker Diverticulum; Minimally Invasive Surgical Procedures; Endoscopy

Summary: the main purpose of this trial is to evaluate two devices used in the treatment of zenker diverticulum using flexible endoscopy (ligasure and sb-knife). analyze the technical success, clinical success, relapses, complications, and the mean procedure time with each device prospectively in order to transfer objective and uniform results to routine clinical practice.

patients who meet the inclusion criteria will be randomized on the day of the procedure using a computer system that generates a table of random numbers, to perform endoscopic diverticulotomy using a ligasure device (ls 1500, covidien; medtronic, minneapolis, mn, usa) or with stag beetle (sb) knife standard (sumitomo bakelite co. tokyo, japan). prophylactic intravenous antibiotic therapy is administered prior to the procedure and will be performed under deep sedation with control by an endoscopist or anesthesiologist in the cases indicated. gastroscopy will be performed to identify zenker's diverticulum, and isolate the septum under endoscopic control using a diverticuloscope or flexible overtube (zd overtube, zdo 22/30 cook medical), after placing a guide (0.035 ", 450 cm jagwire, boston scientific, natick ma, usa) in the esophageal lumen. the overtube has two leaflets at one of its ends, a longer one that is placed in the esophageal lumen and the short leaflet is placed in the diverticulum. in those cases in which it is not possible to place the diverticuloscope, the septum will be isolated with the help of a cap on the end of the endoscope. in these cases, the device used will always be the sb-knife since it is not possible to use the ligasure and they will be excluded from the study analysis. the time of the procedure will be counted from when the overtube is placed until it is removed after diverticulotomy.

Eligibility criteria:
inclusion criteria: * patients with endoscopically confirmed zenker's diverticulum and presenting symptoms related to it. * those who complete the symptom and quality of life questionnaires. * they must sign informed consent. exclusion criteria: * previous treatment of zenker's diverticulum * those for whom zenker's diverticulum is ruled out at endoscopy. * chewing disorders and/or dysphagia secondary to neurological pathology and oesophageal motility disorders * those who do not want to participate in the study and/or who do not sign the informed consent.
the medacta international gmk sphere cementless post-marketing surveillance study

Conditions: Arthritis; Traumatic Arthritis; Rheumatoid Arthritis; Poly-arthritis; Avascular Necrosis

Summary: this is a post-marketing surveillance study of gmk sphere cementless knee prosthesis.


Eligibility criteria:
inclusion criteria: * a disabled or severely disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis, poly-arthritis or avascular necrosis * patients between the age of 18 and 80 at the time of consent * listed for total knee replacement surgery. * patients who are willing and able to give informed written consent exclusion criteria: * progressive local or systemic infection * muscular loss, neuromuscular disease or vascular deficiency of the affected limb, making the operation unjustifiable * severe instability secondary to advance destruction of condralar structures or loss of integrity of the medial or lateral ligament * those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems * patient whose bmi exceeds 40 * any case not described in the inclusion criteria
safety and effectiveness of giving cpi-1189 to hiv-infected patients with aids dementia

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give cpi-1189 to patients with aids dementia. advanced hiv infection can cause aids dementia (brain damage due to hiv leading to loss of memory and muscle control). cpi-1189 may be able to postpone aids dementia or slow it down.

late-stage hiv infection can cause aids dementia (brain damage due to hiv leading to loss of memory and muscle control). cpi-1189 may be able to postpone aids dementia or slow it down. patients are randomized to receive either placebo or one of two oral doses of cpi-1189 daily. patients are assessed for safety and tolerability during weeks 2, 6, and 10. at week 10, efficacy assessments are also made. for those who volunteer, a sample of cerebrospinal fluid is obtained at baseline and at week 10. blood samples for cpi-1189 pharmacokinetic trough measurements are taken at weeks 2 and 10. the open-label phase starts at week 11. at weeks 13 and 16, a safety evaluation is performed. at the end of the open-label phase, week 22, a final set of safety and efficacy assessments and a blood sample for cpi-1189 pharmacokinetic trough measurement are obtained.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * are at least 18 years old. * have symptoms of aids dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control. * have been on stable anti-hiv drug therapy for the past 6 weeks (if you are taking anti-hiv drugs). exclusion criteria you will not be eligible for this study if you: * have certain serious medical conditions, such as a mental disorder or an opportunistic (aids-related) infection.

Keywords: aids dementia complex anti-hiv agents
a study of gb491 in combination with letrozole in patients with hr positive and her2 negative advanced breast cancer

Conditions: Breast Cancer

Summary: the main purpose of this study is to evaluate the efficacy and safety of gb491 combined with letrozole versus placebo combined with letrozole in the treatment of hr+/her2- locally advanced or metastatic breast cancer without prior systemic antitumor therapy


Eligibility criteria:
inclusion criteria: * 1. age: 18-75 years old; * have a pathologically-confirmed diagnosis of hormone receptor-positive (hr+), human epidermal growth factor receptor 2-negative (her2-) breast cancer; * no previous systematic antitumor therapy for locally advanced or metastatic breast cancer; * eastern cooperative oncology group \[ecog\] 0-1; * have adequate organ and marrow function; * agree to sign the informed consent; exclusion criteria: * systematic treatment with any other cdk4/6 inhibitor； * subjects with known allergy to gb491 or any component of letrozole； * confirmed diagnosis of her2 positive disease; * known uncontrolled, or symptomatic central nervous system metastases; * had major surgery (or is expected to require major surgery during the study period), chemotherapy, radiation, any investigational drug, or other antitumor therapy within 4 weeks prior to randomization; * have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer; * clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, congestive heart failure, or ventricular arrhythmia which need medical intervention； * known history of hiv infection or hiv seropositivity (including hiv antibody positive at the time of screening)

Keywords: hr+/her2- locally advanced or metastatic breast cancer gb491
assessment of the treatment of severely burned with anabolic agents on clinical outcomes, recovery and rehabilitation

Conditions: Burns

Summary: the purpose of the program is to study and characterize the outcome of burn injury with particular attention to improving the rehabilitation of burn survivors, including children. various agents are assessed for effectiveness on long term burn outcome, such as growth hormone, oxandrolone, propranolol,ketoconazole, inhospital exercise and home exercise.

the university of texas medical branch(utmb) project improves outcomes for severely burned children by instituting and evaluating two modifications to traditional rehabilitation: (1) an intensive rehabilitation program including active resistance exercise; (2) long term administration of anabolic agents. effectiveness is assessed by comparison with functional outcomes achieved in traditional outpatient rehabilitation programs. results indicate improvement in strength, endurance and bone density with these modifications. the project also maintains a longitudinal database that includes measures of cardiopulmonary function, growth and maturation, bone density, range of motion, and psychosocial adjustment.

Eligibility criteria:
inclusion criteria: * burn 30% total body surface area (tbsa) or greater * ages 0-80 yrs * negative pregnancy test * informed consent exclusion criteria: * untreated malignancy, known history of aids, aids related complex, hiv * recent history of myocardial infarction (6 wks) * tuberculosis, arthritis, cirrhosis, hyperlipidemia, bone or endocrine diseases, autoimmune diseases * chronic glucocorticoid or non steroidal anti inflammatory drug therapy * diabetes mellitus prior to burn injury * renal insufficiency (defined by creatinine \>3.0 mg/dl) * hepatic disease (bilirubin \> 3.0 mg/dl)

Keywords: anabolic agents exercise
binge drinking and addiction : case-control study in hospital

Conditions: Alcohol Dependence

Summary: case control study : objective: frequent binge drinking during 18-25 years is a risk factor of alcohol addiction in adulthood (25-40 years) hypothesis: 25% of frequent binge drinking, or = 2, power 80%, alpha risk : 5% 126 cases aged 25 to 40 years: alcohol addict patients recruited in addiction unit in rouen university hospital 126 controls aged 25 to 40 years: non alcohol addict recruited by the clinical investigation center in rouen university hospital an anonymous self-questionnaire was completed binge drinking during 18-25 years was retrospectively evaluated confusion biais was also recorded


Eligibility criteria:
inclusion criteria * 25 to 40 years: * alcohol addiction for the cases exclusion criteria * age \ 40 * alcohol addiction for the controls

Keywords: binge drinking
magnetically controlled capsule endoscope system in stomach examination of moderately and severely obese patients

Conditions: Obesity

Summary: this study is a prospective, multicenter clinical trial. the study is planned to be conducted at a qualified clinical trial center, and 30 subjects are planned to be enrolled to evaluate the feasibility and safety of magnetically controlled capsule endoscopy (mce) system in the examination of gastric disorders in patients with moderate to severe obesity (bmi ≥ 35 kg/m2).

metabolic surgery, as one of the most important treatments for obesity, has been widely used worldwide. esophagogastroduodenoscopy (egd) is mostly used in the perioperative preoperative application of metabolic surgery to improve or exclude preoperative diagnosis, including gastrointestinal tumors, various types of upper gi mucosal lesions, esophagitis, esophageal hiatal hernia, gastrointestinal interstitial tumors, etc. however, egd is an invasive examination and can cause discomfort without anesthesia, resulting in low patient compliance. in 2013, ankon took the lead in developing the world's first capsule endoscope system that utilizes precise multi-dimensional rotational movement of a robotic arm and adaptive matching to achieve precise magnetic control, which is convenient for observing specific lesions from an appropriate angle and has been shown to have high diagnostic accuracy for gastric diseases (highly consistent with egd, with sensitivity and specificity of 90.4% and 95.7%, respectively, and accuracy of 93.4%). it has been clinically proven that mce is safe and effective in the upper gastrointestinal tract, but there is a lack of clinical systematic studies on its application to moderately and severely obese people.in summary, this exploratory study is designed to preliminarily verify the clinical feasibility and safety of mce for upper gastrointestinal examination in moderately obese people (bmi ≥ 35 kg/m2).

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of obesity: bmi ≥ 35kg/m2; 2. be scheduled to undergo gastric examination; 3. be able to provide informed consent. exclusion criteria: 1. with swallowing obstruction or disorders; 2. with known or suspected gastrointestinal obstruction, stenosis and fistula; 3. have no conditions for surgery or refuse to undergo any abdominal surgery; 4. be allergic to or have other known contraindication or intolerance to the drug used in the study; 5. with pacemakers or other electronic devices such as electronic cochlear implants, implanted magnetic metal drug infusion pumps, neurostimulators, and magnetic metal foreign bodies; 6. women during pregnancy; 7. currently enrolled in another clinical trial of a drug or device; 8. other conditions determined by the investigator to be inappropriate for enrollment. -

Keywords: obesity capsule endoscopy
virtual reality as a dietary education adjunct for pediatric patients with obesity

Conditions: Diabetes

Summary: childhood obesity is a national crisis, effecting up to 1 in 5 of children in the us. in the lucile packard children's hospital pediatric weight management clinic, the investigators educate parents and caregivers about the importance of dietary modification. in addition to physician guidance, the investigators partner with registered dieticians to counsel families during an hour-long interview. however, traditional methods of education are limited by long-term recall. a typical person only recalls 2- 3% of didactic content after a period of 30 days. in order to improve recall and increase involvement of our pediatric patients in their own dietary modifications, the investigators propose a pragmatic, randomized pilot study investigating the effectiveness of virtual reality (vr) in changing dietary choices and improving recall.


Eligibility criteria:
inclusion criteria: * ages 6-18 years of age * able to consent or have parental consent * diagnosis of obesity grade 1, 2 and 3 at lpch/shc facilities exclusion criteria: * people who do not consent * significant cognitive impairment * history of severe motion sickness * visual problems

Keywords: virtual reality
physical functioning throughout lung cancer treatment

Conditions: Lung Cancer; Exercise Capacity; Physical Activity; Quality of Life

Summary: this trial investigates the impact of lung cancer treatment on physical status, symptoms and quality of life. furthermore this trial investigates possible underlying causes and consequences of deconditioning.

preliminary evidence suggests that patients with lung cancer experience a decrease of exercise tolerance and muscle strength during the course of their treatment. the underlying mechanisms and impact of this change has not yet been investigated. in light of this, our trial will prospectively follow a convenience sample of 150 patients with lung cancer who are undergoing treatment. patients will be assessed before, during and at the end of the treatment (surgery and/or chemotherapy and/or radiotherapy and/or immunotherapy). the aims of the study are to 1. investigate physical status, before start of treatment in lung cancer patients in comparison with healthy controls (primary outcome). 2. investigate changes in physical status over the course of treatment in lung cancer patients (primary outcome). 3. investigate the relationship between changes in physical status with physical activity and symptoms during treatment for lung cancer (secondary outcome). 4. investigate the relationship between physical status after treatment for lung cancer and comorbidities, hospitalizations and cancer-related and all-cause mortality (exploratory outcome).

Eligibility criteria:
inclusion criteria: * undergoing treatment (surgery, chemotherapy, immunotherapy, radiotherapy, and combination of the previous ones) * who performance status of maximal 2 exclusion criteria: * presence of other neoplasms in the last 2 years * bone metastasis * progressive neuromuscular and neurological diseases * unstable cardiac disease * pulmonary hypertension * interstitial lung disease * orthopedic conditions that significantly impair functional status * mental or psychiatric disorders that impair the ability to comply with study procedures. * a history of cerebrovascular accident with remaining functional consequences * a history of lung cancer * difficulties in understanding and speaking dutch
bradycardia risk stratification with loop recorder after syncope

Conditions: Implantable Loop Recorder

Summary: syncope is a common symptom that may be related to a conductive disorder. if no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder. in somes cases, implantable loop recorder records cardiac conductive disorders. in this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. it would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system


Eligibility criteria:
inclusion criteria: * all patients who have benefited from an implantable loop recorder in the nancy's teaching hospital exclusion criteria: * no exclusion criteria

Keywords: syncope arrhythmia
arformoterol/budesonide for covid-19

Conditions: Coronavirus Infection

Summary: this is a multi-center, randomized, double-blind, placebo-controlled, parallel, phase 2 study to evaluate the efficacy and safety of ui030 in covid-19 patients

patients with moderate and severe covid-19 were randomly assigned (1:1) to receive either ui030 (budesonide/arformoterol dry powder inhaler, 2 inhalations b.i.d) or placebo for 2 weeks.

Eligibility criteria:
inclusion criteria: * adult, aged 19 years or above * new onset of symptoms suggestive of covid-19 (fever, cough, soar throat, etc) or diagnosed with covid-19 within 7 days of participant being seen at visit 1 * in the investigator's opinion, is able and willing to comply with all trial requirements exclusion criteria: * a condition requiring invasive oxygen support; * history of hypersensitivity to budesonide and arformoterol * pregnancy, breast-feeding * participation in other clinical studies within 4 weeks prior to enrollment in this study. * refusal of the patient to continue participating in the study/withdrawal of informed consent by the patient.
medical expulsive therapy for ureter stone using naftopidil

Conditions: Ureter Stones

Summary: this study is to investigate whether naftopidil is effective or not for the spontaneous passage of ureteral stones with sizes of 3 to 10 mm.

1. enrollment 1. patients with ureteral stones of sizes from 3 to 10 mm 2. patients aged more than 18 years 2. randomization 1. naftopidil 75 mg qd for 14 days or placebo 2. standard treatment with pain-killers were also applied.(aceclofenac) 3. follow-up for 28 days 1. we confirm the stone free status by ct or x-ray films at 14th and 28th days. 2. rates of active treatment will be also evaluated.

Eligibility criteria:
inclusion criteria: * \>= 20 years * single 3 to 10 mm ureter stone (longest diameter) exclusion criteria: * presence of multiple ureter stones * renal insufficiency (serum cr \> 1.4 mg/dl) * febrile urinary tract infections(fever \> 38°c, evidence of urinary infection) * pregnancy or breast feeding * solitary kidney * hypersensitivity to naftopidil * current use of any alpha-blocker, calcium-channel blocker, corticosteroid (within 4 weeks) * moderate or severe cardiovascular or cerebrovascular disease * hepatic dysfunction (\>2 x normal upper limit) * significant active medical illness which in the opinion of the investigator would preclude protocol treatment * genetic disorder such as galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
therapeutic options for treatment of burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. the purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, b-vitamin injections and informative treatment only.


Eligibility criteria:
inclusion criteria: * newly diagnosed with burning mouth syndrome and excluded local and systemic causes exclusion criteria: * patients who have received treatment for burning mouth earlier * patients with local or systemic causes of burning mouth

Keywords: burning mouth syndrome treatment